NCT05367817

Brief Summary

Individuals with wrist osteoarthritis (OA) can suffer from pain, muscular weakness, and impaired motion of the wrist, which can reduce the quality of life. While there is strong evidence that all patients with OA should receive first-line treatment with education and exercises, this approach has not yet been proposed for individuals with wrist OA. Therefore, this trial aimed to evaluate the effectiveness of a first line neuromuscular joint protective exercise therapy program compared to a training program with range of motion (ROM) exercises in patients with wrist OA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2019

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2023

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

3.4 years

First QC Date

April 27, 2022

Last Update Submit

June 18, 2025

Conditions

Keywords

Wrist Osteoarthritis, SLAC, SNAC, exercise therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 3, 6 and 12 months

Study Arms (2)

Exercise therapy

EXPERIMENTAL

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.

Other: Neuromuscular exercise therapy

Training program

ACTIVE COMPARATOR

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.

Other: Training program

Interventions

Participants perform specific neuromuscular exercises aimed at enhancing the sensorimotor control of the wrist.

Exercise therapy

Participants perform range of motion exercises for the wrist.

Training program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radiographically confirmed and symptomatic wrist OA - SLAC and SNAC stage 1-3
  • Age≥18

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, Skåne County, Sweden

Location

Related Publications (2)

  • Larsson SL, Ekstrand E, Dahlin LB, Bjorkman A, Brogren E. Effects of a neuromuscular joint-protective exercise therapy program for treatment of wrist osteoarthritis: a randomized controlled trial. BMC Musculoskelet Disord. 2024 Jan 5;25(1):38. doi: 10.1186/s12891-023-07157-4.

  • Larsson SL, Ekstrand E, Dahlin LB, Bjorkman A, Brogren E. A self-managed exercise therapy program for wrist osteoarthritis: study protocol for a randomized controlled trial. Trials. 2023 Oct 2;24(1):628. doi: 10.1186/s13063-023-07668-4.

Study Officials

  • Elisabeth Brogren, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 10, 2022

Study Start

October 3, 2019

Primary Completion

March 10, 2023

Study Completion

March 10, 2023

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations