Wrist OsteoarthritisNCT06814821
Web-based Rehabilitation After Surgical Salvage Procedures for Wrist Osteoarthritis
A study testing Web-based rehabilitation and Standard rehabilitation in people with Wrist Osteoarthritis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Wrist osteoarthritis is often caused by past trauma to the wrist. The primary symptom is joint pain. Salvage surgery is the final solution if exercise therapy, analgesics, orthoses, or cortisone injections fail to relieve pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Osteoarthritis
- What is being tested?
- Web-based rehabilitation and Standard rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 2 Apr 2025to 31 Dec 2027
- Phase
- Interventional
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
- Planned surgery:
- Four corner fusion (4CF)
- Lunate-Capitate fusion (LCF)
- Scaphoid-Trapezium-Trapezoid fusion (STT)
- Radius-Scaphoid-Lunate fusion (RSL)
- Proximal Row Carpectomy (PRC)
- Access to digital identification.
Who cannot join
- Unstable rheumatoid arthritis or other chronic inflammatory arthritis. However, stable inflammatory arthritis with unchanged medication during the last 12 weeks is not an exclusion criteria.
- History of psoriasis arthritis, gout, or pseudogout affecting the hand or wrist.
- Symptomatic OA in nearby joints.
- Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction, inability to use web-based tools).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elin M Swärd, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Department of hand handsurgery, Södersjukhuset
Stockholm, 11883
Tobias M Tandrup, +4681236000, tobias.tandrup@regionstockholm.se
Elin M Swärd, MD. PhD, +4681236000, elin.sward@regionstockholm.se
About this study
Official title: Web-based Rehabilitation After Surgical Salvage Procedures for Wrist Osteoarthritis: A Randomized Controlled Trial
Wrist osteoarthritis is often caused by past trauma to the wrist. The primary symptom is joint pain. Salvage surgery is the final solution if exercise therapy, analgesics, orthoses, or cortisone injections fail to relieve pain.
This trial aims to evaluate if a web-based rehabilitation protocol is non-inferior to standard, face-to-face, rehabilitation in terms of patient-reported outcome after surgical salvage procedures.
Read the detailed description
Osteoarthritis (OA) is a chronic disease which affects all tissues of the joint - cartilage, ligaments, synovial membrane, tendons, and bone. The primary symptom is joint pain but other symptoms like swelling, stiffness, crepitus, and joint instability may also be present.
OA is most in common in knee, hip, and hand but all joints can be affected. It is estimated that nearly 50% of women and 25% of men risk hand OA during their lifetime. Interphalangeal joints and thumb base are the primarily affected joints in the hand while the wrist is less common. Wrist OA is, in contrary to interphalangeal joints and thumb base, more common in men than in women and at a younger age.
Wrist OA is often caused by past trauma to the wrist e.g., fractures, dislocations, and ligament injuries. However, avascular necrosis i.e., Mb Kienböck and Mb Preiser, and other medical conditions may also lead to wrist OA.
Although there is no cure, patients with hip and knee OA, may benefit from self-management treatment options. For hand and wrist OA, the effects of exercise therapy are less studied. A Cochrane review found low-quality evidence of small positive effects of exercise on pain, function, and finger joint stiffness. In wrist OA, a recent randomized controlled trial reported that neuromuscular joint-protective exercise therapy was not superior to range of motion exercises in reducing pain and improving function.
Salvage surgery is the final solution if exercise therapy, analgesics, orthoses, or cortisone injections fail to relieve pain. Numerous studies describe different types of surgical salvage procedures in wrist OA but, to our knowledge, none compare different types of rehabilitation after surgery.
Telerehabilitation for acute and chronic musculoskeletal disorders including OA have been used for over a decade, with an increased demand during the Covid 19 pandemic, and continue to evolve. Telerehabilitation is defined as the "Delivery of therapeutic rehabilitation at a distance or offsite using telecommunication technologies" and includes a wide variety of interventions such as assessments, education, or exercises via mobile or tablet applications, web pages and so forth.
Systematic reviews have shown telerehabilitation to be equal to or superior to standard rehabilitation in various musculoskeletal conditions but without a high level of evidence. Few previous studies focus on disorders of the hand and wrist. In conservatively treated hand OA, operated carpal tunnel syndrome, and operatively and nonoperatively treated patients with bony or soft tissue conditions of the hand and wrist, mobile applications were better than home exercise programs on paper in improving upper limb function and decreasing the number of clinical appointments and referral for rehabilitation.
