Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis

Study Overview
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Brief Summary
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Adhesive capsulitis refers to the occurrence of pain and a gradual decline in the range of motion (ROM) due to slow increases in synovial hypertrophy and the adhesion between the synovial membrane and articular surface. It leads to the loss of flexibility and difficulties with the activities of daily living (ADLs) due to chronic inflammation accompanied by intra-articular fibrosis. The real cause of this syndrome is unknown but there are some predisposing factors involved such as synovial cell hyperplasia, fibrosis of the capsule due to cytokines or other inflammatory factors. In the current study investigator will compare the effects of Extracorporeal Shockwave Therapy (ESWT) along with conventional therapy to treat the adhesive capsulitis.

Detailed Description
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This study will be a Randomized Controlled Trail conducted at Horizon hospital, Lahore. The study will be completed within the time duration of Six months. Consecutive sampling technique will be used to collect the data. The sample size of 44 patients will be taken in this study to find the effects of ESWT on pain, ROM, functional mobility. Patient will be divided into two groups. Group A will be treated with ESWT with conventional therapy and Group B will be treated with conventional therapy. Constant Shoulder Score (CSS) and the Oxford Shoulder Score (OSS) tools will be used to measure the outcomes of the study. One session of treatment per week for four weeks will be given. Pretest, posttest at 4th week and followup of 24th weeks will be evaluated.

Official Title
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Effects Of Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis

Conditions
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Adhesive Capsulitis of Shoulder

Intervention / Treatment
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* Device: Extracorporeal Shockwave Therapy
* Other: Conventional Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Relapsed or episode of pain score ≥5 at assessment with a past history of pain for at least 2 months. 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 2months. Unwilling or waiting and did not undergo joint injection. Exclusion Criteria: bilateral shoulder involvement History of previous surgery on the shoulder Shoulder fracture Cancer Glenohumeral or Acromioclavicular arthritis Inflammatory disorders Bleeding disorders Diabetes mellitus Presence of severe osteoporosis Pulmonary diseases Any neuromuscular disorders Pregnancy Implanted pacemaker

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shockwavetherapy Group/Experimental group<br>ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder | Device: Extracorporeal Shockwave Therapy<br>* ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder<br>* Other names: Experimental Group;|
| Active Comparator: Conventional Group<br>Conventional therapy hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder | Other: Conventional Treatment<br>* hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Shoulder Score (CSS) | The functional outcome of shoulder. Grading the Constant Shoulder Score (Difference between normal and Abnormal Side) >30 Poor 21-30 Fair 11-20 Good <11 Excellent | 8 months | 
| Range of motion | Oxford Shoulder Score (OSS), increasing score shows improvement, decrease in scores shows deterioration. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NPRS-numeric pain rating scale | This scale ranges 0-10, 10 means severe pain while 0 means no pain | 8 months |