The Efficacy of Treating Adhesive Capsulitis with Therapeutic

Ultrasound

Research Proposal Project

PES 670: Research Methods for Health, Physical Education, Recreation and Sports
Central Michigan University Doctoral Program in Physical Therapy

By: Alexander Gentile SPT, BS

08/12/16

TABLE OF CONTENTS

CHAPTER

I. INTRODUCTION
Purpose of the Study..................................................................................... 2
Assumptions................................................................................................. 2
Hypothesis.................................................................................................... 2
 Delimitations................................................................................................ 2
Limitations.................................................................................................... 2
Definition of Terms...................................................................................... 2

II. REVIEW OF LITERATURE

Negligence.................................................................................................... 3
Assumption of Risks.................................................................................... 4
Age of Majority............................................................................................ 6
Ways to Defeat a Release............................................................................. 7

III. M ETHODOLOGY
Problem Statement....................................................................................... 14
Sample ......................................................................................................... 14
Instrument..................................................................................................... 15
Data Collection............................................................................................. 15
Statistical Design.......................................................................................... 17

REFERENCES.......................................................................................................... 51

Chapter 1

Introduction

The purpose of this study is to take a closer look at if therapeutic ultrasound is an

effective and efficient treatment intervention for patients with adhesive capsulitis. Physicians

and physical therapists across the nation employ a number of different interventions trying to

combat the debilitating medical condition known as adhesive capsulitis. Finding the most

2
efficient treatment to help treat patients with adhesive capsulitis is a major concern for not just

health professionals. It is a major concern for the patients employers, family members and the

patients themselves as it leads them towards long term disability.

Finding this right combination of medical interventions is no simple task for physicians

and physical therapists because the natural history of the disease is not known. Adhesive

capsulitis is an idiopathic medical condition that physicians have spent years researching the

mechanism that causes the affliction. This leads to a lot of variation in the treatment of adhesive

capsulitis as medical professionals bring their own biases to the table. There have been many

different experiments performed over the years with many different types of interventions

studied to no avail. There have been many different interventions that have been found help to

treat adhesive capsulitis. Though no one intervention stands out among the rest as truly being a

cure for this extremely painful condition.

Many of these treatments have been used in conjunction with each other to help treat

patients with adhesive capsulitis. When combining these interventions together significant

results have been found for exacerbating the healing process of this medical condition. Though

ultrasound is not necessarily included among these because all physical therapy interventions are

grouped together. The research agrees that physical therapy as a whole is affective but never

states what interventions are included in this broad grouping. Physical therapists specialize in

many different expertise and this leads to a wide range of possible interventions that can be used

to treat adhesive capsulitis.

One of the more common interventions in the realm of physical therapy is the use of

ultrasound for therapeutic uses. It has been used as a physical therapy intervention for over 60

years to treat patients with pain, musculoskeletal injuries and soft tissues lesions. Though the use

2
of therapeutic ultrasound is wide spread throughout the physical therapy world the efficacy of it

remains questionable.

This creates an ethical problem for physical therapists in treating adhesive capsulitis. If

they are using an intervention that has no significant effect in treating adhesive capsulitis then

they are wasting valuable time and unethically charging for unnecessary services. This brings

personal biases back into play since there are not enough studies on the use of therapeutic

ultrasound in treating adhesive capsulitis. Some studies exist and show positive results but they

are all flawed in their own was and no repeat studies validating these studies exist.

The hopes of this study is to validate that therapeutic ultrasound is an effaceable

treatment intervention for adhesive capsulitis. This will allow a more standardized approach to

treating adhesive capsulitis and then the focus can be turned to the validation or invalidation of

other treatment interventions for adhesive capsulitis.

Purpose statement

The purpose of this study is to determine the efficacy of therapeutic ultrasound treatments

on patients with adhesive capsulitis of the shoulder. This study is a randomized controlled trial

study that will include subjects between the ages of 40 and 70 years old. These subjects will all

have at least six months of dealing with the symptoms of primary adhesive capsulitis.

Assumptions

The researcher assumes that all journals, online articles, school textbooks and lectures

used to gather information on the subject are factual and display up-to-date information at the

time of publishing. The researcher assumes that the motives of the material sources researched

in this study are of a genuine interest to help advance the treatment of adhesive capsulitis.

