The Effect of Electrotherapy on Young Individuals With Neck Pain

NCT06767839 | Completed DMC

• 1 other identifier: GO 2023/97
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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? 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

Keywords

neck pain; electrotherapy; TENS; HVPGS

Outcome Measures

Primary Outcomes (4)

• 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.

  From enrollment to the end of treatment at 7 weeks

• 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.

  From enrollment to the end of treatment at 7 weeks

• 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).

  From enrollment to the end of treatment at 7 weeks

• 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.

  From enrollment to the end of treatment at 7 weeks

Secondary Outcomes (6)

• Nine-Hole Peg Test

  From enrollment to the end of treatment at 7 weeks

• Gross Grip Strength

  From enrollment to the end of treatment at 7 weeks

• Pinch Grip Strength

  From enrollment to the end of treatment at 7 weeks

• Upper Extremity Strenght

  From enrollment to the end of treatment at 7 weeks

• Semmes-Weinstein Monofilament Test

  From enrollment to the end of treatment at 7 weeks

Study Arms (3)

Group of Transcutaneous Electrical Nerve Stimulation (TENS)

EXPERIMENTAL

Participants assigned to this group will receive TENS for 20 minutes each session for a total of 20 sessions.

Other: Transcutaneous Electrical Nerve Stimulation

Group of High Voltage Pulsed Galvanic Stimulation (HVPGS)

EXPERIMENTAL

Participants assigned to this group will receive HVPGS for 20 minutes each session for a total of 20 sessions.

Other: High Voltage Pulsed Galvanic Stimulation

Group of sham

SHAM COMPARATOR

Individuals 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.

Other: Sham TENS

Interventions

High Voltage Pulsed Galvanic Stimulation OTHER

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.

Also known as: HVPGS

Group of High Voltage Pulsed Galvanic Stimulation (HVPGS)

Transcutaneous Electrical Nerve Stimulation OTHER

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.

Also known as: TENS

Group of Transcutaneous Electrical Nerve Stimulation (TENS)

Sham TENS OTHER

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.

Group of sham

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead
• Pamukkale University: collaborator

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Burdur, Center, 15100, Turkey (Türkiye)

Location

Related Publications (17)

• 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.

  PMID: 24867904 BACKGROUND

• 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.

  PMID: 31681674 BACKGROUND

• 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.

  PMID: 27890121 BACKGROUND

• 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 .

  BACKGROUND

• 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.

  PMID: 24581272 RESULT

• 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.

  PMID: 16461172 RESULT

• 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.

  PMID: 7550627 RESULT

• 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.

  PMID: 25238864 RESULT

• 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.

  PMID: 19319578 RESULT

• 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.

  PMID: 28504014 RESULT

• 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.

  PMID: 25239073 RESULT

• 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.

  PMID: 18467932 RESULT

• 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.

  PMID: 32233180 RESULT

• 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.

  PMID: 26945216 RESULT

• 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.

  PMID: 34643619 RESULT

• Johnston V, Jull G, Darnell R, Jimmieson NL, Souvlis T. Alterations in cervical muscle activity in functional and stressful tasks in female office workers with neck pain. Eur J Appl Physiol. 2008 Jun;103(3):253-64. doi: 10.1007/s00421-008-0696-8. Epub 2008 Feb 22.

  PMID: 18293008 RESULT

• Blozik E, Laptinskaya D, Herrmann-Lingen C, Schaefer H, Kochen MM, Himmel W, Scherer M. Depression and anxiety as major determinants of neck pain: a cross-sectional study in general practice. BMC Musculoskelet Disord. 2009 Jan 26;10:13. doi: 10.1186/1471-2474-10-13.

  PMID: 19171034 RESULT

MeSH Terms

Conditions

Neck Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PT.MSc.

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 10, 2025
• Study Start: January 15, 2025
• Primary Completion: December 21, 2025
• Study Completion: December 21, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)