Adhesive CapsulitisNCT05338853
Comparative Effects of Gongs Mobilization and Scapular Mobilization on Adhesive Capsulitis
A study testing Gongs mobilization and scapular mobilization in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
Adhesive Capsulitis also known as frozen shoulder is a self-limiting disorder of the shoulder joint characterized by pain, loss of joint ROM and functional limitation which usually resolves in 12-15 months. 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 scapular mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Confirmed Adhesive Capsulitis patients (Stage 2 and 3)
- ROM restriction in capsular pattern (External rotation > abduction > internal rotation)
- Functional tests positive (Hand to neck, hand to scapula)
- Both active and passive movement ranges limited.
- Males and Females of age 40-60 years
Who cannot join
- Stage 1 Adhesive Capsulitis.
- Acute inflammation
- Recent fracture in and around the shoulder
- Recent shoulder dislocation
- Past surgery around shoulder joint
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Railway Hospital
Islamabad, Punjab Province, 54000
myera mudassir, MS
About this study
Official title: Comparative Effects of Gongs Mobilization and Scapular Mobilization on Pain, Range of Motion and Disability in Adhesive Capsulitis
Adhesive Capsulitis also known as frozen shoulder is a self-limiting disorder of the shoulder joint characterized by pain, loss of joint ROM and functional limitation which usually resolves in 12-15 months. I Different physical therapy techniques and modalities have been used in reducing pain and increasing ROM in frozen shoulder.
It is a randomized clinical trial and random sampling was used with an inclusion criterion of confirmed adhesive capsulitis patients. This study aims to provide a comparative analysis of two mobilizations: Gongs and Scapular mobilization in terms of effects on pain, range of motion and functional status. Patients having acute inflammation, fracture, dislocation or any surgery around the shoulder joint were excluded from the study. Subjects were randomly allocated into two groups with group A receiving Gongs mobilization and group B receiving scapular mobilization in addition to Continuous passive motion which was given as a baseline therapy to both the groups. Total duration of the study was 6 months. Numeric pain rating scale, universal goniometry and Shoulder pain and disability index were used to measure the pain, range of motion and functionality respectively at the start and end of study. After collecting data from defined study setting, data was entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25. After assessing normality of data by Shapiro-Wilk test, it was decided either parametric or non-parametric test to be used.
Read the detailed description
Adhesive Capsulitis also known as frozen shoulder is a self-limiting disorder of the shoulder joint characterized by pain, loss of joint ROM and functional limitation which usually resolves in 12-15 months. It develops when the glenohumeral capsule undergoes inflammation and is fibrosed as a result. Shoulder of an Adhesive capsulitis patient undergoes three stages; Freezing(0-6 months), Frozen (4 months-6 months) and Thawing(6 months- 2 years). Physical therapy is of considerable importance in management of adhesive capsulitis patients. Different physical therapy techniques and modalities have been used in reducing pain and increasing ROM in frozen shoulder.
It is a randomized clinical trial and random sampling was used with an inclusion criterion of confirmed adhesive capsulitis patients. This study aims to provide a comparative analysis of two mobilizations: Gongs and Scapular mobilization in terms of effects on pain, range of motion and functional status. Patients having acute inflammation, fracture, dislocation or any surgery around the shoulder joint were excluded from the study. Subjects were randomly allocated into two groups with group A receiving Gongs mobilization and group B receiving scapular mobilization in addition to Continuous passive motion which was given as a baseline therapy to both the groups. Total duration of the study was 6 months. Numeric pain rating scale, universal goniometry and Shoulder pain and disability index were used to measure the pain, range of motion and functionality respectively at the start and end of study. After collecting data from defined study setting, data was entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25. After assessing normality of data by Shapiro-Wilk test, it was decided either parametric or non-parametric test to be used.
- Conditions
- Adhesive Capsulitis
- Being tested
- Gongs mobilization, scapular mobilization
- Keywords
- Adhesive capsulitis, Gong's mobilization,
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gongs mobilizationOther
to deal adhesive capsulitis
scapular mobilizationOther
scapular mobilization
| Study group | Role | What they receive |
|---|---|---|
| Gongs Mmobilization | Experimental | to deal adhesive capsulitis Receives: Other: Gongs mobilization |
| scapular mobilization | Experimental | to deal adhesive capsulitis Receives: Other: scapular mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
The 11-point NPRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The respondent is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Measured: 4months
Degree of Range of motion
goniometer will be used to take ranges
Measured: 4 months
The Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start15 Jun 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2022 (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 Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Rabiya Noor, PhD, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338853
- Sponsor's protocol ID
- REC/RCR&AHS/22/0103
- Status last verified
- Jul 2022
- First submitted
- 15 Apr 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Gongs Mobilization and Scapular Mobilization on Pain, Range of Motion and Disability in Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT05338853
- Acronym / sponsor ID
- REC/RCR&AHS/22/0103
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive capsulitis, Gong's mobilization,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 21 Apr 2022 (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 also known as frozen shoulder is a self-limiting disorder of the shoulder joint characterized by pain, loss of joint ROM and functional limitation which usually resolves in 12-15 months. I Different physical therapy techniques and modalities have been used in reducing pain and increasing ROM in frozen shoulder.
