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Instant analgesic effect of radial extracorporeal shock wave therapy on primary dysmenorrhoea according to functional magnetic resonance imaging: study protocol for a randomised placebo-controlled trial.

ABSTRACT: BACKGROUND:Primary dysmenorrhoea (PDM) is defined as a series of pain-dominated symptoms during and after menstruation without organic lesions. Nonsteroidal anti-inflammatory drugs and oral contraceptives are usually recommended as first-line therapy for the clinical treatment of PDM, but their widespread long-term application is controversial. Radial extracorporeal shock wave therapy (rESWT) has been widely applied in musculoskeletal rehabilitation because of its secure and noninvasive characteristics and its confirmed effect in improving pain symptoms. This research seeks to explore the efficacy of rESWT for PDM and the changes in brain function of patients with PDM. METHODS:This clinical research will be a randomised, blind, sham-controlled trial. Thirty-six patients with PDM will be randomly divided into the rESWT group (n?=?18) and the sham rESWT group (n?=?18). In the rESWT group, treatment will be applied once within 48?h of menstruation at six abdominal myofascial trigger points. The sham rESWT group will receive sham shockwave therapy on the same sites but without energy input. Other dysmenorrhoea-related treatments in both groups will be limited. The main indicators include the short form of the McGill Pain Questionnaire and the Cox Menstrual Symptom Scale. The secondary indicators include the Zung Self-rating Anxiety Scale and Self-rating Depression Scale and functional magnetic resonance imaging (fMRI) changes in brain regions. Results will be evaluated at the screening, at baseline, and before and after treatment, and adverse treatments will be examined. Inter- and intragroup analyses will be performed. DISCUSSION:This randomised controlled study is designed to explore the immediate efficacy of rESWT for PDM. After rESWT treatment, PDM symptom tests and pain tests, as well as fMRI data, will be investigated for the potential connections between immediate neuroanalgesic mechanisms, which are associated with pain and brain networks. The main results will be used to assess the efficacy of rESWT, and secondary results will focus on improving the neurobiological understanding of disease treatment. TRIAL REGISTRATION:China Clinical Trial Register, ChiCTR1900020678. Registered on 13 January 2019.

SUBMITTER: Liu S

PROVIDER: S-EPMC7014766 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Instant analgesic effect of radial extracorporeal shock wave therapy on primary dysmenorrhoea according to functional magnetic resonance imaging: study protocol for a randomised placebo-controlled trial.

Liu Shanshan S Wang Lezheng L Yang Jian J

Trials 20200211 1

<h4>Background</h4>Primary dysmenorrhoea (PDM) is defined as a series of pain-dominated symptoms during and after menstruation without organic lesions. Nonsteroidal anti-inflammatory drugs and oral contraceptives are usually recommended as first-line therapy for the clinical treatment of PDM, but their widespread long-term application is controversial. Radial extracorporeal shock wave therapy (rESWT) has been widely applied in musculoskeletal rehabilitation because of its secure and noninvasive ...[more]

PMID: 32046753

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Project description:Conflicting reports in the literature have raised the question whether radial extracorporeal shock wave therapy (rESWT) devices and vibrating massage devices have similar energy signatures and, hence, cause similar bioeffects in treated tissues.We used laser fiber optic probe hydrophone (FOPH) measurements, high-speed imaging and x-ray film analysis to compare fundamental elements of the energy signatures of two rESWT devices (Swiss DolorClast; Electro Medical Systems, Nyon, Switzerland; D-Actor 200; Storz Medical, Tägerwillen, Switzerland) and a vibrating massage device (Vibracare; G5/General Physiotherapy, Inc., Earth City, MO, USA). To assert potential bioeffects of these treatment modalities we investigated the influence of rESWT and vibrating massage devices on locomotion ability of Caenorhabditis elegans (C. elegans) worms.FOPH measurements demonstrated that both rESWT devices generated acoustic waves with comparable pressure and energy flux density. Furthermore, both rESWT devices generated cavitation as evidenced by high-speed imaging and caused mechanical damage on the surface of x-ray film. The vibrating massage device did not show any of these characteristics. Moreover, locomotion ability of C. elegans was statistically significantly impaired after exposure to radial extracorporeal shock waves but was unaffected after exposure of worms to the vibrating massage device.The results of the present study indicate that both energy signature and bioeffects of rESWT devices are fundamentally different from those of vibrating massage devices.Prior ESWT studies have shown that tissues treated with sufficient quantities of acoustic sound waves undergo cavitation build-up, mechanotransduction, and ultimately, a biological alteration that "kick-starts" the healing response. Due to their different treatment indications and contra-indications rESWT devices cannot be equated to vibrating massage devices and should be used with due caution in clinical practice.

