Adhesive CapsulitisNCT06913361
Effects of Gongs Mobilization vs Reverse Distraction Technique in Diabetic Patients With Adhesive Capsulitis
A study testing Gongs Mobilization and Reverse Distraction Technique in people with Adhesive Capsulitis, run by Superior University at 1 site in Pakistan.
Trial summary
Adhesive capsulitis (AC) represents a renowned musculoskeletal condition which has been clinically classified as frozen shoulder (FS). Adhesive capsulitis occurs 3-5% of the time in the general population, but in diabetics, the frequency can reach 20%. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Gongs Mobilization and Reverse Distraction Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 10 Feb 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both males and females.
- Diagnosed case of Unilateral Adhesive Capsulitis.
- Age group of 40-60 years.
- Stage 2 and 3 of Adhesive Capsulitis.
- Diabetes Mellitus Type II.
- Patients with decreased ROM (less than or equal to 120 degrees), pain, and mild to moderate levels of type II diabetics (below or equal to 200 mg/dL).
- No history of shoulder surgeries to the affected shoulder.
Who cannot join
- Systemic arthritic conditions of the shoulder (Rheumatoid arthritis, osteoporosis or malignancies in the shoulder region) .
- Disorders of the Cervical spine .
- Corticosteroids injections in the affected Shoulder in preceding 6 weeks.
- Skin lesions or bruises around the Shoulder.
- Shoulder injuries such as Rotator cuff tear.
- Fracture in and around the shoulder joint.
Trial locations and contacts
1 site in 1 country.
About this study
Adhesive capsulitis (AC) represents a renowned musculoskeletal condition which has been clinically classified as frozen shoulder (FS). Adhesive capsulitis occurs 3-5% of the time in the general population, but in diabetics, the frequency can reach 20%. This study is being conducted to determine the effects of gongs mobilization vs reverse distraction technique in diabetic patients with adhesive capsulitis. This study will be a randomized control trial and data will be collected from Haq Orthopedic Hospital. Sample size is 20 calculated by using G power and adding 20 % attrition.
Read the detailed description
Non-Probability convenient sampling will be used. Participants meeting the inclusion and exclusion criteria will be divided into two groups.10 subjects in group A will be treated Gongs mobilization and group B will be treated with Reverse distraction technique. Conventional therapy will be given to both groups as base line treatment. Both groups have 4 sessions per week for 4 weeks. All participants will be evaluated before and after the treatment using Numeric Pain Rating scale (NPRS), Shoulder pain and Disability Index (SPADI) and goniometer.
- Conditions
- Adhesive Capsulitis
- Being tested
- Gongs Mobilization, Reverse Distraction Technique
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gongs MobilizationDiagnostic test
The treatment begins with moist heat for 10 minutes, Gong's mobilization with conventional therapy for 8 minutes. The total treatment time was 45 minutes once a day for four days per week for four weeks.
Reverse Distraction TechniqueCombination product
The treatment begins with moist heat for 10 minutes, Reverse Distraction technique with conventional therapy for 8 minutes. The total treatment time was 45 minutes once a day for four days per week for four weeks. Position of the patient: side-lying. The patient is lying at the plinth's edge on the unaffected side. In front of the patient is the therapist's position.
| Study group | Role | What they receive |
|---|---|---|
| Gongs Mobilization | Experimental | Not described Receives: Diagnostic Test: Gongs Mobilization |
| Reverse Distraction Technique | Experimental | Not described Receives: Combination Product: Reverse Distraction Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
NUMERIC PAIN RATING SCALE (NPRS)
Value of sensitivity/specificity/ validity/reliability: intra-class correlation coefficient 0.58 to 0.93. Measurement: Numerical Interpretation: The Numeric Pain Rating Scale (NPRS) is a simple and widely used tool for assessing pain intensity. Patients rate their pain on a scale from 0 to 10, where 0 indicates ""no pain"" and 10 indicates ""worst pain imaginable."" The interpretation of NPRS scores helps classify pain severity and monitor changes over time.
