Skip to main content
OpenTrials
Completed

NCT Number: NCT06072313

Monopolar Dielectric Diathermy and Therapeutic Exercise on Chronic Neck Pain and Therapeutic Exercise 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adelaida María Castro Sánchez

Almería, Almeria, 04120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monopolar electrical diathermy plus therapeutic exercise

Other

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.

Therapeutic exercise

Other

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.

Primary outcomes

  1. Neck disability index

    Time frame: 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.

  2. Active and Latent Myofascial Trigger Points (Number of trigger Points)

    Time frame: 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 outcomes

  1. Pain (Visual Analog Scale)

    Time frame: 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).

  2. McGill Pain Questionnaire

    Time frame: Change from baseline pain intensity at four weeks and three months

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

    Time frame: 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.

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

    Time frame: 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.

  5. Cervical Range of Motion

    Time frame: 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.

  6. Tampa scale for kinesiophobia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 10, 2023
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.