Efficacy of Therapy Using Monopolar Dielectric Radiofrequency Signals on the Symptoms of Myofascial Trigger Points in Patients With Chronic Nonspecific Low Back Pain.
Condition: Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

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 three per week for a period of three 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.
    

Detailed description: 
      The technique of applying monopolar electrical diathermy by radiofrequency emission (MDR),
      using the Physicalm® device, allows electromagnetic waves to be applied transcutaneously in a
      capacitive and monopolar manner, making focused energy deposits in the areas compromised with
      the painful process. The intervention with this device consists of different independent
      programs adapted to the different modalities of clinical pain. Through adaptations of the
      digitally modulated electromagnetic signals in terms of their intensity, frequency, form and
      duration, analgesia and pain relief can be obtained in different conditions musculoskeletal.

      Despite being a clinical electrotherapy technique currently widely used by physiotherapists,
      there are few clinical trials on the application of monopolar electrical diathermy by
      radiofrequency emission (MDR) in ailments of lumbar origin caused by myofascial trigger
      points. The difference with other systems that use high-frequency electrophysical agents such
      as short waves or microwaves lies mainly in the ability to penetrate the tissues, producing a
      thermal effect at a greater depth.

      Due to all the structural and functional alterations that occur in chronic non-specific low
      back pain, this randomized clinical trial project was born, with the aim of providing an
      answer to the disabling symptoms suffered by patients with chronic non-specific low back
      pain, searching for tools of safe and effective treatment from the field of Physiotherapy,
      which report a benefit in the symptoms, functionality and quality of life of patients
      diagnosed with chronic non-specific low back pain caused by PGM.

      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).

      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. 3 weekly sessions will be performed for 3
      weeks, a total of 9 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. 3 weekly sessions will be performed for 3 weeks, a total of 9 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).
    

Intervention name(s): Experimental: monopolar dielectric diathermy; Control: Placebo
Intervention type(s): Other; Other
Intervention description(s): 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 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. 3 weekly sessions will be performed for 3 weeks, a total of 9 treatment sessions.; The 30 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.
3 weekly sessions will be held for 3 weeks, a total of 9 treatment sessions.
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 three weeks.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic low back pain; monopolar dielectric diathermy; placebo; randomised double-blind clinical trial