Project description:BackgroundExtracorporeal shock wave therapy (ESWT) is a widely considered treatment option for Achilles tendinopathy. Line-focused ESWT is a novel technique treating a larger tendon area than point-focused ESWT. Monitoring capacities of clinical symptoms with ultrasound under ESWT treatment are unknown.HypothesisPoint- and line-focused ESWT have a superior outcome than placebo ESWT. ESWT leads to morphological tendon changes detectable with ultrasound.Study designSingle-blinded placebo-controlled randomized contolled trial.Level of evidenceLevel 1.MethodsThe study was conducted in 3 cohorts, namely ESWT point (n = 21), ESWT line (n = 24), and ESWT placebo (n = 21). Victorian Institute of Sports Assessment-Achilles (VISA-A) score was measured before the intervention (T0), after 6 weeks (T1), and after 24 weeks (T2). All cohorts performed daily physiotherapy for 24 weeks and received 4 sessions of point-focused, line-focused, or placebo ESWT in the first 6 weeks. Ultrasound was performed with B-mode, power Doppler, shear wave elastography (SWE) at T0 and T2 and with ultrasound tissue characterization (UTC) at T0, T1, and T2. Data were analyzed with a mixed analysis of variance and t test.ResultsThere was a significant VISA-A improvement over time for all groups (P < 0.001). ESWT point had the strongest VISA-A score improvement +23 (ESWT line: +18; ESWT placebo: +15), but there was no significant interaction between time and any of the groups: F(4, 116) = 1.393; P = 0.24. UTC, power Doppler, and B-mode could not show significant alterations over time. SWE revealed a significant increase of elastic properties for ESWT point in the insertion (t = -3.113, P = 0.03) and midportion (t = -2.627, P = 0.02) over time.ConclusionThere is a significant VISA-A score improvement for all study groups without a statistically significant benefit for ESWT point or ESWT line compared with ESWT placebo. Tendon adaptation could only be detected with SWE for ESWT point.Clinical relevanceThe present study could not detect any statistically relevant effect of ESWT compared to placebo. SWE is able to demonstrate tendon adaptation.

Project description:To assess the effects of radial extracorporeal shock wave therapy (rESWT) on plantar flexor muscle spasticity and gross motor function in very young patients with cerebral palsy (CP).The design was case-control study (level of evidence 3).The setting was the Department of Pediatric Neurology and Neurorehabilitation, First Hospital of Jilin University, Changchun, China.Those with a diagnosis of CP and spastic plantar flexor muscles were recruited between April 2014 and April 2015.According to the parents' decision, patients received 1 ESWT session per week for 3 months, with 1500 radial shock waves per ESWT session and leg with positive energy flux density of 0.03?mJ/mm, combined with traditional conservative therapy (rESWT group) or traditional conservative therapy alone (control group).The Modified Ashworth Scale (MAS) (primary outcome measure) and passive range of motion (pROM) measurements were collected at baseline (BL), 1 month (M1), and 3 months (M3) after BL. The Gross Motor Function Measure (GMFM)-88 was collected at BL and M3.Sixty-six patients completed the final review at 3 months and were included in the study. Subjects ranged in age from 12 to 60 months (mean age 27.0?±?13.6 months; median age 22.0 months; 33.3% female). For the rESWT group (n?=?34), mean MAS grades at BL, M1, and M3 were 2.6, 1.9, and 1.5 on the left side and 1.9, 1.7, and 1.2 on the right side. For the control group (n?=?32), mean MAS grades at BL, M1, and M3 were 2.5, 2.4, and 2.1 on the left side and 1.8, 1.8, and 1.5 on the right side. The within-subject effects time?×?side and time?×?treatment were statistically significant (P?<?0.01). Similar results were found for the improvement of mean pROM. GMFM-88 improved from BL to M3, but showed no statistically significant difference between the groups. There were no significant complications.This study demonstrates that the combination of rESWT and traditional conservative therapy is more effective than traditional conservative therapy alone in the treatment of spasticity in very young patients with CP.

Dataset Information

Instant analgesic effect of radial extracorporeal shock wave therapy on primary dysmenorrhoea according to functional magnetic resonance imaging: study protocol for a randomised placebo-controlled trial.

Publications

Instant analgesic effect of radial extracorporeal shock wave therapy on primary dysmenorrhoea according to functional magnetic resonance imaging: study protocol for a randomised placebo-controlled trial.

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