Adhesive Capsulitis of ShoulderNCT05325255
Effect of Myofascial Release of Subscapularis Along With Shoulder Mobilization in Adhesive Capsulitis
A study testing Myofascial release of subscapularis, Maitland mobilization and Stretching exercises in people with Adhesive Capsulitis of Shoulder, run by Dow University of Health Sciences at 2 sites in Pakistan.
Trial summary
This randomized control trial aims to compare the effect of myofascial release of subscapularis along with shoulder mobilization VS mobilization alone among patients with adhesive capsulitis. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- Myofascial release of subscapularis, Maitland mobilization and Stretching exercises
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesPakistan
- Study dates
- 26 Apr 2022to 30 Apr 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 40-65 years
- Diagnosed with sub-acute adhesive capsulitis
- Pain range of 3 to 8 on NPRS
- SPADI score of >40
- Presence of myofascial trigger point in subscapularis muscle
Who cannot join
- History of fracture
- Rheumatoid arthritis
- Shoulder osteoarthritis
- Any malignancy
- Shoulder dislocation
- Subacute adhesive capsulitis with impingement syndrome
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Sindh Institute Physical Medicine and Rehabilitation
Karachi, Sindh, 74200
Aftab Ahmed Mirza Baig, MSAPT, +923002739920, ab.dptrm@gmail.com
Umama Abbasi, DPT
- Recruiting
Dow University Hospital Ojha Campus
Karachi, Sindh
Umama Abbasi, PG student, +923122930340, umamaabbasi42@gmail.com
Umama Abbasi, DPT
About this study
Official title: Effect of Myofascial Release of Subscapularis Along With Shoulder Mobilization Versus Shoulder Mobilization Alone in Adhesive Capsulitis
This randomized control trial aims to compare the effect of myofascial release of subscapularis along with shoulder mobilization VS mobilization alone among patients with adhesive capsulitis. The study will be conducted at physiotherapy outpatient department (OPD) of Sindh Institute of physical medicine and rehabilitation, and Dow University Ojha Campus, Karachi. According to study criteria, 70 patients with sub-acute adhesive capsulitis will be selected through a non-randomized purposive sampling technique by a consultant physician. After taking informed consent, participants will be randomly divided into 2 groups through the sealed envelope method. Both the groups will receive conventional treatment while Group 1 will be given an additional treatment of myofascial release of subscapularis through ischemic compression technique. Total 6 treatment sessions will be provided and assessment will be done at baseline and end of the 6th session.
Read the detailed description
The sample size of 31 per group was determined using planning and specification software (PASS) version 15 software based on two independent sample t-test using 95%confidence interval and 80% power of the test. This sample was raised to 35 per group with 4 patients as drop out per group. Mean and standard deviation will be calculated for the quantitative variables while frequency and percentages will be calculated for qualitative variables. Inter-group comparison at baseline will be calculated using an independent sample t-test. The mean difference between both the techniques in terms of numeric pain rating scale (NPRS), range of motion (ROM), shoulder pain and disability index (SPADI), and pain pressure threshold(PPT) will be determined using Repeated measure 2-way ANOVA.
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- Myofascial release of subscapularis, Maitland mobilization, Stretching exercises, Cold pack
- Keywords
- Adhesive capsulitis, Muscle stretching exercise, Myofascial trigger point, Range of motion, Pain
- Medical subject headings
- Bursitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial release of subscapularisOther
It is the application of manual pressure over myofascial trigger point that induces ischemia and causes release of trigger points
Maitland mobilizationOther
It is the type of mobilization technique that uses passive accessory mobilization to reduce pain and stiffness and increasing range of motion
Stretching exercisesOther
It is the technique use to increase flexibility and range of motion of short and hypomobile structures
Cold packOther
It is the application of cold to provide analgesic effects
| Study group | Role | What they receive |
|---|---|---|
| Maitland mobilization with myofascial trigger point release group | Experimental | Maitland technique: caudal, anteroposterior (AP), and posteroanterior (PA) glides 5 sets of 2-3 glides per second of Grade III and IV for 30 seconds with a rest interval of 30 second between sets.
Ischemic Compression technique: on subscapularis trigger points for 90 secs thrice a week for 2 weeks.
