Efficacy Study of Acupuncture to Treat Spinal Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture & Epidural nerve block

acupuncture plus epidural block

Group Type EXPERIMENTAL

Acupuncture

Intervention Type DEVICE

* BL40, BL60, ST36, GB34 : bilaterally, manual acupuncture.
* Two points on 1st bladder meridian nearest location of back pain : bilaterally, electrical acupuncture.

Epidural nerve block

Intervention Type PROCEDURE

Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).

Epidural nerve block

epidural block alone

Group Type ACTIVE_COMPARATOR

Epidural nerve block

Intervention Type PROCEDURE

Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).

Interventions

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Acupuncture

* BL40, BL60, ST36, GB34 : bilaterally, manual acupuncture.
* Two points on 1st bladder meridian nearest location of back pain : bilaterally, electrical acupuncture.

Intervention Type DEVICE

Epidural nerve block

Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No