Carpal Tunnel Syndrome
Conditions
Keywords
Carpal Tunnel Syndrome, Manual Therapy, Percutaneous Neuromodulation, Physical Therapy, Rehabilitation, Median Nerve, Peripheral Neuropathy, Ultrasound-Guided Intervention, Conservative Treatment, Upper Limb
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.
Detailed description
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.
Interventions
PROCEDURECombined Manual Therapy and Ultrasound-Guided Percutaneous Neuromodulation
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.
OTHERPostsurgical Rehabilitation
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.
Sponsors
Universidad Europea de Valencia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Carpal Tunnel Questionnaire (BCTQ) total score | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Baseline and 6 weeks | Pain intensity assessed using the Visual Analogue Scale (VAS). |
Countries
Spain
Contacts
CONTACTJavier Bonastre Férez, PhD
Outcome results
None listed