The Effect of Extracorporeal Shockwave Therapy on Adhesive Capsulitis Shoulder

Study Overview
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Brief Summary
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￼￼￼Introduction: Adhesive capsulities or Frozen shoulder is one of the common causes of shoulder pain and disability in the upper extremity. It affects the functions of glenohumeral joint, limiting both active and passive movements of the shoulder. One way of non-surgical treatment method that has been receiving attention recently is extracorporeal shockwave therapy (ESWT). ESWT is a pulsed sound wave, characterized by short duration, high pressure amplitude, and relatively low tensile wave component. ESWT has beenrepotreatingtreat a variety of pain conditions effectively and safely. Purpose: The purpose of the present study is to determine whether ESWT could be effective in thetreatment of adhesive capsulitis or frozen shoulder.

Detailed Description
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Methods: Experiment Group patients were given shockwave therapy for 6 weeks as a one session per week follow up after 12 weeks. Control Group patients received shame shockwave therapy inaddition to traditional treatment the same period of the experiment group.Importance: Till date, only a few studies have reported the efficacy and clinical improvements obtained by extracorporeal shockwave therapy (ESWT) on frozen shoulder. Limited by asmall number of studies and insufficient outcomes, it is important and necessary to conduct a new randomized controlled trial

Official Title
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The Effect of Extracorporeal Shockwave Therapy on Adhesive Capsulitis Shoulder: A Randomized Controlled Trial

Conditions
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Adhesive Capsulitis of Shoulder

Intervention / Treatment
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* Combination Product: ESWT+ traditional physical therapy treatment
* Combination Product: Placebo shockwave + traditional physical therapy treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having a relapsed or episode of pain score ≥5 at the assessment with a past history of pain for at least 2 weeks. phase 1 or 2 frozen shoulder confirmed by a physician ROM restriction (>75% ROM loss in ≥2 directions including abduction, flexion and external rotation) no treatment other than analgesics with unresponsive ROM restriction for the past 2 months unwilling or waiting and did not undergo joint injection Diagnosed with shoulder adhesive capsulitis, ≥18 years Diabetes mellitus Exclusion Criteria: bilateral shoulder involvement History of previous surgery on the shoulder Shoulder fracture Cancer Glenohumeral or Acromioclavicular arthritis Inflammatory disorders Bleeding disorders Presence of severe osteoporosis Pulmonary diseases Any neuromuscular disorders Pregnancy Implanted pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial, single blinded, placebo
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESWT+ traditional physical therapy treatment<br>ESWT+ traditional physical therapy treatment | Combination Product: ESWT+ traditional physical therapy treatment<br>* Participants will receive one session per week for 6 weeks on the affected tissue region which will be achieved by a sequence of 2000 shock wave pulses fired with a repetition frequency of 2 pulses per second. Energy level or intensity will be set at a tolerable level by patient (0.2mJ/mm2). The usual physical therapy care consists of hot pack (10min), stretching, pendulum exercises, isometrics exercises of shoulder one per week, and for 12 weeks. home exercises program (HEP)<br>|
| Placebo Comparator: Placebo shockwave + traditional physical therapy treatment<br>Placebo shockwave + traditional physical therapy treatment | Combination Product: Placebo shockwave + traditional physical therapy treatment<br>* Participants will be treated one time a week over a six-week period. Placebo shockwave treatment (apply low intensity with low dose and frequency: intensity 0.1, freq 1, dose 200 shocks). The usual physical therapy care consists of hot pack (10min), stretching, pendulum exercises, isometrics exercises of shoulder one per week, and for 12 weeks. home exercises program (HEP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | Visual analogue scale for pain measurement | 2 months | 
| Range of Motion | Range of Motion is measured by goniometer | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick DASH | Disabilities of the Arm, Shoulder, and Hand (DASH) score. | 2 months | 
| DASS | DASS, the Depression Anxiety Stress Scales, is made up of 42 self-report items | 2 months | 
| SF-36 (short version) | The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frozen shoulder, Extracorporeal shockwave therapy