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

July 20, 2022 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04120
        • Adelaida María Castro-Sánchez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 67 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pain intensity. Visual analogue scale.
Time Frame: 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
At baseline, at 4 weeks and at 2 months
Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
Time Frame: 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.
At baseline, at 4 weeks and at 2 months
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
Time Frame: 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.
At baseline, at 4 weeks and at 2 months
Change from Mcquade Test.
Time Frame: At baseline, at 4 weeks and at 2 months
It measures the isometric endurance of trunk flexion muscles.
At baseline, at 4 weeks and at 2 months
Change from baseline of Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 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.
At baseline, at 4 weeks and at 2 months
Change from baseline on Quality of Life. SF-36 Health questionnaire.
Time Frame: 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.
At baseline, at 4 weeks and at 2 months
Change from baseline in lumbar mobility flexion.
Time Frame: 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).
At baseline, at 4 weeks and at 2 months
Change from baseline in range of motion and lumbar segmental mobility
Time Frame: At baseline, at 4 weeks and at 2 months
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 in Hospital Anxiety and Depression Scale (HADS)
Time Frame: At baseline, at 4 weeks and at 2 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 12, 2021

Primary Completion (ACTUAL)

March 25, 2022

Study Completion (ACTUAL)

May 13, 2022

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (ACTUAL)

December 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UALBIO2021/006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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