Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes

NCT03462420 | Unknown

• 1 other identifier: HSREB#111221
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Adhesive capsulitis; Frozen shoulder; Diabetes; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Shoulder range of motion

  at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment

• Shoulder pain and function

  at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment

• Muscle strength

  at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment

• Physical activity level

  at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment

Study Arms (2)

PT+ walking

EXPERIMENTAL

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

Regular PT

ACTIVE COMPARATOR

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

Interventions

Physical Therapy program OTHER

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.

Also known as: Exercises

PT+ walking; Regular PT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with and without diabetes who have adhesive capsulitis

You may not qualify if:

• Previous shoulder surgery or dislocation
• Shoulder severe osteoarthritis

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

RECRUITING

Related Publications (4)

• 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.

  PMID: 27331029 BACKGROUND

• 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.

  PMID: 27182002 BACKGROUND

• 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.

  PMID: 17631739 BACKGROUND

• 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.

  PMID: 19506108 BACKGROUND

MeSH Terms

Conditions

Bursitis; Diabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joy C MacDermid, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

• Kenneth Faber, MD

  St. Joseph's Health Care London

  STUDY CHAIR

Central Study Contacts

Sanaa A Alsubheen, PhD (c)

CONTACT

0015198789647; slasubhe@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 12, 2018
• Study Start: September 3, 2018
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)