Protocol summary

Summary
Objectives To determine the efficacy of wet-cupping for treating persistent nonspecific low back pain. Inclusion criteria included: (a) lower back pain persisting for 4 weeks or more;(b) age 17–68 years; and; (c) current episode of low back pain having at least a 4-week duration. Exclusion criteria included possible spinal pathology (e.g., carcinoma), severe or progressive motor weakness or central disc prolapse, pending litigation (e.g., workplace injury), bleeding disorders (e.g., hemophilia), and current treatment with wet-cupping. In total, 98 patients aged 17–68 years with nonspecific low back pain; 48 were randomly assigned to experimental group and 50 to the control group. Patients in the experimental group were offered to the wet-cupping service and the control group received usual care. Main outcome measures: Three outcomes assessed at baseline and again 3 months following intervention: the McGill Present Pain Index, Oswestry Pain Disability Index, and the Medication Quantification Scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138707161310N1
Registration date: 2008-10-21, 1387/07/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2008-10-21, 1387/07/30
Registrant information
Name
Alireza Ahmadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 2670
Email address
info-jivr@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences, Iran
Expected recruitment start date
2008-05-14, 1387/02/25
Expected recruitment end date
2009-05-14, 1388/02/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of wet-cupping for nonspecific low back pain
Public title
The effectiveness of wet-cupping for nonspecific low back pain in Iran: A randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: (a) lower back pain persisting for 4 weeks or more; (b) age 17–68 years; and (c) current episode of low back pain having at least a 4-week duration. Exclusion criteria included possible spinal pathology (e.g., carcinoma), severe or progressive motor weakness or central disc prolapse, pending litigation (e.g., workplace injury), bleeding disorders (e.g., hemophilia), and current treatment with wet-cupping.
Age
From 17 years old to 68 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 98
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

1

Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah, Iran
City
Kermanshah
Postal code
Approval date
2008-03-03, 1386/12/13
Ethics committee reference number
87009

Health conditions studied

1

Description of health condition studied
Low Back Pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Low Back Pain
Timepoint
At baseline and 3 months following intervention
Method of measurement
the McGill Present Pain Index

Secondary outcomes

1

Description
Disability
Timepoint
At baseline and again 3 months following intervention
Method of measurement
Oswestry Pain Disability Index

2

Description
Medication
Timepoint
At baseline and again 3 months following intervention
Method of measurement
Medication Quantification Scale.

Intervention groups

1

Description
intervantion: Wet-cupping, Control: drug, rest, physiotherapy
Category
empty

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Habiballah khazaie
Street address
Deputy of Research, Kermanshah University of Medical Sciences
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Nourizad
Street address
Kermanshah University of Medical Sciences, Iran
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Khosro Farhadi
Position
Chair of Anesthesiology Department,
Other areas of specialty/work
Street address
Chair of Anesthesiology Department, Imam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6326
Fax
Email
kh_farhady@yahoo.com
Web page address
www.emamreza-kermanshah-hospital.ir; www.kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Imam Reza Hospital, Anesthesiology Departement
City
Kermanshah University of Medical Sciences
Postal code
6718818838
Phone
+98 83 1724 0890
Fax
Email
ahmadiar1012@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Imam Reza Hospital
City
Kermanshah
Postal code
6718818838
Phone
+98 83 1724 0890
Fax
+98 83 1836 0016
Email
ahmadiar1012@yahoo.com
Web page address
www.kums.ac.ir

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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