Adhesive CapsulitisNCT05779878
Comparative Effects of Myofascial Arm Pull Technique and Post Isometric Relaxation on Pain, Range of Motion and Functional Disability in Adhesive Capsulitis After Mastectomy
A study testing Post Isometric Relaxation and Myofascial arm pull technique in people with Adhesive Capsulitis, run by Sahreen Anwar at 1 site in Pakistan.
Trial summary
Adhesive capsulitis (AC) also known as frozen shoulder typically manifests to decrease range of motion (ROM) and function and increase pain in shoulder .Objective of the study is To compare the effects of Myofascial Arm Pull Technique and Post-isometric Relaxation on Pain, Range of Motion and functional disability in… Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Post Isometric Relaxation and Myofascial arm pull technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Mar 2023to 30 Jun 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Only Female gender
- Age between 25 to 50 years with post mastectomy.
- Diagnosis of breast cancer (grade 1to3 b).
- Post mastectomy state at least 6 months.
- Shoulder pain that began after the breast cancer surgery
Who cannot join
- Bilateral breast cancer.
- History of neurologic deficits affecting shoulder functioning during daily activites.
- On numeric pain rating scale pain will be less than 5.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Allied Hospital
Faisalābad, Punjab Province, 38000
Sobia Nawaz
drtalhahassan97@gmail.com
About this study
Adhesive capsulitis (AC) also known as frozen shoulder typically manifests to decrease range of motion (ROM) and function and increase pain in shoulder .Objective of the study is To compare the effects of Myofascial Arm Pull Technique and Post-isometric Relaxation on Pain, Range of Motion and functional disability in adhesive capsulitis after mastectomy. The study design will be a Randomized Clinical Trial that will be used to compare the effects of Myofascial arm pull technique with post isometric relaxation. Subject with adhesive capsulitis meeting the predetermined inclusion \& exclusion criteria will be divided into two groups. Pre assessment will be done using numeric pain rating scale NPRS for pain , shoulder pain and disability index (SPADI) tool for disability and Goniometer for Range of motion. Consent will be taken from patients by consent form the patients. They will be divided into two groups randomly by Random Number Generator table: Group A and Group B. For common treatment, both the groups will receive Ultrasound with a dosage of 1 MHz in frequency, continuous mode and 1.5 W/ cm2 of intensity for 10 minutes of treatment duration and Movement with mobilization will be applied for 15 times in 3 sets, and a 1- minute rest period was provided between each set. Group A will be given Post isometric relaxation technique with ultrasonic therapy. Group B will be given myofascial arm pull technique with ultrasonic. Total intervention protocol will be given for four weeks of duration 3 sessions per week with total 12 sessions. In Post isometric relaxation technique the therapist will slowly provide resistance in the direction of flexion, abduction, or external rotation, and without the subject intending to move for 15 minutes/ day, 3 times/week for 12 weeks. Similarly, myofascial arm pull technique the therapist will hold arm of the subject firmly and initial stretch will be applied in abduction and external rotation for 8-10 times in each session per day for 3 days/week for 4 weeks. Outcome measures will be measured at baseline, after 2 weeks and after 4 weeks. Data analysis will be done by SPSS version 25.
- Conditions
- Adhesive Capsulitis
- Being tested
- Post Isometric Relaxation, Myofascial arm pull technique
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Isometric RelaxationOther
Post-isometric relaxation (PIR) is a soft tissue stretching technique used by many health care professionals to lengthen both acute and chronic short muscles.
