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Clinical Trial Protocol

Immediate Analgesic Effect of two Modes of Short-Wave Diathermy Application in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial

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Pages 131-139 | Received 29 Mar 2021, Accepted 05 Jul 2021, Published online: 21 Jul 2021
 

Abstract

The aim of this study is to evaluate and compare the immediate analgesic effects of two applications of short-wave diathermy (SWD) in individuals with chronic low back pain. Randomized, controlled, double-blind clinical trial. A total of 159 participants with chronic low back pain will be randomized in three groups: pulsed mode SWD, continuous mode SWD and placebo. SWD will be applied only once for 30 min. The primary outcomes: intensity and quality of pain. Secondary outcomes: depression and anxiety; perception of global improvement; patient satisfaction; disability and influence of psychosocial factors, strength of the lower limbs and the mobility of the posterior chain. Patients will be evaluated before and after the session and 1 week after.

Trial registration number: RBR-2k58f5h Brazilian Registry of Clinical Trials (ReBEC).

Lay abstract

Aim : Low back pain is one of the main health problems in the world. Short-wave diathermy (SWD) is a physiotherapy device that can be used to treat low back pain, but its scientific effectiveness is uncertain. Objective: To evaluate and compare the effects of pain reduction immediately after application of the device (SWD) in two different application methods in individuals with chronic low back pain. Materials & methods: Clinical trial in which 159 individuals will be selected and randomly allocated into three groups: pulsed short-wave diathermy group, n = 53; continuous short-wave diathermy group, n = 53 and placebo group, n = 53. The technique will only be applied once for 30 min. The main result analyzed will be pain. Other results that will also be evaluated are perception of global improvement and treatment satisfaction, functionality (ability to perform daily tasks), leg strength and trunk mobility. It will also be verified the presence of depression, anxiety, psychological and social factors that may influence the response to treatment. Individuals will be evaluated before the first session, immediately after the application of the device and 1 week later. Conclusion: It is expected to verify the decrease in pain soon after the application of the device in the chronic low back pain and find out if there is any difference in this outcome according to the application method.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved. Approved by the Health Sciences Ethics Committee UFPR (CAEE: 44642615.2.0000.0102).

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