- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06399380
In Patients With Carpal Tunnel Syndrome, Median Nerve Conduction is Evaluated After Moving the Wrist Bones
Immediate Effect of Manual Mobilization of the Carpal Bones on the Neural Conduction of the Median Nerve in Patients With Carpal Tunnel Syndrome: Randomized Clinical Trial
The goal of this clinical trial is to analyze the immediate effect of manual mobilization techniques of the carpal bones on the median nerve, in patients with carpal tunnel syndrome. The main question it aims to answer is whether there is an immediate positive effect on the electrophysiological variables of the median nerve in patients with carpal tunnel syndrome after performing this technique.
Participants will undergo a carpal bone mobilization technique. There will be a comparison group that will not undergo the technique. The researchers will compare the control and intervention groups to see if the technique has an immediate positive effect.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Leyre Epifanio
- Phone Number: 610872981
- Email: 784116@unizar.es
Study Locations
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Zaragoza, Spain, 50009
- Recruiting
- Universidad de Zaragoza
-
Contact:
- PT, PhD
- Phone Number: 876554446
- Email: ebueno@unizar.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being over 18 years
- Present carpal tunnel syndrome diagnosed by electroneurogram
- Have understanding and communication skills
- Give consent to participate in the study.
Exclusion Criteria:
- Having received previous surgery on the hand or wrist
- Present limitation of movement of the carpal bones.
- Not signing the informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Placebo group
Placebo
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A technique will be performed that will have no effect; the hands will be placed at a point that will not be the carpal tunnel, such as the forearm.
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Experimental: Manual mobilization group
Manual mobilization of the carpal bones
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The mobilization of the carpal bones will be done in the following way: patient in supine position, with elbow flexion of approximately 90º, so that the forearm and wrist are almost vertical.
The examiner positions the thumb on the dorsal aspect of the scaphoid and trapezius, and the index finger on the dorsal aspect of the piriformis and hamate.
Next, a manual ventral force is applied until the resistance of the wrist tissues is felt for 30 seconds.
The technique will be repeated 5 times, with a 10-second rest between each application.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Distal motor latency (APB) (ms)
Time Frame: Before and immediately after the intervention
|
Before and immediately after the intervention
|
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Motor amplitude (APB) (mV)
Time Frame: Before and immediately after the intervention
|
Before and immediately after the intervention
|
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Median motor velocity (m/s)
Time Frame: Before and immediately after the intervention
|
Before and immediately after the intervention
|
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Median sensory (digit II) (13 cm) (m/sec)
Time Frame: Before and immediately after the intervention
|
Before and immediately after the intervention
|
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Sensory amplitude (μV )
Time Frame: Before and immediately after the intervention
|
Before and immediately after the intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosen I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999 Jul 14;282(2):153-8. doi: 10.1001/jama.282.2.153.
- 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.
- Bueno-Gracia E, Ruiz-de-Escudero-Zapico A, Malo-Urries M, Shacklock M, Estebanez-de-Miguel E, Fanlo-Mazas P, Caudevilla-Polo S, Jimenez-Del-Barrio S. Dimensional changes of the carpal tunnel and the median nerve during manual mobilization of the carpal bones. Musculoskelet Sci Pract. 2018 Aug;36:12-16. doi: 10.1016/j.msksp.2018.04.002. Epub 2018 Apr 4.
- Newington L, Harris EC, Walker-Bone K. Carpal tunnel syndrome and work. Best Pract Res Clin Rheumatol. 2015 Jun;29(3):440-53. doi: 10.1016/j.berh.2015.04.026. Epub 2015 May 27.
- Wolny T, Saulicz E, Linek P, Shacklock M, Mysliwiec A. Efficacy of Manual Therapy Including Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2017 May;40(4):263-272. doi: 10.1016/j.jmpt.2017.02.004. Epub 2017 Apr 8.
- Ibrahim I, Khan WS, Goddard N, Smitham P. Carpal tunnel syndrome: a review of the recent literature. Open Orthop J. 2012;6:69-76. doi: 10.2174/1874325001206010069. Epub 2012 Feb 23.
- Marquardt TL, Gabra JN, Li ZM. Morphological and positional changes of the carpal arch and median nerve during wrist compression. Clin Biomech (Bristol, Avon). 2015 Mar;30(3):248-53. doi: 10.1016/j.clinbiomech.2015.01.007. Epub 2015 Jan 31.
- Bueno-Gracia E, Perez-Bellmunt A, Lopez-de-Celis C, Shacklock M, Salas-Lopez A, Simon M, Alvarez-Diaz P, Tricas-Moreno JM. Dimensional changes of the carpal tunnel and median nerve during manual mobilization of the carpal bones - Anatomical study. Clin Biomech (Bristol, Avon). 2018 Nov;59:56-61. doi: 10.1016/j.clinbiomech.2018.09.001. Epub 2018 Sep 3.
- Kim DH, Marquardt TL, Gabra JN, Shen ZL, Evans PJ, Seitz WH, Li ZM. Pressure-morphology relationship of a released carpal tunnel. J Orthop Res. 2013 Apr;31(4):616-20. doi: 10.1002/jor.22271. Epub 2012 Nov 26.
- 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.
- Jimenez-Del-Barrio S, Cadellans-Arroniz A, Ceballos-Laita L, Estebanez-de-Miguel E, Lopez-de-Celis C, Bueno-Gracia E, Perez-Bellmunt A. The effectiveness of manual therapy on pain, physical function, and nerve conduction studies in carpal tunnel syndrome patients: a systematic review and meta-analysis. Int Orthop. 2022 Feb;46(2):301-312. doi: 10.1007/s00264-021-05272-2. Epub 2021 Dec 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI23-440
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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