3
 Hypothesis

For developing treatment plans to treat adhesive capsulitis physicians and physical

therapists have to find the right combination of interventions to speed up the healing process.

The research will show that physical therapists that include therapeutic ultrasound as an

intervention in their plan of care (POC) will have significant effects on shortening adhesive

capsulitis time of effect.

Delimitations

This study is delimited to south eastern Michigan residents who have had at least six

months of primary adhesive capsulitis signs and symptoms. This study is delimited to residents

of south eastern Michigan because of the researchers geographic location. The researcher needs

the participants of the study to be able to regularly make their scheduled appoints multiple times

a week so travel time is an issue. The author chose this because of the external threat to validity

of intertester reliability of range of motion (ROM) tools. The study is also delimited to a

population ranging from 40 to 70 years old because this is the age period where adhesive

capsulitis peaks. Developing adhesive capsulitis under the age of 40 is a rare occurrence

especially in children.

Limitations

The limitations of this study cannot be determined until after the data has been collected

and analyzed. There are some possible potential limitations in the selection of the population.

Adhesive capsulitis is found much more commonly in women than in men. With multiple

sources stating varying statistics it is perceived that around 70% of this 40 to 70 year old

population is made up of women. Another possible limitation to the study could be mortality

4
since the population cap is including elderly participants. The risk of mortality also increases

because the risk of developing adhesive capsulitis increases in patients with insulin-dependent

diabetes mellitus. This opens the studys population to increase risk of co-morbidities that leads

to the overall increased risk of mortality.

Definition of Terms

Ultrasound. A treatment modality that is commonly used in physical therapy. It uses

sonic vibrations to apply deep heating to soft tissues of the body.

`Intervention. An act performed to interfere and modify an outcome to help treat or cure

a medical condition.

Idiopathic. Any disease or condition that spontaneously arises with unknown origins.

Soft Tissue. Bodily tissues that includes tendons, ligaments, fascia, skin, fibrous tissues,

fat, synovial membranes, muscles, nerves and blood vessels.

Lesions. An abnormal change in an organ or part due to a disease or condition.

Mechanism. A natural process by which something is brought about.

Primary Adhesive Capsulitis. Is global capsular inflammation and fibrosis occurring in

the absence of other lesions.

Plan Of Care (POC). Is the document developed after a patient assessment that identifies

a diagnosis, prognosis and maps out what interventions will be used during treatment sessions.

Range Of Motion (ROM). Is the measurement of the available movement that a joint

possesses.

5
 Co-Morbidities. The simultaneous presence of two chronic diseases or conditions in a

patient.

CHAPTER 2
REVIEW OF RELATED LITERATURE

The purpose of this study is to determine the efficacy of therapeutic ultrasound treatments

on patients with adhesive capsulitis of the shoulder. This study is a randomized controlled trial

study that will include subjects between the ages of 40 and 70 years old. These subjects will

have at least six months of dealing with symptoms of primary adhesive capsulitis.

6
 In this chapter several critical issues related to adhesive capsulitis, therapeutic ultrasound

effects and therapeutic ultrasound used on adhesive capsulitis are reviewed. These issues will be

discussed in different sub topics such as: adhesive capsulitis pathology, population and

prevalence, conventional treatments, effects of therapeutic ultrasound and treatment of adhesive

capsulitis with therapeutic ultrasound. This review will provide the detailed background

knowledge on why adhesive capsulitis is such a problem, the uncertainty of therapeutic

ultrasound in physical therapy and in treating adhesive capsulitis.

Adhesive Capsulitis Pathology, Population and Prevalence

Adhesive capsulitis is an idiopathic debilitating medical condition that drastically

changes a persons life. Adhesive capsulitis is a condition that brings about great physical pain

those afflicted along with severely restrict ROM and functional status. People who contract this

condition undergo long periods of time dealing with these symptoms to no avail. Many people go

on disability or even permanent disability and never fully regain the capabilities they used to

have. This condition is known to be self-limiting because it is of an idiopathic pathology.

