Dataset Information

Efficacy and safety of treating chronic nonspecific low back pain with radial extracorporeal shock wave therapy (rESWT), rESWT combined with celecoxib and eperisone (C + E) or C + E alone: a prospective, randomized trial.

ABSTRACT:

Background

To investigate whether respectively radial extracoporeal shock wave therapy (rESWT) or a combination of rESWT, celecoxib and eperisone (rESWT + C + E) are superior in reducing pain in patients with chronic nonspecific low back pain (cnsLBP) compared to C + E alone (a standard treatment of this condition in China).

Methods

140 patients with cnsLBP were randomly allocated to rESWT (n = 47), rESWT + C + E (n = 45) or C + E alone (n = 48) for four weeks between November 2017 and March 2019. Outcome was evaluated using the Pain Self-Efficacy Questionnaire (PSEQ), Numerical Rating Scale (NRS), Oswestry Low Back Pain Disability Questionnaire and Patient Health Questionnaire 9, collected at baseline as well as one week (W1), W2, W3, W4 and W12 after baseline.

Results

All scores showed a statistically significant improvement over time. The PSEQ and NRS scores showed a significant Time × Treatment effect. Patients treated with rESWT had significantly lower mean NRS values than patients treated with rESWT + C + E at W1 and W3, as well as than patients treated with C + E alone at W3 and W4. No severe adverse events were observed.

Conclusions

rESWT may not be inferior to respectively rESWT + C + E or C + E alone in reducing pain in patients with cnsLBP.

Level of evidence

Level I, prospective, randomized, active-controlled trial.

Trial registration

Clinicaltrials.gov Identifier NCT03337607. Registered November 09, 2017, https://www.clinicaltrials.gov/ct2/show/NCT03337607 .

Level of evidence

Level I; prospective, randomized, controlled trial.

SUBMITTER: Guo X

PROVIDER: S-EPMC8642949 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPlantar fasciopathy is a common cause of plantar heel pain, with a reported prevalence of up to 10%. The choice of best practice in these patients is debated. Two randomised studies reported that radial extracorporeal shock wave therapy is effective, but a meta-analysis concluded that due to methodological limitations, the evidence is questionable. There are few studies reporting the effect of exercise programs with high-load strength training, despite widespread use. The objective of this placebo-controlled, observer-blinded and partly patient blinded trial is to compare rESWT, sham-rESWT, standardised exercise programme and usual care for alleviating heel pain at 6 and 12 months follow-up.Methods/designA double-blind, randomised, sham-controlled trial is conducted at a hospital outpatient clinic of physical medicine and rehabilitation. Patients with chronic (> 3 months) pain due to plantar fasciopathy, aged 18 to 70 years old, are eligible for inclusion in the trial. Patients will be randomly allocated in 1:1 ratio to receive rESWT, sham-rESWT, standardised exercises or usual care. The sample size is estimated to 200 patients, 50 in each group. rESWT or sham-rESWT will be given once a week for 3 weeks. A physiotherapist will supervise the exercises, with a total of 8 sessions over 12 weeks. The patients in the usual care group will receive information, advice and foot orthosis only. All patients, regardless of group, will receive the same information and get an individual customised foot orthosis made by an orthopaedic technician. The primary outcome measure is heel pain intensity during activity in the last week, using a numeric rating scale (NRS, 0 to 10) at the 6 months follow-up adjusted for baseline pain intensity. The secondary outcomes are at the 6- and 12-month follow-up and include Foot Functional Index Revised Short Version (FFI-RS), Patient Global Impression of Change Scale (7-point Likert scale), RAND-12 Health Status Inventory (RAND-12), NRS during rest and NRS during activity (12 months). The patients receiving rESWT/sham-rESWT and the outcome assessor will be blinded to the group assignment.DiscussionThis trial is designed in order to provide results important for future clinical practice.Trial registrationClinicalTrials.gov NCT03472989 . Registered on 14 March 2018.

