Heavy Slow Resistance Training in Adults With Frozen Shoulder (HSRFSRCT)

July 17, 2022 updated by: N.A.RAFI AHMED, Ministry of Health, Kuwait

Efficacy of Heavy Slow Resistance Training in Adults With Frozen Shoulder- a Double Blind Randomised Controlled Trial

The aim of the study is to evaluate the efficacy of Heavy Slow Resistance exercise in patients diagnosed with frozen shoulder using randomized controlled trial design

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral painful, restricted active and passive range of motion of the shoulder, with loss of passive external rotation of at least 50% compared to opposite side at 0 deg of abduction
  • Symptoms present for at least 3 months
  • Normal x-rays on anteroposterior, axillary and lateral views

Exclusion Criteria:

  • Severe degeneration, or trauma involving the shoulder
  • Inflammatory joint disease affecting the shoulder.
  • Pain or disorders of the cervical spine, elbow, wrist, or hand
  • Stroke or peripheral nerve neuropathy Injection with corticosteroids in the affected shoulder in the preceding 4 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heavy Slow Resistance group
Heavy slow resistance exercise will be given along with traditional physical therapy program
Other: Heavy Slow Resistance
Heavy slow resistance exercise will be given twice a week for 12 weeks along with traditional physical therapy program
Other: Control group
Traditional physical therapy program only will be given twice a week for 12 weeks
Placebo Comparator: Control group
Traditional physical therapy program will be given to the control group
Other: Control group
Traditional physical therapy program only will be given twice a week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion measurement for external rotation and abduction using clinometer application at week 12
Time Frame: week 12 from baseline measurement
The smart phone clinometer is a validated tool to measure range of motion
week 12 from baseline measurement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick DASH(Quick Disabilities of the of Arm Shoulder and Hand)
Time Frame: week 12 from baseline measurement
Quick DASH is an 11 item questionnaire to measure physical function and symptoms in people presenting with one or more disabilities of the arm, shoulder, and hand. The higher the score from 0 to 100 scale the higher the disability.
week 12 from baseline measurement
12-Item Short Form Health Survey (SF-12)
Time Frame: week 12 from baseline measurement

SF-12 is a 12 item ,self-reported outcome measure for assessing quality of life.

Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
week 12 from baseline measurement
The Oxford Shoulder Score(OSS)
Time Frame: week 12 from baseline measurement
The Oxford Shoulder Score is validated tool for measuring pain and disability caused by shoulder pathology. It has 12 items with a score ranging from 0 to 48 with 48 being the best outcome.
week 12 from baseline measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Kuwait

Investigators

  • Principal Investigator: Rafi Ahmed, MPT, Ministry of Health, Kuwait

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

July 17, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 17, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be available on request.

IPD Sharing Time Frame

Five years after completing the study

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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