Monopolar Dielectric Diathermy by Radiofrequency and Therapeutic Exercise in Patients With Chronic Low Back Pain.

Study Overview
=================
Brief Summary
-----------------
A total of 60 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 30 and 65 years. A random distribution will be made into two treatment groups (diathermy combined with supervised therapeutic exercise versus supervised therapeutic exercise). Participants will receive treatment once a week for a period of four weeks, in the physiotherapy laboratories of the University of Almería, with a follow-up evaluation at three weeks and two months after the start 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.

Detailed Description
-----------------
After randomization, participants will be assigned to the experimental group (8 sessions of monopolar dielectric diathermy by emission of radiofrequency combined with 8 sessions of supervised therapeutic exercise) or to the control group (8 sessions of supervised exercise). The number of participants will be identical between the groups. The randomization sequence will be performed by the principal investigator. The number of participants for each group will be 30. The results of the random assignment will be sealed in opaque envelopes before being delivered to the participants. 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).

Official Title
-----------------
Effectiveness of Monopolar Dielectric Diathermy by Radiofrequency and Supervised Therapeutic Exercise in Pain, Functionality, Mobility of the Spine and Quality of Life of Patients With Non-specific Chronic Low Back Pain.

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Experimental: monopolar dielectric diathermy and supervised therapeutic exercise
* Other: Active Comparator: Supervised therapeutic exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain ≥ 3 months. Age between 30 and 67 years old. Score ≥ 4 points on the Roland Morris Disability Questionnaire. Not being receiving physical therapy. Exclusion Criteria: (1) patients with sensory and/or coagulation disorders; (2) a history of spinal surgery; (3) heart complications; (4) concurrent severe central or peripheral nervous system disease; (5) epilepsy; (6) needle phobia; (7) serious pathologies that can be the main cause of chronic LBP (for example, presence of lumbar stenosis, spondylolisthesis, tumours, etc.); (8) or patients contraindicated for radiofrequency (diathermy).

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 67 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: monopolar dielectric diathermy and supervised therapeutic exercise<br>The Experimental Group formed by 30 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 musculature 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. Once the application of (MDR) is finished, an exercise program supervised by a physiotherapist will be carried out. The exercise program will consist mainly of three types: stability and lumbo-pelvic motor control, strengthening and stretching of the lumbar muscles (Annex XIV), with a duration of 20 minutes. 2 weekly sessions will be held for 4 weeks, distributed as follows: Monday and Wednesday or Tuesday and Thursday, a total of 8 treatment sessions. | Other: Experimental: monopolar dielectric diathermy and supervised therapeutic exercise<br>* The Experimental Group formed by 30 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 musculature 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. Once the application of (MDR) is finished, an exercise program supervised by a physiotherapist will be carried out. The exercise program will consist mainly of three types: stability and lumbo-pelvic motor control, strengthening and stretching of the lumbar muscles (Annex XIV), with a duration of 20 minutes. 2 weekly sessions will be held for 4 weeks, distributed as follows: Monday and Wednesday or Tuesday and Thursday, a total of 8 treatment sessions.<br>|
| Active Comparator: Supervised therapeutic exercise<br>The Control Group formed by 30 subjects will be administered a training program consisting of three types of exercises, taking into account: stability and lumbopelvic motor control, strengthening and stretching of the lumbar muscles, exactly the same as the Experimental Group. With a duration of 20 minutes. 2 weekly sessions will be held for 4 weeks, distributed as follows: Monday and Wednesday or Tuesday and Thursday with a total of 8 treatment sessions. | Other: Active Comparator: Supervised therapeutic exercise<br>* The Control Group formed by 30 subjects will be administered a training program consisting of three types of exercises, taking into account: stability and lumbopelvic motor control, strengthening and stretching of the lumbar muscles, exactly the same as the Experimental Group. With a duration of 20 minutes. 2 weekly sessions will be held for 4 weeks, distributed as follows: Monday and Wednesday or Tuesday and Thursday with a total of 8 treatment sessions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Roland Morris Disability Questionnaire (RMDQ). | 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. | At baseline, at 4 weeks and at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in disability. Oswestry Low Back Pain Disability Idex. | It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points. | At baseline, at 4 weeks and at 2 months | 
| Change from baseline in pain intensity. Visual analogue scale. | A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain | At baseline, at 4 weeks and at 2 months | 
| Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia. | 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. | At baseline, at 4 weeks and at 2 months | 
| Change from baseline on Quality of Life. SF-36 Health questionnaire. | SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life. | At baseline, at 4 weeks and at 2 months | 
| Change from Mcquade Test. | It measures the isometric endurance of trunk flexion muscles. | At baseline, at 4 weeks and at 2 months | 
| Change from baseline in lumbar mobility flexion. | For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil). | At baseline, at 4 weeks and at 2 months | 
| Change from baseline in range of motion and lumbar segmental mobility | This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way. | At baseline, at 4 weeks and at 2 months | 
| Change from baseline of Pittsburgh Sleep Quality Index (PSQI) | 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. | At baseline, at 4 weeks and at 2 months | 
| Change from baseline in Hospital Anxiety and Depression Scale (HADS) | assessed the emotional distrees. It consists of two subscales (HADA: anxiety and HADD: depression) with seven items each that score from 0 (normal) to 3 (abnormal) | At baseline, at 4 weeks and at 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-specific chronic low back pain, Supervised therapeutic exercise, monopolar dielectric diathermy, randomised single-blind clinical trial