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Neck PainNCT06767839

The Effect of Electrotherapy on Young Individuals With Neck Pain

A study testing Transcutaneous Electrical Nerve Stimulation and High Voltage Pulsed Galvanic Stimulation in people with Neck Pain, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).

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

The aim of this clinical study was to investigate the effects of different electrotherapy interventions on pain and hand function in young individuals with neck pain. The main question that the study aimed to answer is: are two different electrotherapy interventions superior to each other for pain and hand function?… Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Neck Pain
What is being tested?
Transcutaneous Electrical Nerve Stimulation and High Voltage Pulsed Galvanic Stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jan 2025to 21 Dec 2025
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 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Being between 18-30 years old
  • Complaining of neck pain
  • Volunteering to participate in the study

Who cannot join

  • Having received any anti-inflammatory treatment in the last 3 months
  • Having received any physical therapy and rehabilitation treatment in the last 3 months
  • Doing regular exercise
  • Not attending work sessions

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Burdur Mehmet Akif Ersoy University

    Burdur, Center, 15100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Different Electrotherapy Interventions on Pain and Hand Function in Young Individuals With Neck Pain: a Randomized Controlled Double-blind Trial

The aim of this clinical study was to investigate the effects of different electrotherapy interventions on pain and hand function in young individuals with neck pain.

The main question that the study aimed to answer is: are two different electrotherapy interventions superior to each other for pain and hand function? Participants will be assigned to either transcutaneous electrical nerve stimulation, high-voltage pulsed galvanic stimulation, or placebo. Participants will receive a total of 20 sessions of electrotherapy intervention, 20 minutes per day, 3 days a week. Participants will be evaluated before the intervention, after 1 session, and 1 week after the completion of the 20-session intervention.

Conditions
Neck Pain
Being tested
Transcutaneous Electrical Nerve Stimulation, High Voltage Pulsed Galvanic Stimulation, Sham TENS
Keywords
neck pain, electrotherapy, TENS, HVPGS
Medical subject headings
Neck Pain

What participants receive

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

  • Transcutaneous Electrical Nerve StimulationOther

    Also called TENS

    The current parameters for the TENS to be applied in the study were determined as 100 Hz, 100 microsecond pulse duration, and asymmetric biphasic waveform. The current intensity will be increased until the person feels a tingling sensation and will be applied for a total of 20 minutes. Two superficial electrodes will be placed to cover the application area to create an effect in deep tissue.

  • High Voltage Pulsed Galvanic StimulationOther

    Also called HVPGS

    YVKGS is a monophasic waveform current with double peaks, short pulse duration and a voltage higher than 100 Volts, the frequency of which can be adjusted optionally. In the study, the current parameters of YVKGS were determined as a frequency of 100 Hz, continuous pulse, double peak monophasic waveform. The current intensity will be applied for 20 minutes at the voltage at which the person feels a tingling sensation. Two superficial electrodes will be placed to cover the application area to create an effect in deep tissue.

  • Sham TENSOther

    The current will be applied to the sham TENS group with the same parameters as the TENS group, and will be reduced and turned off after a while. In TENS application, people normally report that they no longer feel tingling after a few minutes of starting the application. Therefore, it will be explained to the sham TENS group that this situation is normal, and that they no longer feel tingling because they have become accustomed to the applied current.

Study groups in NCT06767839
Study groupRoleWhat they receive
Group of Transcutaneous Electrical Nerve Stimulation (TENS)ExperimentalParticipants assigned to this group will receive TENS for 20 minutes each session for a total of 20 sessions.
Receives: Other: Transcutaneous Electrical Nerve Stimulation
Group of High Voltage Pulsed Galvanic Stimulation (HVPGS)ExperimentalParticipants assigned to this group will receive HVPGS for 20 minutes each session for a total of 20 sessions.
Receives: Other: High Voltage Pulsed Galvanic Stimulation
Group of shamSham comparatorIndividuals assigned to this group will be started on TENS current for a total of 20 sessions, each session lasting 20 minutes, but the current will be reduced and turned off after 1 minute. It will be explained to the individuals that this current is applied at a subthreshold level.
Receives: Other: Sham TENS

What is being measured

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

  1. Visual Analog Scale

    The Visual Analog Scale is a 10-centimeter (cm) scale, with 0 being defined as "no pain" and 10 as "unbearable pain." It is a valid and reliable method for assessing the severity of musculoskeletal pain and is frequently used in clinical studies. In a study conducted on patients with chronic musculoskeletal pain, a VAS value of less than 3.4 cm was classified as mild pain, a VAS value between 3.5 and 7.4 cm was classified as moderate pain, and a VAS value greater than 7.5 cm was classified as severe pain.

    Measured: From enrollment to the end of treatment at 7 weeks

  2. Treshold Faradic Test

    Pain threshold measurement is performed by applying a surge faradic current with a frequency of 50 Hz and a transition time of 0.1-1 msec. The point at which the current is first felt is defined as the pain threshold. In this test, the active electrode is placed at the motor point of the relevant muscle, while the passive electrode can be placed in a more distal or proximal region.

