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

12 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

150

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

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Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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.
Comparatore attivo: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Boston Carpal Tunnel Questionnaire (BCTQ) total score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain intensity
Lasso di tempo: Baseline and 6 weeks
Pain intensity assessed using the Visual Analogue Scale (VAS).
Baseline and 6 weeks

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Upper-limb disability
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad Europea de Valencia

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

12 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UEV-CTS-MTPNM-2026-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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