Osteoarthritis WristNCT05367817
Effects of a Neuromuscular Exercise Therapy Program for Treatment of Wrist Osteoarthritis: a Randomized Controlled Trial
A study testing Neuromuscular exercise therapy and Training program in people with Osteoarthritis Wrist, run by Region Skane at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Wrist
- What is being tested?
- Neuromuscular exercise therapy and Training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- 3 Oct 2019to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiographically confirmed and symptomatic wrist OA - SLAC and SNAC stage 1-3
- Age≥18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Neuromuscular Joint Protective Exercise Therapy Program for Treatment of Wrist Osteoarthritis: a Randomized Controlled Trial
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.
Read the 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 function 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.
- Conditions
- Osteoarthritis Wrist
- Being tested
- Neuromuscular exercise therapy, Training program
- Keywords
- Wrist Osteoarthritis, SLAC, SNAC, exercise therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular exercise therapyOther
Participants perform specific neuromuscular exercises aimed at enhancing the sensorimotor control of the wrist.
Training programOther
Participants perform range of motion exercises for the wrist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start3 Oct 2019
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis WristStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Brogren, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367817
- Sponsor's protocol ID
- 2019-02437; 2020-03807
- Other IDs
- 2019
- Status last verified
- Jun 2025
- First submitted
- 27 Apr 2022
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsson SL, Ekstrand E, Dahlin LB, Bjorkman A, Brogren E. Long-term effects of neuromuscular exercise therapy and the need for surgical conversion in wrist osteoarthritis: 24-month results from a randomized controlled trial. BMC Musculoskelet Disord. 2025 Dec 30;27(1):76. doi: 10.1186/s12891-025-09463-5.
PubMed 41469620Larsson 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.
PubMed 38183045Larsson 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.
PubMed 37784197
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Neuromuscular Joint Protective Exercise Therapy Program for Treatment of Wrist Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05367817
- Acronym / sponsor ID
- 2019-02437; 2020-03807
- Conditions
- Osteoarthritis Wrist
- Keywords
- Wrist Osteoarthritis, SLAC, SNAC, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 function 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Exercise therapy | Experimental | Other: Neuromuscular exercise therapyThe 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. |
| Training program | Active comparator | Other: Training programThe training program for the control group will consist of ROM exercises only that will be also be performed twice a day for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Radiographically confirmed and symptomatic wrist OA - SLAC and SNAC stage 1-3
- Age≥18
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular exercise therapyParticipants perform specific neuromuscular exercises aimed at enhancing the sensorimotor control of the wrist. | Other | Exercise therapy |
| Training programParticipants perform range of motion exercises for the wrist. | Other | Training program |
Primary outcome
Change from baseline in pain and function on the Patient-Rated Wrist Evaluation (PRWE) at 3, 6 and 12 months.
Time frame: Baseline, 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Derived from this study: PubMed 41469620Larsson SL, Ekstrand E, Dahlin LB, Bjorkman A, Brogren E. Long-term effects of neuromuscular exercise therapy and the need for surgical conversion in wrist osteoarthritis: 24-month results from a randomized controlled trial. BMC Musculoskelet Disord. 2025 Dec 30;27(1):76. doi: 10.1186/s12891-025-09463-5.
- Derived from this study: PubMed 38183045Larsson 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.
- Derived from this study: PubMed 37784197Larsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Brogren, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular exercise therapy and Training program in people with Osteoarthritis Wrist, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain and function on the Patient-Rated Wrist Evaluation (PRWE) at 3, 6 and 12 months. (time frame: Baseline, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05367817, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.