Monopolar Dielectric Diathermy and Yoga on Chronic Neck Pain and Therapeutic Yoga on Pain, Functionality, Movement Phobia on Pain, Functionality, Movement Phobia and Quality of Life of Patients of Patients With Chronic Neck Pain. Randomized Clinical Trial

Sponsor

Universidad de Almeria (Other)

Overall Status

Recruiting

CT.gov ID

NCT06072313

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

14.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Neck Pain	Other: Monopolar electrical diathermy plus therapeutic yoga Other: Therapeutic Yoga	N/A

Detailed Description

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 yoga has been included as a common intervention in clinical practice worldwide.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Single

Primary Purpose:

Treatment

Official Title:

Efficacy of Monopolar Dielectric Diathermy and Therapeutic Yoga on Pain, Functionality, Movement Phobia and Quality of Life in Patients With Chronic Neck Pain.

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Jan 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Monopolar electrical diathermy plus therapeutic yoga 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 Yoga The yoga 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 yoga posture.
Active Comparator: Therapeutic Yoga The Control Group formed by 30 subjects will be administered a supervised therapeutic yoga 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 yoga. Classes will be led by a certified Iyengar yoga instructor and physical therapist. The yoga 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 yoga 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 yoga 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 yoga per week.

Arm

Intervention/Treatment

Experimental: Monopolar electrical diathermy plus therapeutic yoga

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 Yoga

The yoga 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 yoga posture.

Active Comparator: Therapeutic Yoga

The Control Group formed by 30 subjects will be administered a supervised therapeutic yoga 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 yoga. Classes will be led by a certified Iyengar yoga instructor and physical therapist. The yoga 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 yoga 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 yoga

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 yoga per week.

Outcome Measures

Primary Outcome Measures

Neck disability index [Change from baseline disability at four weeks and three months]
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.
Active and Latent Myofascial Trigger Points (Number of trigger Points) [Change from baseline myofascial trigger points at four weeks and three months]
Myofascial Trigger Points will be explored in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus.

Secondary Outcome Measures

Pain (Visual Analog Scale) [Change from baseline pain intensity at four weeks and three months]
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 [Change from baseline pain intensity at four weeks and three months]
Quality of Life (SF-36 quality of life questionnaire) [Change from baseline quality of life at four weeks and three months]
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.
Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index) [Change from baseline quality of sleep at four weeks and three months]
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.
Cervical Range of Motion [Change from baseline range of motion at four weeks and three months]
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.
Tampa scale for kinesiophobia [Change from baseline phobia of movement at four weeks and three months]
The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 67 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men and women between 30 and 65 years of age.
Diagnosed by a specialist physician of chronic cervical pain of non-specific origin.
Acceptance and signature of informed consent for voluntary participation in the research study.
Not to be undergoing any type of physical therapy or pharmacological treatment.
Acceptance to attend the treatment sessions of the present research study.

Exclusion Criteria:

Being under rehabilitation or pharmacological treatment of lumbar pathology.
Alterations of sensitivity or coagulation.
Thermal sensitivity problems.
Present osteosynthesis material at lumbar level.
Present cardiac, epilepsy or tumor complications.
Non-acceptance of the informed consent or non-attendance to all the sessions that make up the treatment.