Clinical trial NCT05149690: Monopolar Dielectric Diathermy by Radiofrequency and Therapeutic Exercise in Patients With Chronic Low Back Pain.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: non-specific chronic low back pain
Supervised therapeutic exercise
monopolar dielectric diathermy
randomised single-blind clinical trial
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
timeFrame: At baseline, at 4 weeks and at 2 months
Secondary outcomes:
measure: Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
timeFrame: At baseline, at 4 weeks and at 2 months
measure: Change from baseline in pain intensity. Visual analogue scale.
timeFrame: At baseline, at 4 weeks and at 2 months
measure: Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
timeFrame: At baseline, at 4 weeks and at 2 months
measure: Change from baseline on Quality of Life. SF-36 Health questionnaire.
timeFrame: At baseline, at 4 weeks and at 2 months
measure: Change from Mcquade Test.
timeFrame: At baseline, at 4 weeks and at 2 months
measure: Change from baseline in lumbar mobility flexion.
timeFrame: At baseline, at 4 weeks and at 2 months
measure: Change from baseline in range of motion and lumbar segmental mobility
timeFrame: At baseline, at 4 weeks and at 2 months
measure: Change from baseline of Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At baseline, at 4 weeks and at 2 months
measure: Change from baseline in Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline, at 4 weeks and at 2 months
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Adelaida María Castro-Sánchez
Study officials:
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