Project description:BackgroundThere are scanty data to apply radial extracorporeal shock wave therapy (rESWT) on the acupuncture points in the lower abdomen to reduce the menstrual pain. This trial aimed to test the rESWT safety and efficacy for treating primary dysmenorrhea (PD).MethodsForty-four young-women with PD were randomly assigned to one of the three groups: to receive rESWT on the acupuncture points during the follicular phase (Group A, n = 15) or during the luteal phase (Group B, n = 14), or to apply heat patch to the acupuncture points during the follicular phase as the control (Group C, n = 15) over three menstrual cycles. The pain severity (using 0-to-10 visual analog scale), the pain duration (hours), plasma PGF2α prostaglandin F2alpha and prostaglandin E2 (PGE2), self-rating anxiety scale and menstrual blood loss were assessed before and after interventions.ResultsThe pain severity and duration significantly decreased in all groups after interventions. Although the reduced pain duration was not different among the groups, the reduced pain severity was more significant (P = .003) in Groups A (-53.8 ± 33.7%) and B (-59.3 ± 36.7%) than in Group C (-18.7 ± 27.1%). The rESWT intervention did not change plasma prostaglandins in Group A, although there was a decreased prostaglandin F2alpha (-20.5 ± 32.9%) in Group B or a decreased PGE2 (-18.9 ± 17.8%) in Group C. The anxiety level showed no change after intervention. The menstrual blood volume reduced slightly after intervention and the change of menstrual blood loss in Group B was significant (P = .038).ConclusionThe rESWT applications on the abdominal acupuncture points safely and effectively reduced the menstrual pain, which was not associated with the prostaglandin changes. The rESWT-reduced pain seemed equally effective with the intervention applied during the follicular phase or luteal phase of the menstrual cycle. Heat patch placed on the abdominal acupuncture points also reduced the pain severity and duration, indicating that the improved blood flow could effectively alleviate the menstrual pain with PD. The changes in anxiety level and menstrual blood loss were slight after intervention.

Project description:BACKGROUND:Acute injuries of the hamstring muscle complex (HMC) type 3b (interfascicle/bundle-tear) are frequently observed in various sports disciplines both in elite and recreational sport. The treatment of choice of acute HMC injuries type 3b is a progressive physiotherapeutic exercise programme. Besides this, there is currently only insufficient scientific evidence to support other treatment methods, including local infiltrations and injections of platelet-rich-plasma. Very recently, it was demonstrated that extracorporeal shock wave therapy (ESWT) may accelerate regeneration after acute skeletal muscle injury. The aim of the present study is to test the hypothesis that the combination of radial ESWT (rESWT) and a specific rehabilitation program (RP) is effective and safe in treatment of acute HMC injury type 3b in athletes, and is statistically significantly more effective than the combination of sham-rESWT and RP. METHODS:We will perform a double blind, randomized, sham-controlled clinical trial at the clinic KinEf Kinesiología Deportiva, Ciudad Autónoma de Buenos Aires, Argentina. Forty patients with acute HMC injury type 3b will be randomly allocated to receive either rESWT (nine rESWT sessions; three sessions per week; 2500 radial extracorporeal shock waves (rESWs) per session; energy density depending on what the patient tolerates) or sham-rESWT. In addition, all patients will receive a specific rehabilitation program that will last for 8 weeks. The primary outcome measure will be the individual time (days) necessary to return to play. Secondary outcomes will include the presence or absence of reinjury during a time period of 6 months after inclusion into the study. DISCUSSION:Because of the lack of adequate treatment options for acute HMC injury type 3b in athletes and particularly the high reinjury rate, we hypothesize that the results of this trial will be of importance and have impact on clinical practice. TRIAL REGISTRATION:ClinicalTrials.gov ID NCT03473899 . Registered March 22, 2018.

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.

Dataset Information

Efficacy and safety of treating chronic nonspecific low back pain with radial extracorporeal shock wave therapy (rESWT), rESWT combined with celecoxib and eperisone (C + E) or C + E alone: a prospective, randomized trial.

Background

Methods

Results

Conclusions

Level of evidence

Trial registration

Level of evidence

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