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Carpal Tunnel SyndromeMANUCTSNCT07654621

Combined Manual Therapy and Percutaneous Neuromodulation for Moderate Carpal Tunnel Syndrome

A study testing Combined Manual Therapy and Ultrasound-Guided Percutaneous Neuromodulation and Postsurgical Rehabilitation in people with Carpal Tunnel Syndrome, run by Universidad Europea de Valencia at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 50 years
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Combined Manual Therapy and Ultrasound-Guided Percutaneous Neuromodulation and Postsurgical Rehabilitation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSpain
Study dates
Jul 2026to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Javier Bonastre Férez, PhD contact

+34644120315

javier.bonastre@universidadeuropea.es

Spain1 site
  • European University of Valencia

    Valencia, Valencia, 46010

    Javier Bonastre Férez, 644120315, javier.bonastre@universidadeuropea.es

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Combined Manual Therapy and Ultrasound-Guided Percutaneous Neuromodulation, Postsurgical Rehabilitation
Keywords
Carpal Tunnel Syndrome, Manual Therapy, Percutaneous Neuromodulation, Physical Therapy, Rehabilitation, Median Nerve, Peripheral Neuropathy, Ultrasound-Guided Intervention, Conservative Treatment, Upper Limb
Medical subject headings
Carpal Tunnel Syndrome, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined Manual Therapy and Ultrasound-Guided Percutaneous NeuromodulationProcedure or surgery

    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 RehabilitationOther

    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.

Study groups in NCT07654621
Study groupRoleWhat they receive
Combined Manual Therapy and Percutaneous NeuromodulationExperimentalParticipants 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.
Receives: Procedure: Combined Manual Therapy and Ultrasound-Guided Percutaneous Neuromodulation
Postsurgical Rehabilitation.Active comparatorParticipants 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.
Receives: Other: Postsurgical Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6 weeks

Secondary outcomes (1)
  1. Pain intensity

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

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07654621
Sponsor's protocol ID
UEV-CTS-MTPNM-2026-01
Acronym
MANUCTS
Status last verified
Jun 2026
First submitted
12 Jun 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • 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.

    PubMed 12115985
  • 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.

    PubMed 36987682
  • 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.

    PubMed 33876885
  • 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.

    PubMed 39674759
  • 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.

    PubMed 35167691
  • 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.

    PubMed 27011304
  • 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.

    PubMed 26281946
  • Bland JD. Carpal tunnel syndrome. BMJ. 2007 Aug 18;335(7615):343-6. doi: 10.1136/bmj.39282.623553.AD. No abstract available.

    PubMed 17703044
  • 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.

    PubMed 27461181
  • 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.

    PubMed 28577858
  • 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.

    PubMed 25679928
  • 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.

    PubMed 31039688
  • 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.

    PubMed 17613571
  • 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.

    PubMed 17216630
  • 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.

    PubMed 10194028

Questions about this trial

What is this clinical trial studying?

A study testing Combined Manual Therapy and Ultrasound-Guided Percutaneous Neuromodulation and Postsurgical Rehabilitation in people with Carpal Tunnel Syndrome, run by Universidad Europea de Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Javier Bonastre Férez, PhD (+34644120315, javier.bonastre@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Boston Carpal Tunnel Questionnaire (BCTQ) total score (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07654621, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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