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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05319288
• Other study ID #: Acupuncture for ALBP
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2023
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Zhong Lidan	Kowloon Tong	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	low back pain intensity(in VAS scores)	The primary outcome will be the change in low back pain intensity(in VAS scores) before and after the treatment.	before and four weeks after the treatment
Secondary	Oswestry Disability Index	The secondary outcomes will be the Oswestry Disability Index.	before and four weeks after the treatment