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Carpal Tunnel SyndromeNCT06399380

In Patients With Carpal Tunnel Syndrome, Median Nerve Conduction is Evaluated After Moving the Wrist Bones

A study testing Manual mobilization of the carpal bones. in people with Carpal Tunnel Syndrome, run by Universidad de Zaragoza at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Manual mobilization of the carpal bones.
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSpain
Study dates
15 Jan 2024to 15 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Leyre Epifanio contact

610872981

784116@unizar.es

Spain1 site, 1 recruiting

  • Universidad de Zaragoza

    Zaragoza, 50009

    PT, PhD, 876554446, ebueno@unizar.es

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Being tested
Manual mobilization of the carpal bones., Placebo
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

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

  • Manual mobilization of the carpal bones.Other

    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.

  • 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.

Study groups in NCT06399380
Study groupRoleWhat they receive
Manual mobilization groupExperimentalManual mobilization of the carpal bones
Receives: Other: Manual mobilization of the carpal bones.
Placebo groupPlacebo comparatorPlacebo
Receives: Other: Placebo

What is being measured

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

  1. Distal motor latency (APB) (ms)

    Measured: Before and immediately after the intervention

  2. Motor amplitude (APB) (mV)

    Measured: Before and immediately after the intervention

  3. Median motor velocity (m/s)

    Measured: Before and immediately after the intervention

  4. Median sensory (digit II) (13 cm) (m/sec)

    Measured: Before and immediately after the intervention

  5. Sensory amplitude (μV )

    Measured: Before and immediately after the intervention

Timeline

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

  1. First posted3 May 2024
  2. Study start15 Jan 2024
  3. Primary completion10 May 2024 (estimated)
  4. Study completion15 Jun 2024 (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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06399380
Sponsor's protocol ID
PI23-440
Status last verified
May 2024
First submitted
25 Apr 2024
Last updated
3 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28395984

  • 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.

    PubMed 23184493

  • 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.

    PubMed 25661267

  • 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.

    PubMed 10411196

  • 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.

    PubMed 29635191

  • 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.

    PubMed 27751557

  • 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

  • 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.

    PubMed 22470412

  • 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.

    PubMed 26612240

  • 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.

    PubMed 30195102

  • 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.

    PubMed 34862562

Questions about this trial

What is this clinical trial studying?

A study testing Manual mobilization of the carpal bones. in people with Carpal Tunnel Syndrome, run by Universidad de Zaragoza 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 3 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: status not confirmed, as of the sponsor's last update on 3 May 2024. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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

Contact Leyre Epifanio (610872981, 784116@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distal motor latency (APB) (ms) (time frame: Before and immediately after the intervention). The study lists 5 primary outcomes in all. 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 NCT06399380, which also lists 11 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 3 May 2024.

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