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Chronic PainNCT06072313

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

A study testing Monopolar electrical diathermy plus therapeutic exercise and Therapeutic Exercise in people with Chronic Pain and Neck Pain, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 67 years
Conditions the study is for
Chronic Pain, Neck Pain
What is being tested?
Monopolar electrical diathermy plus therapeutic exercise and Therapeutic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSpain
Study dates
1 Sep 2023to 30 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 67 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Adelaida María Castro Sánchez

    Almería, Almeria, 04120

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Monopolar electrical diathermy plus therapeutic exercise, Therapeutic Exercise
Keywords
monopolar electrical diathermy, therapeutic exercise
Medical subject headings
Chronic Pain, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monopolar electrical diathermy plus therapeutic exerciseOther

    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 ExerciseOther

    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.

Study groups in NCT06072313
Study groupRoleWhat they receive
Monopolar electrical diathermy plus therapeutic yogaExperimentalThe 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.
Receives: Other: Therapeutic Exercise
Therapeutic ExerciseActive comparatorThe 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.
Receives: Other: Monopolar electrical diathermy plus therapeutic exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline disability at four weeks and three months

  2. 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.

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

Secondary outcomes (6)

  1. 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).

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

  2. McGill Pain Questionnaire

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

  3. 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.

    Measured: Change from baseline quality of life at four weeks and three months

  4. 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.

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

  5. 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.

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

  6. Tampa scale for kinesiophobia

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

    Measured: Change from baseline phobia of movement at four weeks and three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start1 Sep 2023
  3. Primary completion1 Nov 2023
  4. Study completion30 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06072313
Sponsor's protocol ID
UALBIO2022/019
Status last verified
May 2025
First submitted
2 Oct 2023
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vassilaki M, Hurwitz EL. Insights in public health: perspectives on pain in the low back and neck: global burden, epidemiology, and management. Hawaii J Med Public Health. 2014 Apr;73(4):122-6. No abstract available.

    PubMed 24765562

  • Hogg-Johnson S, van der Velde G, Carroll LJ, Holm LW, Cassidy JD, Guzman J, Cote P, Haldeman S, Ammendolia C, Carragee E, Hurwitz E, Nordin M, Peloso P. The burden and determinants of neck pain in the general population: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S46-60. doi: 10.1016/j.jmpt.2008.11.010.

    PubMed 19251074

  • Monticone M, Iovine R, de Sena G, Rovere G, Uliano D, Arioli G, Bonaiuti D, Brugnoni G, Ceravolo G, Cerri C, Dalla Toffola E, Fiore P, Foti C; Italian Society of Physical and Rehabilitation Medicine (SIMFER). The Italian Society of Physical and Rehabilitation Medicine (SIMFER) recommendations for neck pain. G Ital Med Lav Ergon. 2013 Jan-Mar;35(1):36-50.

    PubMed 23798233

  • Strine TW, Hootman JM. US national prevalence and correlates of low back and neck pain among adults. Arthritis Rheum. 2007 May 15;57(4):656-65. doi: 10.1002/art.22684.

    PubMed 17471542

  • US Burden of Disease Collaborators; Mokdad AH, Ballestros K, Echko M, Glenn S, Olsen HE, Mullany E, Lee A, Khan AR, Ahmadi A, Ferrari AJ, Kasaeian A, Werdecker A, Carter A, Zipkin B, Sartorius B, Serdar B, Sykes BL, Troeger C, Fitzmaurice C, Rehm CD, Santomauro D, Kim D, Colombara D, Schwebel DC, Tsoi D, Kolte D, Nsoesie E, Nichols E, Oren E, Charlson FJ, Patton GC, Roth GA, Hosgood HD, Whiteford HA, Kyu H, Erskine HE, Huang H, Martopullo I, Singh JA, Nachega JB, Sanabria JR, Abbas K, Ong K, Tabb K, Krohn KJ, Cornaby L, Degenhardt L, Moses M, Farvid M, Griswold M, Criqui M, Bell M, Nguyen M, Wallin M, Mirarefin M, Qorbani M, Younis M, Fullman N, Liu P, Briant P, Gona P, Havmoller R, Leung R, Kimokoti R, Bazargan-Hejazi S, Hay SI, Yadgir S, Biryukov S, Vollset SE, Alam T, Frank T, Farid T, Miller T, Vos T, Barnighausen T, Gebrehiwot TT, Yano Y, Al-Aly Z, Mehari A, Handal A, Kandel A, Anderson B, Biroscak B, Mozaffarian D, Dorsey ER, Ding EL, Park EK, Wagner G, Hu G, Chen H, Sunshine JE, Khubchandani J, Leasher J, Leung J, Salomon J, Unutzer J, Cahill L, Cooper L, Horino M, Brauer M, Breitborde N, Hotez P, Topor-Madry R, Soneji S, Stranges S, James S, Amrock S, Jayaraman S, Patel T, Akinyemiju T, Skirbekk V, Kinfu Y, Bhutta Z, Jonas JB, Murray CJL. The State of US Health, 1990-2016: Burden of Diseases, Injuries, and Risk Factors Among US States. JAMA. 2018 Apr 10;319(14):1444-1472. doi: 10.1001/jama.2018.0158.

