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The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis.

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rotator interval hydro-dissection with dextrose 5%
Rotator interval hydro-dissection with corticosteroid solution
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: patients with primary adhesive capsulitis aged 35 to 65 years of age duration of symptoms in between 3 to 18 months limitation in flexion, abduction, and external rotation greater than 30 degrees compared to normal limitation in internal rotation with hand to back shoulder test below L4 Exclusion Criteria: diagnosis of connective tissue disease or inflammatory arthritis history of surgery to the affected shoulder history of shoulder dislocation/ fracture neurological weakness of the affected upper limb ultrasound findings of rotator cuff or LHBT tendinopathy plain radiographs showing significant glenohumeral joint osteoarthritis (Kallgren-Lawrence grade 3 or 4) other sources of chronic pain bilateral adhesive capsulitis history of pain intervention to the shoulder joint in the past 3 months allergic reaction to local anesthetic agent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Dextrose 5%

    Corticosteroid

    Arm Description

    Rotator interval hydro-dissection with dextrose 5% solution

    Rotator interval hydro-dissection with corticosteroid solution

    Outcomes

    Primary Outcome Measures

    Shoulder pain
    Shoulder pain based on Shoulder Pain and Disability Index (SPADI) pain scale. The SPADI pain scale ranges from 0 to 50, with higher score indicating greater level of pain.

    Secondary Outcome Measures

    Shoulder range of motion
    Shoulder range of motion in flexion, abduction, external rotation, internal rotation
    Shoulder function
    Shoulder function based on Shoulder Pain and Disability Index (SPADI) disability scale. The SPADI disability scale ranges from 0 to 80, with higher score indicating greater level of disability.

    Full Information

    First Posted
    July 19, 2023
    Last Updated
    August 2, 2023
    Sponsor
    University of Malaya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05977985
    Brief Title
    The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis.
    Official Title
    The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis. A Two-arm Double-blind Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    July 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Malaya

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Adhesive capsulitis (AC) is a significant cause of chronic shoulder pain and disability. Non-surgical option consisting of intraarticular corticosteroid (IA CS) injection with structured physiotherapy (PT) is the current standard of care. More recent randomized controlled trials have found that rotator interval (RI) hydro-dissection approach leads to better improvement in pain as compared to IA approach. Despite being non-inferior to surgical management, long-term outcome studies of patients treated with IA CS injection and PT have shown that patients only achieve satisfactory outcomes in 72.3% of patients after a mean symptom duration of 41.8 months. Furthermore, CS injections are associated with significant systemic and local adverse effects such as Cushing syndrome, osteopenia/ osteoporosis, infection, and hyperglycemia. In recent years, dextrose injection has emerged as an effective alternative to CS-based injections to treat chronic painful musculoskeletal conditions such as chronic low back pain, peripheral nerve entrapment and lateral epicondylitis. The investigators aim to study the effects of RI hydro-dissection with dextrose 5% (D5%) on pain relief, shoulder ROM and shoulder function in patients with primary AC.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adhesive Capsulitis of Shoulder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dextrose 5%
    Arm Type
    Experimental
    Arm Description
    Rotator interval hydro-dissection with dextrose 5% solution
    Arm Title
    Corticosteroid
    Arm Type
    Active Comparator
    Arm Description
    Rotator interval hydro-dissection with corticosteroid solution
    Intervention Type
    Drug
    Intervention Name(s)
    Rotator interval hydro-dissection with dextrose 5%
    Intervention Description
    Single injection of 20ml dextrose 5% into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe
    Intervention Type
    Drug
    Intervention Name(s)
    Rotator interval hydro-dissection with corticosteroid solution
    Intervention Description
    Single injection of 20ml corticosteroid solution (1 ml triamcinolone 40 mg/ml + 19 ml saline 0.9%) into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe
    Primary Outcome Measure Information:
    Title
    Shoulder pain
    Description
    Shoulder pain based on Shoulder Pain and Disability Index (SPADI) pain scale. The SPADI pain scale ranges from 0 to 50, with higher score indicating greater level of pain.
    Time Frame
    1 week, 4 weeks and 12 weeks post injection
    Secondary Outcome Measure Information:
    Title
    Shoulder range of motion
    Description
    Shoulder range of motion in flexion, abduction, external rotation, internal rotation
    Time Frame
    4 weeks and 12 weeks post injection
    Title
    Shoulder function
    Description
    Shoulder function based on Shoulder Pain and Disability Index (SPADI) disability scale. The SPADI disability scale ranges from 0 to 80, with higher score indicating greater level of disability.
    Time Frame
    4 weeks and 12 weeks post injection
    Other Pre-specified Outcome Measures:
    Title
    Adverse events
    Description
    Adverse events during or after injection
    Time Frame
    from time to injection up till 1 week post injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients with primary adhesive capsulitis aged 35 to 65 years of age duration of symptoms in between 3 to 18 months limitation in flexion, abduction, and external rotation greater than 30 degrees compared to normal limitation in internal rotation with hand to back shoulder test below L4 Exclusion Criteria: diagnosis of connective tissue disease or inflammatory arthritis history of surgery to the affected shoulder history of shoulder dislocation/ fracture neurological weakness of the affected upper limb ultrasound findings of rotator cuff or LHBT tendinopathy plain radiographs showing significant glenohumeral joint osteoarthritis (Kallgren-Lawrence grade 3 or 4) other sources of chronic pain bilateral adhesive capsulitis history of pain intervention to the shoulder joint in the past 3 months allergic reaction to local anesthetic agent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Richard Teo
    Email
    richardskteo@ummc.edu.my

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis.

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