NCT06108843

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 25, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

Adhesive CapsulitisActive Release TechniqueMyofacial Arm Pull TechniquePainRange of Motion

Outcome Measures

Primary Outcomes (3)

  • 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

  • Goniometer

    Changes from Baseline. Physical therapists use goniometry to objectively measure passive and active range of motion (ROM).

    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

    4 week

Study Arms (2)

Myofascial arm pull technique and Active Release Technique

EXPERIMENTAL

Participant will receive both Myofascial arm pull and active release technique along with Ultrasound therapy.

Other: Myofascial Arm Pull and Active Release Technique

Myofascial arm pull technique

ACTIVE COMPARATOR

Participant will receive Myofascial arm pull along with ultrasound therapy.

Other: Myofacial Arm Pull

Interventions

Six weekly sessions of the treatment will be given over the course of four weeks. Baseline treatment includes Ultrasound for 10 minutes.

Myofascial arm pull technique 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.

Myofascial arm pull technique

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arif Memorial Teaching Hospital

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (6)

  • 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.

    PMID: 18455944BACKGROUND
  • 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.

    PMID: 35397306BACKGROUND
  • Breckenridge JD, McAuley JH. Shoulder Pain and Disability Index (SPADI). J Physiother. 2011;57(3):197. doi: 10.1016/S1836-9553(11)70045-5.

    PMID: 21843839BACKGROUND
  • 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.

    PMID: 16720638BACKGROUND
  • 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.

    PMID: 20557263BACKGROUND
  • 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.

    PMID: 3685114BACKGROUND

MeSH Terms

Conditions

BursitisPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • FAIZA AMJAD, M.PHILL

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

IMRAN AMJAD, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A participant in a single-blind study does not know which study group they are in, but the study doctor does.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

May 8, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations