Electrotherapy Combined With Neck Exercises for Non-Specific Neck Pain

NCT06842381 | Active Not Recruiting

• 1 other identifier: SICEIA-2024-000820
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: The objective of this study is to compare the effectiveness of telerehabilitation versus a face-to-face program in the therapeutic approach to non-specific neck pain through exercise and analgesic electrotherapy. Methods: Randomized clinical trial on 100 participants with nonspecific neck pain who will be randomized into two groups to receive analgesic electrotherapy combined with a cervical exercise program through telemedicine or face to face. A total of 24 sessions will be applied over 8 weeks. Demographic and clinical data, disability, pain intensity, kinesiophobia, isometric spinal muscle strength, quality of life, and cervical mobility will be collected. Assessments will be performed at the beginning of the study (baseline), at 8 weeks (post-treatment) and 2 months after the end of the intervention (follow-up).

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Neck disability index

  The neck disability index consists of 10 questions addressing functional activities such as personal care, lifting, reading, work, driving, sleeping, recreational, pain intensity, concentration and headache. Each item will be scored on a scale from 0 (no limitation). (severe limitation or inability to perform the activity). The total score will be calculated by summing the item scores, dividing by the maximum possible score of 50 (if all 10 questions are answered), and multiplying by 100 to generate a percentage. A score of 0% indicates full independence, while 100% represents complete dependence.

  At baseline, 8 weeks and 6 months (follow up).

Secondary Outcomes (9)

• Pain (Visual Analog Scale)

  At baseline, 8 weeks and 6 months (follow up).

• McGill Pain Questionnaire (Disability)

  At baseline, 8 weeks and 6 months (follow up).

• Quality of Life (SF-36 quality of life questionnaire)

  At baseline, 8 weeks and 6 months (follow up).

• Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)

  At baseline, 8 weeks and 6 months (follow up).

• Tampa scale for kinesiophobia

  At baseline, 8 weeks and 6 months (follow up).

Study Arms (2)

Telerehabilitation Program

EXPERIMENTAL

Patients will be instructed in the therapeutic approach through a telerehabilitation program using a portable TENS (Transcutaneous Electrical Nerve Stimulation) with a specific program for cervical pain (ENRAF NONIOUS Iberica, SA, Spain) while performing McKenzie exercises. The specific program will consist of a conventional low-frequency, high-phase duration TENS (80 Hz/200 μs) applied directly to the cervical area using four electrodes (5x5 cm) at the bilateral paravertebral level. In patients who present radicular pain, the electrodes will be placed along the path of the affected nerve.

Other: Face to Face Program

Face to Face Program

ACTIVE COMPARATOR

Patients will be instructed in the therapeutic approach through a face to face program using a portable TENS (Transcutaneous Electrical Nerve Stimulation) with a specific program for cervical pain (ENRAF NONIOUS Iberica, SA, Spain) while performing McKenzie exercises. The specific program will consist of a conventional low-frequency, high-phase duration TENS (80 Hz/200 μs) applied directly to the cervical area using four electrodes (5x5 cm) at the bilateral paravertebral level. In patients who present radicular pain, the electrodes will be placed along the path of the affected nerve.

Other: Telerehabilitation Program

Interventions

Telerehabilitation Program OTHER

A support system for the treatment of cervical pain based on Web technologies will be used, accredited as a health website. This system has a structure based on 4 sections: database treatment, database user profiles, recommendations, and feedback/biofeedback procedures. This system allows the registration and introduction of a subject, and modification of a treatment with electroanalgesia and exercises, according to the symptomatic evolution of the pain. It is based on an initial patient assessment system.

Face to Face Program

Face to Face Program OTHER

Electroanalgesia therapy and the McKenzie exercise protocol will be applied by six therapists with more than 10 years of experience in both procedures. This program will be developed in the Health Sciences clinical units of the Universities of Almeria, Granada and Malaga.

Telerehabilitation Program

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients between the ages of 30 and 65, with a medical diagnosis of cervical pain of non-specific origin,
• Acceptance and signature of informed consent for voluntary participation in the research study.
• Not receiving physical therapy.
• Chronic cervical pain lasting 3 months or more and not receiving any other type of physiotherapy treatment.

You may not qualify if:

• Patients undergoing rehabilitation treatment for pathologies of cervical origin.
• Patients have osteosynthesis material at the cervical level and/or cardiac complications, epilepsy or tumors.
• Patients who have undergone radiotherapy in the last 6 months.

Sponsors & Collaborators

• Adelaida María Castro-Sánchez: lead
• Andaluz Health Service: collaborator

Study Sites (1)

University of Almeria

Almería, Almeria, 04120, Spain

Location

Related Publications (12)

• Ozden F, Sari Z, Karaman ON, Aydogmus H. The effect of video exercise-based telerehabilitation on clinical outcomes, expectation, satisfaction, and motivation in patients with chronic low back pain. Ir J Med Sci. 2022 Jun;191(3):1229-1239. doi: 10.1007/s11845-021-02727-8. Epub 2021 Aug 6.

