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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06399380
Other study ID # PI23-440
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date June 15, 2024

Study information

Verified date May 2024
Source Universidad de Zaragoza
Contact Leyre Epifanio
Phone 610872981
Email 784116@unizar.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 15, 2024
Est. primary completion date May 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Manual mobilization of the carpal bones.
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.
Placebo
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.

Locations

Country Name City State
Spain Universidad de Zaragoza Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Distal motor latency (APB) (ms) Before and immediately after the intervention
Primary Motor amplitude (APB) (mV) Before and immediately after the intervention
Primary Median motor velocity (m/s) Before and immediately after the intervention
Primary Median sensory (digit II) (13 cm) (m/sec) Before and immediately after the intervention
Primary Sensory amplitude (µV ) Before and immediately after the intervention
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