Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes

Study Overview
=================
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.

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.

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

Conditions
-----------------
Adhesive Capsulitis, Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Physical Therapy program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with and without diabetes who have adhesive capsulitis Exclusion Criteria: Previous shoulder surgery or dislocation Shoulder severe osteoarthritis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PT+ walking<br>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<br>* 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.<br>* Other names: Exercises;|
| Active Comparator: Regular PT<br>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<br>* 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.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adhesive capsulitis, Frozen shoulder, Diabetes, Physiotherapy