Clinical trial NCT06814821: Web-based Rehabilitation After Surgical Salvage Procedures for Wrist Osteoarthritis
Official title: Web-based Rehabilitation After Surgical Salvage Procedures for Wrist Osteoarthritis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wrist Osteoarthritis
Keywords: web-based rehabilitation
wrist osteoarthritis
SLAC
SNAC
exercise therapy
arthritis
randomized controlled trial
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2025-02-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Patient Rated Wrist Evaluation (PRWE) score, 3 months after cast removal compared to baseline.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
Secondary outcomes:
measure: Pain at rest and on load - change in score from baseline to cast removal and 3 months after cast removal.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
measure: Quality of life (EQ-5D-5L) - change in score from baseline to cast removal and 3 months after cast removal.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
measure: Pain catastrophizing scale - change in score from baseline to cast removal and 3 months after cast removal.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
measure: Tampa Scale of Kinesiophobia - change in score from baseline to cast removal and 3 months after cast removal.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
measure: Range of motion - change from baseline to cast removal and 3 months after cast removal.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
measure: Grip strength - change in score from baseline to 3 months after cast removal.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
measure: Patient Reported Experience Measures (PREM).
timeFrame: 3 months after cast removal.
measure: Adherence to excercise program.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
measure: Complications - number of participants.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
measure: Length of sick leave, ability to return to previous work.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
measure: Number of consultations.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
measure: Differences in direct costs - between groups.
timeFrame: From enrollment to the end of treatment at 3 months after cast removal.
Other outcomes:
Locations:
Study officials:
affiliation: KI Department of Clinical Science and Education, Södersjukhuset
name: Elin M Swärd, PhD
role: PRINCIPAL_INVESTIGATOR
References: