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A Self-managed Exercise Therapy Program for Wrist Osteoarthritis - a Randomized Controlled Trial

Primary Purpose

Osteoarthritis Wrist

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Neuromuscular exercise therapy
Training program
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Wrist focused on measuring Wrist Osteoarthritis, SLAC, SNAC, exercise therapy, self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CT-verified wrist OA

Exclusion Criteria:

  • People suffering from severe medical conditions
  • Presence of other diseases or disorders that could affect arm and hand function
  • Inability to understand and follow test instructions due to communicative, mental, or cognitive impairments
  • Difficulty in mastering the Swedish language

Sites / Locations

  • Lund UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise therapy

Training program

Arm Description

The program consists of two parts. The first part of the program contains unloaded active ROM exercises for the wrist in flexion/extension, radial-/ulnardeviation and pronation/supination. The second part of the program consists of three neuromuscular exercises that focus on coordination, wrist stability and strength. The participants will perform the program twice a day for 12 weeks.

The training program for the control group will consist of ROM exercises only that will be also be performed twice a day for 12 weeks. home base exercises twice a day for 12 weeks.

Outcomes

Primary Outcome Measures

Change from baseline in pain and function on the Patient-Rated Wrist Evaluation (PRWE) at 3, 6 and 12 months.
The PRWE is a self-reported questionnaire that includes 15 questions, divided into two subscales assessing pain (5 items) and function (10 items, 6 concerning specific tasks and 4 the ability to perform daily activities) over the past week. The questions are scored on a 10-point ordered categorical scale, ranging from no pain or no difficulty (0 points), to worst pain or unable to do (10 points). The total score of the subscales pain (sum of 5 items) and function (sum of 10 items divided by 2) ranges from 0 to 50. The maximum total score of PRWE is 100 and represents the worst disability, whereas 0 represents no disability.

Secondary Outcome Measures

Full Information

First Posted
April 27, 2022
Last Updated
March 13, 2023
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT05367817
Brief Title
A Self-managed Exercise Therapy Program for Wrist Osteoarthritis - a Randomized Controlled Trial
Official Title
A Self-managed Exercise Therapy Program for Wrist Osteoarthritis - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane

4. Oversight

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

5. Study Description

Brief Summary
Self-management programs, including exercise therapy and joint protective strategies, are core treatments in knee and hip OA. Since the complex wrist joint cannot fully be compared to larger weight-bearing joints as the knee and hip, there is a need to develop exercise therapy programs specially designed for the wrist. Such a program should be part of a comprehensive joint protective standard care and could be beneficial to decrease disability and postpone, or possibly even eliminate, the need for surgery in individuals with wrist OA. Aim: This is a randomized controlled trial (RCT) with the aim to investigate if a self-managed exercise therapy program with joint protective strategies to improve neuromuscular control (intervention group) will reduce pain and improve functioning more compared to a training program with range of motion (ROM) exercises (control group).
Detailed Description
Background: Post-traumatic wrist OA develops slowly, and the joint degeneration may eventually lead to pain, muscular weakness, and stiffness of the wrist. As a result, this can affect the function of the entire upper limb, which can interfere with activities of daily living and the ability to work; thus, leading to reduced quality of life. A progress of disproportionate joint load and disturbed neuromuscular control are frequently present and may even make the condition worse. Exercise therapy has been defined as a regime of physical activities designed and prescribed for precise therapeutic goals, aiming at educating the performance of specific exercises to improve neuromuscular control, reduce pain and achieve functional joint stability. Self-management programs, including exercise therapy and joint protective strategies, are core treatments in knee and hip OA. Since the complex wrist joint cannot fully be compared to larger weight-bearing joints as the knee and hip, there is a need to develop exercise therapy programs specially designed for the wrist. Such a program should be part of a comprehensive joint protective standard care and could be beneficial to decrease disability and postpone, or possibly even eliminate, the need for surgery in individuals with wrist OA. Aim: This is a randomized controlled trial (RCT) with the aim to investigate if a self-managed exercise therapy program with joint protective strategies to improve neuromuscular control (intervention group) will reduce pain and improve functioning more compared to a training program with range of motion (ROM) exercises (control group). Material and methods: This study is a single-blinded randomized controlled trial (RCT) in patients with symptomatic and radiographically verified wrist OA with two treatment arms. The participants will be randomly assigned either to an exercise therapy program (intervention group) or to a training program including ROM exercises only. The participants in both groups will receive structured education on 1) wrist anatomy; 2) pathophysiology; 3) joint protective self-management strategies and 4) management of pain and fatigue by exercises. Both program will consist of home exercises twice a day for 12 weeks. The treatments will be followed up by the treating physiotherapist at the department of hand surgery in Malmö, Sweden at 2-, 6- and 12-weeks post baseline, and the participants will be contacted by telephone at 4 and 8 weeks post baseline. Assessments will be performed at baseline and at 3, 6, and 12 months after baseline by an independent assessor, who is blinded to the participants' group allocation. At the 3- and 6-months follow-up, the participants will rate their global rating of change (GROC) regarding how they perceive their wrist pre- and post-training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Wrist
Keywords
Wrist Osteoarthritis, SLAC, SNAC, exercise therapy, self-management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise therapy
Arm Type
Experimental
Arm Description
The program consists of two parts. The first part of the program contains unloaded active ROM exercises for the wrist in flexion/extension, radial-/ulnardeviation and pronation/supination. The second part of the program consists of three neuromuscular exercises that focus on coordination, wrist stability and strength. The participants will perform the program twice a day for 12 weeks.
Arm Title
Training program
Arm Type
Active Comparator
Arm Description
The training program for the control group will consist of ROM exercises only that will be also be performed twice a day for 12 weeks. home base exercises twice a day for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Neuromuscular exercise therapy
Intervention Description
Participants perform specific neuromuscular exercises aimed at enhancing the sensorimotor control of the wrist.
Intervention Type
Other
Intervention Name(s)
Training program
Intervention Description
Participants perform range of motion exercises for the wrist.
Primary Outcome Measure Information:
Title
Change from baseline in pain and function on the Patient-Rated Wrist Evaluation (PRWE) at 3, 6 and 12 months.
Description
The PRWE is a self-reported questionnaire that includes 15 questions, divided into two subscales assessing pain (5 items) and function (10 items, 6 concerning specific tasks and 4 the ability to perform daily activities) over the past week. The questions are scored on a 10-point ordered categorical scale, ranging from no pain or no difficulty (0 points), to worst pain or unable to do (10 points). The total score of the subscales pain (sum of 5 items) and function (sum of 10 items divided by 2) ranges from 0 to 50. The maximum total score of PRWE is 100 and represents the worst disability, whereas 0 represents no disability.
Time Frame
Baseline, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Radiographically confirmed and symptomatic wrist OA - SLAC and SNAC stage 1-3 Age≥18 Exclusion criteria: The presence of other diseases or disorders that could affect arm and hand function Previous surgery to the wrist Intraarticular wrist cortisone injection within the last 3 months Inability to understand and follow test instructions due to communicative, mental, or cognitive impairments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Larsson, MSc
Phone
+46706300213
Email
sara.larsson.5408@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Lars B Dahlin, PhD
Phone
+4640331724
Email
lars.dahlin@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Brogren, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University
City
Lund
State/Province
Skåne
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Larsson, MSc
Phone
+46706300213
Email
sara.larsson.5408@med.lu.se

12. IPD Sharing Statement

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A Self-managed Exercise Therapy Program for Wrist Osteoarthritis - a Randomized Controlled Trial

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