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

NCT06072313 | Completed

• 1 other identifier: UALBIO2022/019
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Neck Pain

Keywords

monopolar electrical diathermy; therapeutic exercise

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Change from baseline myofascial trigger points at four weeks and three months

Secondary Outcomes (6)

• Pain (Visual Analog Scale)

  Change from baseline pain intensity at four weeks and three months

• 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

• Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)

  Change from baseline quality of sleep at four weeks and three months

• Cervical Range of Motion

  Change from baseline range of motion at four weeks and three months

Study Arms (2)

Monopolar electrical diathermy plus therapeutic yoga

EXPERIMENTAL

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

Therapeutic Exercise

ACTIVE COMPARATOR

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

Interventions

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

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.

Monopolar electrical diathermy plus therapeutic yoga

Eligibility Criteria

• Age: 30 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Adelaida María Castro Sánchez

Almería, Almeria, 04120, Spain

Location

Related Publications (21)

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  BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Neck Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 10, 2023
• Study Start: September 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: March 30, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)