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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

Primary Purpose

Chronic Pain, Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Monopolar electrical diathermy plus therapeutic yoga
Therapeutic Yoga
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring monopolar electrical diathermy, therapeutic exercise, yoga

Eligibility Criteria

30 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Adelaida María Castro SánchezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Monopolar electrical diathermy plus therapeutic yoga

Therapeutic Yoga

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
McGill Pain Questionnaire
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.
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.
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.
Tampa scale for kinesiophobia
The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.

Full Information

First Posted
October 2, 2023
Last Updated
October 2, 2023
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT06072313
Brief Title
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
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Neck Pain
Keywords
monopolar electrical diathermy, therapeutic exercise, yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monopolar electrical diathermy plus therapeutic yoga
Arm Type
Experimental
Arm Description
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.
Arm Title
Therapeutic Yoga
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Monopolar electrical diathermy plus therapeutic yoga
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neck disability index
Description
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
Title
Active and Latent Myofascial Trigger Points (Number of trigger Points)
Description
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
Secondary Outcome Measure Information:
Title
Pain (Visual Analog Scale)
Description
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
Title
McGill Pain Questionnaire
Time Frame
Change from baseline pain intensity at four weeks and three months
Title
Quality of Life (SF-36 quality of life questionnaire)
Description
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
Title
Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)
Description
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
Title
Cervical Range of Motion
Description
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
Title
Tampa scale for kinesiophobia
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Adelaida María Castro Sánchez
City
Almería
State/Province
Almeria
ZIP/Postal Code
04120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adelaida María Castro Sánchez, PhD
Phone
950214602
Ext
0034
Email
adelaid@ual.es

12. IPD Sharing Statement

Plan to Share IPD
No
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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

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