Combined Manual Therapy and Percutaneous Neuromodulation for Moderate Carpal Tunnel Syndrome (MANUCTS)
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Javier Bonastre Férez, PhD
- Número de telefone: +34644120315
- E-mail: javier.bonastre@universidadeuropea.es
Locais de estudo
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Valencia
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Valencia, Valencia, Espanha, 46010
- European University of Valencia
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Contato:
- Javier Bonastre Férez
- Número de telefone: 644120315
- E-mail: javier.bonastre@universidadeuropea.es
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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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.
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Comparador Ativo: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Boston Carpal Tunnel Questionnaire (BCTQ) total score
Prazo: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain intensity
Prazo: Baseline and 6 weeks
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Pain intensity assessed using the Visual Analogue Scale (VAS).
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Baseline and 6 weeks
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Upper-limb disability
Prazo: Baseline, 3 weeks, 6 weeks, and 4-week follow-up
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Upper-limb disability assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
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Baseline, 3 weeks, 6 weeks, and 4-week follow-up
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Median nerve sensory conduction velocity
Prazo: Baseline, 3 weeks, 6 weeks, and 4-week follow-up
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Sensory conduction velocity (m/s) assessed by standardized nerve conduction studies.
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Baseline, 3 weeks, 6 weeks, and 4-week follow-up
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Median nerve distal motor latency
Prazo: Baseline, 3 weeks, 6 weeks, and 4-week follow-up
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Distal motor latency (ms) assessed by standardized nerve conduction studies.
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Baseline, 3 weeks, 6 weeks, and 4-week follow-up
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11.
- Foley M, Silverstein B, Polissar N. The economic burden of carpal tunnel syndrome: long-term earnings of CTS claimants in Washington State. Am J Ind Med. 2007 Mar;50(3):155-72. doi: 10.1002/ajim.20430.
- Piazzini DB, Aprile I, Ferrara PE, Bertolini C, Tonali P, Maggi L, Rabini A, Piantelli S, Padua L. A systematic review of conservative treatment of carpal tunnel syndrome. Clin Rehabil. 2007 Apr;21(4):299-314. doi: 10.1177/0269215507077294.
- San-Emeterio-Iglesias R, Minaya-Munoz F, Romero-Morales C, De-la-Cruz-Torres B. Correct Sciatic Nerve Management to Apply Ultrasound-Guided Percutaneous Neuromodulation in Patients With Chronic Low Back Pain: A Pilot Study. Neuromodulation. 2021 Aug;24(6):1067-1074. doi: 10.1111/ner.13396. Epub 2021 Apr 20.
- Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9.
- Jimenez Del Barrio S, Bueno Gracia E, Hidalgo Garcia C, Estebanez de Miguel E, Tricas Moreno JM, Rodriguez Marco S, Ceballos Laita L. Conservative treatment in patients with mild to moderate carpal tunnel syndrome: A systematic review. Neurologia (Engl Ed). 2018 Nov-Dec;33(9):590-601. doi: 10.1016/j.nrl.2016.05.018. Epub 2016 Jul 22. English, Spanish.
- Fernandez-de-Las-Penas C, Ortega-Santiago R, De-la-Llave-Rincon AI, Cleland JA, Pareja JA, Fahandezh-Saddi-Diaz H, Arias-Buria JL. Ultrasound-guided percutaneous electrical nerve stimulation versus surgery for women with unilateral carpal tunnel syndrome: A randomized parallel-group trial. Eur J Pain. 2023 Aug;27(7):860-870. doi: 10.1002/ejp.2117. Epub 2023 Apr 7.
- Fernandez-de-Las Penas C, Ortega-Santiago R, de la Llave-Rincon AI, Martinez-Perez A, Fahandezh-Saddi Diaz H, Martinez-Martin J, Pareja JA, Cuadrado-Perez ML. Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: A Randomized Parallel-Group Trial. J Pain. 2015 Nov;16(11):1087-94. doi: 10.1016/j.jpain.2015.07.012. Epub 2015 Aug 15.
- Harinesan N, Silsby M, Simon NG. Carpal tunnel syndrome. Handb Clin Neurol. 2024;201:61-88. doi: 10.1016/B978-0-323-90108-6.00005-3.
- Feng B, Gong C, You L, Lin Y, Wang Y, Ip WY, Wang Y. Central Sensitization in Patients with Chronic Pain Secondary to Carpal Tunnel Syndrome and Determinants. J Pain Res. 2023 Dec 19;16:4353-4366. doi: 10.2147/JPR.S441786. eCollection 2023.
