Web-based Rehabilitation After Surgical Salvage Procedures for Wrist Osteoarthritis
ConditionWrist Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Four corner fusion (4CF)
Lunate-Capitate fusion (LCF)
Scaphoid-Trapezium-Trapezoid fusion (STT)
Radius-Scaphoid-Lunate fusion (RSL)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Web-based rehabilitation
Other interventionParticipants perform their rehabilitation independently with the instructions from the web-based platform.
Standard rehabilitation
Other interventionParticipants attend physical visits at the clinic to get instructions and support in their rehabilitation. Written and verbal instructions will be given.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Web-based rehabilitationExperimental treatment 1 intervention
Group B: Standard rehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 3 months after cast removal.Secondary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 3 months after cast removal.2
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.
Time frame
From enrollment to the end of treatment at 3 months after cast removal.3
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.
Time frame
From enrollment to the end of treatment at 3 months after cast removal.4
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).
Time frame
From enrollment to the end of treatment at 3 months after cast removal.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
Source ClinicalTrials.gov