Efficacy Study of Acupuncture to Treat Spinal Pain

Low Back Pain Clinical Trial

Official title:

Pilot Study of Efficacy and Safety of Acupuncture on Patient With Spinal Pain Due to Spondylolithesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01909284
• Other study ID #: CIMI-13-01-20
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2013
• Last updated: February 2, 2014
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: February 2014
• Source: Daegu Catholic University Medical Center
• Contact: Un-Suk Noh, M.D,Ph.D
• Phone: +82 53 650 4054
• Email: usno[@]cu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back Pain

Intervention

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

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

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu	Kyungsangbukdo

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	We will confirm the safety of acupuncture by determining the red blood cell (RBC) count, hemoglobin level, platelet count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), hematocrit (Hct), total white blood cell (WBC) count, Erythrocyte Sedimentation Rate (ESR), aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum urea nitrogen (BUN), creatinine level, serum sodium level, serum potassium level, and serum chloride level. All patients were evaluated 3 times, including a final follow-up visit 4 weeks after the initiation of acupuncture.	After the initiation of acupuncture, 2 weeks, and 4 weeks	Yes
Primary	Visual analogue scale(VAS)	This outcome will measure changes in the participant's level of low back pain.	Change from baseline to 5 weeks	No
Secondary	Short form McGill pain questionnaire		Chagnes from baseline to 5 weeks	No
Secondary	Oswestry Disability Index		Changes from baseline to 5 weeks	No
Secondary	Present pain intensity(PPI)		Changes from baseline to 5 weeks	No
Secondary	Pain vision	A device Pain vision ? PS-2100 calculates a "degree of pain" in cancer patients in addition to VAS	Chagnes from baseline to 5 weeks	No