It is a randomized clinical trial and random sampling was used with an inclusion criterion of confirmed adhesive capsulitis patients. This study aims to provide a comparative analysis of two mobilizations: Gongs and Scapular mobilization in terms of effects on pain, range of motion and functional status. Patients having acute inflammation, fracture, dislocation or any surgery around the shoulder joint were excluded from the study. Subjects were randomly allocated into two groups with group A receiving Gongs mobilization and group B receiving scapular mobilization in addition to Continuous passive motion which was given as a baseline therapy to both the groups. Total duration of the study was 6 months. Numeric pain rating scale, universal goniometry and Shoulder pain and disability index were used to measure the pain, range of motion and functionality respectively at the start and end of study. After collecting data from defined study setting, data was entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25. After assessing normality of data by Shapiro-Wilk test, it was decided either parametric or non-parametric test to be used.
Detailed description
Adhesive Capsulitis also known as frozen shoulder is a self-limiting disorder of the shoulder joint characterized by pain, loss of joint ROM and functional limitation which usually resolves in 12-15 months. It develops when the glenohumeral capsule undergoes inflammation and is fibrosed as a result. Shoulder of an Adhesive capsulitis patient undergoes three stages; Freezing(0-6 months), Frozen (4 months-6 months) and Thawing(6 months- 2 years). Physical therapy is of considerable importance in management of adhesive capsulitis patients. Different physical therapy techniques and modalities have been used in reducing pain and increasing ROM in frozen shoulder.
It is a randomized clinical trial and random sampling was used with an inclusion criterion of confirmed adhesive capsulitis patients. This study aims to provide a comparative analysis of two mobilizations: Gongs and Scapular mobilization in terms of effects on pain, range of motion and functional status. Patients having acute inflammation, fracture, dislocation or any surgery around the shoulder joint were excluded from the study. Subjects were randomly allocated into two groups with group A receiving Gongs mobilization and group B receiving scapular mobilization in addition to Continuous passive motion which was given as a baseline therapy to both the groups. Total duration of the study was 6 months. Numeric pain rating scale, universal goniometry and Shoulder pain and disability index were used to measure the pain, range of motion and functionality respectively at the start and end of study. After collecting data from defined study setting, data was entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25. After assessing normality of data by Shapiro-Wilk test, it was decided either parametric or non-parametric test to be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gongs Mmobilization | Experimental | Other: Gongs mobilizationto deal adhesive capsulitis |
| scapular mobilization | Experimental | Other: scapular mobilizationto deal adhesive capsulitis |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Confirmed Adhesive Capsulitis patients (Stage 2 and 3)
- ROM restriction in capsular pattern (External rotation > abduction > internal rotation)
- Functional tests positive (Hand to neck, hand to scapula)
- Both active and passive movement ranges limited.
- Males and Females of age 40-60 years
Key exclusion criteria (5 listed)
- Stage 1 Adhesive Capsulitis.
- Acute inflammation
- Recent fracture in and around the shoulder
- Recent shoulder dislocation
- Past surgery around shoulder joint
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 mobilizationto deal adhesive capsulitis | Other | Gongs Mmobilization |
| scapular mobilizationscapular mobilization | Other | scapular mobilization |
Primary outcome
Numeric pain rating scale
Time frame: 4months
The 11-point NPRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The respondent is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Degree of Range of motion
Time frame: 4 months
goniometer will be used to take ranges
The Shoulder Pain and Disability Index (SPADI)
Time frame: 4 months
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Adhesive Capsulitis
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Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
Active, not recruiting
Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
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.
Dr. Rabiya Noor, PhD study chair
Riphah International University
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 scapular mobilization in people with Adhesive Capsulitis, run by Riphah International 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Rabiya Noor, PhD (00923344355660, rabiya.noor@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 4months). The study lists 3 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 19 Jul 2022.