Telerehabilitation after OA surgery has shown good results in both patient satisfaction and clinical outcomes, but previous studies have mainly focused on hip and knee OA. Although a steadily increasing number of studies, investigators have not been able to find any studies comparing web-based or telerehabilitation to standard, face-to-face, rehabilitation after surgical salvage procedures for wrist OA.
Research question:
Is a web-based rehabilitation protocol non-inferior to standard, face-to-face, rehabilitation in terms of patient-reported outcome after surgical salvage procedures for wrist osteoarthritis?
Hypothesis:
A postoperative web-based rehabilitation protocol is non-inferior to standard rehabilitation in terms of patient-reported outcome measured by Patient Reported Wrist Evaluation (PRWE) 3 months after cast removal in patients operated with surgical salvage procedures for wrist osteoarthritis.
- Conditions
- Wrist Osteoarthritis
- Being tested
- Web-based rehabilitation, Standard rehabilitation
- Keywords
- web-based rehabilitation, wrist osteoarthritis, SLAC, SNAC, exercise therapy, arthritis, randomized controlled trial
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based rehabilitationOther
Participants perform their rehabilitation independently with the instructions from the web-based platform.
Standard rehabilitationOther
Participants attend physical visits at the clinic to get instructions and support in their rehabilitation. Written and verbal instructions will be given.
| Study group | Role | What they receive |
|---|---|---|
| Web-based rehabilitation | Experimental | The web-based platform contains text, images, and videos which will educate and inform the patient regarding the operation and rehabilitation.
There will be no scheduled physical consultations, however participants may request additional video consultations and can send text messages to the hand therapist. Receives: Other: Web-based rehabilitation |
| Standard rehabilitation | Active comparator | The control group receive the same education and exercises. The information is provided verbally and a booklet with images of the exercises is given. However, they do not get access to the web-based platform and follow-up appointments are face-to-face at the clinic.
At the follow-up appointments, participants perform their exercises, and adjustments and corrections are made when needed. Receives: Other: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Rated Wrist Evaluation (PRWE) score, 3 months after cast removal compared to baseline.
Patient Rated Wrist Evaluation (PRWE) score (0-100 points). A higher score indicates a worse outcome.
Measured: From enrollment to the end of treatment at 3 months after cast removal.
Secondary outcomes (8)
Pain at rest and on load - change in score from baseline to cast removal and 3 months after cast removal.
Pain Numerical Rating Scale (PNRS). A higher score indicates a worse outcome.
Measured: From enrollment to the end of treatment at 3 months after cast removal.
Quality of life (EQ-5D-5L) - change in score from baseline to cast removal and 3 months after cast removal.
EQ-5D-5L (0-1 points). A lower score indicates a worse outcome.
Measured: From enrollment to the end of treatment at 3 months after cast removal.
Tampa Scale of Kinesiophobia - change in score from baseline to cast removal and 3 months after cast removal.
Tampa Scale of Kinesiophobia (TSK-17) (17-68 points). A higher score indicates a worse outcome.
Measured: From enrollment to the end of treatment at 3 months after cast removal.
Range of motion - change from baseline to cast removal and 3 months after cast removal.
Range of motion (ROM) of the wrist (extension/flexion, radial/ulnar deviation, pronation/supination).
Measured: From enrollment to the end of treatment at 3 months after cast removal.
Grip strength - change in score from baseline to 3 months after cast removal.
Grip strength (hydraulic hand dynamometer)
Measured: From enrollment to the end of treatment at 3 months after cast removal.
Patient Reported Experience Measures (PREM).
- Are you satisfied with how you can contact your healthcare provider?
- Did you receive enough information about your surgery and rehabilitation?
- Do you feel that your rehabilitation needs have been met?
- Are you satisfied with your rehabilitation?
Measured: 3 months after cast removal.
Adherence to excercise program.
Adherence, using an exercise diary.
Measured: From enrollment to the end of treatment at 3 months after cast removal.
Differences in direct costs - between groups.
Differences in costs of rehabilitation, defined as hand therapist-delivered contacts, including face-to-face, telephone, and video consultations.
Measured: From enrollment to the end of treatment at 3 months after cast removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start2 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Elin Swärd, Karolinska Institutet
- Investigators
- Elin M Swärd, PhD, Principal investigator, KI Department of Clinical Science and Education, Södersjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814821
- Sponsor's protocol ID
- Web-based rehab - wrist OA
- Status last verified
- Sep 2026
- First submitted
- 27 Nov 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to de-identified study data may be granted to qualified researchers upon reasonable request and subject to approval by the Swedish Ethical Review Authority. Requests should be directed to the corresponding author.