- American Association of Electrodiagnostic Medicine, American Academy of Neurology, and American Academy of Physical Medicine and Rehabilitation. Practice parameter for electrodiagnostic studies in carpal tunnel syndrome: summary statement. Muscle Nerve. 2002 Jun;25(6):918-22. doi: 10.1002/mus.10185. No abstract available.
- Mogedano-Cruz S, Lopez-Perez M, Gijon-Lago D, Romero-Morales C, Alonso-Perez JL, Villafane JH, Saiz SLJ, Sosa-Reina MD. Peripheral Percutaneous Electrical Nerve Stimulation for Neuropathies: A Systematic Review and Meta-analysis. Pain Manag Nurs. 2025 Feb;26(1):93-101. doi: 10.1016/j.pmn.2024.11.005. Epub 2024 Dec 13.
- Beltran-Alacreu H, Serrano-Munoz D, Martin-Caro Alvarez D, Fernandez-Perez JJ, Gomez-Soriano J, Avendano-Coy J. Percutaneous Versus Transcutaneous Electrical Nerve Stimulation for the Treatment of Musculoskeletal Pain. A Systematic Review and Meta-Analysis. Pain Med. 2022 Aug 1;23(8):1387-1400. doi: 10.1093/pm/pnac027.
- Fernandez-de-Las-Penas C, Cleland JA, Salom-Moreno J, Palacios-Cena M, Martinez-Perez A, Pareja JA, Ortega-Santiago R. Prediction of Outcome in Women With Carpal Tunnel Syndrome Who Receive Manual Physical Therapy Interventions: A Validation Study. J Orthop Sports Phys Ther. 2016 Jun;46(6):443-51. doi: 10.2519/jospt.2016.6348. Epub 2016 Mar 23.
- Bland JD. Carpal tunnel syndrome. BMJ. 2007 Aug 18;335(7615):343-6. doi: 10.1136/bmj.39282.623553.AD. No abstract available.
- Huisstede BM, van den Brink J, Randsdorp MS, Geelen SJ, Koes BW. Effectiveness of Surgical and Postsurgical Interventions for Carpal Tunnel Syndrome-A Systematic Review. Arch Phys Med Rehabil. 2018 Aug;99(8):1660-1680.e21. doi: 10.1016/j.apmr.2017.04.024. Epub 2017 May 31.
- Manterola C, Asenjo-Lobos C, Otzen T. [Hierarchy of evidence: levels of evidence and grades of recommendation from current use]. Rev Chilena Infectol. 2014 Dec;31(6):705-18. doi: 10.4067/S0716-10182014000600011. Spanish.
- Carpal Tunnel Syndrome: A Summary of Clinical Practice Guideline Recommendations-Using the Evidence to Guide Physical Therapist Practice. J Orthop Sports Phys Ther. 2019 May;49(5):359-360. doi: 10.2519/jospt.2019.0501.
- Atroshi I, Gummesson C, Johnsson R, Sprinchorn A. Symptoms, disability, and quality of life in patients with carpal tunnel syndrome. J Hand Surg Am. 1999 Mar;24(2):398-404. doi: 10.1016/s0363-5023(99)70014-6.
- Zanette G, Marani S, Tamburin S. Proximal pain in patients with carpal tunnel syndrome: a clinical-neurophysiological study. J Peripher Nerv Syst. 2007 Jun;12(2):91-7. doi: 10.1111/j.1529-8027.2007.00127.x.
- Zanette G, Marani S, Tamburin S. Extra-median spread of sensory symptoms in carpal tunnel syndrome suggests the presence of pain-related mechanisms. Pain. 2006 Jun;122(3):264-270. doi: 10.1016/j.pain.2006.01.034. Epub 2006 Mar 13.
- Gebrye T, Jeans E, Yeowell G, Mbada C, Fatoye F. Global and Regional Prevalence of Carpal Tunnel Syndrome: A Meta-Analysis Based on a Systematic Review. Musculoskeletal Care. 2024 Dec;22(4):e70024. doi: 10.1002/msc.70024.
- Instituto Nacional de Seguridad y Salud en el Trabajo (INSST). Directrices para la decisión clínica en enfermedades profesionales. Trastornos musculoesqueléticos de origen profesional del miembro superior: síndrome del túnel carpiano por compresión del nervio mediano en la muñeca. Madrid: INSST; 2022.
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- UEV-CTS-MTPNM-2026-01
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