    Measured: From enrollment to the end of treatment at 7 weeks

  3. Patient-Specific Functional Scale

    Patients are asked to list the three activities that cause the most difficulty with their neck pain. Each activity is then scored from 0 (unable to perform the activity) to 10 (able to perform the activity at the same level as before the onset of symptoms).

    Measured: From enrollment to the end of treatment at 7 weeks

  4. Core Outcome Meassure Index-Neck

    It is a symptom-specific measurement tool that includes all the parameters that need to be evaluated in patients with low back pain (pain, function, quality of life, disability), and has the advantages of being short and easy to apply. It consists of six questions and each question is scored between 0 and 10. Higher scores indicate worse results.

    Measured: From enrollment to the end of treatment at 7 weeks

Secondary outcomes (6)
  1. Nine-Hole Peg Test

    It is a standardized, valid and reliable test that measures upper extremity functions and motor speed, consisting of nine cylindrical wooden sticks and a board with nine round holes. Individuals are asked to quickly take 9 wooden sticks from the box they are in, place them in the holes randomly without observing the order, quickly take them out of the holes without waiting and place them back in the box. The total time that elapses while the individuals insert and remove the sticks from the holes is recorded with a stopwatch in seconds.

    Measured: From enrollment to the end of treatment at 7 weeks

  2. Gross Grip Strength

    Gross grip strength will be measured with a Jamar® digital hand dynamometer. The gross grip strength measurement will be performed in the standard measurement position recommended by the American Hand Therapists Association, with the patient sitting in a chair without elbow support, the arm in adduction and neutral rotation, the elbow in 90-degree flexion, and the forearm and wrist in a neutral position. The test will be repeated 3 times. The average of the 3 tests will be taken.

    Measured: From enrollment to the end of treatment at 7 weeks

  3. Pinch Grip Strength

    Pinch grip strength will be measured with a Jamar® digital pinchmeter. The pinch grip strength measurement position will be performed with the patient sitting in a chair without elbow support, the arm in adduction and neutral rotation, the elbow in 90 degrees flexion, the forearm in 90 degrees supination, and the wrist in a neutral position. The test will be repeated 3 times. The average of the 3 tests will be taken.

    Measured: From enrollment to the end of treatment at 7 weeks

  4. Upper Extremity Strenght

    The strength of individuals' shoulder flexor, extensor, abductor, adductor and rotator muscles, elbow flexor and extensor muscles, wrist flexor and extensor muscles will be evaluated with a sphygmomanometer. The evaluation will be carried out with the protocol of the person being measured applying maximum force against the device while the person measuring holds the sphygmomanometer steady.

    Measured: From enrollment to the end of treatment at 7 weeks

  5. Semmes-Weinstein Monofilament Test

    It is a test used to evaluate light touch sensation in individuals. Monofilaments contain different values from 1.65 to 6.65. Monofilaments between 1.65 and 2.83 are interpreted as normal sensation, while an increase in the perceived thickness indicates a sensory defect. The test will be applied to the C3-C8 dermatomes on both upper extremities. The evaluation will start with the 2.83 monofilament, which is considered optimal, and 3 strokes, each lasting 3 seconds, will be applied to each point with the monofilament. Individuals will be asked to give the answer "I felt it". If individuals respond, a lower monofilament will be applied, and if no response is received, a higher monofilament will be applied and the test will be continued.

    Measured: From enrollment to the end of treatment at 7 weeks

  6. Cervical Endurance Test

    To assess the endurance of the cervical flexors, individuals perform cervical flexion while lying on their back in a chin position, and the time they maintain this position is recorded in seconds. To assess the endurance of the cervical extensors, individuals attempt to maintain a neutral neck position while lying on their stomach with their head hanging off the bed, and the time they maintain this position is recorded in seconds. The test is terminated when the head position changes in the direction of flexion or extension, or when individuals want to stop the test.

    Measured: From enrollment to the end of treatment at 7 weeks

Timeline

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

  1. First posted10 Jan 2025
  2. Study start15 Jan 2025
  3. Primary completion21 Dec 2025
  4. Study completion21 Dec 2025

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
Model description
The sample of the study is Burdur Health Services Vocational School students with neck pain. Participants will be assigned to 3 intervention groups by stratified randomization. The strata are age and gender.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06767839
Sponsor's protocol ID
GO 2023/97
Status last verified
Mar 2026
First submitted
17 Dec 2024
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Acedo AA, Luduvice Antunes AC, Barros dos Santos A, Barbosa de Olveira C, Tavares dos Santos C, Colonezi GL, Fontana FA, Fukuda TY. Upper trapezius relaxation induced by TENS and interferential current in computer users with chronic nonspecific neck discomfort: An electromyographic analysis. J Back Musculoskelet Rehabil. 2015;28(1):19-24. doi: 10.3233/BMR-140482.

