Adhesive CapsulitisNCT06108843
Effects of the Myofascial Arm Pull With and Without Active Release Technique in Adhesive Capsulitis
A study testing Myofascial Arm Pull and Active Release Technique and Myofacial Arm Pull in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the study is to determine the effects of the myofascial arm pull with and without active release technique on pain, ROM and disability in adhesive capsulitis. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Myofascial Arm Pull and Active Release Technique and Myofacial Arm Pull
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 8 May 2023to Jan 2024
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both Male and Female; mean age (35-60).
- Case diagnosed with adhesive capsulitis, both primary and secondary origin.
- Freezing stage of adhesive capsulitis.
- Those with at least a 50% reduction in the range of motion (ROM).
Who cannot join
- History of shoulder surgery or manipulation under anesthesia, local corticosteroid injection administration to the affected shoulder within the last 3 months.
- Neurological deficit affecting the shoulder functioning during daily activities.
- Pathology of the shoulder joint other than adhesive capsulitis.
- Pain or disorder of the cervical spine, elbow, wrist or hand.
- Patients diagnosed with cancer
Trial locations and contacts
1 site in 1 country.
IMRAN AMJAD, PHD contact
Pakistan1 site, 1 recruiting
- Recruiting
Arif Memorial Teaching Hospital
Lahore, Punjab Province
FAIZA AMJAD, M.PHILL, 03338013182, faiza.amjad@riphah.edu.pk
KOMAL JAVED, MS-OMPT
About this study
Official title: Effects of the Myofascial Arm Pull With and Without Active Release Technique on Pain, Range of Motion and Disability in Adhesive Capsulitis
The aim of the study is to determine the effects of the myofascial arm pull with and without active release technique on pain, ROM and disability in adhesive capsulitis.
Read the detailed description
Adhesive capsulitis (frozen shoulder), a painful disorder caused by capsular inflammation that results in fibrosis and rigidity of the glenohumeral joint capsule, is characterized by a progressive loss of both active and passive glenohumeral movements. Frozen shoulder can be primary (also known as idiopathic) if there is no underlying cause of disease or it can be secondary. The term "secondary frozen shoulder" is associated with injury, trauma, cardiovascular diseases, hemiparesis, or diabetes.Active release technique and myofascial arm pull technique are both effective treatment options for patients with adhesive capsulitis. These techniques help to improve range of motion and reduce pain by releasing tension and adhesions in the affected area. Active release technique focuses on releasing tension and adhesions in the soft tissues surrounding the affected joint, while the Myofascial arm pull technique aims to improve range of motion by stretching the muscle and fascia in the affected area. By incorporating these techniques into a comprehensive treatment plan, patients of adhesive capsulitis can see significant improvement in their pain, range of motion and disability.
Because the method of treatment is inexpensive, findings of this study could be beneficial in revision of the clinical protocols to manage the patients of adhesive capsulitis.
- Conditions
- Adhesive Capsulitis
- Being tested
- Myofascial Arm Pull and Active Release Technique, Myofacial Arm Pull
- Keywords
- Adhesive Capsulitis, Active Release Technique, Myofacial Arm Pull Technique, Pain, Range of Motion
- 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 Arm Pull and Active Release TechniqueOther
Six weekly sessions of the treatment will be given over the course of four weeks. Baseline treatment includes Ultrasound for 10 minutes.
Myofacial Arm PullOther
Six weekly sessions of the treatment will be given over the course of four weeks. Baseline treatment includes Ultrasound for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial arm pull technique and Active Release Technique | Experimental | Participant will receive both Myofascial arm pull and active release technique along with Ultrasound therapy. Receives: Other: Myofascial Arm Pull and Active Release Technique |
| Myofascial arm pull technique | Active comparator | Participant will receive Myofascial arm pull along with ultrasound therapy. Receives: Other: Myofacial Arm Pull |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and disability index (SPADI)
Changes from Baseline. The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability
Measured: 4 week
Goniometer
Changes from Baseline. Physical therapists use goniometry to objectively measure passive and active range of motion (ROM).
Measured: 4 week
Numeric Pain Rating Scale (NPRS)
Changes from Baseline. The NPRS is a self-reported, or clinician administered, measurement tool The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10.
