Clinical trial NCT05319288: Treating ALBP With Acupuncture - Comparison of the Efficacy Between Distal Points and Local Points
Official title: Treating Acute Low Back Pain With Acupuncture - Comparison of the Efficacy Between Distal Points and Local Points
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Acute
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: low back pain intensity(in VAS scores)
timeFrame: before and four weeks after the treatment
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: before and four weeks after the treatment
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Zhong Lidan
state: Kowloon
Study officials:
References: