Web-based Rehabilitation After Surgical Salvage Procedures for Wrist Osteoarthritis

NCT ID: NCT06814821

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2027-02-02

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.

Conditions

Wrist Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Web-based rehabilitation

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.

Group Type: EXPERIMENTAL

Web-based rehabilitation

Intervention Type: OTHER

Participants perform their rehabilitation independently with the instructions from the web-based platform.

Standard rehabilitation

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.

Group Type: ACTIVE_COMPARATOR

Standard rehabilitation

Intervention Type: OTHER

Participants attend physical visits at the clinic to get instructions and support in their rehabilitation. Written and verbal instructions will be given.

Interventions

Web-based rehabilitation

Participants perform their rehabilitation independently with the instructions from the web-based platform.

Intervention Type: OTHER

Standard rehabilitation

Participants attend physical visits at the clinic to get instructions and support in their rehabilitation. Written and verbal instructions will be given.

Intervention Type: OTHER

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

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Elin Swärd

Principal Investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elin M Swärd, PhD

Role: PRINCIPAL_INVESTIGATOR

KI Department of Clinical Science and Education, Södersjukhuset

Central Contacts

Tobias Tandrup, MSc, PhD student

Role: CONTACT

tobias.tandrup@ki.se

+46812364394

Elin M Swärd, PhD

Role: CONTACT

elin.sward@regionstockholm.se

Other Identifiers

Web-based rehab - wrist OA

Identifier Type: -

Identifier Source: org_study_id