Electrotherapy Combined With Neck Exercises for Non-Specific Neck Pain

December 15, 2025 updated by: Adelaida María Castro-Sánchez

Electrotherapy Combined With Neck Exercises for Non-Specific Neck Pain: Telerehabilitation Versus Face-to-Face Program: Study Protocol for a Multicenter Randomized Controlled Trial

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction: Neck pain is a common problem in the working-age population, with a high recurrence rate and one of the highest health costs globally. Exercise is considered one of the keys in the management of this pathology, and electrotherapy is consolidated as a safe and proven analgesic measure. Telemedicine facilitates access to health care by eliminating geographical barriers and reducing costs, allowing consultations from any location and favoring the patient's work-life balance. The widespread availability of smartphones, tablets and computers makes telerehabilitation more accessible than ever.

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 with 100 participants with non-specific 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).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Almeria
      • Almería, Almeria, Spain, 04120
        • University of Almeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation Program
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
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.
Active Comparator: Face to Face Program
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck disability index
Time Frame: At baseline, 8 weeks and 6 months (follow up).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (Visual Analog Scale)
Time Frame: At baseline, 8 weeks and 6 months (follow up).
Pain will be assessed with the Visual Analog Scale (VAS), which assesses the pain intensity and degree of relief experienced by the patient (scored of 0 = no pain; 10 = unbearable pain).
At baseline, 8 weeks and 6 months (follow up).
McGill Pain Questionnaire (Disability)
Time Frame: At baseline, 8 weeks and 6 months (follow up).
The McGill Pain Questionnaire is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is a multi-dimesional tool for pain assessment and it has three components, which are the sensory intensity, the cognitive evaluation of pain and the emotional impact of pain. Interpretation: • minimum pain score: 0 (would not be seen in a person with true pain). • maximum pain score: 78. • The higher the pain score the greater the pain.
At baseline, 8 weeks and 6 months (follow up).
Quality of Life (SF-36 quality of life questionnaire)
Time Frame: At baseline, 8 weeks and 6 months (follow up).
The SF-36 quality of life questionnaire assesses 8 domains including physical functioning, physical role, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100% (with higher scores indicating greater health), reflecting the individual's self-perceived health-related quality of life.
At baseline, 8 weeks and 6 months (follow up).
Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)
Time Frame: At baseline, 8 weeks and 6 months (follow up).
The Pittsburgh Quality of Sleep Questionnaire Index (PSQI) will be used to study the quality of sleep. It comprises 24 items where the subjects respond to 19 of these items, and individual living in the same dwelling (or hospital room) responds to the remaining 5. Scores are obtained on each of 7 components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficacy, sleep perturbations, use of hypnotic medication, and daily dysfunction. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always"). Scores on items belong to factors 2 and 5 (restoration after sleep and satisfaction with sleep) and are reversed before being tallied. Total scores can range from 0 to 84, with higher scores demoting more acute sleep problems.
At baseline, 8 weeks and 6 months (follow up).
Tampa scale for kinesiophobia
Time Frame: At baseline, 8 weeks and 6 months (follow up).
The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury. Participants rate their beliefs regarding kinesiophobia on a 4-point Likert scale, ranging from "strongly disagree" to "strongly agree".
At baseline, 8 weeks and 6 months (follow up).
Pain Catastrophizing Scale
Time Frame: At baseline, 8 weeks and 6 months (follow up).
The Pain Catastrophizing Scale (PCS) is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. Catastrophizing is commonly described as an exaggerated negative orientation toward noxious stimuli and plays an important role in experiencing and coping with pain. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale. The PCS consists of 13 statements containing several thoughts and feelings one may experience when having pain.
At baseline, 8 weeks and 6 months (follow up).
Cervical Range of Motion (Pro Motion Capture. Werium)
Time Frame: At baseline, 8 weeks and 6 months (follow up).
Cervical range of motion is assessed with the patient sitting comfortably on a chair, with both feet flat on the floor, hips and knees at 90º of flexion, and buttocks positioned against the back of the chair.
At baseline, 8 weeks and 6 months (follow up).
Spinal Isometric Strength (SIS)
Time Frame: At baseline, 8 weeks and 6 months (follow up).
The investigators will measure the maximum isometric strength of the neck extensor muscles using a hand-held dynamometer (HHD). The patient will remain seated in a chair, with their feet flat on the floor, their hips and knees at 90º of flexion and the neck in the anatomical position, the patient will hold the HHD with both hands resting on their occiput, opposing the extension, and will be asked to perform a progressive isometric cervical extension for 3 seconds until reaching their maximum level of strength.
At baseline, 8 weeks and 6 months (follow up).
Neck Flexor Muscle Endurance Test (NFME)
Time Frame: At baseline, 8 weeks and 6 months (follow up).
To measure the isometric endurance of the neck flexors, the investigators will place the patient in a supine position and ask him/her to perform a double chin tuck, which he/she must maintain throughout the test. While maintaining this position, he/she must flex his/her neck until his/her head is 2.5 cm off the table and maintain this position for as long as possible. The evaluator will time the duration of the test, which will be terminated if the patient loses the position for more than one second or asks to end due to fatigue or pain.
At baseline, 8 weeks and 6 months (follow up).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adelaida María Castro-Sánchez

Collaborators

Andaluz Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SICEIA-2024-000820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study data will be available by email at adelaid@ual.es, provided that a reasonable request is made with justification for its scientific use and that citation is guaranteed.

IPD Sharing Time Frame

Data will be available beginning with the first article publication; ending 5 years following article publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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