Electrotherapy Combined With Neck Exercises for Non-Specific Neck Pain: Telerehabilitation Versus Face-to-Face Program: Study Protocol for a Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Neck disability index
Study Overview
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).
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Face to Face Program (Other)
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.
Intervention: Telerehabilitation Program (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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).)
- Cervical Range of Motion (Pro Motion Capture. Werium)(At baseline, 8 weeks and 6 months (follow up).)
- Pain Catastrophizing Scale(At baseline, 8 weeks and 6 months (follow up).)
- Spinal Isometric Strength (SIS)(At baseline, 8 weeks and 6 months (follow up).)
- Neck Flexor Muscle Endurance Test (NFME)(At baseline, 8 weeks and 6 months (follow up).)
Investigators
Adelaida María Castro-Sánchez
Full Professor
Universidad de Almeria