Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Manual Therapy and Percutaneous Neuromodulation | Experimental | 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. |
|
| Postsurgical Rehabilitation. | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Manual Therapy and Ultrasound-Guided Percutaneous Neuromodulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Carpal Tunnel Questionnaire (BCTQ) total score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity assessed using the Visual Analogue Scale (VAS). | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Upper-limb disability | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier Bonastre Férez, PhD | Contact | +34644120315 | javier.bonastre@universidadeuropea.es |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European University of Valencia | Valencia | Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12115985 | Background | 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. | |
| 36987682 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
This is a multicenter, parallel-group, non-randomized controlled trial. Participants will be allocated to one of two study arms based on their clinical background. Individuals with previous carpal tunnel release surgery will be assigned to the postsurgical rehabilitation group, whereas eligible participants without previous surgery will receive the combined manual therapy and ultrasound-guided percutaneous neuromodulation intervention. Baseline differences between groups will be addressed using propensity score adjustment in the statistical analysis.
Not provided
Not provided
Due to the nature of the interventions, blinding of participants and treating physiotherapists is not feasible. Outcome assessors and data analysts will remain blinded to group allocation throughout the study. At the end of the study, outcome assessors will be asked to indicate whether they believe each participant belonged to the intervention group, the control group, or whether they are unable to determine group allocation in order to assess the success of assessor blinding.
|
| Postsurgical Rehabilitation | Other | 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. |
|
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 | Distal motor latency (ms) assessed by standardized nerve conduction studies. | Baseline, 3 weeks, 6 weeks, and 4-week follow-up |
| 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. |
| 33876885 | Background | 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. |
| 39674759 | Background | 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. |
| 35167691 | Background | 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. |
| 27011304 | Background | 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. |
| 26281946 | Background | 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. |
| 17703044 | Background | Bland JD. Carpal tunnel syndrome. BMJ. 2007 Aug 18;335(7615):343-6. doi: 10.1136/bmj.39282.623553.AD. No abstract available. |
| 27461181 | Background | 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. |
| 28577858 | Background | 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. |
| 25679928 | Background | 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. |
| 31039688 | Background | 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. |
| 17613571 | Background | 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. |
| 17216630 | Background | 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. |
| 10194028 | Background | 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. |
| 17565533 | Background | 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. |
| 16530966 | Background | 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. |
| 38145037 | Background | 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. |
| 25630774 | Background | Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9. |
| 39672798 | Background | 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. |
| 38697747 | Background | 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. |
| Background | 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. |
| 27751557 | Background | 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. |
| D009408 |
| Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |