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临床试验/NCT05319288
NCT05319288招募中不适用

Treating Acute Low Back Pain With Acupuncture - Comparison of the Efficacy Between Distal Points and Local Points

Hong Kong Baptist University2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
2
主要终点
low back pain intensity(in VAS scores)

研究概览

简要总结

This study is a randomized controlled trial on acupuncture for Acute Low Back Pain(ALBP). According to literature, using distal acupoints only to treat ALBP is mostly recognized, but in our daily clinical practice, it is common to use local acupoints mainly combined with distal acupoints. Which method leads to better effect is one important clinical question in treating Low Back Pain(LBP) by acupuncture.

In this proposed study, the investigators aim to compare the efficacy of using "distal acupoints only" and "local acupoints mainly combined with distal acupoints" on ALBP.

详细描述

It will be a randomized controlled trial on acupuncture for ALBP, conducted at the Pok Oi Hospital - Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre (Kowloon City District) (KCDCMCTR). Registered Chinese Medicine Practitioner(RCMP) with at least two years of clinical experience and trained to treat participants in accordance with study protocols. 102 (18-65 years in age) participants with ALBP will be recruited from the public through advertisement and from the clinic (KCDCMCTR). Eligible participants will be randomly assigned to two groups. The participants are randomly allocated into two groups: distal acupoints only group(DPOG) and local acupoints mainly combined with distal acupoints group(LPMG). The DPOG (n=51) will receive acupuncture of distal acupoints only(SI3, EX-UE7). The LPMG (n=51) will receive acupuncture of local acupoints mainly(BL23, BL25, BL32) combined with distal points(BL40). Participants will be treated twice a week for a total of four weeks. Every participant will be administered 8 sessions of acupuncture. The primary outcome will be the change in low back pain intensity(in VAS scores) before and after the treatment. The secondary outcomes will be the Oswestry Disability Index. All outcomes will be evaluated at every session of treatment and the follow up period. Follow-up will be scheduled 1 month and 3 months after the completion of treatments. This clinical trial lasts 4 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Low Back Pain as chief complaint: pain and discomfort, localized below the costal margin and above the inferior gluteal folds, with or without leg pain;
  • Participants' aged between 18 and 65 years old;
  • Acute onset of symptom: lasting less than 6 weeks;
  • Provided informed consent prior to the study.

排除标准

  • Low back pain lasting more than 6 weeks;
  • Alerting features (Red Flags) or serious conditions associated with acute low back pain: Significant trauma, unexplained weight loss, past history of malignancy, fever, age >65 years old, severe and unremitting night-time pain;
  • Contraindication of acupuncture, including needle phobia, severe cutaneous condition, excessive hunger/exhaustion/overeat, emotional instability, pregnancy(relative contraindication) etc.;
  • Received acupuncture treatment during the last month.

结局指标

主要结局

low back pain intensity(in VAS scores)

时间窗: before and four weeks after the treatment

The primary outcome will be the change in low back pain intensity(in VAS scores) before and after the treatment.

次要结局

  • Oswestry Disability Index(before and four weeks after the treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhong Lidan

Assistant Professor

Hong Kong Baptist University

研究点 (2)

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