1) Objectives: In this study we aimed to compare the effect of calorie restricted diet with ad libitum diet on pain and disability in patients with sciatic pain
2) Design: 96 patients with chronic sciatic pain who were recruited to Urmia Imam Khomeini hospital, and were candidate for nonsurgical treatment were selected.
3) Setting and conduct: Patients were divided into two groups with Simple randomization software which were equal in sex and age, one group with ad libitum diet and intervention group with 1200 calorie diet for one month. First we recorded weight of patients and then filled McGill and Roland-Morris questionnaire for them. We repeated these at 15th, 30th and 60th day.
4) Participants including major eligibility criteria: patients with chronic sciatic pain for more than 3 months, without history of spine surgery
5) Intervention: 1200k calorie diet per day for a month for intervention group
6) Main outcome measures (variables): pain severity, disability
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030316819N1
Registration date:2014-11-22, 1393/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-22, 1393/09/01
Registrant information
Name
Aisan Nozad
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 44 3348 1143
Email address
nozad@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Without funding source
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2014-01-05, 1392/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Restricted Calorie diet and ad libitum diet on pain and disability in patients with chronic Sciatic pain
Public title
Effect of Restricted Calorie diet in sciatic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. candidate for non-surgical treatment of sciatica pain with his treating orthopedist confirmed
2. Low back pain lasts for more than three months
3. BMI between 25 and 40
4. Age 25 to 60 years
5. constant weight (less than 6 kg of weight change during 6 months)
Exclusion criteria:
1. Having other spine diseases such as kyphosis, scoliosis, spondylolisthesis
2. Having a history of spinal surgery
3. Treated with morphine or having drug addiction
4. Diabetes
5. The current chronic physical or mental illness
6. Pregnant women
7.Lactating women
8. The history of inflammatory joint diseases such as rheumatoid arthritis and ankylosing spondylitis
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
khalij fars highway , tehran
City
tehran
Postal code
Approval date
2013-04-10, 1392/01/21
Ethics committee reference number
41/168152
Health conditions studied
1
Description of health condition studied
Sciatic pain
ICD-10 code
M54.4 , M5
ICD-10 code description
Lumbago with sciatica , Lumbar and other intervertebral disc disorders with radiculopathy
Primary outcomes
1
Description
severity of pain
Timepoint
At beginning, 15th day, 30th day, 60th day
Method of measurement
Mc gill questionnaire
Secondary outcomes
1
Description
Disability
Timepoint
At beginning, 15th day, 30th day, 60th day
Method of measurement
Roland- Morris Questionnaire
Intervention groups
1
Description
Intervention 1: Low Calorie Diet (1200 kcal/day) for one month administered by nutrition specialist.
We explained completely for patients how to manage their diet and follow them by phone.
Category
Lifestyle
2
Description
Intervention 2: continue diet without restriction for patients in control group
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Imam Khomeini Hospital
Full name of responsible person
Aisan Nozad
Street address
Ershad Ave.
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shahed University
Full name of responsible person
Mohsen Naseri
Street address
3d Dashtestan Ave., Shariaty Ave., Tehran
City
Tehran
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, Shahed University
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
Shahed University
Full name of responsible person
Aisan Nozad
Position
Traditional Medicine PHD Candidate
Other areas of specialty/work
Street address
3rd Dashtestan Ave., Shariaty Ave., Tehran
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
aisannozad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Aisan Nozad
Position
Traditional Medicine PHD Candidate
Other areas of specialty/work
Street address
3rd Dashtestan Ave., Shariaty Ave., Tehran
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
aisannozad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Aisan Nozad
Position
Other areas of specialty/work
Street address
Tehran
City
Postal code
Phone
+98 21 2288 2521
Fax
Email
aisannozad@gmail.com , nozadaisan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)