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Chronic PainNCT06842381

Electrotherapy Combined With Neck Exercises for Non-Specific Neck Pain

A study testing Telerehabilitation Program and Face to Face Program in people with Chronic Pain, run by Adelaida María Castro-Sánchez 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

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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Chronic Pain
What is being tested?
Telerehabilitation Program and Face to Face Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
1 Jun 2025to 28 Jun 2026
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 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • University of Almeria

    Almería, Almeria, 04120

Other trials in Spain

About this study

Official title: 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).

Read the 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).

Conditions
Chronic Pain
Being tested
Telerehabilitation Program, Face to Face Program
Medical subject headings
Chronic Pain

What participants receive

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

  • Telerehabilitation ProgramOther

    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 ProgramOther

    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.

Study groups in NCT06842381
Study groupRoleWhat they receive
Telerehabilitation ProgramExperimentalPatients 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.
Receives: Other: Face to Face Program
Face to Face ProgramActive comparatorPatients 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.
Receives: Other: Telerehabilitation Program

What is being measured

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

  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.

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

Secondary outcomes (9)
  1. Pain (Visual Analog Scale)

    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).

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

  2. McGill Pain Questionnaire (Disability)

    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.

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

  3. Quality of Life (SF-36 quality of life questionnaire)

    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.

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

  4. Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)

    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.

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

  5. Tampa scale for kinesiophobia

    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".

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

  6. Pain Catastrophizing Scale

    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.

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

  7. Cervical Range of Motion (Pro Motion Capture. Werium)

    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.

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

  8. Spinal Isometric Strength (SIS)

    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.

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

  9. Neck Flexor Muscle Endurance Test (NFME)

    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.

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

Timeline

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

  1. First posted24 Feb 2025
  2. Study start1 Jun 2025
  3. Primary completion30 Dec 2025
  4. Study completion28 Jun 2026

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06842381
Sponsor's protocol ID
SICEIA-2024-000820
Status last verified
Jul 2026
First submitted
12 Feb 2025
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34357527
  • 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.

    PubMed 38461844
  • 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.

    PubMed 37982411
  • 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.

    PubMed 35532971
  • 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.

    PubMed 37649362
  • 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.

    PubMed 35035234
  • 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.

    PubMed 38406873
  • 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.

    PubMed 39580408
  • 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.

    PubMed 37338972
  • 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.

    PubMed 33814062
  • 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.

    PubMed 35407414
  • 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.

    PubMed 41877337

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation Program and Face to Face Program in people with Chronic Pain, run by Adelaida María Castro-Sánchez 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 4 inclusion and 3 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 23 Jul 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 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?

Neck disability index (time frame: At baseline, 8 weeks and 6 months (follow up).). 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 NCT06842381, which also lists 12 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 23 Jul 2026.

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