Recruiting

Physiotherapy Program

Sponsor:

Western University, Canada

Code:

NCT03462420

Conditions

Adhesive Capsulitis

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Physical Therapy program

Study Details

Brief summary:

This pilot randomized trial will compare the preliminary effect of a regular physiotherapy (PT) program to a regular PT combined with a progressive walking program (PT+) in patients with and without diabetes who have adhesive capsulitis. After signing the consent form, recruited participants will be randomized into either PT group (control) or PT+ group (experimental). Participants in both groups will be referred to a physical therapy facility. The intervention will be chosen by treating physical therapist. In PT+ group, participants will also be asked to perform free walking at their own pace. Outcomes measures for the primary outcome (shoulder functional performance) will be evaluated at baseline and after 6 weeks. Secondary outcomes (shoulder ROM, pain and function, muscle strength, and physical activity level) will be evaluated at baseline, at 3 and 6 weeks, and again at 12 weeks after enrolment. We expect adding a progressive walking program to regular PT will result in better outcomes.

Conditions

Adhesive Capsulitis

Diabetes Mellitus

Study ID

NCT03462420

Start date

Sep 3, 2018

Status verified date

Oct, 2019

Completion date

May, 2020

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients with and without diabetes who have adhesive capsulitis

Exclusion Criteria:

  • Previous shoulder surgery or dislocation
  • Shoulder severe osteoarthritis

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PT+ walking

Participants in this group will be referred to a physical therapy facility according to their preferences and the intervention will be chosen by the treating physical therapist. In addition, participants will be asked to perform free walking at their own pace for 30-45 min, 5 days per week for 6 consecutive weeks and to record their walking date/time on a diary form provided by the research team before commencing the study. Participants in PT+ group will also be provided with accelerometer to accurately estimate their physical activity level.

active comparator: Regular PT

Participants in this group will be referred to a physical therapy facility according to their preferences and the intervention will be chosen by the treating physical therapist. Participants in this group will not be notified about the walking program.

Interventions

Physical Therapy program

The physical therapy program will be chosen by the treating therapist. However, the most common physiotherapy interventions include therapeutic exercises, joint mobilization techniques and electrotherapy.

Primary outcome measure

  • Change of shoulder performance from baseline to 6 weeks after physiotherapy [ Time Frame: At baseline and again after 6 weeks ]

Central Contacts and Locations

Central contacts

Sanaa A Alsubheen, PhD (c)

0015198789647slasubhe@uwo.ca

Locations

St. Joseph's Health Care London

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Joy C MacDermid, PhD

jmacderm@uwo.ca

More Information

Sponsor

Western University, Canada

Last update posted

Oct 24, 2019

Last verified

Oct, 2019

Keywords

  • Adhesive capsulitis
  • Frozen shoulder
  • Diabetes
  • Physiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2019-10-24.