Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes

Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes: A Pilot Randomized Trial

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus; Adhesive Capsulitis
• Intervention / Treatment: Other: Physical Therapy program

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 12 weeks after enrollment.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • Recruiting
      • St. Joseph's Health Care London
      • Contact: Joy C MacDermid, PhD; Email: jmacderm@uwo.ca
      • Sub-Investigator: Sanaa A Alsubheen, PHDc
      • Sub-Investigator: Kenneth Faber, MD
      • Sub-Investigator: Tom Overend, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with and without diabetes who have adhesive capsulitis

Exclusion Criteria:

• Previous shoulder surgery or dislocation
• Shoulder severe osteoarthritis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of shoulder performance from baseline to 6 weeks after physiotherapy	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.	At baseline and again after 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder range of motion	Shoulder range of motion in flexion, abduction, and external rotation	at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment
Shoulder pain and function	Shoulder pain and function will be assessed using Shoulder Pain and Disability Index (SPADI) questionnaire	at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment
Muscle strength	The muscle power of the shoulder flexors and abductors muscles will be assessed	at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment
Physical activity level	The level of activity will be assessed using Rapid Assessment of Physical Activity (RAPA) questionnaire	at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment

Collaborators and Investigators

• Sponsor: Western University, Canada
• Investigators: Principal Investigator: Joy C MacDermid, PhD, Western University, Canada; Study Chair: Kenneth Faber, MD, St. Joseph's Health Care London

Publications and helpful links

General Publications

• Zreik NH, Malik RA, Charalambous CP. Adhesive capsulitis of the shoulder and diabetes: a meta-analysis of prevalence. Muscles Ligaments Tendons J. 2016 May 19;6(1):26-34. doi: 10.11138/mltj/2016.6.1.026. eCollection 2016 Jan-Mar.
• Hsu CL, Sheu WH. Diabetes and shoulder disorders. J Diabetes Investig. 2016 Sep;7(5):649-51. doi: 10.1111/jdi.12491. Epub 2016 Mar 16. No abstract available.
• Laslett LL, Burnet SP, Jones JA, Redmond CL, McNeil JD. Musculoskeletal morbidity: the growing burden of shoulder pain and disability and poor quality of life in diabetic outpatients. Clin Exp Rheumatol. 2007 May-Jun;25(3):422-9.
• Marwick TH, Hordern MD, Miller T, Chyun DA, Bertoni AG, Blumenthal RS, Philippides G, Rocchini A; Council on Clinical Cardiology, American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee; Council on Cardiovascular Disease in the Young; Council on Cardiovascular Nursing; Council on Nutrition, Physical Activity, and Metabolism; Interdisciplinary Council on Quality of Care and Outcomes Research. Exercise training for type 2 diabetes mellitus: impact on cardiovascular risk: a scientific statement from the American Heart Association. Circulation. 2009 Jun 30;119(25):3244-62. doi: 10.1161/CIRCULATIONAHA.109.192521. Epub 2009 Jun 8. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes; Physiotherapy; Adhesive capsulitis; Frozen shoulder
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Joint Diseases; Musculoskeletal Diseases; Diabetes Mellitus; Bursitis
• Other Study ID Numbers: HSREB#111221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No