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Combined Manual Therapy and Percutaneous Neuromodulation for Moderate Carpal Tunnel Syndrome (MANUCTS)

12. Juni 2026 aktualisiert von: Dr. Javier Bonastre Férez, Universidad Europea de Valencia

Combined Manual Therapy and Percutaneous Neuromodulation Versus Postsurgical Rehabilitation for Moderate Carpal Tunnel Syndrome: Protocol for a Non-Randomized Controlled Trial

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and can cause pain, numbness, tingling, and functional impairment of the hand. Although surgical decompression is considered an effective treatment for moderate CTS, there is increasing interest in conservative therapeutic strategies that may improve symptoms and function while avoiding surgery.

The aim of this multicenter non-randomized controlled trial is to evaluate the effectiveness of a combined intervention consisting of manual therapy and ultrasound-guided percutaneous neuromodulation compared with conventional postsurgical rehabilitation in patients with moderate CTS.

Participants allocated to the experimental group will receive a standardized multimodal physiotherapy program including manual therapy techniques and ultrasound-guided percutaneous neuromodulation, whereas participants in the control group will undergo standard rehabilitation following carpal tunnel release surgery. The primary outcome will be symptom severity and functional status assessed with the Boston Carpal Tunnel Questionnaire. Secondary outcomes will include pain intensity, nerve conduction parameters, ultrasound measures, hand strength, patient-reported outcomes, and adverse events.

The findings of this study are expected to provide evidence regarding the potential role of combined conservative treatment as an alternative therapeutic strategy for patients with moderate carpal tunnel syndrome.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Carpal tunnel syndrome (CTS) is the most prevalent peripheral entrapment neuropathy and represents a major cause of pain, sensory disturbances, and functional disability affecting the upper limb. Although surgical decompression is commonly recommended for patients with moderate CTS, interest in conservative treatment strategies has increased due to their potential to improve symptoms while avoiding surgery and its associated risks.

This multicenter non-randomized controlled trial aims to compare the effectiveness of a multimodal conservative intervention consisting of manual therapy combined with ultrasound-guided percutaneous neuromodulation versus conventional postsurgical rehabilitation in adults diagnosed with moderate CTS.

Group allocation will be based on clinical background. Participants with previous carpal tunnel release surgery will constitute the postsurgical rehabilitation group, whereas participants without previous surgery who meet the eligibility criteria will receive the combined conservative intervention. Statistical analyses will account for baseline differences between groups using propensity score adjustment in addition to intention-to-treat principles.

The primary objective is to determine whether the combined conservative intervention improves symptom severity and functional status as assessed by the Boston Carpal Tunnel Questionnaire. Secondary objectives include evaluating pain intensity, electrophysiological and ultrasound parameters, hand function, patient-reported outcomes, and treatment safety.

The results of this study are expected to contribute to the evidence base supporting conservative management strategies for moderate CTS and to inform future comparative clinical trials in musculoskeletal rehabilitation.

Studientyp

Interventionell

Einschreibung (Geschätzt)