Physicians and scientists alike have been aware of the condition for decades and still do not

know how or why the condition comes about. There are two types of adhesive capsulitis known

as primary adhesive capsulitis and secondary adhesive capsulitis.2 The difference between these

two types of adhesive capsulitis is how they are contracted. Primary adhesive capsulitis is

always contracted idiopathically.1 This means that physicians and physical therapists do not

know why or how the patient contracted adhesive capsulitis. Secondary adhesive capsulitis is

when one or more known pathologies are causing the condition to manifest.1 Having a known

cause for secondary adhesive capsulitis allows healthcare providers to single out pathologies that

7
are causing the condition. By treating these known pathologies first, the secondary adhesive

capsulitis with resolve with the resolution of the affecting pathologies.

This condition has become a very common pathology in outpatient physical therapy

clinics currently as the population has shifted to an older generation. With the baby boomers

falling into the 40-70 age range they have increased the prevalence of the condition over time.

The condition is usually only found in those within this age range of 40-70 years old. It is very

rare for anyone younger than 40 years old to contract this pathology and extremely rare for

children to be afflicted by it. According to Griesser et al, the United States population has a

prevalence of 2%-5%.2 Though patients that have insulin-dependent diabetes mellitus have a

prevalence of 30%.2 This might not seem like a very high rate but when you take into account

the United States total population of over 320 million people that is roughly 16 million people

across the country.

To understand what these people with adhesive capsulitis are going through you have to

understand exactly what adhesive capsulitis is. Adhesive capsulitis as defined by the American

Academy of Orthopedic surgeons is a condition of varying severity characterized by the gradual

development of global limitation of active and passive shoulder motion where radiographic

findings other than osteopenia are absent.2 These resulting signs and symptoms of the disease

take place on a continuum over the course of adhesive capsulitis life span. The life span of this

condition takes anywhere from months to years over the multiple stages of the condition. There

are 4 agreed upon stages of adhesive capsulitis that are not exact periods of time and will often

mesh together creating the continuum.

The first stage of this condition is when there is a gradual onset of pain referred to the

insertion of the deltoid.1 This stage is defined by signs and symptoms of achy pain at rest, sharp

8
pain with movement, night pain, and an inability to sleep on the affected side.1 Physical

therapists will find pain with deep palpations or while performing passive stretches on their

patients.1 Their patients will display empty end-feels and progressions of lost ROM starting with

external rotation.1 The second stage of adhesive capsulitis is a combo of acute synovitis and

progressive capsular contracture.1 This second stage is also known as the freezing stage of

adhesive capsulitis.1 The signs and symptoms of this stage are persistent pain that increases at

night.1 Physical therapists will find that their patients will be restricted in forward shoulder

flexion, shoulder abduction, external shoulder rotation and internal shoulder rotation.1 The third

stage is known as the maturation stage or the frozen stage of adhesive capsulitis.1 This frozen

stage is characterized by significant stiffness in all movements of the shoulder.1 Physical

therapists will find that patients in this stage will have pain present at end ranges of their

shoulder movements.1 The final stage of adhesive capsulitis is known as the chronic or thawing

stage.1 This stage is typically characterized by minimal pain and a slight but continual

improvement of ROM.1 Physical therapists will find that by the end of this stage some patients

will get back their normal ROMs. Depending on the severity of the individual condition, some

patients will not get back their normal ROMs. These adhesive capsulitis stages have their own

general time spans. Stage one has a duration of around three months or less.1 The freezing

stage has a duration that lasts up to 9 months.2 The frozen stage has a duration that will last at

least four months but no more than 20 months.2 The final stage known as the thawing stage

can last anywhere from five months to 26 months.2 The overall combined time that this

condition can last is 17 to 57 months, or 1.5 to 4.75 years on average. Some severe cases have

been known to last up to seven years.

9
 Conventional Treatments for Adhesive Capsulitis

As medical science currently stands there are a number of different treatment

interventions used to help people with adhesive capsulitis. Over time through research,

experimental studies and case studies these treatments have been found to help patients. Though

no one is 100% sure of the validity and efficacy of these treatments. On a large number of these

conventional treatments healthcare providers are split on the effectiveness of said treatments.

This creates a lot of bias in treating adhesive capsulitis because no one gold standard has been

found to treat it. Several treatment interventions have been found to have small effects on

treating adhesive capsulitis but none of them have the capabilities of stopping the medical

condition dead in its tracks. This has led to the current methodology of treating adhesive

capsulitis where healthcare providers take a couple of these treatments that have smaller effects

and combine them together to help combat adhesive capsulitis.