Measured: 12 Months
SHOULDER PAIN AND DISABILITY INDEX
The items of the questionnaire are assessed on a 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability. The sum of the seven items equals the total score of the PDI, which ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913361
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/791
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gongs Mobilization vs Reverse Distraction Technique in Diabetic Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06913361
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/791
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 6 Apr 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.
Adhesive capsulitis (AC) represents a renowned musculoskeletal condition which has been clinically classified as frozen shoulder (FS). Adhesive capsulitis occurs 3-5% of the time in the general population, but in diabetics, the frequency can reach 20%. This study is being conducted to determine the effects of gongs mobilization vs reverse distraction technique in diabetic patients with adhesive capsulitis. This study will be a randomized control trial and data will be collected from Haq Orthopedic Hospital. Sample size is 20 calculated by using G power and adding 20 % attrition.
Detailed description
Non-Probability convenient sampling will be used. Participants meeting the inclusion and exclusion criteria will be divided into two groups.10 subjects in group A will be treated Gongs mobilization and group B will be treated with Reverse distraction technique. Conventional therapy will be given to both groups as base line treatment. Both groups have 4 sessions per week for 4 weeks. All participants will be evaluated before and after the treatment using Numeric Pain Rating scale (NPRS), Shoulder pain and Disability Index (SPADI) and goniometer.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gongs Mobilization | Experimental | Diagnostic Test: Gongs Mobilization |
| Reverse Distraction Technique | Experimental | Combination Product: Reverse Distraction Technique |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Both males and females.
- Diagnosed case of Unilateral Adhesive Capsulitis.
- Age group of 40-60 years.
- Stage 2 and 3 of Adhesive Capsulitis.
- Diabetes Mellitus Type II.
Key exclusion criteria (6 listed)
- Systemic arthritic conditions of the shoulder (Rheumatoid arthritis, osteoporosis or malignancies in the shoulder region) .
- Disorders of the Cervical spine .
- Corticosteroids injections in the affected Shoulder in preceding 6 weeks.
- Skin lesions or bruises around the Shoulder.
- Shoulder injuries such as Rotator cuff tear.
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 |
|---|---|---|
| Gongs MobilizationThe treatment begins with moist heat for 10 minutes, Gong's mobilization with conventional therapy for 8 minutes. The total treatment time was 45 minutes once a day for four days per week for four weeks. | Diagnostic test | Gongs Mobilization |
| Reverse Distraction TechniqueThe treatment begins with moist heat for 10 minutes, Reverse Distraction technique with conventional therapy for 8 minutes. The total treatment time was 45 minutes once a day for four days per week for four weeks. Position of the patient: side-lying. The patient is lying at the plinth's edge on the unaffected side. In front of the patient is the therapist's position. | Combination product | Reverse Distraction Technique |
Primary outcome
NUMERIC PAIN RATING SCALE (NPRS)
Time frame: 12 Months
Value of sensitivity/specificity/ validity/reliability: intra-class correlation coefficient 0.58 to 0.93. Measurement: Numerical Interpretation: The Numeric Pain Rating Scale (NPRS) is a simple and widely used tool for assessing pain intensity. Patients rate their pain on a scale from 0 to 10, where 0 indicates ""no pain"" and 10 indicates ""worst pain imaginable."" The interpretation of NPRS scores helps classify pain severity and monitor changes over time.
SHOULDER PAIN AND DISABILITY INDEX
Time frame: 12 Months
The items of the questionnaire are assessed on a 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability. The sum of the seven items equals the total score of the PDI, which ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities
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 6 Apr 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gongs Mobilization and Reverse Distraction Technique in people with Adhesive Capsulitis, run by Superior University at 1 site in Pakistan.
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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 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 Pakistan. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NUMERIC PAIN RATING SCALE (NPRS) (time frame: 12 Months). 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?
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 6 Apr 2025.