    PubMed 24867904
  • Alsalameh AM, Harisi MJ, Alduayji MA, Almutham AA, Mahmood FM. Evaluating the relationship between smartphone addiction/overuse and musculoskeletal pain among medical students at Qassim University. J Family Med Prim Care. 2019 Sep 30;8(9):2953-2959. doi: 10.4103/jfmpc.jfmpc_665_19. eCollection 2019 Sep.

    PubMed 31681674
  • Xie Y, Szeto G, Dai J. Prevalence and risk factors associated with musculoskeletal complaints among users of mobile handheld devices: A systematic review. Appl Ergon. 2017 Mar;59(Pt A):132-142. doi: 10.1016/j.apergo.2016.08.020. Epub 2016 Sep 11.

    PubMed 27890121
  • Özünlü Pekyavaş, N. , Bastug Yuruk, O. & Saygılı, F. (2020). Artan Mobil Teknoloji Kullanımının Yol Açtığı Ağrı Sendromu: "Text Neck" . Adnan Menderes Üniversitesi Sağlık Bilimleri Fakültesi Dergisi , 4 (3) , 251-257 .

  • Parazza S, Vanti C, O'Reilly C, Villafane JH, Tricas Moreno JM, Estebanez De Miguel E. The relationship between cervical flexor endurance, cervical extensor endurance, VAS, and disability in subjects with neck pain. Chiropr Man Therap. 2014 Mar 3;22(1):10. doi: 10.1186/2045-709X-22-10.

    PubMed 24581272
  • Olson LE, Millar AL, Dunker J, Hicks J, Glanz D. Reliability of a clinical test for deep cervical flexor endurance. J Manipulative Physiol Ther. 2006 Feb;29(2):134-8. doi: 10.1016/j.jmpt.2005.12.009.

    PubMed 16461172
  • Bell-Krotoski JA, Fess EE, Figarola JH, Hiltz D. Threshold detection and Semmes-Weinstein monofilaments. J Hand Ther. 1995 Apr-Jun;8(2):155-62. doi: 10.1016/s0894-1130(12)80314-0.

    PubMed 7550627
  • Raji P, Ansari NN, Naghdi S, Forogh B, Hasson S. Relationship between Semmes-Weinstein Monofilaments perception Test and sensory nerve conduction studies in Carpal Tunnel Syndrome. NeuroRehabilitation. 2014;35(3):543-52. doi: 10.3233/NRE-141150.

    PubMed 25238864
  • Mannion AF, Porchet F, Kleinstuck FS, Lattig F, Jeszenszky D, Bartanusz V, Dvorak J, Grob D. The quality of spine surgery from the patient's perspective. Part 1: the Core Outcome Measures Index in clinical practice. Eur Spine J. 2009 Aug;18 Suppl 3(Suppl 3):367-73. doi: 10.1007/s00586-009-0942-8. Epub 2009 Mar 25.

    PubMed 19319578
  • Stevens A, Koke A, van der Weijden T, Beurskens A. The development of a patient-specific method for physiotherapy goal setting: a user-centered design. Disabil Rehabil. 2018 Aug;40(17):2048-2055. doi: 10.1080/09638288.2017.1325943. Epub 2017 May 13.

    PubMed 28504014
  • Boonstra AM, Schiphorst Preuper HR, Balk GA, Stewart RE. Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain. Pain. 2014 Dec;155(12):2545-2550. doi: 10.1016/j.pain.2014.09.014. Epub 2014 Sep 17.

    PubMed 25239073
  • Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.

    PubMed 18467932
  • Yalcinkaya G, Kara B, Arda MN. Cross-cultural adaptation, reliability and validity of the Turkish version of Patient-Specific Functional Scale in patients with chronic neck pain. Turk J Med Sci. 2020 Jun 23;50(4):824-831. doi: 10.3906/sag-1905-91.

    PubMed 32233180
  • Dissanayaka TD, Pallegama RW, Suraweera HJ, Johnson MI, Kariyawasam AP. Comparison of the Effectiveness of Transcutaneous Electrical Nerve Stimulation and Interferential Therapy on the Upper Trapezius in Myofascial Pain Syndrome: A Randomized Controlled Study. Am J Phys Med Rehabil. 2016 Sep;95(9):663-72. doi: 10.1097/PHM.0000000000000461.

    PubMed 26945216
  • Chen PY, Cheen JR, Jheng YC, Wu HK, Huang SE, Kao CL. Clinical applications and consideration of interventions of electrotherapy for orthopedic and neurological rehabilitation. J Chin Med Assoc. 2022 Jan 1;85(1):24-29. doi: 10.1097/JCMA.0000000000000634.

    PubMed 34643619

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Electrical Nerve Stimulation and High Voltage Pulsed Galvanic Stimulation in people with Neck Pain, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).

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 4 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 9 Mar 2026. 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 Turkey (Türkiye). 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?

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?

Visual Analog Scale (time frame: From enrollment to the end of treatment at 7 weeks). The study lists 4 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 NCT06767839, 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 9 Mar 2026.

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