Together these smaller effect treatments do a decent job of speeding up adhesive

capsulitis life span and shorten the four stages. There are two main categories of treatment for

adhesive capsulitis, they are operative and non-operative procedures.1 The operative procedures

for treating adhesive capsulitis are manipulation under anesthesia and arthroscopic capsular

release. These operative procedures are often risky and usually are the secondary options if non-

operative procedures do not produce significant results.

The first operative procedure is manipulation under anesthesia. This procedure is also

known as closed manipulation. In this procedure, a surgeon will put the patient under anesthesia

10
to render them unconscious. Then the surgeon will then take control of the unconscious patients

affected shoulder and move it through the full ROM. This passive movement of the shoulder by

the surgeon allows for the breakup of scar tissue that has developed on the glenohumeral capsule.

This is only achievable when the patient is unconscious because the break up of scar tissue

would be excruciatingly painful for the patient if they were conscious.

The second operative procedure is arthroscopic capsular release. This procedure is

usually performed on patients in the second or third stages of adhesive capsulitis. The surgeon

will place the patient under anesthesia and begin to operate on the shoulder. Small incisions are

made into the shoulder which are known as portals. These portals allow for the surgeon to insert

a small camera and other instruments into the shoulder. Using these portals allows the procedure

to be performed without have to completely open up the shoulder and thereby decreasing the

overall risk of the procedure. Then the surgeon will surgically release any of the scar tissue that

is limiting the patients ROM and causing pain.

There are more procedures/interventions in the non-operative category than there are in

the operative one. The non-operative category presents with significantly less risk than the

operative category but the effects will take longer to present. Non-operative procedures are the

first line of defense for patients with adhesive capsulitis because they are low risk to the patient.

This allows physicians and physical therapists to exhaust their options before they decide to go

the operative route with little risk to their patients. The common non-operative

procedures/treatments are nonsteroidal anti-inflammatory drugs (NSIDs), corticosteroid

injections, and physical therapy.2

NSAIDs are pharmaceutical drugs used to relieve pain. NSAIDs are among the most

common pain relief medications taken across the world. These drugs are great for reducing pain

11
associated with headaches, sprains, arthritis, and other daily discomforts. In addition to pain

relief NSAIDs also help to reduce swelling and lower fevers. All this is achieved by blocking

reactions on a chemical level. The NSAIDs block enzymes that are responsible for creating

prostaglandins which means less pain and swelling. These drugs are usually prescribed to all

patients who display signs and symptoms of adhesive capsulitis for short term pain relief. These

drugs are not shown to have long term effects as it is necessary to take multiple pills a day

depending on the dosage. These NSAIDs are usually combined with other non-operative

interventions to help treat adhesive capsulitis. They can either be obtained in low dosages over

the counter or through written prescriptions from a physician.

Corticosteroid injections are the next type of non-operative procedure to be discussed.

They are powerful anti-inflammatory medications that decrease swelling and pain in a localized

area. These injections are known to have significant effects of decreasing pain and increasing

ROM. Though these effects are only transient because after the injections wear off the pain

comes back and ROM is once again limited. While corticosteroid injects have significant short

term effects on treating adhesive capsulitis it has no significant effects when compared to other

interventions at the later follow ups. Also there are some adverse side effects when the

frequency of the injections becomes too great. Since corticosteroid injections are so powerful

they can prevent normal protective measures from taking place leading to degeneration and total

destruction of the joint. So using corticosteroid injections in conjunction with other non-

operative interventions allows for fewer injections and a decreased risk for adverse side effects.

The last non-operative procedure is an all-encompassing non-operative intervention that

includes treatments such as manual therapy, therapeutic exercise and therapeutic modalities.

Therapeutic ultrasound falls under the category of therapeutic modalities in the sub category of

12
physical therapy. Physical therapy is the mainstay of treatment for adhesive capsulitis even

though there is a lack of high grade evidence for it.1 The benefit of physical therapy in treatment

of adhesive capsulitis is that physical therapist are able to tailor POCs to each individual patient.1

This form of non-operative treatment is where the most biasing occurs because each individual

physical therapist has their own form of therapy they specialize in. More often than not physical

therapy is able to combat the effects of adhesive capsulitis but it is most beneficial when

combined with other non-operative treatments. Usually operative procedures are chosen only if

physical therapy has no significant effects on the patients condition.

