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NCT Number: NCT07654621

Combined Manual Therapy and Percutaneous Neuromodulation for Moderate Carpal Tunnel Syndrome

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.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Boston Carpal Tunnel Questionnaire (BCTQ) total score

    Time frame: 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.

Secondary outcomes

  1. Pain intensity

    Time frame: Baseline and 6 weeks

    Pain intensity assessed using the Visual Analogue Scale (VAS).

Other outcomes

  1. Upper-limb disability

    Time frame: 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.

  2. Median nerve sensory conduction velocity

    Time frame: Baseline, 3 weeks, 6 weeks, and 4-week follow-up

    Sensory conduction velocity (m/s) assessed by standardized nerve conduction studies.

  3. Median nerve distal motor latency

    Time frame: Baseline, 3 weeks, 6 weeks, and 4-week follow-up

    Distal motor latency (ms) assessed by standardized nerve conduction studies.

Study contacts

Contact information is provided by the study sponsor or research team.

Javier Bonastre Férez, PhD

CONTACT

[email protected]

+34644120315

Sponsors and collaborators

Lead sponsor

Universidad Europea de Valencia

Other

Registry information

Official study title

Combined Manual Therapy and Percutaneous Neuromodulation Versus Postsurgical Rehabilitation for Moderate Carpal Tunnel Syndrome: Protocol for a Non-Randomized Controlled Trial

Acronym: MANUCTS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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