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

March 5, 2023 updated by: Zhong Lidan, Hong Kong Baptist University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Kowloon
      • Kowloon Tong, Kowloon, Hong Kong, 637551
        • Recruiting
        • Zhong Lidan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
low back pain intensity(in VAS scores)
Time Frame: 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.
before and four weeks after the treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: before and four weeks after the treatment
The secondary outcomes will be the Oswestry Disability Index.
before and four weeks after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hong Kong Baptist University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Acupuncture for ALBP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings