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Webbasierte Rehabilitation nach chirurgischen Bergungsverfahren für die Arthrie-Handgelenk-Arthritis

2. Oktober 2026 aktualisiert von: Elin Swärd, Karolinska Institutet

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

90

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.

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

Aktiver Komparator: 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.

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient Rated Wrist Evaluation (PRWE) score, 3 months after cast removal compared to baseline.
Zeitfenster: From enrollment to the end of treatment at 3 months after cast removal.

Patient Rated Wrist Evaluation (PRWE) score (0-100 points). A higher score indicates a worse outcome.

From enrollment to the end of treatment at 3 months after cast removal.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain at rest and on load - change in score from baseline to cast removal and 3 months after cast removal.
Zeitfenster: From enrollment to the end of treatment at 3 months after cast removal.

Pain Numerical Rating Scale (PNRS). A higher score indicates a worse outcome.

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.
Zeitfenster: From enrollment to the end of treatment at 3 months after cast removal.

EQ-5D-5L (0-1 points). A lower score indicates a worse outcome.

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.
Zeitfenster: From enrollment to the end of treatment at 3 months after cast removal.

Tampa Scale of Kinesiophobia (TSK-17) (17-68 points). A higher score indicates a worse outcome.

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.
Zeitfenster: From enrollment to the end of treatment at 3 months after cast removal.

Range of motion (ROM) of the wrist (extension/flexion, radial/ulnar deviation, pronation/supination).

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.
Zeitfenster: From enrollment to the end of treatment at 3 months after cast removal.

Grip strength (hydraulic hand dynamometer)

From enrollment to the end of treatment at 3 months after cast removal.
Patient Reported Experience Measures (PREM).
Zeitfenster: 3 months after cast removal.
  • 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?
3 months after cast removal.
Adherence to excercise program.
Zeitfenster: From enrollment to the end of treatment at 3 months after cast removal.

Adherence, using an exercise diary.

From enrollment to the end of treatment at 3 months after cast removal.
Differences in direct costs - between groups.
Zeitfenster: From enrollment to the end of treatment at 3 months after cast removal.

Differences in costs of rehabilitation, defined as hand therapist-delivered contacts, including face-to-face, telephone, and video consultations.

From enrollment to the end of treatment at 3 months after cast removal.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Mitarbeiter

Ermittler

  • Hauptermittler: Elin M Swärd, PhD, KI Department of Clinical Science and Education, Södersjukhuset

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

2. April 2025

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

27. November 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Februar 2025

Zuerst gepostet (Tatsächlich)

7. Februar 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Oktober 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Web-based rehab - wrist OA

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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