  PMID: 34357527 RESULT

• Hinman RS, Campbell PK, Kimp AJ, Russell T, Foster NE, Kasza J, Harris A, Bennell KL. Telerehabilitation consultations with a physiotherapist for chronic knee pain versus in-person consultations in Australia: the PEAK non-inferiority randomised controlled trial. Lancet. 2024 Mar 30;403(10433):1267-1278. doi: 10.1016/S0140-6736(23)02630-2. Epub 2024 Mar 7.

  PMID: 38461844 RESULT

• Xiang W, Wang JY, Ji BJ, Li LJ, Xiang H. Effectiveness of Different Telerehabilitation Strategies on Pain and Physical Function in Patients With Knee Osteoarthritis: Systematic Review and Meta-Analysis. J Med Internet Res. 2023 Dec 4;25:e40735. doi: 10.2196/40735.

  PMID: 37982411 RESULT

• Lara-Palomo IC, Gil-Martinez E, Ramirez-Garcia JD, Capel-Alcaraz AM, Garcia-Lopez H, Castro-Sanchez AM, Antequera-Soler E. Efficacy of e-Health Interventions in Patients with Chronic Low-Back Pain: A Systematic Review with Meta-Analysis. Telemed J E Health. 2022 Dec;28(12):1734-1752. doi: 10.1089/tmj.2021.0599. Epub 2022 May 9.

  PMID: 35532971 RESULT

• Villatoro-Luque FJ, Rodriguez-Almagro D, Aibar-Almazan A, Fernandez-Carnero S, Pecos-Martin D, Ibanez-Vera AJ, Castro-Martin E, Achalandabaso-Ochoa A. Telerehabilitation for the treatment in chronic low back pain: A randomized controlled trial. J Telemed Telecare. 2025 Jun;31(5):637-646. doi: 10.1177/1357633X231195091. Epub 2023 Aug 30.

  PMID: 37649362 RESULT

• Janela D, Costa F, Molinos M, Moulder RG, Lains J, Francisco GE, Bento V, Cohen SP, Correia FD. Asynchronous and Tailored Digital Rehabilitation of Chronic Shoulder Pain: A Prospective Longitudinal Cohort Study. J Pain Res. 2022 Jan 8;15:53-66. doi: 10.2147/JPR.S343308. eCollection 2022.

  PMID: 35035234 RESULT

• Bobos P, Pereira TV, Pouliopoulou DV, Charakopoulou-Travlou M, Nazari G, MacDermid JC. Which Remote Rehabilitation Interventions Work Best for Chronic Musculoskeletal Pain and Depression? A Bayesian Network Meta-Analysis. J Orthop Sports Phys Ther. 2024 Jun;54(6):361-376. doi: 10.2519/jospt.2024.12216.

  PMID: 38406873 RESULT

• Sivertsson J, Sernert N, Ahlund K. Exercise-based telerehabilitation in chronic low back pain - a scoping review. BMC Musculoskelet Disord. 2024 Nov 23;25(1):948. doi: 10.1186/s12891-024-07952-7.

  PMID: 39580408 RESULT

• Peterson G, Peolsson A. Efficacy of Neck-Specific Exercise With Internet Support Versus Neck-Specific Exercise at a Physiotherapy Clinic in Chronic Whiplash-Associated Disorders: Multicenter Randomized Controlled Noninferiority Trial. J Med Internet Res. 2023 Jun 20;25:e43888. doi: 10.2196/43888.

  PMID: 37338972 RESULT

• Nanda U, Luo J, Wonders Q, Pangarkar S. Telerehabilitation for Pain Management. Phys Med Rehabil Clin N Am. 2021 May;32(2):355-372. doi: 10.1016/j.pmr.2021.01.002. Epub 2021 Mar 6.

  PMID: 33814062 RESULT

• Cuenca-Martinez F, Lopez-Bueno L, Suso-Marti L, Varangot-Reille C, Calatayud J, Herranz-Gomez A, Romero-Palau M, Casana J. Implementation of Online Behavior Modification Techniques in the Management of Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. J Clin Med. 2022 Mar 24;11(7):1806. doi: 10.3390/jcm11071806.

  PMID: 35407414 RESULT

• Castro-Sanchez AM, Sanchez-Ferre C, Munoz-Manzaneda JM, Gomez-Garcia S, Payan-Ibarra CM, Saavedra-Hernandez M, Lara-Palomo IC. Telerehabilitation versus face-to-face programme on electrical stimulation and neck exercises for non-specific neck pain: a study protocol for a randomised controlled trial. BMJ Open. 2026 Mar 23;16(3):e103742. doi: 10.1136/bmjopen-2025-103742.

  PMID: 41877337 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 24, 2025
• Study Start: June 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 28, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning with the first article publication; ending 5 years following article publication.
• Access Criteria: Data will be accessed via the contact email adelaid@ual.es, provided that its scientific use and citation of our protocol are guaranteed. Access provided at no cost, unless repository policies require otherwise.

Locations

ES (1)