Efficacy of Static Progressive Stretching Technique Versus Traditional Stretching in Primary Adhesive Capsulitis: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Function
Study Overview
Brief Summary
This study will be conducted to compare the effectiveness of static progressive stretching using the joint active system (JAS) shoulder device with cyclic manual stretching and controls on shoulder range of motion (ROM), time to gain ROM, and function in patients with adhesive capsulitis. The study includes three groups. Group A (15 patients) will receive static progressive stretch using the JAS device. Group B (15 patients) will receive cyclic manual stretching in flexion, abduction, and external and internal rotations. Group C (15 patients) is a control group that will receive no treatment until the end of the study.
Detailed Description
The study design: Prospective single-blinded randomized controlled trial (therapy, level 1B). A flow diagram according to the Consolidated Standards of Reporting Trials (CONSORT) statement will be presented to illustrate the progression of the study.
The sample size is calculated using G*power software (version 3.1.9.7, Franz Faul, Universitat Kiel, Germany) and it suggests that 42 participants (14 per group) will be needed using the MANOVA test. Cohen's d is set to be 0.25 with 80% power (alpha = 0.05) to detect an effect size.
Patients are randomly assigned to either of three groups (A, B, or C) using a computer-generated list. They are allocated by an outside party who isn't involved in the treatment using sequentially numbered sealed envelopes.
Inclusion criteria: (1) Patients of both genders with unilateral primary adhesive capsulitis (2) Patients aged between 40-65. (3) Pain duration of three months or more. (4) Range of motion loss of greater than 25% in at least 2 planes and passive external rotation loss that is greater than 50% of the uninvolved shoulder or less than 30° of external rotation.
Exclusion criteria: (1) Previous surgery or manipulation under anesthesia. (2) Other conditions affecting the shoulder as (rheumatoid arthritis, osteoarthritis, rotator cuff disease, or malignancies). (3) Neurological deficits affecting shoulder function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants were blinded to which treatment they would receive.
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of both genders with unilateral primary adhesive capsulitis.
- •Patients aged between 40-
- •Pain duration of three months or more.
- •Range of motion loss of greater than 25% in at least 2 planes and passive external rotation loss that is greater than 50% of the uninvolved shoulder or less than 30° of external rotation.
Exclusion Criteria
- •Previous surgery or manipulation under anesthesia.
- •Other conditions affecting the shoulder as (rheumatoid arthritis, osteoarthritis, rotator cuff disease, or malignancies).
- •Neurological deficits affecting shoulder function.
Arms & Interventions
Static progressive stretch
Intervention: Static progressive stretching (Device)
Cyclic manual stretch
Intervention: Cyclic manual stretching (Other)
No treatment
Outcomes
Primary Outcomes
Function
Time Frame: Three months
The patient will be advised to select the number that best reflects the intensity of their discomfort and the degree of trouble they are having using the affected shoulder using SPADI.
Range of motion
Time Frame: Three months
Shoulder flexion, extension, abduction, external rotation and internal rotation will be measured using Baseline Digital Absolute Axis Goniometer
Secondary Outcomes
- Time to gain range motion(Three months)
Investigators
Shaimaa Ramadan Ibrahim Abdul-ghani El Deab
assistant lecturer
Cairo University