0=No pain
1 to 4=Mild pain. 5 or 6=Moderate pain 7 to 10=Severe pain
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start8 May 2023
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Model description
- A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FAIZA AMJAD, M.PHILL, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108843
- Sponsor's protocol ID
- REC/RCR&AHS/23/0162
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dogru H, Basaran S, Sarpel T. Effectiveness of therapeutic ultrasound in adhesive capsulitis. Joint Bone Spine. 2008 Jul;75(4):445-50. doi: 10.1016/j.jbspin.2007.07.016. Epub 2008 May 2.
PubMed 18455944Sumariva-Mateos J, Leon-Valenzuela A, Vinolo-Gil MJ, Bautista Troncoso J, Del Pino Algarrada R, Carmona-Barrientos I. Efficacy of myofascial therapy and kinesitherapy in improving function in shoulder pathology with prolonged immobilization: A randomized, single-blind, controlled trial. Complement Ther Clin Pract. 2022 Aug;48:101580. doi: 10.1016/j.ctcp.2022.101580. Epub 2022 Apr 4.
PubMed 35397306Breckenridge JD, McAuley JH. Shoulder Pain and Disability Index (SPADI). J Physiother. 2011;57(3):197. doi: 10.1016/S1836-9553(11)70045-5.
PubMed 21843839Angst F, Goldhahn J, Pap G, Mannion AF, Roach KE, Siebertz D, Drerup S, Schwyzer HK, Simmen BR. Cross-cultural adaptation, reliability and validity of the German Shoulder Pain and Disability Index (SPADI). Rheumatology (Oxford). 2007 Jan;46(1):87-92. doi: 10.1093/rheumatology/kel040. Epub 2006 May 23.
PubMed 16720638Mullaney MJ, McHugh MP, Johnson CP, Tyler TF. Reliability of shoulder range of motion comparing a goniometer to a digital level. Physiother Theory Pract. 2010 Jul;26(5):327-33. doi: 10.3109/09593980903094230.
PubMed 20557263Gajdosik RL, Bohannon RW. Clinical measurement of range of motion. Review of goniometry emphasizing reliability and validity. Phys Ther. 1987 Dec;67(12):1867-72. doi: 10.1093/ptj/67.12.1867.
PubMed 3685114
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Myofascial Arm Pull With and Without Active Release Technique on Pain, Range of Motion and Disability in Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06108843
- Acronym / sponsor ID
- REC/RCR&AHS/23/0162
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive Capsulitis, Active Release Technique, Myofacial Arm Pull Technique, Pain, Range of Motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 31 Oct 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.
The aim of the study is to determine the effects of the myofascial arm pull with and without active release technique on pain, ROM and disability in adhesive capsulitis.
Detailed description
Adhesive capsulitis (frozen shoulder), a painful disorder caused by capsular inflammation that results in fibrosis and rigidity of the glenohumeral joint capsule, is characterized by a progressive loss of both active and passive glenohumeral movements. Frozen shoulder can be primary (also known as idiopathic) if there is no underlying cause of disease or it can be secondary. The term "secondary frozen shoulder" is associated with injury, trauma, cardiovascular diseases, hemiparesis, or diabetes.Active release technique and myofascial arm pull technique are both effective treatment options for patients with adhesive capsulitis. These techniques help to improve range of motion and reduce pain by releasing tension and adhesions in the affected area. Active release technique focuses on releasing tension and adhesions in the soft tissues surrounding the affected joint, while the Myofascial arm pull technique aims to improve range of motion by stretching the muscle and fascia in the affected area. By incorporating these techniques into a comprehensive treatment plan, patients of adhesive capsulitis can see significant improvement in their pain, range of motion and disability.
Because the method of treatment is inexpensive, findings of this study could be beneficial in revision of the clinical protocols to manage the patients of adhesive capsulitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions.
| Arm | Type | Receives |
|---|---|---|
| Myofascial arm pull technique and Active Release Technique | Experimental | Other: Myofascial Arm Pull and Active Release TechniqueParticipant will receive both Myofascial arm pull and active release technique along with Ultrasound therapy. |
| Myofascial arm pull technique | Active comparator | Other: Myofacial Arm PullParticipant will receive Myofascial arm pull along with ultrasound therapy. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both Male and Female; mean age (35-60).
