Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02012205
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2013-12-03
Brief Title:
Wet Cupping in Non-specific Low Back Pain
Sponsor:
National Center for Complementary and Alternative Medicine Saudi Arabia
Organization:
National Center for Complementary and Alternative Medicine Saudi Arabia
Study Overview
Official Title:
Safety and Efficacy of Wet Cupping on Persistent Non-specific Low Back Pain A Randomized Controlled Open-label Parallel-group
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Persistent nonspecific low back pain PNSLBP is one of the most common low back pains worldwide Many interventions were tried including wet cupping which is commonly used for pain conditions in Saudi Arabia and other parts in the world but without solid scientific evidence
Aims This study aims at determining safety and efficacy of wet cupping for treating PNSLBP
Methods This is a randomized wait-listed controlled clinical trial Eligible patients with history of at least 3 months of PNSLBP will be randomized in to two groups 45 patients each The first group will be given wet-cupping treatment at two acupuncture points of urinary Bladder BL meridians among the BL23 BL24 and BL25 6 times within 2 weeks The second group will serve as a control group Usual care including providing brochures for exercise general advice for PNSLBP and acetaminophen will be allowed in both groups Separate assessors participated in the outcome assessment Investigators will use the 0 to100 numerical rating scale NRS for pain the McGill Pain questionnaire for pain intensity PPI and the Oswestry Disability Questionnaire ODQ and to assess acetaminophen use and safety issues
Expected Results To provide data on the safety and effectiveness of wet cupping in treating PNSLBP and open the way for integrative medicine in Saudi Arabia
Aims This study aims at determining safety and efficacy of wet cupping for treating PNSLBP
Methods This is a randomized wait-listed controlled clinical trial Eligible patients with history of at least 3 months of PNSLBP will be randomized in to two groups 45 patients each The first group will be given wet-cupping treatment at two acupuncture points of urinary Bladder BL meridians among the BL23 BL24 and BL25 6 times within 2 weeks The second group will serve as a control group Usual care including providing brochures for exercise general advice for PNSLBP and acetaminophen will be allowed in both groups Separate assessors participated in the outcome assessment Investigators will use the 0 to100 numerical rating scale NRS for pain the McGill Pain questionnaire for pain intensity PPI and the Oswestry Disability Questionnaire ODQ and to assess acetaminophen use and safety issues
Expected Results To provide data on the safety and effectiveness of wet cupping in treating PNSLBP and open the way for integrative medicine in Saudi Arabia
Detailed Description:
Objectives
To evaluate the effectiveness of wet cupping in the treatment of NSLBP
1 Primary objective To assess the effect of wet cupping on Pain difference in the NRS from base to the end of two weeks compared to the control group
2 Secondary objectives
I-To compare Functioning Oswestry Disability Questionnaire from the base to the end of the two weeks of wet cupping sessions two weeks later in the two groups II-To compare NRS from base to two weeks after the end of cupping III-To compare Number of Acetaminophen tables taken at the end of two weeks IV-To evaluate Safety of wet cupping
SPECIFIC HYPOTHESIS The hypothesis of this study is that the improvement of Numeric Rating Scale NRS for Pain at the end of the study will be greater in the Wet Cupping Treatment group than in the Control group
Overall Design a randomised waiting-list controlled open-label parallel trial
Study Type Interventional
Condition Persistent Non Specific Low Back Pain PNSLBP
Case definition parameters
Low back pain is defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds with or without referred leg pain
Persistent low back pain is defined as low back pain persisting for at least 12 weeks We do not deal specifically with repeated short bouts of pain
Nonspecific low back pain is defined as low back pain that is not attributable to a recognizable known specific pathology eg infection tumour osteoporosis fracture structural deformity inflammatory disorder eg ankylosing spondylitis radicular syndrome or caudal equine syndrome
Study Design
To evaluate the effectiveness of wet cupping in the treatment of NSLBP
1 Primary objective To assess the effect of wet cupping on Pain difference in the NRS from base to the end of two weeks compared to the control group
2 Secondary objectives
I-To compare Functioning Oswestry Disability Questionnaire from the base to the end of the two weeks of wet cupping sessions two weeks later in the two groups II-To compare NRS from base to two weeks after the end of cupping III-To compare Number of Acetaminophen tables taken at the end of two weeks IV-To evaluate Safety of wet cupping
SPECIFIC HYPOTHESIS The hypothesis of this study is that the improvement of Numeric Rating Scale NRS for Pain at the end of the study will be greater in the Wet Cupping Treatment group than in the Control group
Overall Design a randomised waiting-list controlled open-label parallel trial
Study Type Interventional
Condition Persistent Non Specific Low Back Pain PNSLBP
Case definition parameters
Low back pain is defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds with or without referred leg pain
Persistent low back pain is defined as low back pain persisting for at least 12 weeks We do not deal specifically with repeated short bouts of pain
Nonspecific low back pain is defined as low back pain that is not attributable to a recognizable known specific pathology eg infection tumour osteoporosis fracture structural deformity inflammatory disorder eg ankylosing spondylitis radicular syndrome or caudal equine syndrome
Study Design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None