An interventional study of Monopolar electrical diathermy plus therapeutic exercise and Therapeutic Exercise in Chronic Pain and Neck Pain, sponsored by Universidad de Almeria. Completed at 1 site in Spain. Open to participants aged 30 Years to 67 Years. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment
The aim of this study is to compare the effects of applying monopolar dielectric radiofrequency diathermy plus therapeutic neck yoga with performing only therapeutic neck yoga in patients with non-specific chronic neck pain.
Chronic non-specific neck pain (CNNP) is a widespread public health problem in the modern world. CNNP is considered persistent neck pain or severe neck discomfort for more than 3 months, which is caused by poor posture and mechanical and degenerative changes, excluding pain due to neck cancer, infections, hernias or other neck disorders or pathologies. In the general population, 71% of adults have neck pain at some time in their lives, and its annual prevalence in the general and working population varies between 30% and 50%. In addition, CNNP is an important cause of work absenteeism and disability.
The research of effective techniques and therapies in the approach of this ailment is a current need within the field of physiotherapy and would mean a reduction of the direct and indirect costs in the health systems generated by patients diagnosed with non-specific chronic neck pain. One of the therapies that is achieving positive results in the symptomatology of different musculoskeletal pathologies such as fibromyalgia syndrome , multiple sclerosis or femoropatellar pain syndrome, is the technique of applying monopolar electric diathermy by radiofrequency emission (MDR), using the Physicalm® device which produces an increase in local temperature due to the action of electromagnetic waves that stimulate tissue metabolism and reduce pain.
Due to all the structural and functional alterations that occur in CNNP, within clinical practice guidelines exercise is one of the most important components in rehabilitation programs for patients with neck pain. Recently, supervised therapeutic exercise has been included as a common intervention in clinical practice worldwide.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
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Exclusion Criteria:
The Experimental Group formed by 30 subjects will receive two sessions per week of monopolar electrical diathermy by radiofrequency emission (MDR) by means of the Physicalm® device (device developed by Biotronic Advance Develops SL), and one session of therapeutic neck yoga per week. Diathermy is applied by means of rotational and translational movements, adapting to the muscular fibers of the cervical area, with a pulsed emission of 840 KHz AND 30v dynamically during a treatment time of 20 minutes.
Other: Therapeutic Exercise
The Control Group formed by 30 subjects will be administered a supervised therapeutic exercise with the same protocol of postures and sequences as in the Experimental Group, but for three days a week. The duration of the sessions will be 60 minutes. The yoga program will be designed specifically for people who have chronic neck pain and no previous experience with therapeutic exercise. Classes will be led by a certified Iyengar yoga instructor and physical therapist. The exercise program will consist of standing, seated and supine postures, starting with simple postures and moving on to more complex ones. Props such as belts, blocks, and blankets will be used to enhance safety and alignment. Participants will be asked to focus on their posture, joint positions, and muscle tension in each exercise posture. No formal breathing techniques will be used, but participants will be instructed to align their breath with their movements.
Other: Monopolar electrical diathermy plus therapeutic exercise
The Experimental Group will undergo two sessions per week of monopolar electrical diathermy by radiofrequency emission (MDR) using the Physicalm® device and one session of therapeutic neck exercise per week.
The exercise program will consist of standing, seated and supine postures, starting with simple postures and moving on to more complex ones. Participants will be asked to focus on their posture, joint positions and muscle tension in each exercise posture.
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.
Time frame: Change from baseline disability at four weeks and three months
Active and Latent Myofascial Trigger Points (Number of trigger Points)
Myofascial Trigger Points will be explored in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus.
Time frame: Change from baseline myofascial trigger points at four weeks and three months
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).
Time frame: Change from baseline pain intensity at four weeks and three months
McGill Pain Questionnaire
Time frame: Change from baseline pain intensity at four weeks and three months
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.
Time frame: Change from baseline quality of life at four weeks and three months
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.
Time frame: Change from baseline quality of sleep at four weeks and three months
Cervical Range of Motion
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.
Time frame: Change from baseline range of motion at four weeks and three months
Tampa scale for kinesiophobia
The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.
Time frame: Change from baseline phobia of movement at four weeks and three months
Plan to share: No
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Universidad de Almeria