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Effect of accupuncture on pain and quality of life in canal stenosis

Protocol summary

Summary
Neurogenic claudication is a complex of symptoms that are caused by degenerative stenosis of spinal canal and inflammatory and biochemical factors that cause pain. Symptoms include pain in both lower extremities and buttock that is aggravated by walking and standing and is alleviated by sitting. Primary treatment is non surgical and includes anti-inflammatory drugs, physical therapy, bracing and epidural steroid injections. Many patients continue to have the symptoms despite these treatments and may become debilitated. Acupuncture is an alternative method that its analgesic effect has been proved in many studies. In study that has been performed in Japan acupuncture and electro acupuncture had been effective in decreasing pain in canal stenos is patients. A pilot study by Dr Hadianfar in 6 patients had good results. Of course method of needle insertion and duration in which needles stay is important. In this study 24 patients with proved canal stenosis by MRI or electro diagnosis underwent 10 episodes of acupuncture and pain and quality of life was evaluated before and after intervention and six weeks later by VAS (visual analogue scale) and SF-36 The acupoints used were:BL-23,BL-25,BL-26,BL-37,BL-40,BL-54,BL-57,,DU-20 BL-60,DU-3,DU-4,LI-4

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138905104450N1
Registration date: 2010-09-04, 1389/06/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-09-04, 1389/06/13
Registrant information
Name
Ali Aminlari
Name of organization / entity
Shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5134
Email address
aminlaria@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research
Expected recruitment start date
2009-09-01, 1388/06/10
Expected recruitment end date
2010-09-01, 1389/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of accupuncture on pain and quality of life in canal stenosis
Public title
Effect of accupuncture on pain and quality of life in canal stenosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Neurogenic claudication attributed to canal stenosis that hasn't responded to drugs or physiotherapy in recent six months. Exclusion criteria: Diabetes mellitus, very severe disease and acute stage that needs surgery
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz university of medical science
Street address
Zand ave
City
Shiraz
Postal code
713004846374
Approval date
2010-03-14, 1388/12/23
Ethics committee reference number
CT-88-1557

Health conditions studied

1

Description of health condition studied
Lumbar canal stenosis
ICD-10 code
M99.3; cat
ICD-10 code description
Lumnbar Osseous stenosis of neural canal

Primary outcomes

1

Description
Pain
Timepoint
before and after intervention and 6 weeks later
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
Quality of life
Timepoint
Before and after intervention and 6 weeks later
Method of measurement
SF-36 questionnaire

Intervention groups

1

Description
acupuncture- 10 sessions in following accupoints:BL-23,BL-25,BL-26,BL-37,BL-40,BL-54,BL-57,,DU-20 BL-60,DU-3,DU-4,LI-4 Each session takes 30 minutes
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of physical medicine and rehabilitation -medical school- Shiraz university of medical sci
Full name of responsible person
Ali Aminlari
Street address
zand Ave-Faghihi hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz university of medical sciences- Vice chancellor for research
Full name of responsible person
Dr Dabbaghmanesh
Street address
Zand Ave- shiraz university of medical science
City
Shiraz
Grant name
فصل دوم برنامه تحقیقاتی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of medical sciences- Vice chancellor for research
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
Shiraz university of Medical sciences-collegue of medicne-Department of physical medicine and rehabi
Full name of responsible person
Ali Aminlari
Position
resident
Other areas of specialty/work
Street address
Zand Ave-Faghihi hospital-Department of physical medicine and rehabilitation
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
aminlaria@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz university of medical sciences-College of medicine-Department of physical medicine and rehabi
Full name of responsible person
Mohammad Javad Hadianfard
Position
Specialist-Associate professor
Other areas of specialty/work
Street address
Zand ave-Faghihi hospital-Department of physical medicine and rehabilitation
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
hadianj@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of medical sciences-College of medicine-Department of physical medicine and rehabi
Full name of responsible person
Ali Aminlari
Position
Resident
Other areas of specialty/work
Street address
Zand Ave-Faghihi hosptal--Department of physical medicine and rehabilitation
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
aminlaria@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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