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Traumeel S for pain relief following hallux valgus surgery: a randomized controlled trial.

ABSTRACT: In spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain.We performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery.Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04).Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance.This study was registered at ClinicalTrials.gov. # NCT00279513.

SUBMITTER: Singer SR

PROVIDER: S-EPMC2873239 | biostudies-literature | 2010 Apr

REPOSITORIES: biostudies-literature

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Traumeel S for pain relief following hallux valgus surgery: a randomized controlled trial.

Singer Shepherd R SR Amit-Kohn Michal M Weiss Samuel S Rosenblum Jonathan J Maoz Guy G Samuels Noah N Lukasiewicz Esther E Freedman Laurence L Paltiel Ora O Itzchaki Menachem M Niska Meir M Oberbaum Menachem M

BMC clinical pharmacology 20100412

<h4>Background</h4>In spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain.<h4>Method</h4>We performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S in minimizing post-operative pain and analgesic consumption following surgica ...[more]

PMID: 20380750

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Project description:IntroductionHallux valgus surgery is one of the most commonly performed operations in Orthopaedics. Multiple surgical techniques have been described including arthrodesis, osteotomies and soft tissue procedures. The endoscopic-assisted distal soft tissue procedure is one of the minimally invasive surgical options with a good long-term outcome. The rehabilitation protocol for this soft tissue procedure consists of 6-weeks of non-weight bearing walking. This prolonged period of non-weight-bearing walking may ensure a good stabilization of the alignment but is difficult for the patient from a social-economical perspective. In addition, earlier mobilisation has other theoretical advantages including less atrophy and better range of motion. The objective of this trial is to investigate the effect of an earlier weight-bearing regime at 2-weeks post-surgery.MethodsRandomised control trial of patients undergoing the endoscopic-assisted distal soft tissue procedure. Allocation and randomization of subjects were performed immediately after completion of surgery to avoid intra-operative biases. The control group underwent the usual protocol of 6-weeks of non-weight-bearing walking while the intervention group underwent 2-weeks of post-operative non-weight-bearing walking. Foot function was measured using the Foot and Ankle Outcome Score (FAOS) at the baseline, 12-week post-surgery and 26-weeks post-surgery. The hallux valgus angle, 1,2 inter-metatarsal angle and tibial sesamoid position were also measured during those time-points.ResultsA total of 51 participants completed the study, 29 in the control group and 22 in the early weight-bearing group. 1 patient form the early weight-bearing group was complicated with hallux varus requiring revision surgery. All the patients had significantly improved radiological angles and foot function in both the control and early weight-bearing group. At the 12-week time point, the radiological angles were the same for both groups but foot function was significantly better in the early weightbearing group.DiscussionEarly postoperative weight-bearing did not lead to pre-mature implant failures or increased recurrence rates. It actually resulted in fewer symptoms like stiffness, lessened pain, better performance in daily activities and a better quality of life.ConclusionEarly weight-bearing walking at 2-week after distal soft tissue reconstruction of hallux valgus is not only safe, it may help accelerate the rehabilitation process and allow patients to return their usual life faster.The translational potential of this article: Being a clinical trial, our results are directly translatable to hallux valgus patients. The results of this study show that a shortened non-weight bearing duration after hallux valgus surgery improves foot function at 12 weeks while not affecting recurrence risks.

Project description:Many women experience pain during hysterosalpingogram (HSG). This prospective, randomized, double-blinded, placebo-controlled study assessed whether the use of benzocaine spray during HSG is associated with reduced pain as compared with placebo. Thirty women presenting for HSG were enrolled and randomized to either benzocaine or saline spray. Treatment groups were similar in age, race, parity, pre-procedure oral analgesic use and history of dysmenorrhoea and/or chronic pelvic pain. Median change in pain score from baseline to procedure was 50.6mm (-7.4 to 98.8mm) in the benzocaine group and 70.4mm (19.8 to 100mm) in the placebo group. There was no difference between groups after adjusting for history of dysmenorrhoea. There was no difference in resolution of pain in benzocaine versus placebo groups at 5 min post procedure--median pain score difference -11.1 (-90.1 to 18.5) versus -37.0 (-100 to 1.2)--or at 30 min post procedure. Satisfaction scores did not differ by treatment and did not correlate with pain score during the procedure (rho=0.005). The use of benzocaine spray does not significantly improve pain relief during HSG nor does it hasten resolution of pain post HSG. Of interest, patient satisfaction was not correlated with pain. Many women experience pain during hysterosalpingogram (HSG), which is a test used to evaluate the uterine cavity and fallopian tube. We conducted a prospective, randomized, double-blinded, placebo-controlled study to assess whether the use of benzocaine spray during HSG is associated with reduced pain as compared with placebo. Thirty women presenting for HSG were enrolled and randomized to either benzocaine or saline spray. Treatment groups were similar in age, race, previous pregnancies, pre-procedure oral analgesic use and history of dysmenorrhoea (painful periods) and/or chronic pelvic pain. There was no difference in pain scores or resolution of pain between the two groups. Satisfaction scores did not differ by treatment group and did not correlate with the pain score during the procedure. We conclude that the use of benzocaine spray does not significantly improve pain relief during HSG nor does it hasten resolution of pain post HSG. Of interest, patient satisfaction was not correlated with pain.

Project description:BackgroundThough moxibustion is frequently used to treat primary dysmenorrhea in China, relevant evidence supporting its effectiveness is still scanty.MethodsThis study was a pragmatic randomized, conventional drug controlled, open-labeled clinical trial. After initial screen, 152 eligible participants were averagely randomized to receive two different treatment strategies: Moxibustion and conventional drugs. Participants and practitioners were not blinded in this study. The duration of each treatment was 3 months. The primary outcome was pain relief measured by the Visual Analogue Scale. The menstrual pain severity was recorded in a menstrual pain diary.Results152 eligible patients were included but only 133 of them eventually completed the whole treatment course. The results showed that the menstrual pain intensity in experimental group and control group was reduced from 6.38±1.28 and 6.41±1.29, respectively, at baseline, to 2.54±1.41 and 2.47±1.29 after treatment. The pain reduction was not significantly different between these two groups (P = 0.76), however; the pain intensity was significantly reduced relative to baseline for each group (P<0.01). Three months after treatment, the effectiveness of moxibustion sustained and started to be superior to the drug's effect (-0.87, 95%CI -1.32 to -0.42, P<0.01). Secondary outcome analyses showed that moxibustion was as effective as drugs in alleviating menstrual pain-related symptoms. The serum levels of pain mediators, such as PGF2α, OT, vWF, β-EP, PGE2, were significantly improved after treatment in both groups (P<0.05). No adverse events were reported in this trial.ConclusionsBoth moxibustion and conventional drug showed desirable merits in managing menstrual pain, given their treatment effects and economic costs. This study as a pragmatic trial only demonstrates the effectiveness, not the efficacy, of moxibustion for menstrual pain. It can't rule out the effect of psychological factors during treatment process, because no blind procedure or sham control was used due to availability. In clinical practice, moxibustion should be used at the discretion of patients and their physicians.Trial registrationClinialTrials.gov NCT01972906.

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Traumeel S for pain relief following hallux valgus surgery: a randomized controlled trial.

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Traumeel S for pain relief following hallux valgus surgery: a randomized controlled trial.

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