Comparison of two treatments in frozen shoulder

Phase 2

Not yet recruiting

Conditions: Stiffness of joint, not elsewhereclassified,

Registration Number: CTRI/2023/02/049467

Lead Sponsor: Asem Rangita Chanu

Brief Summary: Adhesive capsulitis (AC) of the shoulder is characterized by painful, restricted shoulder ROM in patients with normal radiographs and has long been considered self-limiting with spontaneous resolution (over a period of 18â€“24 months) that renders invasive treatment modalities superfluous. However, even after a fair trial of conservative measures (e.g., physical modalities, anti-inflammatory medications, exercises, corticosteroid injections), it has been reported that around 30% of patients do not improve clinically, thereby prolonging their functional limitations, emotional and economic hardships. In patients who do not improve with conservative treatment, further invasive treatments (such as manipulation under anesthesia and arthroscopic lysis of adhesions) have been tried. However, there has been no universally accepted method regarding invasive treatment options for refractory cases. Suprascapular Nerve Block (SSNB) has been tried in refractory AC but suboptimal response and complications can occur especially with the surface landmark technique and in the hands of those with limited expertise. Some studies have shown capsular hydrodilatation as a potential non-surgical option in the management of AC. However, its role compared with more established treatments for AC remains undefined. The present study aims to compare the effect of Suprascapular Nerve Block (SSNB) and capsular hydrodilatation in refractory cases of AC of the shoulder. We hypothesize that capsular hydrodilatation is as efficacious as SSNB in refractory cases of AC of the shoulder.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

a) Patients of either sex aged between 18 and 75 years attending the outpatient clinic of the Department of Physical Medicine & Rehabilitation with complaints of shoulder pain and stiffness for at least 3 months will be screened for eligibility b) Clinical diagnosis of AC made by a thorough history and clinical examination of each shoulder c) Normal plain radiographic appearance and presence of no secondary causes for the patientâ€™s complaints d) Patients who receive conservative management (hot fomentation of affected shoulder, Codmanâ€™s exercise, Range of Motion exercises and activities of affected shoulder, acetaminophen 650mg when required for pain up to a maximum of 5 tablets a day) for at least 2 weeks with no meaningful relief (less than 50% improvement in the passive range of movement in the affected shoulder for at least two of the three movements: forward flexion, abduction or external rotation).

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in function (SPADI score) of the shoulder	1, 4 and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Change in passive ROM of the shoulder	1, 4 and 6 weeks
Change in triple-phase bone scan findings of the shoulder	6 weeks
Relationship between ultrasound findings and change in function and passive ROM of the shoulder	NA

Trial Locations

Locations (1): Department of PMR, All India Institute of Medical Sciences, New Delhi
🇮🇳
West, DELHI, India
Department of PMR, All India Institute of Medical Sciences, New Delhi
🇮🇳West, DELHI, India
Asem Rangita Chanu
Principal investigator
7598621688
rangita8@gmail.com