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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06108843
Other study ID # REC/RCR&AHS/23/0162
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 8, 2023
Est. completion date January 2024

Study information

Verified date October 2023
Source Riphah International University
Contact IMRAN AMJAD, PHD
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date January 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 35 Years to 60 Years
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Myofascial Arm Pull and Active Release Technique
Six weekly sessions of the treatment will be given over the course of four weeks. Baseline treatment includes Ultrasound for 10 minutes.
Myofacial Arm Pull
Six weekly sessions of the treatment will be given over the course of four weeks. Baseline treatment includes Ultrasound for 10 minutes.

Locations

Country Name City State
Pakistan Arif Memorial Teaching Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Angst 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. — View Citation

Breckenridge JD, McAuley JH. Shoulder Pain and Disability Index (SPADI). J Physiother. 2011;57(3):197. doi: 10.1016/S1836-9553(11)70045-5. — View Citation

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. — View Citation

Gajdosik 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. — View Citation

Mullaney 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. — View Citation

Sumariva-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 4 week
Primary Goniometer Changes from Baseline. Physical therapists use goniometry to objectively measure passive and active range of motion (ROM). 4 week
Primary 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
4 week
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