Myofascial arm pull techniqueOther
Myofascial therapy is described as the promotion of psychophysiological, neurological and structural adaptive capability as multiplexed via the myofascial system. Fascia covers all body structures, particularly muscles and their constituent myofibrils
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group A | Experimental | This group will be given Post isometric relaxation technique. Total intervention protocol will be given for four weeks of duration 3 sessions per week with total 12 sessions. Receives: Other: Post Isometric Relaxation |
| Interventional Group B | Experimental | This Group will be given myofascial arm pull technique . Total intervention protocol will be given for four weeks of duration 3 sessions per week with total 12 sessions. Receives: Other: Myofascial arm pull technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain in Shoulder Joint
Pain will be measured by using Numeric pain rating scale
Measured: 4 weeks
Range of motion in all planes
Range of motions in all planes will be measured by using goniometer
Measured: 4 weeks
Functional disability
Functional disability will be measured by using Shoulder Pain and Disability Index
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start9 Mar 2023
- Primary completion9 Jun 2023 (estimated)
- Study completion30 Jun 2023 (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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahreen Anwar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sahreen Anwar, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779878
- Sponsor's protocol ID
- REC_FSD_00319
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 22 Mar 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Myofascial Arm Pull Technique and Post Isometric Relaxation on Pain, Range of Motion and Functional Disability in Adhesive Capsulitis After Mastectomy
- ClinicalTrials.gov ID
- NCT05779878
- Acronym / sponsor ID
- REC_FSD_00319
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sahreen AnwarUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 9 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Mar 2023 (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) also known as frozen shoulder typically manifests to decrease range of motion (ROM) and function and increase pain in shoulder .Objective of the study is To compare the effects of Myofascial Arm Pull Technique and Post-isometric Relaxation on Pain, Range of Motion and functional disability in adhesive capsulitis after mastectomy. The study design will be a Randomized Clinical Trial that will be used to compare the effects of Myofascial arm pull technique with post isometric relaxation. Subject with adhesive capsulitis meeting the predetermined inclusion \& exclusion criteria will be divided into two groups. Pre assessment will be done using numeric pain rating scale NPRS for pain , shoulder pain and disability index (SPADI) tool for disability and Goniometer for Range of motion. Consent will be taken from patients by consent form the patients. They will be divided into two groups randomly by Random Number Generator table: Group A and Group B. For common treatment, both the groups will receive Ultrasound with a dosage of 1 MHz in frequency, continuous mode and 1.5 W/ cm2 of intensity for 10 minutes of treatment duration and Movement with mobilization will be applied for 15 times in 3 sets, and a 1- minute rest period was provided between each set. Group A will be given Post isometric relaxation technique with ultrasonic therapy. Group B will be given myofascial arm pull technique with ultrasonic. Total intervention protocol will be given for four weeks of duration 3 sessions per week with total 12 sessions. In Post isometric relaxation technique the therapist will slowly provide resistance in the direction of flexion, abduction, or external rotation, and without the subject intending to move for 15 minutes/ day, 3 times/week for 12 weeks. Similarly, myofascial arm pull technique the therapist will hold arm of the subject firmly and initial stretch will be applied in abduction and external rotation for 8-10 times in each session per day for 3 days/week for 4 weeks. Outcome measures will be measured at baseline, after 2 weeks and after 4 weeks. Data analysis will be done by SPSS version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group A | Experimental | Other: Post Isometric RelaxationThis group will be given Post isometric relaxation technique. Total intervention protocol will be given for four weeks of duration 3 sessions per week with total 12 sessions. |
| Interventional Group B | Experimental | Other: Myofascial arm pull techniqueThis Group will be given myofascial arm pull technique . Total intervention protocol will be given for four weeks of duration 3 sessions per week with total 12 sessions. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Only Female gender
- Age between 25 to 50 years with post mastectomy.
- Diagnosis of breast cancer (grade 1to3 b).
- Post mastectomy state at least 6 months.
- Shoulder pain that began after the breast cancer surgery
Key exclusion criteria (3 listed)
- Bilateral breast cancer.
- History of neurologic deficits affecting shoulder functioning during daily activites.
- On numeric pain rating scale pain will be less than 5.
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 |
|---|---|---|
| Post Isometric RelaxationPost-isometric relaxation (PIR) is a soft tissue stretching technique used by many health care professionals to lengthen both acute and chronic short muscles. | Other | Interventional Group A |
| Myofascial arm pull techniqueMyofascial therapy is described as the promotion of psychophysiological, neurological and structural adaptive capability as multiplexed via the myofascial system. Fascia covers all body structures, particularly muscles and their constituent myofibrils | Other | Interventional Group B |
Primary outcome
Pain in Shoulder Joint
Time frame: 4 weeks
Pain will be measured by using Numeric pain rating scale
Range of motion in all planes
Time frame: 4 weeks
Range of motions in all planes will be measured by using goniometer
Functional disability
Time frame: 4 weeks
Functional disability will be measured by using Shoulder Pain and Disability Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post Isometric Relaxation and Myofascial arm pull technique in people with Adhesive Capsulitis, run by Sahreen Anwar 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 3 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 22 Mar 2023. 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 Sahreen Anwar, Ph.D (00923346591705, sahreenanwar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain in Shoulder Joint (time frame: 4 weeks). 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 22 Mar 2023.