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

12 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

150

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
Comparador activo: 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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Boston Carpal Tunnel Questionnaire (BCTQ) total score
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain intensity
Periodo de tiempo: Baseline and 6 weeks
Pain intensity assessed using the Visual Analogue Scale (VAS).
Baseline and 6 weeks

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Upper-limb disability
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de enero de 2028

Fechas de registro del estudio

Enviado por primera vez

12 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de junio de 2026

Publicado por primera vez (Actual)

17 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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