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Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes

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ClinicalTrials.gov Identifier: NCT03462420
Recruitment Status : Not yet recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Western University, Canada

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 3 and 6 months after enrolment. We expect adding a progressive walking program to regular PT will result in better outcomes.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Diabetes Mellitus Other: Physical Therapy program Not Applicable

Detailed Description:

In this pilot randomized clinical trial, participants will be recruited from an Orthopedic clinic at St. Joseph's Health Care Centre via surgeon referrals and from local primary health care clinics via posters advertising the study. Potential participants will be contacted by the research team at Hand and Upper Limb Centre (HULC) to arrange for their initial evaluation and sign a consent form. Participants who agree to participate in this study will be asked to complete 2 outcomes questionnaires (i.e. SPADI, RAPA) and Katz comorbidity scale.

Next, patients will be randomly assigned to one of the two groups: regular Physical Therapy program (PT) or regular PT which add a progressive walking program (PT+). Stratified randomization by diabetic status and sex will be used. All participants will be referred to a physical therapy facility according to their preferences and the intervention will be chosen by the treating physical therapist. In PT+ group, 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. Outcomes measures for the shoulder functional performance test (primary outcome) 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 3 and 6 months after enrollment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes: A Pilot Randomized Trial
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: 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.
Other Name: Exercises

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.
Other: 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.
Other Name: Exercises




Primary Outcome Measures :
  1. Change of shoulder performance from baseline to 6 weeks after physiotherapy [ Time Frame: At baseline and again after 6 weeks ]
    This test is based on repeated shoulder movements at waist and eye level, and over head work. The test will be performed using Functional Impairment Test- Hand and Neck/ Shoulder/Arm (FIT-HaNSA) tests.


Secondary Outcome Measures :
  1. Shoulder range of motion [ Time Frame: at baseline, at 3 and 6 weeks, and again at 3 and 6 months after enrollment ]
    Shoulder range of motion in flexion, abduction, and external rotation

  2. Shoulder pain and function [ Time Frame: at baseline, at 3 and 6 weeks, and again at 3 and 6 months after enrollment ]
    Shoulder pain and function will be assessed using Shoulder Pain and Disability Index (SPADI) questionnaire

  3. Muscle strength [ Time Frame: at baseline, at 3 and 6 weeks, and again at 3 and 6 months after enrollment ]
    The muscle power of the shoulder flexors and abductors muscles will be assessed

  4. Physical activity level [ Time Frame: at baseline, at 3 and 6 weeks, and again at 3 and 6 months after enrollment ]
    The level of activity will be assessed using Rapid Assessment of Physical Activity (RAPA) questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with and without diabetes who have adhesive capsulitis

Exclusion Criteria:

  • Previous shoulder surgery or dislocation, shoulder osteoarthritis, patients with cardiovascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462420


Contacts
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Contact: Sanaa A Alsubheen, PhD (c) 0015198789647 slasubhe@uwo.ca

Locations
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Canada, Ontario
St. Joseph's Health Care London Not yet recruiting
London, Ontario, Canada, N6A 4V2
Contact: Joy C MacDermid, PhD       jmacderm@uwo.ca   
Sub-Investigator: Sanaa A Alsubheen, PHDc         
Sub-Investigator: Kenneth Faber, MD         
Sub-Investigator: Tom Overend, PhD         
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Joy C MacDermid, PhD Western University, Canada
Study Chair: Kenneth Faber, MD St. Joseph's Health Care London

Publications:
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Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT03462420     History of Changes
Other Study ID Numbers: HSREB#111221
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Western University, Canada:
Adhesive capsulitis
Frozen shoulder
Diabetes
Physiotherapy
Additional relevant MeSH terms:
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Bursitis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Joint Diseases
Musculoskeletal Diseases