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

Not Applicable

Completed

• Conditions: Adhesive Capsulitis of Shoulder
• Interventions: Device: Extracorporeal Shockwave Therapy; Other: Conventional Treatment

• Registration Number: NCT04578366
• Lead Sponsor: Riphah International University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-10-15
• Primary Completion: 2020-06-20
• Study Completion: 2020-06-28
• Study First Submitted: 2020-09-25
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-06
• Last Update Submitted: 2020-10-06
• Study First Posted: 2020-10-08
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shockwavetherapy Group/Experimental group	Extracorporeal Shockwave Therapy	ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder
Conventional Group	Conventional Treatment	Conventional therapy hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder

Primary Outcome Measures

Name	Time	Method
Constant Shoulder Score (CSS)	8 months	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
Range of motion	8 months	Oxford Shoulder Score (OSS), increasing score shows improvement, decrease in scores shows deterioration.

Secondary Outcome Measures

Name	Time	Method
NPRS-numeric pain rating scale	8 months	This scale ranges 0-10, 10 means severe pain while 0 means no pain

Trial Locations

Locations (1)

Riphah IU; 🇵🇰 Lahore, Pakistan