NCT05319288

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

March 16, 2022

Last Update Submit

March 5, 2023

Conditions

Keywords

Acute

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Oswestry Disability Index

    before and four weeks after the treatment

Study Arms (2)

Distal acupoints only group

ACTIVE COMPARATOR

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

Device: Acupuncture

Local acupoints mainly combined with distal acupoints group

ACTIVE COMPARATOR

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

Device: Acupuncture

Interventions

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

Distal acupoints only groupLocal acupoints mainly combined with distal acupoints group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhong Lidan

Kowloon Tong, Kowloon, 637551, Hong Kong

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 8, 2022

Study Start

September 1, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations