- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07328295
Additional Effects of Thoracic Spine Mobilization Combined With Glenohumeral Joint Mobilization on Pain, Range of Motion, and Functional Disability in Adhesive Capsulitis
Adhesive capsulitis is a debilitating shoulder condition characterized by pain, restricted range of motion (ROM), and significant functional limitations. Conventional treatment primarily targets the glenohumeral joint, often neglecting the role of regional interdependence, particularly the thoracic spine's influence on shoulder mobility. Emerging evidence suggests that thoracic spine mobility plays a crucial role in optimizing shoulder mechanics, yet its therapeutic application in adhesive capsulitis remains underexplored. This study aims to investigate the additional effects of thoracic spine mobilization combined with glenohumeral joint mobilization, providing a more comprehensive rehabilitation approach to enhance pain relief, ROM, and functional outcomes.
A randomized controlled trial (RCT) will be conducted over one year at the Rehabilitation Department of Fauji Foundation Hospital (FFH) after obtaining ethical approval. Participants diagnosed with adhesive capsulitis will be selected through non-probability purposive sampling based on predefined inclusion and exclusion criteria. Subjects will be randomly assigned to either the experimental group receiving thoracic spine mobilization alongside glenohumeral joint mobilization or the control group receiving glenohumeral joint mobilization alone. Randomization will be conducted using the coin toss method and block randomization to ensure balanced subject distribution.
Outcome measures include the Numeric Pain Rating Scale (NPRS) for pain assessment, the Shoulder Pain and Disability Index (SPADI) for functional disability evaluation, and a goniometer for ROM measurement. Baseline and post-treatment scores will be statistically analyzed using SPSS to determine intervention effectiveness. By integrating thoracic spine mobilization into standard treatment, this study seeks to refine clinical rehabilitation protocols, improve functional recovery, and enhance patient outcomes. Findings may contribute to evidence-based practice, supporting the inclusion of thoracic spine mobilization in treatment guidelines for adhesive capsulitis.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laiba Malik, DPT
- Phone Number: +3495049904
- Email: mlaiba085@gmail.com
Study Contact Backup
- Name: Marwa Asim, MS-OMPT
- Phone Number: +923335339457
- Email: marwa.asim17@gmail.com
Study Locations
-
-
Punjab Province
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Islamabad, Punjab Province, Pakistan, 46000
- Recruiting
- Foundation University College of Physical Therapy
-
Contact:
- Laiba Malik, DPT
- Phone Number: +923495049904
- Email: mlaiba085@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Both male and female patients with a primary complaint of unilateral or bilateral shoulder pain
- Pain has persisted for at least 3 to 4 months
- Decreased shoulder ROM observed, including external shoulder rotation, abduction, internal rotation, and flexion
- Age range between 40 to 65 years
- Diagnosed with stage 2nd or 3rd of the disease.
Exclusion Criteria:
• Patients if they had any shoulder pain resulting from systematic disease such as Rheumatoid Arthritis (morning stiffness > 1 hour, multiple small joints pain/swelling) Infection, Tumors, and conditions like myelopathy (Hoffman's sign).
- Recent shoulder joint fracture/ trauma.
- Thoracic Outlet Syndrome (Roos test).
- The presence of Cervical radiculopathy (Spurling's test)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Thoracic spine mobilization with Glenohumeral joint mobilization
Participant receive Thoracic spine mobilization with Glenohumeral joint mobilization to enhance shoulder mechanics and outcomes
|
Thoracic spine mobilization: Central posterior-anterior (PA) oscillatory mobilizations in prone position; 30 repetitions per set, with a 1-minute rest between 2 sets. Glenohumeral joint mobilization: Oscillatory techniques, 2-3 oscillations per second for 30 seconds, repeated for 5 sets. |
|
Active Comparator: Glenohumeral joint mobilization
Participant receive Glenohumeral joint mobilization only to enhance shoulder mechanics and outcomes
|
Glenohumeral joint mobilization only Technique: Oscillatory mobilizations, 2-3 oscillations per second for 30 seconds, repeated for 5 sets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 4 weeks
|
Pain intensity will be checked by Numeric pain rating scale NPRS, where patient will rate pain from 0 to 10, 0 being no pain and 10 means worst pain.
|
4 weeks
|
|
Functional disability
Time Frame: 4 weeks
|
Shoulder Pain and Disability Index (SPADI) used to assess functional disability and it is 13-question survey (5 pain, 8 disability) on a 0-100 scale, where 0 is best (no pain/difficulty) and 100 is worst (severe pain/complete disability), indicating higher scores mean greater impairment; it's interpreted by looking at general ranges (0-20 mild, 21-40 moderate, etc.) and tracking changes (a 10-20 point shift suggests clinical significance) to gauge treatment effectiveness.
|
4 weeks
|
|
Shoulder Range of Motion
Time Frame: 4 weeks
|
Goniometer used to measure shoulder joint range of motion.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2025/22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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