The main reason as to why many of these conventional treatments are necessary to help

treat adhesive capsulitis is the fact that no one knows what causes it. Since nobody has been able

to find the root cause of adhesive capsulitis no specific POC can be developed to treat the

condition. That is why all of these different treatments and procedures have been developed over

time because none of them are guaranteed to work. Though healthcare providers have been able

to identify risk factors for adhesive capsulitis as: being female, trauma to the shoulder, greater

than 40 years of age, diabetes, prolonged immobilization, thyroid disease, stroke, myocardial

infarction and the presence of autoimmune disease.2 Through a thorough examination of an

individuals medical history healthcare providers can find these risk factors of adhesive capsulitis

as a marker of why an individual may have contracted adhesive capsulitis. This will then allow

healthcare providers to develop the proper POC necessary to combat adhesive capsulitis without

causing further harm to the patient.

Effects of Therapeutic Ultrasound

Therapeutic ultrasound has been used by physical therapists for over 60 years and has

become a common practice of physical therapists.3 It is one of the most widely and frequently

13
used electrophysical agents used by physical therapists for its purposed healing effects.4 Physical

therapists often use therapeutic ultrasound to treat patients with pain, musculoskeletal injuries

and soft tissue lesions.4 Adhesive capsulitis belongs to a couple of these issues which is why

some physical therapists decide to implement it into their POC. The only problem with this is

that the actual effects of therapeutic ultrasound remain questionable.4 Few studies have been

found to have adequate methods for establishing the effectiveness of therapeutic ultrasound.4

The dosages used in these studies have also been substantially varied and dont provide the

necessary rationale as to why they were chosen.4 Also the few studies that have shown

significant results in the therapeutic properties of ultrasound have not been replicated to

consolidate the original studies findings.3

Healthcare providers use the purported biophysical effects of therapeutic ultrasound as

scientific evidence as to why it is used to treat patients with pain, musculoskeletal injuries and

soft tissue lesions. It is also claimed that therapeutic ultrasound has significant biophysical

effects on soft tissue extensibility.3 While these biophysical effects have been found to exist in

vitro there is very little evidence that they exist in vivo.3 The problem with the scientifically

proven effects found in vitro is that while in vivo any molecular change in extracellular fluid

initiates a protective reaction to minimize the effect on the cells.3 These protective mechanisms

are responsible for the discrepancy between the high-quality in vitro results and the suspect in

vivo results. There are two different types of therapeutic ultrasound each with their own

biophysical effects. They are known as thermal ultrasound and non-thermal ultrasound.3

Non-thermal ultrasound is a form of ultrasound where the duty cycle is less than 100%.

This means that the therapeutic ultrasound is cycling on and off while the modality is being

applied to the patient. Even though this ultrasound is titled as non-thermal it is still accompanied

14
by some heating because it is impossible to not have any heat emitting from the ultrasound head.

This means that the two types of ultrasound are not separable and they exist on a continuum.

The effects of non-thermal ultrasound are associated with cavitation.3 Cavitation has been found

to occur in vitro but not occur in vivo.3 So with the lack of cavitation in vivo the purported

effects of accelerated tissue healing are in question.

Thermal ultrasound is when the duty cycle is at 100%. This means that the therapeutic

ultrasound is always on while the modality is being applied to the patient. Since the ultrasound

is on the entire time it provides a form of deep heating to the tissues the ultrasound head passes

over. This is supposed to allow for increased tissue extensibility, increased blood flow, decreased

pain and increased enzymatic activity resulting in increased mobility/function. Though

protective mechanisms such as homeostasis tend to interfere with the intended temperature rise

limiting these effects in vivo.3 It generally takes greater than therapeutic doses (1.5 W/cm^2

at 1 MHz for 8 min) to achieve these thermal ultrasound effects. Though it was

found that the therapeutic doses do slightly increase tissue extensibility. 3 These

findings were not found to be significant. 3 The believed reasoning behind the lack

of thermal effects in vivo is that blood flow has a cooling effect on the heat

dissipation.3

All of the information points to the biophysical effects of ultrasound being

unlikely beneficial in the clinical setting. 3 Though there are alleged physiological

responses to the biophysical effects of therapeutic ultrasound that physical

therapists use to justify therapeutic ultrasound as an effective modality. 3 Physical

