Comparing the effect of acupuncture and medical treatment on subjective symptoms and Electromyography/Nerve Conduction Velocity (EMG/NCV) change in patients with cervical 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 cervical disc herniation referring to Imam Reza Hospital. Design: in this interventional study, 90 patients with clinical diagnosis of cervical disc herniation by a rheumatologist are randomly assigned to either the "acupuncture" or "medical treatment" and “ Sham acupuncture” groups. Setting and conduct: Before the study starts, both groups fill a clinical symptoms questionnaire and accordingly are evaluated by electro-diagnostic tests. Patients in the medical group perform four different types of isometric exercises and receive two tablets of Celebrex 100mg daily divided in morning and night 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 yrs of age; confirmed diagnosis of cervical disc herniation; willing to participate in the study. Interventions: Acupuncture treatment is given 3 times a week (12 sessions) and each session is 30 minutes. Needle insertion points are fixed in all sessions. After the treatment ends, questionnaires are filled by patients again. Main outcome measures variables: three months after the end of treatment, patients refer to clinic in order to fill the questionnaire and to be evaluated both for clinical symptoms (neck, shoulder and arm pain, tingling, and numbness) and EMG/NCV changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070311912N4
Registration date:2015-11-13, 1394/08/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-13, 1394/08/22
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
Vice Chancellor for Research 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 subjective symptoms and Electromyography/Nerve Conduction Velocity (EMG/NCV) change in patients with cervical disk herniation
Public title
Comparing the effect of acupuncture and medical treatment on subjective symptoms and neuromuscular electrophysiologic changes in patients with cervical disk herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Major eligibility criteria: age older than 20 years old; confirmed diagnosis of cervical disc herniation; willing to participate in the study. 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 cervical disc herniation; 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; definite indication for surgery based on rheumatologic consult and red and yellow flags.
Age
From 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
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.,
City
Mashhad
Postal code
Approval date
2013-04-13, 1392/01/24
Ethics committee reference number
IR.MUMS.REC.1392.21
Health conditions studied
1
Description of health condition studied
Cervical disc herniation
ICD-10 code
M50
ICD-10 code description
Cervical disc disorders
Primary outcomes
1
Description
Changes in electrodiagnostic tests (CMAP, DML, DSL, MNCV)
Timepoint
Three months after the intervention
Method of measurement
Repeating the mentioned tests
Secondary outcomes
1
Description
Clinical symptoms (neck, shoulder or arm pain, numbness and tingling)
Timepoint
Three months after the end of intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention: acupuncture with 0.25*40 mm size needles on 20 acupoints , 3 times a week, each session 30 min for one month.
Category
Other
2
Description
Control group: four different types of isometric exercises plus 100 mg Celebrex tablets, twice daily (morning and night)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Electrodiagnostics clinic and acupuncture clinic of Imam Reza Hospital,
Full name of responsible person
Hosein Hasanabadi
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mina Ramezani
Street address
Ghoreyshi Building, Daneshgah St.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hosein Hasanabadi
Position
Assistant Prof of Physical Rehabilitation medicine