150

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienkontakt

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

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Adults aged 30 to 50 years.
  • Clinical diagnosis of moderate carpal tunnel syndrome confirmed by nerve conduction studies according to the American Association of Electrodiagnostic Medicine criteria.
  • Symptoms persisting for at least 3 months.
  • Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  • Previous surgery for carpal tunnel syndrome in the affected hand (experimental group only).
  • Severe carpal tunnel syndrome requiring urgent surgical intervention.
  • History of wrist fracture or major upper-limb trauma affecting the study limb.
  • Pregnancy.
  • Diabetes mellitus or other systemic diseases associated with peripheral neuropathy.
  • Cervical radiculopathy or other neurological disorders affecting the upper limb.
  • Rheumatoid arthritis or other inflammatory arthropathies involving the wrist.
  • Previous corticosteroid injection for carpal tunnel syndrome within the last 3 months.
  • Contraindications to percutaneous neuromodulation (e.g., pacemaker, active infection at the treatment site, bleeding disorders, or anticoagulant therapy when considered clinically inappropriate).
  • Inability to comply with the study protocol or follow-up assessments.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Combined Manual Therapy and Percutaneous Neuromodulation
Participants allocated to the experimental arm will receive a multimodal conservative intervention consisting of manual therapy combined with ultrasound-guided percutaneous neuromodulation. The manual therapy program will include myofascial release techniques, passive accessory joint mobilizations, cervical mobilization when indicated, and median nerve neurodynamic mobilization. Ultrasound-guided percutaneous neuromodulation will be applied to the median nerve using low-frequency electrical stimulation according to a standardized treatment protocol. Participants will receive 12 treatment sessions over a 6-week period.
Verfahren: Combined Manual Therapy and Ultrasound-Guided Percutaneous Neuromodulation
Participants will receive a multimodal conservative treatment consisting of manual therapy and ultrasound-guided percutaneous neuromodulation. Manual therapy will include myofascial release, passive accessory joint mobilization, cervical mobilization when indicated, and median nerve neurodynamic mobilization. Ultrasound-guided percutaneous neuromodulation will be applied to the median nerve using low-frequency electrical stimulation according to a standardized protocol.
Aktiver Komparator: Postsurgical Rehabilitation.
Participants allocated to the postsurgical rehabilitation arm will receive a standardized physiotherapy program following carpal tunnel release surgery. The rehabilitation protocol will include transcutaneous electrical nerve stimulation (TENS), active and passive mobilization exercises, strengthening exercises for the wrist and hand, stretching exercises, cryotherapy, and soft tissue techniques as clinically indicated. Participants will receive 18 treatment sessions over a 6-week period.
Sonstiges: Postsurgical Rehabilitation
Participants will receive a standardized physiotherapy program following carpal tunnel release surgery, including transcutaneous electrical nerve stimulation (TENS), active and passive mobilization exercises, strengthening exercises, stretching, cryotherapy, and soft tissue techniques as clinically indicated.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Boston Carpal Tunnel Questionnaire (BCTQ) total score
Zeitfenster: Baseline and 6 weeks
The primary outcome is the change in symptom severity and functional status assessed using the Boston Carpal Tunnel Questionnaire (BCTQ), a validated patient-reported outcome measure for carpal tunnel syndrome.
Baseline and 6 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain intensity
Zeitfenster: Baseline and 6 weeks
Pain intensity assessed using the Visual Analogue Scale (VAS).
Baseline and 6 weeks

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Upper-limb disability
Zeitfenster: Baseline, 3 weeks, 6 weeks, and 4-week follow-up
Upper-limb disability assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
Baseline, 3 weeks, 6 weeks, and 4-week follow-up
Median nerve sensory conduction velocity
Zeitfenster: Baseline, 3 weeks, 6 weeks, and 4-week follow-up
Sensory conduction velocity (m/s) assessed by standardized nerve conduction studies.
Baseline, 3 weeks, 6 weeks, and 4-week follow-up
Median nerve distal motor latency
Zeitfenster: Baseline, 3 weeks, 6 weeks, and 4-week follow-up
Distal motor latency (ms) assessed by standardized nerve conduction studies.
Baseline, 3 weeks, 6 weeks, and 4-week follow-up

Mitarbeiter und Ermittler

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

Sponsor

Universidad Europea de Valencia

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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 (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. September 2027

Studienabschluss (Geschätzt)

1. Januar 2028

Studienanmeldedaten

Zuerst eingereicht

12. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Juni 2026

Zuerst gepostet (Tatsächlich)

17. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UEV-CTS-MTPNM-2026-01

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Beschreibung des IPD-Plans

At the time of registration, no final decision has been made regarding the sharing of individual participant data. Any future data-sharing plan will be determined in accordance with applicable ethical approvals, institutional policies, participant consent, and data protection regulations.

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Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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