Stretching exercises in direction of abduction, external rotation (ER), internal rotation (IR), and flexion. 6 repetitions of each stretch for 10 seconds Cold pack for 20 mins Receives: Other: Myofascial release of subscapularis; Other: Maitland mobilization; Other: Stretching exercises; Other: Cold pack |
| Maitland mobilization alone group | Active comparator | Maitland technique: caudal, anteroposterior (AP), and posteroanterior (PA) glides 5 sets of 2-3 glides per second of Grade III and IV for 30 seconds with a rest interval of 30 second between sets.
Stretching exercises in direction of abduction, external rotation (ER), internal rotation (IR), and flexion. 6 repetitions of each stretch for 10 seconds Cold pack for 20 mins Receives: Other: Maitland mobilization; Other: Stretching exercises; Other: Cold pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pain intensity on Numeric Pain Rating Scale in scores at 6th session (10 days)
It will be use to assess pain intensity. It will be administered by simply asking the intensity of pain experienced in last 24 hours. The response of 0 represent no pain rather the responses between 1-3, 4-6, and 7-9 represents mild, moderate, and severe pain respectively. While 10 is the worst possible pain ever experienced by the person
Measured: At baseline and after 6 sessions (10 days)
Change from baseline joint range of motion on universal goniometer in degrees at 6th session (10 days)
It will be assessed by using standard universal goniometer and measured in degrees
Measured: At baseline and after 6 sessions (10 days)
change from baseline shoulder disability on Shoulder pain and disability index in percentage at 6th session (10 days)
Shoulder pain and disability index is used to assess shoulder disability. It consist of 13 questions i .e. 5 to assess pain and 8 to assess disability. Results will be calculated in percentage and higher results indicate increased disability. lower the percentage better will be the outcome.
Measured: At baseline and after 6 sessions (10 days)
Change from baseline pain pressure threshold on algometer in kilogram/centimeter2 at 6th session (10 days)
assessed through algometer which provide sustained pressure from 0.05Newton/second to 20 Newton/second. Results will be recorded in kilogram/centimeter2 and higher values indicate decrease sensitivity of myofascial trigger points
Measured: At baseline and after 6 sessions (10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start26 Apr 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umama Abbasi, Dow University of Health Sciences
- Investigators
- Umama Abbasi, DPT, Principal investigator, Dow University of Health SciencesRabail R Soomro, PhD Scholar, Study director, Sindh Institute of Physical Medicine and RehabilitationAftab Ahmed Mirza Baig, MSAPT, Study director, Sindh Institute of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325255
- Sponsor's protocol ID
- UAbbasi
- Status last verified
- Feb 2023
- First submitted
- 28 Mar 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myofascial Release of Subscapularis Along With Shoulder Mobilization Versus Shoulder Mobilization Alone in Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT05325255
- Acronym / sponsor ID
- UAbbasi
- Conditions
- Adhesive Capsulitis of Shoulder
- Keywords
- Adhesive capsulitis, Muscle stretching exercise, Myofascial trigger point, Range of motion, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 13 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.
This randomized control trial aims to compare the effect of myofascial release of subscapularis along with shoulder mobilization VS mobilization alone among patients with adhesive capsulitis. The study will be conducted at physiotherapy outpatient department (OPD) of Sindh Institute of physical medicine and rehabilitation, and Dow University Ojha Campus, Karachi. According to study criteria, 70 patients with sub-acute adhesive capsulitis will be selected through a non-randomized purposive sampling technique by a consultant physician. After taking informed consent, participants will be randomly divided into 2 groups through the sealed envelope method. Both the groups will receive conventional treatment while Group 1 will be given an additional treatment of myofascial release of subscapularis through ischemic compression technique. Total 6 treatment sessions will be provided and assessment will be done at baseline and end of the 6th session.
