Cervical SyndromeNCT04729270

Treatment of Neck Pain With Transcranial Direct Current Stimulation

A study testing Physiotherapy treatment with physium device. and Conventional physiotherapy treatment. in people with Cervical Syndrome, run by University of Cadiz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Cervical Syndrome
What is being tested?: Physiotherapy treatment with physium device. and Conventional physiotherapy treatment.
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSpain
Study dates: 6 Feb 2023to 20 Nov 2023
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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Policlínica Santa María
Cadiz, Cádiz, 11007

Other trials in Spain

About this study

Official title: Treatment of Neck Pain With Transcranial Direct Current Stimulation: A Single Blind Randomized Controlled Trial

Read the detailed description

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: Cervical Syndrome
Being tested: Physiotherapy treatment with physium device., Conventional physiotherapy treatment.
Keywords: Neck Pain, Physical Therapy Modalities, Manual Therapy, massage, Transcranial Direct Current Stimulation, Transcutaneous electrical nerve stimulation
Medical subject headings: Neck Pain

What participants receive

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

Physiotherapy treatment with physium device.Procedure or surgery
The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.
Conventional physiotherapy treatment.Procedure or surgery
The intervention for this group consisted of 10 sessions with Electrical Nerve Stimulation (TENS) for a month.

Study groups in NCT04729270
Study group	Role	What they receive
EXPERIMENTAL GROUP	Experimental	The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month. Receives: Procedure: Physiotherapy treatment with physium device.
CONTROL GROUP	Experimental	The intervention for this group consisted of 10 sessions with Transcutaneous Electrical Nerve Stimulation (TENS) for a month. Receives: Procedure: Conventional physiotherapy treatment.

What is being measured

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

The intensity of cervical pain
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.
Measured: Baseline

Secondary outcomes (5)

The intensity of cervical pain
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.
Measured: Four weeks
The intensity of cervical pain
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.
Measured: Twelve weeks
Active cervical range of motion
Measured by goniometer type crom
Measured: Baseline,four weeks and Twelve weeks.
Pressure pain thresholds in cervical trigger points
Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline,
Measured: Baseline,four weeks and Twelve weeks.
Neck Disability Index (NDI).
Questionnaire Neck Disability Index (NDI).
Measured: Baseline,four weeks and Twelve weeks.

Timeline

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

6 Feb 202320 Nov 2023

First posted28 Jan 2021
Study start6 Feb 2023
Primary completion15 Mar 2023
Study completion20 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Cervical SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Model description: RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
Masking: Single blind
Who is masked: Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04729270
Sponsor's protocol ID: tDCS
Status last verified: Apr 2024
First submitted: 24 Jan 2021
Last updated: 17 Apr 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 29961845
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.
PubMed 25659245
Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
PubMed 28807894
Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
PubMed 28666405
Cote P, Yu H, Shearer HM, Randhawa K, Wong JJ, Mior S, Ameis A, Carroll LJ, Nordin M, Varatharajan S, Sutton D, Southerst D, Jacobs C, Stupar M, Taylor-Vaisey A, Gross DP, Brison RJ, Paulden M, Ammendolia C, Cassidy JD, Loisel P, Marshall S, Bohay RN, Stapleton J, Lacerte M. Non-pharmacological management of persistent headaches associated with neck pain: A clinical practice guideline from the Ontario protocol for traffic injury management (OPTIMa) collaboration. Eur J Pain. 2019 Jul;23(6):1051-1070. doi: 10.1002/ejp.1374. Epub 2019 Feb 28.
PubMed 30707486
Fitzgibbon BM, Schabrun SM. Transcranial Direct Current Stimulation for Pain Disorders: Challenges and New Frontiers. Clin Pharmacol Ther. 2019 Oct;106(4):717-719. doi: 10.1002/cpt.1544. Epub 2019 Jul 15. No abstract available.
PubMed 31309544
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.
PubMed 24889393
Schwartz DP, Robbins MS. Primary headache disorders and neuro-ophthalmologic manifestations. Eye Brain. 2012 Sep 13;4:49-61. doi: 10.2147/EB.S21841. eCollection 2012.
PubMed 28539781
Nitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618.
PubMed 22085959
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.
PubMed 24144382
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.
PubMed 32289698
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.
PubMed 32330607
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.
PubMed 26236199
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.
PubMed 23061303
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.
PubMed 29783893

