Treating ALBP With Acupuncture - Comparison of the Efficacy Between Distal Points and Local Points

Sponsor
Hong Kong Baptist University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05319288
Collaborator
(none)
102
2
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Acupuncture
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treating Acute Low Back Pain With Acupuncture - Comparison of the Efficacy Between Distal Points and Local Points
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Distal acupoints only group

The DPOG (n=51) will receive acupuncture of distal acupoints only(SI3, EX-UE7) for ALBP.

Device: Acupuncture
In DPOG, motion style acupuncture would be used; in LPMG, Traditional Chinese Medicine acupuncture is used.

Active Comparator: Local acupoints mainly combined with distal acupoints group

LPMG (n=51) will receive acupuncture of local acupoints mainly(BL23, BL25, BL32) combined with distal points(BL40) for ALBP.

Device: Acupuncture
In DPOG, motion style acupuncture would be used; in LPMG, Traditional Chinese Medicine acupuncture is used.

Outcome Measures

Primary Outcome Measures

  1. low back pain intensity(in VAS scores) [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.

Secondary Outcome Measures

  1. Oswestry Disability Index [before and four weeks after the treatment]

    The secondary outcomes will be the Oswestry Disability Index.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hong Kong Baptist University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhong Lidan, Assistant Professor, Hong Kong Baptist University
ClinicalTrials.gov Identifier:
NCT05319288
Other Study ID Numbers:
  • Acupuncture for ALBP
First Posted:
Apr 8, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhong Lidan, Assistant Professor, Hong Kong Baptist University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022