The role of homoeopathic treatment in individuals suffering from backache following caesarean section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Short form McGill Pain Questionnaire (SF-MPQ; translated Bengali version)
研究概览
简要总结
Context: An open observational trialwas carried out at National Institute of Homoeopathy, India, to assess thepossible effects of individualised Homoeopathy in individuals suffering frompost-caesarean backache. Aim: Theaim of the study was to find the role of homoeopathic treatment inindividuals suffering from post-caesarean backache. **Methods:**Fifty subjects were enrolled. The Short-FormMcGill Pain Questionnaire (SF-MPQ) and Oswestry Low BackPain Disability Questionnaire (ODQ) were used as the outcome measures, assessedat baseline and after 3 months of treatment. Medicines prescribed followedhomoeopathic principles. Non-parametric Wilcoxon signed rank test was appliedto compare the dependent observations. P < 0.05 two-tailed was considered statistically significant. **Results:**Five subjects dropped out and 45completed the trial. Intention-to-treat sample (n = 50) was analysed. There werestatistically significant reductions in pain rating index percentage score(median 83.3 (IQR 66.7 to 100) vs. median 66.7 (IQR 33.3 to 71.1), P <0.001); visual analogue scale score (median 7.0 (IQR 6.0 to 8.0)vs. median 6.0 (IQR 4.8 to 7.0), P < 0.001); present pain index score(median 3.0 (IQR 2.0 to 3.0) vs. median 2.0 (IQR 2.0 to 3.0), P = 0.019)and ODQ% score (median 44.0 (IQR 39.5 to 50.0) vs. median 39.0 (IQR 31.9 to44.0), P < 0.001) over 3 months of treatment. Natrum muriaticum (n= 11, 22%); Staphysagria (n = 8, 16%); Bryonia alba andRhus toxicodendron (n = 6 each, 12%) and Pulsatilla nigricans(n = 4, 8%) were prescribed frequently. Conclusion: Indicatedhomoeopathic medicines reduced SF-MPQ and ODQ scores. Further randomised trials arewarranted with enhanced methodological rigour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients suffering from backache over 3 months following caesarean section
- •Female subjects of reproductive age group of 18-45 years
- •Patients willing to take part in the study and giving written consent.
排除标准
- •Patients who are too sick for consultation
- •Unable to read patient information sheets and not giving consent to take part
- •Postmenopausal women
- •Subjects presenting with confounding variable like pre-existing backache before Caesarean Section
- •Subjects with immediate complications after Caesarean Section
- •Diagnosed cases of unstable psychiatric illness or other systemic disease affecting quality of life
- •Currently receiving homeopathic treatment for chronic condition(s)
- •Pregnant and lactating women
- •Self-reported immune-compromised state
- •Substance abuse and/or dependence.
结局指标
主要结局
Short form McGill Pain Questionnaire (SF-MPQ; translated Bengali version)
时间窗: Baseline and 3 months
次要结局
- Oswestry Low Back Pain Questionnaire (translated Bengali version)(Baseline and 3 months)