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Neck Pain With Transcranial Direct Current Stimulation: A Single Blind Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04729270
Acronym / sponsor ID: tDCS
Conditions: Cervical Syndrome
Keywords: Neck Pain, Physical Therapy Modalities, Manual Therapy, massage, Transcranial Direct Current Stimulation, Transcutaneous electrical nerve stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of CadizUniversity, hospital or other
Study start: 6 Feb 2023 (actual)
Primary completion: 15 Mar 2023 (actual)
Study completion: 20 Nov 2023 (actual)
First posted: 28 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.

Arm	Type	Receives
EXPERIMENTAL GROUP	Experimental	Procedure: Physiotherapy treatment with physium device.The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.
CONTROL GROUP	Experimental	Procedure: Conventional physiotherapy treatment.The intervention for this group consisted of 10 sessions with Transcutaneous Electrical Nerve Stimulation (TENS) for a month.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physiotherapy treatment with physium device.The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.	Procedure or surgery	EXPERIMENTAL GROUP
Conventional physiotherapy treatment.The intervention for this group consisted of 10 sessions with Electrical Nerve Stimulation (TENS) for a month.	Procedure or surgery	CONTROL GROUP

Primary outcome

The intensity of cervical pain
Time frame: Baseline
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.

5 secondary outcomes

The intensity of cervical pain
Time frame: Four weeks
The intensity of cervical pain
Time frame: Twelve weeks
Active cervical range of motion
Time frame: Baseline,four weeks and Twelve weeks.
Pressure pain thresholds in cervical trigger points
Time frame: Baseline,four weeks and Twelve weeks.
Neck Disability Index (NDI).
Time frame: Baseline,four weeks and Twelve weeks.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
Background: PubMed 29961845Whiteford 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.
Background: PubMed 25659245Cohen 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.
Background: PubMed 28807894Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
Background: PubMed 28666405Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
Background: PubMed 30707486Cote P, Yu H, Shearer HM, Randhawa K, Wong JJ, Mior S, Ameis A, Carroll LJ, Nordin M, Varatharajan S, Sutton D, Southerst D, Jacobs C, Stupar M, Taylor-Vaisey A, Gross DP, Brison RJ, Paulden M, Ammendolia C, Cassidy JD, Loisel P, Marshall S, Bohay RN, Stapleton J, Lacerte M. Non-pharmacological management of persistent headaches associated with neck pain: A clinical practice guideline from the Ontario protocol for traffic injury management (OPTIMa) collaboration. Eur J Pain. 2019 Jul;23(6):1051-1070. doi: 10.1002/ejp.1374. Epub 2019 Feb 28.
Background: PubMed 31309544Fitzgibbon BM, Schabrun SM. Transcranial Direct Current Stimulation for Pain Disorders: Challenges and New Frontiers. Clin Pharmacol Ther. 2019 Oct;106(4):717-719. doi: 10.1002/cpt.1544. Epub 2019 Jul 15. No abstract available.
Background: PubMed 24889393Yalinay 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.
Background: PubMed 28539781Schwartz DP, Robbins MS. Primary headache disorders and neuro-ophthalmologic manifestations. Eye Brain. 2012 Sep 13;4:49-61. doi: 10.2147/EB.S21841. eCollection 2012.
Background: PubMed 22085959Nitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618.
Background: PubMed 24144382Martelletti 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.
Background: PubMed 32289698Charvet 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.
Background: PubMed 32330607Caulfield 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

manuel Rodríguez Huguet, Physiotherapy principal investigator

University of Cádiz

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physiotherapy treatment with physium device. and Conventional physiotherapy treatment. in people with Cervical Syndrome, run by University of Cadiz 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 17 Apr 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The intensity of cervical pain (time frame: Baseline). 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 NCT04729270, which also lists 17 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 17 Apr 2024.