NCT05149690

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Universidad de Almeria · Academic / Other
• Sex: All
• Age: 30 Years – 67 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Pain

Interventions

Type	Name	Description
OTHER	Experimental: monopolar dielectric diathermy and supervised therapeutic exercise	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	Active Comparator: Supervised therapeutic exercise	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.

Timeline

• Start date: 2021-12-12
• Primary completion: 2022-03-25
• Completion: 2022-05-13
• First posted: 2021-12-08
• Last updated: 2022-07-21

Locations

1 site across 1 country: Spain