Chronic Pain
Conditions
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).
Interventions
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.
OTHERFace 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.
Sponsors
Adelaida María Castro-Sánchez
Andaluz Health Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck disability index | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain (Visual Analog Scale) | 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). |
| McGill Pain Questionnaire (Disability) | 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. |
| Quality of Life (SF-36 quality of life questionnaire) | 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. |
| Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index) | 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. |
| Tampa scale for kinesiophobia | 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". |
| Pain Catastrophizing Scale | 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. |
| Cervical Range of Motion (Pro Motion Capture. Werium) | 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. |
| Spinal Isometric Strength (SIS) | 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. |
| Neck Flexor Muscle Endurance Test (NFME) | 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. |
Countries
Spain
Outcome results
None listed