Efficacy of Therapy Using Monopolar Dielectric Radiofrequency Signals on the Symptoms of Myofascial Trigger Points in Patients With Chronic Nonspecific Low Back Pain.

Sponsor

Universidad de Almeria (Other)

Overall Status

Completed

CT.gov ID

NCT05471258

Collaborator

(none)

Enrollment

Location

Arms

5.5

Actual Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A total of 74 people diagnosed with non-specific chronic low back pain of more than 3 months of evolution and who are not currently undergoing any type of treatment will be recruited, with ages between 35 and 65 years. A random distribution will be made into two treatment groups (monopolar diathermy by radiofrequency versus placebo). Participants will receive treatment twice per week for a period of four weeks, in the physiotherapy laboratories of the University of Almería, with a follow-up evaluation post-intervention (one months) and two months after the end of treatment. At their first visit, participants will be screened for study eligibility according to the study inclusion and exclusion criteria, and will be evaluated by a therapist blinded to the intervention. After this face-to-face evaluation, patients will be randomly assigned to one of the two groups and will receive treatment for low back pain according to their random assignment group by two therapists belonging to the research group and trained in the techniques used.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Other: Experimental: monopolar dielectric diathermy Other: Control: Placebo	N/A

Detailed Description

The 37 subjects of the experimental group (EG) will receive an application of monopolar electrical diathermy by radiofrequency emission (MDR) by means of the Physicalm® device (developed by the electro-medicine company Biotronic Advance Develops SL), on the lumbar muscles by means of rotary movements and translation, adapting to the muscle fibers of the lower back, contacting and applying the treatment to the active myofascial trigger points of the following muscles: quadratus lumborum, multifidus and iliocostalis, following the PGM maps described by Travell and Simons. A pulsed emission of 840 KHz and 30v will be carried out dynamically for a treatment time of 20 minutes. 2 weekly sessions will be performed for 4 weeks, a total of 8 treatment sessions.

The 37 subjects in the control group (CG) will be administered a placebo treatment consisting of the same execution protocol as the EG, but with a non-emitting device whose software and hardware will be exactly the same as that used in the EG. The intervention will be simulated for 20 minutes.

A pulsed emission of 840 KHz and 30v will be carried out dynamically for a treatment time of 20 minutes. 2 weekly sessions will be performed for 4 weeks, a total of 8 treatment sessions.

The outcome assessor and study statistician will be blinded throughout the entire process.

A baseline assessment of the primary and secondary outcome measures will be performed before randomization of the participants to the different groups, an immediate post-treatment assessment (1 day after the last intervention) and an assessment two months after the end of the procedure intervention (follow-up).

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Once the study is over, the control group will have the opportunity to receive radiofrequency treatment for one month.Once the study is over, the control group will have the opportunity to receive radiofrequency treatment for one month.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participants are not familiar with diathermy, and will lie prone while receiving treatment. They will also be cited on different days of the week to the experimental group. The therapist assessing the outcome measures does not know which group the patients belong to, and will be supervised by the principal investigator so that they do not ask any questions about it.

Primary Purpose:

Treatment

Official Title:

Efficacy of Therapy Using Monopolar Dielectric by Radiofrequency on the Symptoms of Myofascial Trigger Points in Patients With Chronic Non-specific Low Back Pain.

Actual Study Start Date :

Jan 15, 2022

Actual Primary Completion Date :

Mar 1, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: monopolar dielectric diathermy The Experimental Group formed by 37 subjects will undergo an application of monopolar electrical diathermy by radiofrequency emission (MDR) using the Physicalm® device developed by the electro-medicine company Biotronic Advance Develops SL, on the lumbar muscles by means of rotary movements and translation, adapting to the muscle fibers of the lumbar area. A pulsed emission of 840 KHz and 30v will be made dynamically during a treatment time of 20 minutes. 2 weekly sessions will be performed for 4 weeks, a total of 8 treatment sessions.	Other: Experimental: monopolar dielectric diathermy The Experimental Group formed by 37 subjects will undergo an application of monopolar electrical diathermy by radiofrequency emission (MDR) using the Physicalm® device developed by the electro-medicine company Biotronic Advance Develops SL, on the lumbar muscles by means of rotary movements and translation, adapting to the muscle fibers of the lumbar area. A pulsed emission of 840 KHz and 30v will be made dynamically during a treatment time of 20 minutes. 2 weekly sessions will be performed for 4 weeks, a total of 8 treatment sessions.
Placebo Comparator: Placebo The 37 participants in the control group will receive a placebo treatment, consisting of the same execution protocol as the EG, but with a non-emitting device whose software and hardware will be exactly the same as that used in the EG. The intervention will be simulated for 20 minutes. 2 weekly sessions will be held for 4 weeks, a total of 8 treatment sessions.	Other: Control: Placebo The 37 participants in the control group will receive a placebo treatment, consisting of the same execution protocol as the EG, but with a non-emitting device whose software and hardware will be exactly the same as that used in the EG. The intervention will be simulated for 20 minutes. 2 weekly sessions will be held for 4 weeks, a total of 8 treatment sessions.

