Frozen ShoulderSSMPNCT06763601
Effect of Shoulder Symptom Modification Procedure (SSMP) in Managing Patients with Frozen Shoulder
A study testing SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional program and MWM,Isometric exercise, eccentric exercise, heavy slow resistance , functional program in people with Frozen Shoulder, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional program and MWM,Isometric exercise, eccentric exercise, heavy slow resistance , functional program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jan 2025to 16 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- Having any history of shoulder dislocation
- Humerus fractures or trauma
- Diagnosed with any sort of cancer
- History of cardiovascular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Thumbay Physical Therapy and Rehabilitation Hospital
Ajman
sharmilla bano, +971 06 703 1555, info@thumbayrehab.com
Dr sharad patil, +971 06 703 1555
About this study
Official title: 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
- Conditions
- Frozen Shoulder
- Being tested
- SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional program, MWM,Isometric exercise, eccentric exercise, heavy slow resistance , functional program, sham mobilization
- Keywords
- SSMP, MWM, sham mobilization, frozen shoulder
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional programProcedure or surgery
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
MWM,Isometric exercise, eccentric exercise, heavy slow resistance , functional programProcedure or surgery
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
sham mobilizationProcedure or surgery
Sham mobilization followed by isometrics, eccentric training and heavy resistance training and finally the functional program .
| Study group | Role | What they receive |
|---|---|---|
| SSMP | Experimental | SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional program Receives: Procedure: SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional program |
| MWM | Experimental | MWM procedure followed by Isometric exercise, eccentric exercise, heavy slow resistance , functional program Receives: Procedure: MWM,Isometric exercise, eccentric exercise, heavy slow resistance , functional program |
| sham mobilization | Placebo comparator | Sham mobilization will be given for placebo effect followed by Isometric exercise, eccentric exercise, heavy slow resistance , functional program Receives: Procedure: sham mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain And Disability Index
shoulder pain and disability index is use to measure shoulder pain and disability where 0 is the best score and 130 is the worst
Measured: from enrollment to week 4,6,8
Numeric Pain Rating Scale
numeric pain rating scale where 0 indicates no pain and 10 indicates worst pain
Measured: from enrollment to 8 weeks
Secondary outcomes (2)
Range Of Motion
range of motion of shoulder joint that includes flexion, extension abduction, adduction, internal and external rotation
Measured: week 4,6,8
Patients' Global Impression of Change (PGIC) scale
PGIC is a 7 point scale depicting a patient's rating of overall improvement. where 1 indicates very much improved and 7 indicates worst
Measured: at enrollment and on 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Jan 2025
- Primary completion22 Mar 2025 (estimated)
- Study completion16 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- each participant will be randomly allocated one group. there are three groups in total
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763601
- Sponsor's protocol ID
- IRB-COHS-STD-112-Dec-2024
- Other IDs
- Internal review board
- Acronym
- SSMP
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Seemab A, Arulsingh W, Muthukrishnan R, Kandakurti PK, Saiyad R. Effectiveness of shoulder symptom modification approaches in managing patients with frozen shoulder: study protocol for a randomized sham-controlled trial. Trials. 2026 Apr 16;27(1):395. doi: 10.1186/s13063-026-09661-z.
PubMed 41992361
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shoulder Symptom Modification Procedure (SSMP) in Managing Patients with Frozen Shoulder: a Pilot Study
- ClinicalTrials.gov ID
- NCT06763601
- Acronym / sponsor ID
- SSMP / IRB-COHS-STD-112-Dec-2024
- Conditions
- Frozen Shoulder
- Keywords
- SSMP, MWM, sham mobilization, frozen shoulder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 22 Mar 2025 (estimated)
- Study completion
- 16 May 2025 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- each participant will be randomly allocated one group. there are three groups in total
| Arm | Type | Receives |
|---|---|---|
| SSMP | Experimental | Procedure: SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional programSSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional program |
| MWM | Experimental | Procedure: MWM,Isometric exercise, eccentric exercise, heavy slow resistance , functional programMWM procedure followed by Isometric exercise, eccentric exercise, heavy slow resistance , functional program |
| sham mobilization | Placebo comparator | Procedure: sham mobilizationSham mobilization will be given for placebo effect followed by Isometric exercise, eccentric exercise, heavy slow resistance , functional program |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Diagnosis of adhesive capsulitis confirmed by a healthcare professional.
Key exclusion criteria (4 listed)
- Having any history of shoulder dislocation
- Humerus fractures or trauma
- Diagnosed with any sort of cancer
- History of cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional programIn 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 | Procedure or surgery | SSMP |
| MWM,Isometric exercise, eccentric exercise, heavy slow resistance , functional programin this mobilization with movement in first phase will be given followed by isometrics, eccentrics and heavy slow resistance exercise and finally the functional program | Procedure or surgery | MWM |
| sham mobilizationSham mobilization followed by isometrics, eccentric training and heavy resistance training and finally the functional program . | Procedure or surgery | sham mobilization |
Primary outcome
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
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
2 secondary outcomes
Range Of Motion
Time frame: week 4,6,8
Patients' Global Impression of Change (PGIC) scale
Time frame: at enrollment and on 8th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Derived from this study: PubMed 41992361Seemab A, Arulsingh W, Muthukrishnan R, Kandakurti PK, Saiyad R. Effectiveness of shoulder symptom modification approaches in managing patients with frozen shoulder: study protocol for a randomized sham-controlled trial. Trials. 2026 Apr 16;27(1):395. doi: 10.1186/s13063-026-09661-z.
- Individual participant dataSharing planned: Undecided
Related trials for Frozen Shoulder
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
RecruitingPhase 4
Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
Frozen Shoulder
Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
Recruiting
Maitland Mobilization With and Without Stroking Release Technique of Rotator Cuff Muscle in Frozen Shoulder
Adhesive Capsulitis
Not yet recruiting
Spencer's Technique Versus Mulligan's Technique for Stage II Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional program and MWM,Isometric exercise, eccentric exercise, heavy slow resistance , functional program in people with Frozen Shoulder, run by Gulf Medical University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayesha seemab, BPT (+971502423798, 2023mpt08@mygmu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain And Disability Index (time frame: from enrollment to week 4,6,8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06763601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.