- Case diagnosed with adhesive capsulitis, both primary and secondary origin.
- Freezing stage of adhesive capsulitis.
- Those with at least a 50% reduction in the range of motion (ROM).
Key exclusion criteria (5 listed)
- History of shoulder surgery or manipulation under anesthesia, local corticosteroid injection administration to the affected shoulder within the last 3 months.
- Neurological deficit affecting the shoulder functioning during daily activities.
- Pathology of the shoulder joint other than adhesive capsulitis.
- Pain or disorder of the cervical spine, elbow, wrist or hand.
- Patients diagnosed with cancer
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 Arm Pull and Active Release TechniqueSix weekly sessions of the treatment will be given over the course of four weeks. Baseline treatment includes Ultrasound for 10 minutes. | Other | Myofascial arm pull technique and Active Release Technique |
| Myofacial Arm PullSix weekly sessions of the treatment will be given over the course of four weeks. Baseline treatment includes Ultrasound for 10 minutes. | Other | Myofascial arm pull technique |
Primary outcome
Shoulder Pain and disability index (SPADI)
Time frame: 4 week
Changes from Baseline. The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability
Goniometer
Time frame: 4 week
Changes from Baseline. Physical therapists use goniometry to objectively measure passive and active range of motion (ROM).
Numeric Pain Rating Scale (NPRS)
Time frame: 4 week
Changes from Baseline. The NPRS is a self-reported, or clinician administered, measurement tool The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10. 0=No pain 1 to 4=Mild pain. 5 or 6=Moderate pain 7 to 10=Severe pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 18455944Dogru H, Basaran S, Sarpel T. Effectiveness of therapeutic ultrasound in adhesive capsulitis. Joint Bone Spine. 2008 Jul;75(4):445-50. doi: 10.1016/j.jbspin.2007.07.016. Epub 2008 May 2.
- Background: PubMed 35397306Sumariva-Mateos J, Leon-Valenzuela A, Vinolo-Gil MJ, Bautista Troncoso J, Del Pino Algarrada R, Carmona-Barrientos I. Efficacy of myofascial therapy and kinesitherapy in improving function in shoulder pathology with prolonged immobilization: A randomized, single-blind, controlled trial. Complement Ther Clin Pract. 2022 Aug;48:101580. doi: 10.1016/j.ctcp.2022.101580. Epub 2022 Apr 4.
- Background: PubMed 21843839Breckenridge JD, McAuley JH. Shoulder Pain and Disability Index (SPADI). J Physiother. 2011;57(3):197. doi: 10.1016/S1836-9553(11)70045-5.
- Background: PubMed 16720638Angst F, Goldhahn J, Pap G, Mannion AF, Roach KE, Siebertz D, Drerup S, Schwyzer HK, Simmen BR. Cross-cultural adaptation, reliability and validity of the German Shoulder Pain and Disability Index (SPADI). Rheumatology (Oxford). 2007 Jan;46(1):87-92. doi: 10.1093/rheumatology/kel040. Epub 2006 May 23.
- Background: PubMed 20557263Mullaney MJ, McHugh MP, Johnson CP, Tyler TF. Reliability of shoulder range of motion comparing a goniometer to a digital level. Physiother Theory Pract. 2010 Jul;26(5):327-33. doi: 10.3109/09593980903094230.
- Background: PubMed 3685114Gajdosik RL, Bohannon RW. Clinical measurement of range of motion. Review of goniometry emphasizing reliability and validity. Phys Ther. 1987 Dec;67(12):1867-72. doi: 10.1093/ptj/67.12.1867.
- 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.
IMRAN AMJAD, PHD contact
FAIZA AMJAD, M.PHILL principal investigator
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 Myofascial Arm Pull and Active Release Technique and Myofacial Arm Pull 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 4 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 31 Oct 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 IMRAN AMJAD, PHD (03324390125, imran.amjad@riphah.edu.pk), 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 (SPADI) (time frame: 4 week). 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?
On the ClinicalTrials.gov record for NCT06108843, which also lists 6 linked publications.
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 31 Oct 2023.