Efficacy Study of Acupuncture to Treat Spinal Pain

Not Applicable

• Conditions: Low Back Pain
• Interventions: Procedure: Epidural nerve block; Device: Acupuncture

• Registration Number: NCT01909284
• Lead Sponsor: Daegu Catholic University Medical Center

Brief Summary

This study is being conducted to investigate the effectiveness and safety of acupuncture for alleviating pain of spondylosis.

Detailed Description

This study is being conducted at the Daegu Catholic University Medical Center. Enrolled participants will be randomized into two groups : acupuncture treatment plus epidural block and epidural block alone.

This trial will include treatments during 3 weeks, and then follow up after 2 weeks. Participants will have acupuncture treatments of three times per week and epidural block of once per week. All examinations and treatments will be provided free of charge. Compared with epidural block group, acupuncture plus epidural block group will give more effectiveness for alleviate pain caused by lumbar spondylosis.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-26
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-02
• Last Update Posted: 2014-02-04
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Age 18 to 65 years
• Meyerding Grade I-II spondylolisthesis
• Low back pain of at least 1-year duration
• Follow-up possible during the clinical trial
• Written informed consent voluntarily

Exclusion Criteria

• Cauda equina syndrome, persistently exacerbated symptoms, progressive neurologic signs (sensory or motor changes)
• Previous spine surgery
• Senile dementia, impaired cognitive function or other cerebral disease, severe psychiatric or psychological disorders
• Severe, concomitant disease (neuromuscular scoliosis, neurodegenerative disease)
• All contraindications to corticosteroid injection (e.g., insulin-dependent diabetes)
• Alcohol/drug abuse
• Significant renal or hepatic disease
• Pregnant, lactating or planning a pregnancy
• Hypersensitive reaction to acupuncture treatment
• Inability to comprehend or express oneself in the Korean language
• An individual deemed to be ineligible by a physician
• Refusal to participate in the trial or to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural nerve block	Epidural nerve block	epidural block alone
Acupuncture & Epidural nerve block	Acupuncture	acupuncture plus epidural block
Acupuncture & Epidural nerve block	Epidural nerve block	acupuncture plus epidural block

Primary Outcome Measures

Name	Time	Method
Visual analogue scale(VAS)	Change from baseline to 5 weeks	This outcome will measure changes in the participant's level of low back pain.

Secondary Outcome Measures

Name	Time	Method
Short form McGill pain questionnaire	Chagnes from baseline to 5 weeks
Oswestry Disability Index	Changes from baseline to 5 weeks
Present pain intensity(PPI)	Changes from baseline to 5 weeks
Pain vision	Chagnes from baseline to 5 weeks	A device Pain vision Ⓡ PS-2100 calculates a "degree of pain" in cancer patients in addition to VAS

Trial Locations

Locations (1)

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Kyungsangbukdo, Korea, Republic of