Detailed description
The sample size of 31 per group was determined using planning and specification software (PASS) version 15 software based on two independent sample t-test using 95%confidence interval and 80% power of the test. This sample was raised to 35 per group with 4 patients as drop out per group. Mean and standard deviation will be calculated for the quantitative variables while frequency and percentages will be calculated for qualitative variables. Inter-group comparison at baseline will be calculated using an independent sample t-test. The mean difference between both the techniques in terms of numeric pain rating scale (NPRS), range of motion (ROM), shoulder pain and disability index (SPADI), and pain pressure threshold(PPT) will be determined using Repeated measure 2-way ANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maitland mobilization with myofascial trigger point release group | Experimental | Other: Myofascial release of subscapularis, Other: Maitland mobilization, Other: Stretching exercises, Other: Cold packMaitland technique: caudal, anteroposterior (AP), and posteroanterior (PA) glides 5 sets of 2-3 glides per second of Grade III and IV for 30 seconds with a rest interval of 30 second between sets. Ischemic Compression technique: on subscapularis trigger points for 90 secs thrice a week for 2 weeks. Stretching exercises in direction of abduction, external rotation (ER), internal rotation (IR), and flexion. 6 repetitions of each stretch for 10 seconds Cold pack for 20 mins |
| Maitland mobilization alone group | Active comparator | Other: Maitland mobilization, Other: Stretching exercises, Other: Cold packMaitland technique: caudal, anteroposterior (AP), and posteroanterior (PA) glides 5 sets of 2-3 glides per second of Grade III and IV for 30 seconds with a rest interval of 30 second between sets. Stretching exercises in direction of abduction, external rotation (ER), internal rotation (IR), and flexion. 6 repetitions of each stretch for 10 seconds Cold pack for 20 mins |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged between 40-65 years
- Diagnosed with sub-acute adhesive capsulitis
- Pain range of 3 to 8 on NPRS
- SPADI score of >40
- Presence of myofascial trigger point in subscapularis muscle
Key exclusion criteria (6 listed)
- History of fracture
- Rheumatoid arthritis
- Shoulder osteoarthritis
- Any malignancy
- Shoulder dislocation
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 |
|---|---|---|
| Myofascial release of subscapularisIt is the application of manual pressure over myofascial trigger point that induces ischemia and causes release of trigger points | Other | Maitland mobilization with myofascial trigger point release group |
| Maitland mobilizationIt is the type of mobilization technique that uses passive accessory mobilization to reduce pain and stiffness and increasing range of motion | Other | Maitland mobilization alone group, Maitland mobilization with myofascial trigger point release group |
| Stretching exercisesIt is the technique use to increase flexibility and range of motion of short and hypomobile structures | Other | Maitland mobilization alone group, Maitland mobilization with myofascial trigger point release group |
| Cold packIt is the application of cold to provide analgesic effects | Other | Maitland mobilization alone group, Maitland mobilization with myofascial trigger point release group |
Primary outcome
Change from baseline pain intensity on Numeric Pain Rating Scale in scores at 6th session (10 days)
Time frame: At baseline and after 6 sessions (10 days)
It will be use to assess pain intensity. It will be administered by simply asking the intensity of pain experienced in last 24 hours. The response of 0 represent no pain rather the responses between 1-3, 4-6, and 7-9 represents mild, moderate, and severe pain respectively. While 10 is the worst possible pain ever experienced by the person
Change from baseline joint range of motion on universal goniometer in degrees at 6th session (10 days)
Time frame: At baseline and after 6 sessions (10 days)
It will be assessed by using standard universal goniometer and measured in degrees
change from baseline shoulder disability on Shoulder pain and disability index in percentage at 6th session (10 days)
Time frame: At baseline and after 6 sessions (10 days)
Shoulder pain and disability index is used to assess shoulder disability. It consist of 13 questions i .e. 5 to assess pain and 8 to assess disability. Results will be calculated in percentage and higher results indicate increased disability. lower the percentage better will be the outcome.
Change from baseline pain pressure threshold on algometer in kilogram/centimeter2 at 6th session (10 days)
Time frame: At baseline and after 6 sessions (10 days)
assessed through algometer which provide sustained pressure from 0.05Newton/second to 20 Newton/second. Results will be recorded in kilogram/centimeter2 and higher values indicate decrease sensitivity of myofascial trigger points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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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.
Umama Abbasi, DPT principal investigator
Dow University of Health Sciences
Rabail R Soomro, PhD Scholar study director
Sindh Institute of Physical Medicine and Rehabilitation
Aftab Ahmed Mirza Baig, MSAPT study director
Sindh Institute of Physical Medicine and Rehabilitation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release of subscapularis, Maitland mobilization and Stretching exercises in people with Adhesive Capsulitis of Shoulder, run by Dow University of Health Sciences at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Umama Abbasi, DPT (+923122930340, umamaabbasi42@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain intensity on Numeric Pain Rating Scale in scores at 6th session (10 days) (time frame: At baseline and after 6 sessions (10 days)). The study lists 4 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 16 Feb 2023.