- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06763601
Effect of Shoulder Symptom Modification Procedure (SSMP) in Managing Patients with Frozen Shoulder (SSMP)
January 7, 2025 updated by: Gulf Medical University
Effect of Shoulder Symptom Modification Procedure (SSMP) in Managing Patients with Frozen Shoulder: a Pilot Study
the study is about intervention to patient with frozen shoulder to help patients improve function and shoulder disability , reduce pain and improve range of motion, the main aim of this study is to find out which treatment intervention SSMP , MWM and sham mobilization give effective results
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ayesha seemab, BPT
- Phone Number: +971502423798
- Email: 2023mpt08@mygmu.ac.ae
Study Contact Backup
- Name: Watson Watson Arulsingh, PhD
- Phone Number: +971505708763
- Email: dr.watson@gmu.ac.ae
Study Locations
-
-
-
Ajman, United Arab Emirates
- Recruiting
- Thumbay Physical Therapy and Rehabilitation Hospital
-
Contact:
- sharmilla bano
- Phone Number: +971 06 703 1555
- Email: info@thumbayrehab.com
-
Contact:
- Dr sharad patil
- Phone Number: +971 06 703 1555
-
Contact:
- Ayesha seemab
-
Contact:
- Arulsingh
-
Contact:
- Dr ram prasad muthukrishna
-
Contact:
- Dr sharad Patil
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• Diagnosis of adhesive capsulitis confirmed by a healthcare professional.
- Scores more than 2 in adhesive capsulitis scale
- Range of motion affected in capsular pattern
- Age between 40-65 years.
- Willingness to participate by signing informed consent
Exclusion Criteria:
- Having any history of shoulder dislocation
- Humerus fractures or trauma
- Diagnosed with any sort of cancer
- History of cardiovascular disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SSMP
SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional program
|
In this group the patients will be given symptom modification procedure in the first phase followed by isometric exercises in second phase, eccentrics and HSR in third phase and functional program in fourth phase
|
|
Experimental: MWM
MWM procedure followed by Isometric exercise, eccentric exercise, heavy slow resistance , functional program
|
in this mobilization with movement in first phase will be given followed by isometrics, eccentrics and heavy slow resistance exercise and finally the functional program
|
|
Placebo Comparator: sham mobilization
Sham mobilization will be given for placebo effect followed by Isometric exercise, eccentric exercise, heavy slow resistance , functional program
|
Sham mobilization followed by isometrics, eccentric training and heavy resistance training and finally the functional program .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Pain And Disability Index
Time Frame: from enrollment to week 4,6,8
|
shoulder pain and disability index is use to measure shoulder pain and disability where 0 is the best score and 130 is the worst
|
from enrollment to week 4,6,8
|
|
Numeric Pain Rating Scale
Time Frame: from enrollment to 8 weeks
|
numeric pain rating scale where 0 indicates no pain and 10 indicates worst pain
|
from enrollment to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range Of Motion
Time Frame: week 4,6,8
|
range of motion of shoulder joint that includes flexion, extension abduction, adduction, internal and external rotation
|
week 4,6,8
|
|
Patients' Global Impression of Change (PGIC) scale
Time Frame: at enrollment and on 8th week
|
PGIC is a 7 point scale depicting a patient's rating of overall improvement.
where 1 indicates very much improved and 7 indicates worst
|
at enrollment and on 8th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2025
Primary Completion (Estimated)
March 22, 2025
Study Completion (Estimated)
May 16, 2025
Study Registration Dates
First Submitted
December 11, 2024
First Submitted That Met QC Criteria
January 7, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 7, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-COHS-STD-112-Dec-2024
- Internal review board (Other Identifier: Gulf medical University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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-
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Clinical Trials on SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional program
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-
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-
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-
Bispebjerg HospitalFonden for Faglig Udvikling af Speciallægepraksis, DenmarkCompleted