Persistent Non Specific Low Back PainNCT02012205
Wet Cupping in Non-specific Low Back Pain
A study testing wet cupping in people with Persistent Non Specific Low Back Pain, run by National Center for Complementary and Alternative Medicine, Saudi Arabia at 3 sites in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Persistent Non Specific Low Back Pain
- What is being tested?
- wet cupping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesSaudi Arabia
- Study dates
- Apr 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Patients who have had non-specific low back pains at least 12 weeks now.
- - Interested in using wet cupping therapy
- - Age equal or more than 18 years up to 60 years of age.
Who cannot join
- 1-Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
- 2-Patients who are inappropriate to the wet cupping treatment.
- ◦AIDS, Active Hepatitis, Tuberculosis, Syphilis. (N.B.)Referring physicians will be advised to exclude patients with the above mentioned diseases.
- ◦Patients who regularly take anticoagulants, antiplatelet drugs
- ◦Anemia, thrombocytopenia
- ◦Hemorrhagic disease like hemophilia
Show all 10Show fewer
- ◦Diabetes
- ◦Severe cardiovascular disease
- ◦Kidney diseases (renal failure, chronic renal disease)
- 3-Patients who have experiences of wet cupping treatment during last 3 months. 4-Patients who have had treatment for low back pain during last 2 weeks. 5-Patients who are in pregnancy or have plan to conception. 6-Patients who have vertebra surgery or have plan of surgery.
Trial locations and contacts
3 sites in 1 country.
Saudi Arabia3 sites
King Fahad Specialist Hospital
Jeddah, Jeddah
King Fahad Hospital
Madinah, Madinah
Prince Salman Hospital
Riyadh, Riyadh Region
About this study
Official title: Safety and Efficacy of Wet Cupping on Persistent Non-specific Low Back Pain: A Randomized, Controlled, Open-label, Parallel-group
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.
Read more
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
Read the detailed description
Objectives:
To evaluate the effectiveness of wet cupping in the treatment of NSLBP:
- 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
- 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 (e.g. infection, tumour, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis), radicular syndrome or caudal equine syndrome)."
Study Design:
- Conditions
- Persistent Non Specific Low Back Pain
- Being tested
- wet cupping
- Keywords
- wet cupping - back pain - NSLBP - Saudi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wet cuppingProcedure or surgery
Also called Hijamah
Participants assigned to the treatment group will receive wet-cupping therapy 3 times per week for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| wet cupping | Experimental | patient will receive wet cupping Receives: Procedure: wet cupping |
| control | No intervention | not cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Difference in Numeric Rating Score at the base and at the end of two weeks of cupping sessions.
Measured: at the end of the two weeks wet cupping sessions.
Secondary outcomes (3)
Scores of the McGill Pain questionnaire for pain intensity (PPI)
Change in the score from base line
Measured: at the end of two weeks of cupping sessions and two weeks later
the Oswestry Disability Questionnaire (ODQ),
change in the score from the base line
Measured: at the end of two weeks of cupping sessions and two weeks later
Number of Participants with Serious and Non-Serious Adverse Events
Differences in number of participants with Serious and Non-Serious Adverse Events.
Measured: at the last visit, one week after the end of the last sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Non Specific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Alternative Medicine, Saudi Arabia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Abdullah M AlBedah, MD, Principal investigator, National Center for Complementary and Integrative Health (NCCIH)Mohamed K.M. Khalil, MD, Study director, National Center for Complementary and Integrative Health (NCCIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012205
- Sponsor's protocol ID
- MOH044
- Status last verified
- Mar 2015
- First submitted
- 3 Dec 2013
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Al-Eidi SM, Mohamed AG, Abutalib RA, AlBedah AM, Khalil MKM. Wet Cupping-Traditional Hijamah Technique versus Asian Cupping Technique in Chronic Low Back Pain Patients: A Pilot Randomized Clinical Trial. J Acupunct Meridian Stud. 2019 Dec;12(6):173-181. doi: 10.1016/j.jams.2019.04.005. Epub 2019 Apr 24.
PubMed 31028971
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Wet Cupping on Persistent Non-specific Low Back Pain: A Randomized, Controlled, Open-label, Parallel-group
- ClinicalTrials.gov ID
- NCT02012205
- Acronym / sponsor ID
- MOH044
- Conditions
- Persistent Non Specific Low Back Pain
- Keywords
- wet cupping - back pain - NSLBP - Saudi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Center for Complementary and Alternative Medicine, Saudi ArabiaOther government
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Objectives:
To evaluate the effectiveness of wet cupping in the treatment of NSLBP:
- 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
- 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 (e.g. infection, tumour, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis), radicular syndrome or caudal equine syndrome)."
Study Design:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wet cupping | Experimental | Procedure: wet cuppingpatient will receive wet cupping |
| control | No intervention | –not cupping |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- - Patients who have had non-specific low back pains at least 12 weeks now.
- - Interested in using wet cupping therapy
- - Age equal or more than 18 years up to 60 years of age.
Key exclusion criteria (10 listed)
- 1-Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
- 2-Patients who are inappropriate to the wet cupping treatment.
- 3-Patients who have experiences of wet cupping treatment during last 3 months. 4-Patients who have had treatment for low back pain during last 2 weeks. 5-Patients who are in pregnancy or have plan to conception. 6-Patients who have vertebra surgery or have plan of surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wet cuppingAlso: HijamahParticipants assigned to the treatment group will receive wet-cupping therapy 3 times per week for 2 weeks | Procedure or surgery | wet cupping |
Primary outcome
NRS
Time frame: at the end of the two weeks wet cupping sessions.
Difference in Numeric Rating Score at the base and at the end of two weeks of cupping sessions.
3 secondary outcomes
Scores of the McGill Pain questionnaire for pain intensity (PPI)
Time frame: at the end of two weeks of cupping sessions and two weeks later
the Oswestry Disability Questionnaire (ODQ),
Time frame: at the end of two weeks of cupping sessions and two weeks later
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: at the last visit, one week after the end of the last sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Derived from this study: PubMed 31028971Al-Eidi SM, Mohamed AG, Abutalib RA, AlBedah AM, Khalil MKM. Wet Cupping-Traditional Hijamah Technique versus Asian Cupping Technique in Chronic Low Back Pain Patients: A Pilot Randomized Clinical Trial. J Acupunct Meridian Stud. 2019 Dec;12(6):173-181. doi: 10.1016/j.jams.2019.04.005. Epub 2019 Apr 24.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdullah M AlBedah, MD principal investigator
National Center for Complementary and Integrative Health (NCCIH)
Mohamed K.M. Khalil, MD study director
National Center for Complementary and Integrative Health (NCCIH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wet cupping in people with Persistent Non Specific Low Back Pain, run by National Center for Complementary and Alternative Medicine, Saudi Arabia at 3 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: at the end of the two weeks wet cupping sessions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02012205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.