    PubMed 29634829

  • Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.

    PubMed 15999284

  • Cote P, van der Velde G, Cassidy JD, Carroll LJ, Hogg-Johnson S, Holm LW, Carragee EJ, Haldeman S, Nordin M, Hurwitz EL, Guzman J, Peloso PM. The burden and determinants of neck pain in workers: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S70-86. doi: 10.1016/j.jmpt.2008.11.012.

    PubMed 19251078

  • Kjellman G, Skargren E, Oberg B. Prognostic factors for perceived pain and function at one-year follow-up in primary care patients with neck pain. Disabil Rehabil. 2002 May 10;24(7):364-70. doi: 10.1080/10.1080/09638280110101532.

    PubMed 12022786

  • Hurwitz EL, Carragee EJ, van der Velde G, Carroll LJ, Nordin M, Guzman J, Peloso PM, Holm LW, Cote P, Hogg-Johnson S, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: noninvasive interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S123-52. doi: 10.1097/BRS.0b013e3181644b1d.

    PubMed 18204386

  • Ibanez-Vera AJ, Garcia-Romero JC, Alvero-Cruz JR, Lomas-Vega R. Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Apr 3;17(7):2465. doi: 10.3390/ijerph17072465.

    PubMed 32260313

  • Hochsprung A, Escudero-Uribe S, Ibanez-Vera AJ, Izquierdo-Ayuso G. Effectiveness of monopolar dielectric transmission of pulsed electromagnetic fields for multiple sclerosis-related pain: a pilot study. Neurologia (Engl Ed). 2021 Jul-Aug;36(6):433-439. doi: 10.1016/j.nrleng.2018.03.003. Epub 2020 Feb 7.

    PubMed 34238526

  • Albornoz-Cabello M, Ibanez-Vera AJ, Aguilar-Ferrandiz ME, Espejo-Antunez L. Monopolar dielectric diathermy by emission of radiofrequency in Patellofemoral pain. A single-blind-randomized clinical trial. Electromagn Biol Med. 2020 Oct 1;39(4):282-289. doi: 10.1080/15368378.2020.1793169. Epub 2020 Jul 19.

    PubMed 32683992

  • Albornoz-Cabello M, Ibanez-Vera AJ, De la Cruz-Torres B. Efficacy of monopolar dielectric transmission radio frequency in panniculus adiposus and cellulite reduction. J Cosmet Laser Ther. 2017 Nov;19(7):422-426. doi: 10.1080/14764172.2017.1342041. Epub 2017 Jul 5.

    PubMed 28678582

  • Kumaran B, Watson T. Skin thermophysiological effects of 448 kHz capacitive resistive monopolar radiofrequency in healthy adults: A randomised crossover study and comparison with pulsed shortwave therapy. Electromagn Biol Med. 2018;37(1):1-12. doi: 10.1080/15368378.2017.1422260. Epub 2018 Jan 8.

    PubMed 29308927

  • 17. Kumaran, B., Herbland, A., Watson, T. 2017. Continuous mode 448 kHz capacitive resistive monopolar radiofrequency induces greater deep blood flow changes compared to pulsed mode shortwave: A crossover study in healthy adults. Eur. J. Physiotherapy 19:137-46.

Questions about this trial

What is this clinical trial studying?

A study testing Monopolar electrical diathermy plus therapeutic exercise and Therapeutic Exercise in people with Chronic Pain and Neck Pain, run by Universidad de Almeria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck disability index (time frame: Change from baseline disability at four weeks and three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06072313, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.

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