search
Back to results

Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes

Primary Purpose

Adhesive Capsulitis, Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical Therapy program
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Adhesive capsulitis, Frozen shoulder, Diabetes, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with and without diabetes who have adhesive capsulitis

Exclusion Criteria:

  • Previous shoulder surgery or dislocation
  • Shoulder severe osteoarthritis

Sites / Locations

  • St. Joseph's Health Care LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PT+ walking

Regular PT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Shoulder range of motion
Shoulder range of motion in flexion, abduction, and external rotation
Shoulder pain and function
Shoulder pain and function will be assessed using Shoulder Pain and Disability Index (SPADI) questionnaire
Muscle strength
The muscle power of the shoulder flexors and abductors muscles will be assessed
Physical activity level
The level of activity will be assessed using Rapid Assessment of Physical Activity (RAPA) questionnaire

Full Information

First Posted
February 27, 2018
Last Updated
October 21, 2019
Sponsor
Western University, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT03462420
Brief Title
Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes
Official Title
Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes: A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis, Diabetes Mellitus
Keywords
Adhesive capsulitis, Frozen shoulder, Diabetes, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PT+ walking
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular PT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Therapy program
Other Intervention Name(s)
Exercises
Intervention Description
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 Information:
Title
Change of shoulder performance from baseline to 6 weeks after physiotherapy
Description
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.
Time Frame
At baseline and again after 6 weeks
Secondary Outcome Measure Information:
Title
Shoulder range of motion
Description
Shoulder range of motion in flexion, abduction, and external rotation
Time Frame
at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment
Title
Shoulder pain and function
Description
Shoulder pain and function will be assessed using Shoulder Pain and Disability Index (SPADI) questionnaire
Time Frame
at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment
Title
Muscle strength
Description
The muscle power of the shoulder flexors and abductors muscles will be assessed
Time Frame
at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment
Title
Physical activity level
Description
The level of activity will be assessed using Rapid Assessment of Physical Activity (RAPA) questionnaire
Time Frame
at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with and without diabetes who have adhesive capsulitis Exclusion Criteria: Previous shoulder surgery or dislocation Shoulder severe osteoarthritis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanaa A Alsubheen, PhD (c)
Phone
0015198789647
Email
slasubhe@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy C MacDermid, PhD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Faber, MD
Organizational Affiliation
St. Joseph's Health Care London
Official's Role
Study Chair
Facility Information:
Facility Name
St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy C MacDermid, PhD
Email
jmacderm@uwo.ca
First Name & Middle Initial & Last Name & Degree
Sanaa A Alsubheen, PHDc
First Name & Middle Initial & Last Name & Degree
Kenneth Faber, MD
First Name & Middle Initial & Last Name & Degree
Tom Overend, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27331029
Citation
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.
Results Reference
background
PubMed Identifier
27182002
Citation
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.
Results Reference
background
PubMed Identifier
17631739
Citation
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.
Results Reference
background
PubMed Identifier
19506108
Citation
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.
Results Reference
background

Learn more about this trial

Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes

We'll reach out to this number within 24 hrs