Treatment of Neck Pain With Transcranial Direct Current Stimulation

NCT ID: NCT04729270

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2023-11-20

Brief Summary

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This study aim to investigate the effects of Transcranial Direct Current Stimulation for improving pressure pain thresholds (PPTs), range of motion,Neck Disability Index, the multidimensional health related quality of life (SF-12) and the multidimensional health related quality of life and pain in patients with mechanical neck pain (NP).

Detailed Description

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Fifty-four participants with NP will randomly allocated to either an Transcranial Direct Current Stimulation (ten sessions) or transcutaneous electric nerve stimulation (TENS) (ten sessions) during two weeks. . Visual Analogue Scale (VAS), Neck Disability Index ( NDI), range of motion and (CROM), Questionnaire SF-12 and PPTs in sub-occipital and upper trapezius muscles were measured at baseline, at the end of treatment and at 1 month follow-up. T-tests and a repeated-measures multivariate analysis of variance (RM-MANOVA) were used for VAS, CROM and PPTs, respectively.

Conditions

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Cervical Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Blind researcher

Study Groups

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EXPERIMENTAL GROUP

The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.

Group Type EXPERIMENTAL

Physiotherapy treatment with physium device.

Intervention Type PROCEDURE

The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.

CONTROL GROUP

The intervention for this group consisted of 10 sessions with Transcutaneous Electrical Nerve Stimulation (TENS) for a month.

Group Type EXPERIMENTAL

Conventional physiotherapy treatment.

Intervention Type PROCEDURE

The intervention for this group consisted of 10 sessions with Electrical Nerve Stimulation (TENS) for a month.

Interventions

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Physiotherapy treatment with physium device.

The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.

Intervention Type PROCEDURE

Conventional physiotherapy treatment.

The intervention for this group consisted of 10 sessions with Electrical Nerve Stimulation (TENS) for a month.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients of both sexes,
* Aged between 18 and 60 years, in an
* Active state of pain and diagnosed with a month of evolution.

Exclusion Criteria

\- Patients who are pregnant, have pacemaker and those Surgically operated cervical spine - Patients who have been treated with Transcranial Direct Current Stimulation a month earlier.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cadiz

OTHER

Sponsor Role lead

Responsible Party

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Manuel Rodriguez Huguet

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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manuel Rodríguez Huguet, Physiotherapy

Role: PRINCIPAL_INVESTIGATOR

University of Cádiz

Locations

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Policlínica Santa María

Cadiz, Cádiz, Spain

Site Status

Countries

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Spain

References

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Whiteford CM, Steinbeck L, Dommerholt J. On "Clinical Practice Guideline for Physical Therapy Assessment and Treatment in Patients With Nonspecific Neck Pain," Bier JD, Scholten-Peeters WGM, Staal JB, et al. Phys Ther. 2018;98:162-171. Phys Ther. 2018 Sep 1;98(9):819-820. doi: 10.1093/ptj/pzy078. No abstract available.

Reference Type BACKGROUND
PMID: 29961845 (View on PubMed)

Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.

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Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.

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Yalinay Dikmen P, Yavuz BG, Aydinlar EI. The relationships between migraine, depression, anxiety, stress, and sleep disturbances. Acta Neurol Belg. 2015 Jun;115(2):117-22. doi: 10.1007/s13760-014-0312-0. Epub 2014 Jun 3.

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Martelletti P, Jensen RH, Antal A, Arcioni R, Brighina F, de Tommaso M, Franzini A, Fontaine D, Heiland M, Jurgens TP, Leone M, Magis D, Paemeleire K, Palmisani S, Paulus W, May A; European Headache Federation. Neuromodulation of chronic headaches: position statement from the European Headache Federation. J Headache Pain. 2013 Oct 21;14(1):86. doi: 10.1186/1129-2377-14-86.

Reference Type BACKGROUND
PMID: 24144382 (View on PubMed)

Charvet LE, Shaw MT, Bikson M, Woods AJ, Knotkova H. Supervised transcranial direct current stimulation (tDCS) at home: A guide for clinical research and practice. Brain Stimul. 2020 May-Jun;13(3):686-693. doi: 10.1016/j.brs.2020.02.011. Epub 2020 Feb 10.

Reference Type BACKGROUND
PMID: 32289698 (View on PubMed)

Caulfield KA, Badran BW, DeVries WH, Summers PM, Kofmehl E, Li X, Borckardt JJ, Bikson M, George MS. Transcranial electrical stimulation motor threshold can estimate individualized tDCS dosage from reverse-calculation electric-field modeling. Brain Stimul. 2020 Jul-Aug;13(4):961-969. doi: 10.1016/j.brs.2020.04.007. Epub 2020 Apr 21.

Reference Type BACKGROUND
PMID: 32330607 (View on PubMed)

DaSilva AF, Truong DQ, DosSantos MF, Toback RL, Datta A, Bikson M. State-of-art neuroanatomical target analysis of high-definition and conventional tDCS montages used for migraine and pain control. Front Neuroanat. 2015 Jul 15;9:89. doi: 10.3389/fnana.2015.00089. eCollection 2015.

Reference Type BACKGROUND
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Auvichayapat P, Janyacharoen T, Rotenberg A, Tiamkao S, Krisanaprakornkit T, Sinawat S, Punjaruk W, Thinkhamrop B, Auvichayapat N. Migraine prophylaxis by anodal transcranial direct current stimulation, a randomized, placebo-controlled trial. J Med Assoc Thai. 2012 Aug;95(8):1003-12.

Reference Type BACKGROUND
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Straudi S, Buja S, Baroni A, Pavarelli C, Pranovi G, Fregni F, Basaglia N. The effects of transcranial direct current stimulation (tDCS) combined with group exercise treatment in subjects with chronic low back pain: a pilot randomized control trial. Clin Rehabil. 2018 Oct;32(10):1348-1356. doi: 10.1177/0269215518777881. Epub 2018 May 21.

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Andrade SM, de Brito Aranha REL, de Oliveira EA, de Mendonca CTPL, Martins WKN, Alves NT, Fernandez-Calvo B. Transcranial direct current stimulation over the primary motor vs prefrontal cortex in refractory chronic migraine: A pilot randomized controlled trial. J Neurol Sci. 2017 Jul 15;378:225-232. doi: 10.1016/j.jns.2017.05.007. Epub 2017 May 3.

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Reference Type BACKGROUND
PMID: 28551531 (View on PubMed)

Other Identifiers

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tDCS

Identifier Type: -

Identifier Source: org_study_id

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