therapists have found patients to have physiological responses to therapeutic

ultrasound that have displayed significant results in the clinical setting. 4 Many

physical therapist have found to achieve the expected results of therapeutic

15
ultrasound based on the purported biophysical effects. This lead to another group

of studies being performed to determine if these results where because of the

biophysical effects or perceived effects of the patients expectations. Many of these

trials were flawed in their methodology and have been discounted. 4 The few that

displayed adequate methodology had the problem of varying dosages or unreported

dosages.4 This left the data as inadequate in providing evidence of any patterns

found in the healing properties of therapeutic ultrasound. 4 To prove or disprove any

physiological responses to biophysical effects of therapeutic ultrasound more

studies need to be performed with adequate methodology and accurate reporting of

dosages. This will allow for the studies to be replicated and significant finding to be

proven accurate.

Treatment of Adhesive Capsulitis with Therapeutic Ultrasound

There currently is a lack of evidence regarding the effectiveness of therapeutic ultrasound

in the treatment of adhesive capsulitis.5 Finding out if therapeutic ultrasound is effective in

treating adhesive capsulitis is very important. Physical therapists are split on whether or not

using therapeutic ultrasound to treat adhesive capsulitis is acceptable or not. Many therapists

believe that therapeutic ultrasound does not have any significant effects on adhesive capsulitis.

So that including therapeutic ultrasound in their POC is unethical because they would be

charging the patient for a treatment that they do not need. While the other therapists swear by it

and use it on every patient with adhesive capsulitis. This is a problem because physical therapy

is the first line of defense when it comes to treating adhesive capsulitis. Time should not be

wasted on treatments that dont work because the condition is gradually worsening every day.

So that lead other researchers to study the effects of active ultrasound vs. placebo ultrasound in

the treatment of adhesive capsulitis.

16
 The researcher found a study where 49 subjects between the ages of 41 and 71 were

separated into an ultrasound group (25 subjects) and a placebo group (24 subjects).5 Subjects

were then evaluated to establish baseline subjective and objective measures. These groups then

received identical treatments except for the ultrasound treatments. These treatments occurred 5

days a week for two weeks. After the treatment sessions ended subjects were given identical

HEPs in which they were required to record their compliance.5 Their progress was checked by

reassessing the subjects subjective and objective measures after the tenth treatment session and

at the end of the third month.5

The results of this study found that therapeutic ultrasound and placebo ultrasound have

no relevant differences in treating adhesive capsulitis.5 Both therapeutic ultrasound and placebo

ultrasound were found to have significant intra-group effects.5 The studies internal validity was

threatened by lack of HEP compliance by the therapeutic ultrasound group. The placebo

ultrasound group had a higher HEP compliance rate than the therapeutic ultrasound group. Also

the therapeutic ultrasound groups baseline measures were significantly worse than the placebo

ultrasound group. Both of these factors could have affected the results of the study.

CHAPTER 3
METHODOLOGY

The purpose of this study is to determine the efficacy of therapeutic ultrasound treatments

on patients with adhesive capsulitis of the shoulder. This study is a randomized controlled trial

study that will include subjects between the ages 40 and 70 years old. These subjects will all

have at least six months of dealing with the symptoms of primary adhesive capsulitis. There will

17
be initial testing to establish pain level, ROM, and functional status baselines. Then testing will

occur periodically at specific intervals to track the progression or regression of the subject

groupings. The study was framed by the following research questions:

1. What are the most effective treatment interventions to accelerate through the multiple

stages of adhesive capsulitis?

2. What is the efficacy of therapeutic ultrasound as a treatment intervention for patients with

pain, musculoskeletal injuries or soft tissue injuries?

3. Is there a significant effect of treating adhesive capsulitis with therapeutic ultrasound and

should it be used on patients?

Study Design

This study is of a quantitative design focusing on experimental research for the purpose

of treating adhesive capsulitis. There will be one site location in Fraser, MI that will serve as the

only base of operations for both conducting the experiment and analyzing the data. Along with

the researcher there will be two other physical therapists that will be aiding in administering both

the experimental treatments and controls. There will be three separate randomly assigned groups

that will consist of 25 subjects per group that totals 75 subjects from the selected population.

One of these three groups will be the control group without any use of the ultrasound machine.

