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

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Acute

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhong LidanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Distal acupoints only group

Local acupoints mainly combined with distal acupoints group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Oswestry Disability Index
The secondary outcomes will be the Oswestry Disability Index.

Full Information

First Posted
March 16, 2022
Last Updated
March 5, 2023
Sponsor
Hong Kong Baptist University
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1. Study Identification

Unique Protocol Identification Number
NCT05319288
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Distal acupoints only group
Arm Type
Active Comparator
Arm Description
The DPOG (n=51) will receive acupuncture of distal acupoints only(SI3, EX-UE7) for ALBP.
Arm Title
Local acupoints mainly combined with distal acupoints group
Arm Type
Active Comparator
Arm Description
LPMG (n=51) will receive acupuncture of local acupoints mainly(BL23, BL25, BL32) combined with distal points(BL40) for ALBP.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
In DPOG, motion style acupuncture would be used; in LPMG, Traditional Chinese Medicine acupuncture is used.
Primary Outcome Measure Information:
Title
low back pain intensity(in VAS scores)
Description
The primary outcome will be the change in low back pain intensity(in VAS scores) before and after the treatment.
Time Frame
before and four weeks after the treatment
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
The secondary outcomes will be the Oswestry Disability Index.
Time Frame
before and four weeks after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Zhong Lidan
City
Kowloon Tong
State/Province
Kowloon
ZIP/Postal Code
637551
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong Lidan, Ph.D, MD
Phone
34116523
Email
ldzhong0305@gmail.com

12. IPD Sharing Statement

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

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