Monopolar Dielectric Diathermy by Radiofrequency and Therapeutic Exercise in Patients With Chronic Low Back Pain.
- Conditions
- Chronic Pain
- Registration Number
- NCT05149690
- Lead Sponsor
- Universidad de Almeria
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
(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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in Roland Morris Disability Questionnaire (RMDQ). 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.
- Secondary Outcome Measures
Name Time Method Change from baseline of Pittsburgh Sleep Quality Index (PSQI) 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.
Change from baseline on Quality of Life. SF-36 Health questionnaire. 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.
Change from baseline in disability. Oswestry Low Back Pain Disability Idex. 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.
Change from baseline in pain intensity. Visual analogue scale. 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
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia. 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.
Change from Mcquade Test. At baseline, at 4 weeks and at 2 months It measures the isometric endurance of trunk flexion muscles.
Change from baseline in range of motion and lumbar segmental mobility 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.
Change from baseline in Hospital Anxiety and Depression Scale (HADS) 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)
Change from baseline in lumbar mobility flexion. 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).
Trial Locations
- Locations (1)
Adelaida María Castro-Sánchez
🇪🇸Almería, Spain