NCT06399380

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

April 25, 2024

Last Update Submit

May 1, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Distal motor latency (APB) (ms)

    Before and immediately after the intervention

  • Motor amplitude (APB) (mV)

    Before and immediately after the intervention

  • Median motor velocity (m/s)

    Before and immediately after the intervention

  • Median sensory (digit II) (13 cm) (m/sec)

    Before and immediately after the intervention

  • Sensory amplitude (μV )

    Before and immediately after the intervention

Study Arms (2)

Manual mobilization group

EXPERIMENTAL

Manual mobilization of the carpal bones

Other: Manual mobilization of the carpal bones.

Placebo group

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

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.

Manual mobilization group
PlaceboOTHER

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.

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years
  • Present carpal tunnel syndrome diagnosed by electroneurogram
  • Have understanding and communication skills
  • Give consent to participate in the study.

You may not qualify if:

  • Having received previous surgery on the hand or wrist
  • Present limitation of movement of the carpal bones.
  • Not signing the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Zaragoza

Zaragoza, 50009, Spain

RECRUITING

Related Publications (11)

  • 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.

    PMID: 28395984BACKGROUND
  • 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.

    PMID: 23184493BACKGROUND
  • Marquardt TL, Gabra JN, Li ZM. Morphological and positional changes of the carpal arch and median nerve during wrist compression. Clin Biomech (Bristol). 2015 Mar;30(3):248-53. doi: 10.1016/j.clinbiomech.2015.01.007. Epub 2015 Jan 31.

    PMID: 25661267BACKGROUND
  • 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.

    PMID: 10411196BACKGROUND
  • 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.

    PMID: 29635191BACKGROUND
  • 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.

    PMID: 27751557BACKGROUND
  • 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.

    PMID: 27461181BACKGROUND
  • 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.

    PMID: 22470412BACKGROUND
  • 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.

    PMID: 26612240BACKGROUND
  • 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). 2018 Nov;59:56-61. doi: 10.1016/j.clinbiomech.2018.09.001. Epub 2018 Sep 3.

    PMID: 30195102BACKGROUND
  • 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.

    PMID: 34862562BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Central Study Contacts

Leyre Epifanio

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, PhD

Study Record Dates

First Submitted

April 25, 2024

First Posted

May 3, 2024

Study Start

January 15, 2024

Primary Completion

May 10, 2024

Study Completion

June 15, 2024

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations