The Effect of Acupuncture in Treating Chronic Low-back Pain

NCT02260284 | Unknown DMC

• 1 other identifier: 2014LBP01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain

Conditions

Ankylosing Spondylitis; Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  at 0 week, 12 weeks, 24 weeks

Secondary Outcomes (3)

• Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks

  at 0 week, 12 weeks, 24 weeks

• Changes from baseline on short-form 36 health survey (SF-36)

  at 0 week, 12 weeks, 24 weeks

• Changes from baseline on Visual Analog Scale at 24 weeks

  at 0 week, 12 weeks, 24 weeks

Study Arms (3)

Yaotong points acupuncture

EXPERIMENTAL

patients under the treatment of Yaotong ponts penetration mode

Other: Yaotong points acupuncture

standardized acupuncture

ACTIVE COMPARATOR

patients under the treatment of standardized acupuncture

Other: standardized acupuncture

the usual care

OTHER

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)).

Other: the usual care

Interventions

Yaotong points acupuncture OTHER

Patients receive the treatments of Yaotong points penetration

Yaotong points acupuncture

the usual care OTHER

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))

the usual care

standardized acupuncture OTHER

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.

standardized acupuncture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu PLA General Hospital: lead

Study Sites (1)

General Hospital of Chengdu Military Area Command PLA

Chengdu, Sichuan, 610083, China

Location

Related Publications (1)

• 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.

  PMID: 32186108 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing; Low Back Pain

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 9, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

CN (1)