Clinical trial NCT01909284: Efficacy Study of Acupuncture to Treat Spinal Pain
Official title: Pilot Study of Efficacy and Safety of Acupuncture on Patient With Spinal Pain Due to Spondylolithesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale(VAS)
timeFrame: Change from baseline to 5 weeks
Secondary outcomes:
measure: Short form McGill pain questionnaire
timeFrame: Chagnes from baseline to 5 weeks
measure: Oswestry Disability Index
timeFrame: Changes from baseline to 5 weeks
measure: Present pain intensity(PPI)
timeFrame: Changes from baseline to 5 weeks
measure: Pain vision
timeFrame: Chagnes from baseline to 5 weeks
Other outcomes:
measure: Safety
timeFrame: After the initiation of acupuncture, 2 weeks, and 4 weeks
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
state: Kyungsangbukdo
Study officials:
affiliation: Comprehensive and Intergrative Medicine Institute
name: Jeong-chul Seo, KMD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Daegu Oriental Hospital of Daegu Haany University
name: Min-Ah Gwak, KMD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Comprehensive and Integrative Medicine Insitute
name: Seong-Hoon Park, KMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee HJ, Seo JC, Kwak MA, Park SH, Min BM, Cho MS, Shin I, Jung JY, Roh WS. Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial. Trials. 2014 Apr 2;15:105. doi: 10.1186/1745-6215-15-105.