Though the group will still receive the control treatment made up of other physical therapy

treatments such as: therapeutic exercise, manual therapy, self-stretching and a home exercise

program (HEP). The other two groups will be the experimental groups where a form of

ultrasound will be applied along with the control treatment. One of the two experimental groups

will use active ultrasound (thermal ultrasound) set to 1 MHz, 1.5 W/cm and 100% duty cycle for

eight minutes. The other experimental group will use a false ultrasound machine that mimics the

thermal ultrasound settings without any actual therapeutic effects. This experimental group will

18
be a placebo to assess if the any significant effects found from the active ultrasound group are

real or perceived by the subjects.

The control treatments will be regulated by the researcher with a progression plan put in

place. The other two physical therapists administering the control treatments will be following

the progression plan as to make sure the subjects are receiving the exact same controls. This will

allow the researcher to later examine the efficacy of therapeutic ultrasound as a physical therapy

treatment for adhesive capsulitis.

The researcher and physical therapists will be periodically assessing the subjects

progress through the treatment portion of the study and beyond. There will be scheduled re-

assessments of the subjects pain levels, ROM and functional statuses. These re-assessments will

occur at five treatment sessions, ten treatment sessions, three months post initial treatment, six

months post treatment and two years post treatment. This time line of re-assessment will allow

the researcher to assess the both the short term and long term results of the study. The re-

assessments at each of the scheduled time intervals will be compared with the subjects baseline

subjective and objective measures.

The study will last a total of two years with the experimental portion ending after ten

treatment sessions. The treatment sessions will take place over two weeks with each week

consisting of five treatment sessions per week. After the treatment sessions end every subject

will be given a detailed HEP to keep the patients progressing throughout the two year period.

The HEP will have self-treatment exercises, stretches and modalities that can be performed at

home with detailed explanations. Progression exercises will be included in the HEP and will be

marked for when to start and stop each individual exercise. The progressions will take place at

three months post initial treatment, six months post initial treatment, one year post initial

19
treatment. These home exercises will be performed daily by subjects to keep the progression of

the healing tissues moving forward. At any time during the HEP phase of the study subjects will

have access to the researcher or other physical therapists to ask questions through phone calls,

email conversations or making a scheduled appointment.

The independent variable for the study is the use of therapeutic ultrasound by the

researcher and the other physical therapists. To remove bias from the experimental point of view

of the experimenters, they will not know whether they are applying active or placebo ultrasound.

Since the control group does not receive either form of ultrasound experimenter bias is difficult

to remove. To attempt to remove bias from the control group there will be exact words and

phrases that will be implemented to create an atmosphere of support for the subjects. This will

create satisfaction in the controls groups treatment by making the subjects feel as though they

are not missing out on any special treatments. The dependent variables of this study are the

subjects pain levels, ROM measurements and functional status. These are measured by using

goniometers for ROM measurements, the Shoulder Pain And Disability Index (SPADI), the SF-

36 form, visual analogue scale for pain levels.

POPULATION & SAMPLE

The population for this study is the growing number of Americans who are between the

ages of 40-70 years old. With the baby boomers generation making up a large portion of the

USA population the increase of risk for adhesive capsulitis is increased. Also the health status of

Americans in this age group increases this risk for adhesive capsulitis because a large portion of

the whole USA population is either overweight or obese. With obesity comes a high risk of

insulin-dependent diabetes mellitus which in turn increases peoples risk of contracting adhesive

capsulitis.

20
 The sample frame of this experiment is limited to people living in the south eastern

portion of Michigan where the researchers facility is located. This will allow the subjects to be

able to attend daily treatment sessions without having to up root or change their daily lives. The

sample frame will be formed by the patients of orthopedic physicians in the south eastern region

of Michigan. To gain the co-operation of the orthopedic physicians in south eastern Michigan,

giving them credit as co-authors of this study. It is also the researchers hope to be able to create

an adhesive capsulitis clinic in which these orthopedic physicians work close proximity to

identify patients and accelerate the process of healing for adhesive capsulitis.

The sample will then be randomly selected from the sample frame of patients that agree

to participate in the study. 75 subjects will be chosen and then randomly placed into one of the

three groups consisting of 25 subjects each. Dividing the sample up into groups of 25 subjects

each allows the researcher to obtain a significance level of p > 0.05 to prove the researchers null

hypothesis to be true. Only the control group will know which group they are in since they will

not be receiving either active or placebo ultrasound. The experimenters and the subjects

participating in the experimental groups will not know whether they are receiving active or

placebo ultrasound. This will create an almost complete double blind study to decrease the risk

of subject and experimenter bias as previously mentioned.

