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

November 2, 2023 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Almeria
      • Almería, Almeria, Spain, 04120
        • Recruiting
        • Adelaida María Castro Sánchez
        • Contact:
          • Adelaida María Castro Sánchez, PhD
          • Phone Number: 0034 950214602
          • Email: adelaid@ual.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Exercise
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.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline disability at four weeks and three months
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.
Change from baseline myofascial trigger points at four weeks and three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
Change from baseline pain intensity at four weeks and three months
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.
Change from baseline quality of life at four weeks and three months
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.
Change from baseline quality of sleep at four weeks and three months
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.
Change from baseline range of motion at four weeks and three months
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.
Change from baseline phobia of movement at four weeks and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UALBIO2022/019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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