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The Effect of Acupuncture in Treating Chronic Low-back Pain

Primary Purpose

Ankylosing Spondylitis, Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yaotong points acupuncture
the usual care
standardized acupuncture
Sponsored by
Chengdu PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • with CLBP
  • without taking any other medication for the treatment of CLBP in at least 2 last weeks;
  • aged from 18 to 50 years;
  • without conflict to the written, informed consent signed prior to the enrollment.

Exclusion Criteria:

  • pathological causes of chronic back pain (such as fractures, cancer, spinal stenosis and infections);
  • complicated back problems (such as scoliologic >40° curvature, chronic spondylitis, sciatica, prior back surgery and other medicolegal issues);
  • with contraindications for acupuncture (e.g., cardiac pacemakers, coagulation disfunctions, being in pregnancy, seizure disorder);
  • conditions making treatment difficult (e.g., paralysis, psychoses);
  • conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis, concurrent care from other providers);
  • previous acupuncture treatment for any condition.

Sites / Locations

  • General Hospital of Chengdu Military Area Command PLA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Yaotong points acupuncture

standardized acupuncture

the usual care

Arm Description

patients under the treatment of Yaotong ponts penetration mode

patients under the treatment of standardized acupuncture

In the usual care group, participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS)).

Outcomes

Primary Outcome Measures

Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks
This wellvalidated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.

Secondary Outcome Measures

Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks
It includes curing standard, referring to LBP had disappeared and no difficulty in movement was found; effective standard, referring to the pain was relieved but slight discomfort was found; and ineffective standard, referring to no symptom improvement was found.
Changes from baseline on short-form 36 health survey (SF-36)
Physical and mental health component summary scores of the medical outcomes
Changes from baseline on Visual Analog Scale at 24 weeks
This rating scale involved the selection of a point along a 10-cm line, which described pain intensity on a continuum from "no painat all" to "pain as bad as it could be." This scale has been found to be an excellent measure of self-reported pain

Full Information

First Posted
October 2, 2014
Last Updated
December 5, 2017
Sponsor
Chengdu PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02260284
Brief Title
The Effect of Acupuncture in Treating Chronic Low-back Pain
Official Title
The Effect of Acupuncture in Treating Chronic Low-back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain
Detailed Description
We want to know if the Yaotong points penetration or standardized acupuncture mode are more effective than medical care alone for CLBP; and if Yaotong points penetration is more effective than standardized acupuncture.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yaotong points acupuncture
Arm Type
Experimental
Arm Description
patients under the treatment of Yaotong ponts penetration mode
Arm Title
standardized acupuncture
Arm Type
Active Comparator
Arm Description
patients under the treatment of standardized acupuncture
Arm Title
the usual care
Arm Type
Other
Arm Description
In the usual care group, participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS)).
Intervention Type
Other
Intervention Name(s)
Yaotong points acupuncture
Intervention Description
Patients receive the treatments of Yaotong points penetration
Intervention Type
Other
Intervention Name(s)
the usual care
Intervention Description
participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS))
Intervention Type
Other
Intervention Name(s)
standardized acupuncture
Intervention Description
Patients were given to the standardized acupuncture groups. This prescription included six acupuncture points that are commonly applied for the treatment of CLBP (Bladder 23-bilateral, Bladder 40-bilateral, and Kidney 3-bilateral) on the low back and lower leg.
Primary Outcome Measure Information:
Title
Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks
Description
This wellvalidated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.
Time Frame
at 0 week, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks
Description
It includes curing standard, referring to LBP had disappeared and no difficulty in movement was found; effective standard, referring to the pain was relieved but slight discomfort was found; and ineffective standard, referring to no symptom improvement was found.
Time Frame
at 0 week, 12 weeks, 24 weeks
Title
Changes from baseline on short-form 36 health survey (SF-36)
Description
Physical and mental health component summary scores of the medical outcomes
Time Frame
at 0 week, 12 weeks, 24 weeks
Title
Changes from baseline on Visual Analog Scale at 24 weeks
Description
This rating scale involved the selection of a point along a 10-cm line, which described pain intensity on a continuum from "no painat all" to "pain as bad as it could be." This scale has been found to be an excellent measure of self-reported pain
Time Frame
at 0 week, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: with CLBP without taking any other medication for the treatment of CLBP in at least 2 last weeks; aged from 18 to 50 years; without conflict to the written, informed consent signed prior to the enrollment. Exclusion Criteria: pathological causes of chronic back pain (such as fractures, cancer, spinal stenosis and infections); complicated back problems (such as scoliologic >40° curvature, chronic spondylitis, sciatica, prior back surgery and other medicolegal issues); with contraindications for acupuncture (e.g., cardiac pacemakers, coagulation disfunctions, being in pregnancy, seizure disorder); conditions making treatment difficult (e.g., paralysis, psychoses); conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis, concurrent care from other providers); previous acupuncture treatment for any condition.
Facility Information:
Facility Name
General Hospital of Chengdu Military Area Command PLA
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32186108
Citation
Luo Y, Yang M, Liu T, Zhong X, Tang W, Guo M, Hu Y. Effect of hand-ear acupuncture on chronic low-back pain: a randomized controlled trial. J Tradit Chin Med. 2019 Aug;39(4):587-598.
Results Reference
derived

Learn more about this trial

The Effect of Acupuncture in Treating Chronic Low-back Pain

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