Comparing the effect of acupuncture and medical treatment on clinical symptoms and electromyography/nerve conduction velocity (EMG/NCV) changes in patients with lumbar disk herniation
Objectives: in this study we try to compare the effect of acupuncture and medical treatment on the clinical symptoms and electromyography/nerve conduction velocity (EMG/NCV) changes in patients with lumbar disk herniation referring to Imam Reza Hospital in 2013-2015. Design: In this interventional study, 105 patients with clinical diagnosis of lumbar disc herniation by a rheumatologist are randomly assigned to either the "acupuncture" ,"medical treatment" and “ Sham acupuncture” groups (35 each). Setting and conduct: Before study initiation all participants fill a clinical symptoms questionnaire and are accordingly evaluated by electro-diagnostic tests. Patients in the medical treatment group in addition to two Celebrex 100mg tablets divided in morning and night, the Williams flexion exercises are prescribed daily for one month. The acupuncture groups are referred to an acupuncture specialist to receive acupuncture treatment for one month. Participants including major eligibility criteria: over 20 years of age, confirmed lumbar disc herniation, willing to participate. Interventions: Acupuncture treatment is given 3 times, each session 30 minutes for four weeks. Needle insertion points are fixed in all sessions. Main outcome measure variables: three months after the end of treatment, the patients refer to our clinic to refill the questionnaire and to be re-evaluated for clinical symptoms and EMG/NCV changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122911912N2
Registration date:2015-12-03, 1394/09/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-03, 1394/09/12
Registrant information
Name
Hamidreza Bahrami Taghanaki
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1841 5666
Email address
bahramihr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of acupuncture and medical treatment on clinical symptoms and electromyography/nerve conduction velocity (EMG/NCV) changes in patients with lumbar disk herniation
Public title
Comparing the effect of acupuncture and medical treatment on subjective symptoms and neuromuscular electrophysiologic changes in patients with lumbar disk herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Major eligibility criteria: over 20 years of age, confirmed lumbar disc herniation, willing to participate.
Major exclusion criteria: Polyneuritis or lesions of the cervical radicolopathy; hypothyroidism; multiple myeloma; amyloidosis; inability to perform daily functions individually; previous acupuncture treatment or surgery for low back pain; insulin dependent diabetes; pregnancy or less than 3 month post partum; epilepsy; cardiovascular disease; history of gastrointestinal disease and intolerance for NSAIDS; history of warfarin or heparin consumption or a hemorrhagic disease; having the indications for surgery according to red flags and yellow flags.
Age
From 19 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Deputy of Research, GHoreyshi building, Daneshgah St.,