Aim: A comparison between therapeutic efficacy of wet-cupping vs. conventional treatment in patients with chronic non-specific low back pain.
Design: A controlled, single center, randomized clinical trial.
Studied population: Patients between 16-65 years of age with chronic nonspecific low back pain persisting for at least 4 weeks.
Sample size: 150 cases.
Intervention:
-In intervention group: The treatment itself will be performed by a physician using standard techniques in medical centers. Wet-cupping will be applied in 2 stages: between the two scapulas in the first day and in the sacrum area in 2 weeks; Each wet-cupping treatment procedure will last about 20 min and will be conducted in five steps.
-In control group: control group will receive the standard conventional treatment for low back pain. This treatment includes: (1) encouragement for early return to usual activities, excluding heavy manual labor, (2) activity alteration to minimize symptoms, (3) medical therapy: e.g., acetaminophen or NSAIDs, (4) short duration muscular relaxants, (5) bed rest not more than 2 days.
Outcomes: Primary outcome includes Disability and quality of life index using ODI (Oswestry disability index), and secondary outcome will be the Pain intensity using VAS (Visual analogue scale).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302167274N7
Registration date:2013-02-18, 1391/11/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-18, 1391/11/30
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Science
Expected recruitment start date
2012-11-05, 1391/08/15
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between therapeutic efficacy of wet-cupping vs. conventional treatment in patients with chronic non-specific low back pain.
Public title
Chronic non-specific low back Pain: comparing the efficacy of wet-cupping and conventional treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 16-65 years; Low back pain persisting for 4 weeks or more.
Exclusion criteria: possible spinal pathology (e.g., carcinoma); severe or progressive motor weakness or central disc prolapse in the last 3 years; bleeding disorders (coagulopathies such as hemophilia) and history of treatment with wet-cupping in the last 6 months; radicular or referral back pain with probable discopathy disorders; VAS score lower than 4; and localized tenderness on the spinal process.
Age
From 16 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
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, Guilan University of Medical Sciences
Street address
Vice chancellor for research, Guilan University of Medical Sciences, Namjou avenue
City
Rasht
Postal code
Approval date
2012-10-23, 1391/08/02
Ethics committee reference number
1910231215
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain, Loin pain, Low back strain
Primary outcomes
1
Description
Disability index
Timepoint
Baseline assessment, post treatment and final follow-up visit.
Method of measurement
Oswestry Disability Index
Secondary outcomes
1
Description
Pain intensity
Timepoint
Baseline assessment, post treatment and final follow-up visit.
Method of measurement
Visual analogue scale
Intervention groups
1
Description
In intervention group: The treatment itself will be performed by a physician using standard techniques in a medical center. Wet-cupping will be applied in 2 stages: between the two scapulas in the first day and in the sacrum area in 2 weeks; each wet-cupping treatment procedure will last about 20 min and will be conducted in five steps.
Category
Treatment - Devices
2
Description
In control group: control group will receive the standard conventional treatment for low back pain. This treatment includes: (1) encouragement for early return to usual activities, excluding heavy manual labor, (2) activity alteration to minimize symptoms, (3) medical therapy: e.g., acetaminophen, or NSAIDs, (4) short duration muscular relaxants, (5) bed rest not more than 2 days.