Combined Manual Therapy and Percutaneous Neuromodulation for Moderate Carpal Tunnel Syndrome

NCT07654621 | Not Yet Recruiting

• 1 other identifier: UEV-CTS-MTPNM-2026-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Manual Therapy; Percutaneous Neuromodulation; Physical Therapy; Rehabilitation; Median Nerve; Peripheral Neuropathy; Ultrasound-Guided Intervention; Conservative Treatment; Upper Limb

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Pain intensity

  Baseline and 6 weeks

Other Outcomes (3)

• Upper-limb disability

  Baseline, 3 weeks, 6 weeks, and 4-week follow-up

• Median nerve sensory conduction velocity

  Baseline, 3 weeks, 6 weeks, and 4-week follow-up

• Median nerve distal motor latency

  Baseline, 3 weeks, 6 weeks, and 4-week follow-up

Study Arms (2)

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.

Procedure: Combined Manual Therapy and Ultrasound-Guided Percutaneous Neuromodulation

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.

Other: Postsurgical Rehabilitation

Interventions

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.

Combined Manual Therapy and Percutaneous Neuromodulation

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.

Postsurgical Rehabilitation.

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Valencia: lead

Study Sites (1)

European University of Valencia

Valencia, Valencia, 46010, Spain

Location

Related Publications (23)

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MeSH Terms

Conditions

Carpal Tunnel Syndrome; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Central Study Contacts

Javier Bonastre Férez, PhD

CONTACT

+34644120315; javier.bonastre@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

ES (1)