To be in compliance with the Institute Review Board (IRB), the researchers consent

process will be very thorough and involve a third party to review and witness the process. All

aspects of the study will be explained in great detail and consent will be gained before any type

of treatment is performed. While the initial consent is being obtained all necessary support that

the subject may need will be provided to make sure they understand the study and their rights as

a participant in the study. Aids such as speech translators, brail consent information/documents,

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sign language translators, a simplified consent form for illiterate subjects and the third party

present to step in to discuss the study with the subjects. Participants are allowed to remove

themselves from the study at any time without any repercussions. The data will remain

completely anonymous in all documentation except the master key that only the researcher will

have access to. Once the study is complete an all data has been collected and analyzed the

researcher will delete the master key permanently so that no one can be identified through the

study. At this point all the data will be matched up with the correct individual case and then be

mixed together with all the other subjects so know who each subject is will no longer matter.

VALIDITY ISSUES

For this study there are several issues that threaten the validity of the results. One such

threat to internal validity would be the use of analgesic drugs. Whether they are prescription

drugs from a physician, over the counter drugs or illegally obtained drugs. If the researcher was

to ask subjects not to partake in the use of analgesic drugs this could cause problems with the

IRB. To avoid this issue and limit the threat to the validity of the study patients are asked to keep

daily logs of the drugs they use, how often they consume them and their dosage daily. Another

risk to internal validity would be the phenomenon known as selection bias. The researcher has

planned to limit this by randomly assigning assigning subjects to the groupings without any prior

knowledge of medical history or personality traits. This will allow no unconscious biasing of the

groupings by the researcher to increase the strength of the studies internal validity. As mentioned

previously in the document, the researcher is attempting to blind both the experimenters and the

subjects. The experimenters will not know whether they are applying active or placebo

ultrasound to the subjects. The subjects will also be blind to the type of experimental treatment

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they are receiving. Though for both experimenters and subjects, blinding of the control group is

not possible because the subjects will receive no form of ultrasound.

The external validity of this study appears to sound as it is expected to be generalizable to

the desired population of people ages 40-70 years old. The results will not be generalizable to

the world population because of the age restriction put on the study. Though for the case of

adhesive capsulitis, it is very rare for a persons to develop this medical condition outside of this

age grouping. The ecological validity of this study is great because the setting of the researcher

facility is an outpatient physical therapy setting. This is the exact setting that patients diagnosed

with adhesive capsulitis will be attending in the treatment of this condition. One threat to the

external validity that cannot be avoided is the threat to the studies temporal validity. A

requirement of this study is the subjects must have at least six months of symptoms. While it is

the assumption of the researcher that most subject will be around this six months mark outliers

will occur. Some subjects may be closer to or over a year of the onset of their symptoms which

will put the closer to the end of the conditions timeline. This may result in no significant effects

noticed from the experimental treatment because the adhesive capsulitis may be close to

resolving itself.

The overall assumed validity of this study is perceived to be strong for both internal and

external aspects. Though there are some unavoidable risks that the researcher will not be able to

make up for.

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 References
1. Neviaser AHannafin J. Adhesive Capsulitis: A Review of Current Treatment. The
American Journal of Sports Medicine. 2010;38(11):2346-2356.
doi:10.1177/0363546509348048.
2. 2. Griesser M, Harris J, Campbell J, Jones G. The Journal of Bone and Joint Surgery
(American). 2011;93(18). doi:10.2106/jbjs.j.01275.
3. Robertson V, Baker K. A Review of Therapeutic Ultrasound: Biophysical Effects.
Physical Therapy. 2001; 81(7) 1351-1358.
4. Robertson V, Baker K. A Review of Therapeutic Ultrasound: Effectiveness studies.
Physical Therapy. 2001; 81:1339-1350
5. Dogru H, Basaran S, Sarpel T. Effectiveness of therapeutic ultrasound in adhesive
capsulitis. Joint Bone Spine. 2008; 75(4):445-450. doi:10.1016/j.jbspin.2007.07.016.

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