Arm

Intervention/Treatment

Experimental: Experimental: monopolar dielectric diathermy

The Experimental Group formed by 37 subjects will undergo an application of monopolar electrical diathermy by radiofrequency emission (MDR) using the Physicalm® device developed by the electro-medicine company Biotronic Advance Develops SL, on the lumbar muscles by means of rotary movements and translation, adapting to the muscle fibers of the lumbar area. A pulsed emission of 840 KHz and 30v will be made dynamically during a treatment time of 20 minutes. 2 weekly sessions will be performed for 4 weeks, a total of 8 treatment sessions.

Other: Experimental: monopolar dielectric diathermy

Placebo Comparator: Placebo

The 37 participants in the control group will receive a placebo treatment, consisting of the same execution protocol as the EG, but with a non-emitting device whose software and hardware will be exactly the same as that used in the EG. The intervention will be simulated for 20 minutes. 2 weekly sessions will be held for 4 weeks, a total of 8 treatment sessions.

Other: Control: Placebo

Outcome Measures

Primary Outcome Measures

Changes in pressure algometry (Wagner Algometer) in myofascial trigger points assessment of pressure pain threshold. [At baseline, at 4 weeks and at 2 months]
The algometer consists of a rubber tip and a dial that measures the pressure applied to the MTrP in increments of 0.5 kg. Three measurements were performed for each one of the selected trigger points: iliocostal muscle level L1; multifidus level L2, S1 and S4; quadratus lumbar PGM deep superior, deep inferior, superficial superior and superficial inferior. The average value of 3 repetitive measurements with intervals of 30 to 60 seconds was used for statistical analysis.
Change from baseline in pain intensity. Visual analogue scale. [At baseline, at 4 weeks and at 2 months]
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
Change from baseline in Roland Morris Disability Questionnaire (RMDQ). [At baseline, at 4 weeks and at 2 months]
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.

Secondary Outcome Measures

Change from baseline in disability. Oswestry Low Back Pain Disability Idex. [At baseline, at 4 weeks and at 2 months]
It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points.
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia. [At baseline, at 4 weeks and at 2 months]
Is a 17-item questionnaire that measures the fear of movement and (re)injury. Ratings are summed to yield a total score (ranging from 17-68 points) where higher values reflect greater fear of (re)injury.
Change from baseline on Quality of Life. SF-36 Health questionnaire [At baseline, at 4 weeks and at 2 months]
SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Change from Mcquade Test. [At baseline, at 4 weeks and at 2 months]
It measures the isometric endurance of trunk flexion muscles.
Change from baseline in lumbar mobility flexion [At baseline, at 4 weeks and at 2 months]
For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil).
Change from baseline of Pittsburgh Sleep Quality Index (PSQI) [At baseline, at 4 weeks and at 2 months]
Is a 10-item questionnaire with a total of 19 questions related to sleep habits in the previous month. The questions are divided into 7 areas, each with a score of between 0 and 3 points.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

LBP for/over three months
Age between 30 and 65 years
Score equal or superior of four points on the Roland Morris Disability
Questionnaire Not currently receiving physical therapy.

Exclusion Criteria:

Presence of lumbar stenosis;
Any clinical signs of radiculopathy;
Diagnosis of spondylolisthesis;
Diagnosis of fibromyalgia;
Treatment with corticosteroid or oral medication within the past two weeks;
A history of spinal surgery;
Contraindication for MDR;
Disease of the central or peripheral nervous system; (9) Patients with cardiac complications and / or patients who have recently undergone radiotherapy.