Low Back PainNCT02631382
Wet Cupping (AlHijamah); Double Versus Single Cupping Technique
A study testing wet cupping in people with Low Back Pain, run by National Center for Complementary and Alternative Medicine, Saudi Arabia at 2 sites in Saudi Arabia.
Trial summary
Randomized clinical trial to compare the effectiveness and safety of double (traditional) versus single (Asian) cupping techniques in chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- 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
- 70 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- Nov 2015to May 2016
- 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
- Male and Female
- Age equal or more than 18 years up to 60 years
- Chronic low back pain (at least the duration ≥ 3 months)
- Not on anti-inflammatory or pain killers for the last 15 days.
Who cannot join
- Patients received wet-cupping therapy before in the last three months
- Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, and cauda equinal syndrome)
- Patients who are inappropriate to the wet cupping treatment (AIDS, Hepatitis, Tuberculosis, Syphilis. The referring physicians will be advised to exclude those patients)
- Patients currently receiving any anticoagulant, antiplatelet medications
- Anemia, thrombocytopenia, Coagulopathy or Hemorrhagic disease like hemophilia
- Had undergone a surgery, or had bleeding injury, or had blood donation
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- Uncontrolled hypertension, Ischemic heart disease, previous transient ischemic attack or stroke
- Diabetes, known renal and / or hepatic diseases
- Patients who are in pregnancy or have plan to conception
- Previously or currently drug addicts
- Any other severe disease or disabling medical condition
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
King Fahad Hospital
Jeddah, Jeddah
King Fahad Hospital
Madinah, Madinah
About this study
Official title: Wet Cupping (AlHijamah); Double Versus Single Cupping Technique in Chronic Low Back Pain Patients: Randomized Comparative Clinical Trial, Pilot Study Saudi Arabia, 2015
Randomized clinical trial to compare the effectiveness and safety of double (traditional) versus single (Asian) cupping techniques in chronic low back pain.
Read the detailed description
Chronic Low Back Pain is a very common pain disorder in the primary care. As in many chronic pain conditions, patients are usually asking for alternative options, especially local traditional and therapies including wet cupping, to replace the long-term use of painkillers. The majority of the wet cupping trials conducted abroad used different techniques, which is different from our local traditional wet cupping technique. This study can identify the technique that is more efficacious in reducing pain, prolonging the pain relieve period, and decrease patient dependence on painkillers in chronic low back pain.The aim of this study is to compare the effectiveness and safety of double (traditional) versus single (Asian) cupping techniques in chronic low back pain. This a randomized comparative effectiveness pilot clinical trial. After taking written informed consent, patient with chronic low back pain will be randomized into two groups, one group to receive wet cupping therapy with the Traditional double technique, the other group to receive it with the Asian single technique. Numeric Rating Scale, Present Pain Intensity and Oswestry Disability Questionnaire will be used to measure the outcome before and after the intervention, one week after the intervention, then two weeks after. Wilcoxon rank sum test for the continuous dependent data analysis and the analysis of covariance ANCOVA, to compare both groups mean scores will be used. The outcome baseline for each score will be used as the covariate. Chi square or Fisher's exact test will be used to compare categorical data with Minimal Clinical Improvement Difference within and between the two groups.
- Conditions
- Low Back Pain
- Being tested
- wet cupping
- Keywords
- wet cupping Saudi Arabia
- Medical subject headings
- Low Back Pain
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, wet cupping device
In double cupping (traditional technique): Cupping (suction) then scarification then cupping (suction).
In single cupping (Asian): puncture using auto lancet then cupping (suction). In both techniques 4 out of 6 acupoints (BL23, BL24, BL25 bilateral) will be selected.
| Study group | Role | What they receive |
|---|---|---|
| wet cupping : double cupping | Experimental | wet cupping: (traditional cupping technique): cupping (suction) - Scarification - cupping (suction) Receives: Procedure: wet cupping |
| wet cupping: single cupping | Experimental | wet cupping:(Asian cupping): Puncture by needles then cupping (suction): Receives: Procedure: wet cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numeric rating scale (NRS) before and after intervention
numeric pain scale to be measured before intervention then two weeks after
Measured: 14 DAYS
Secondary outcomes (3)
pain: McGill, Persistent Pain Intensity (PPI)
before intervention and two weeks later
Measured: 14 days
functioning (Disability) using the Oswestry Disability Questionnaire (ODQ)
functionality will be measured using the questionnaire and compared two weeks after intervention
Measured: 14 days
the Safety of the two wet cupping techniques, by collecting safety data after two weeks of the intervention
using the WHO guidelines for classification of adverse events
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Alternative Medicine, Saudi Arabia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sulaiman AlEidi, MBBS, Principal investigator, NCCAM , MOH, Riyadh, Saudi ArabiaMohamed Khalil, MD, Study chair, NCCAM.MOHAshry Gad Mohamed, MD, Study chair, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631382
- Sponsor's protocol ID
- NCCAM - TRIAL - CUPPING2
- Status last verified
- Dec 2015
- First submitted
- 6 Dec 2015
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wet Cupping (AlHijamah); Double Versus Single Cupping Technique in Chronic Low Back Pain Patients: Randomized Comparative Clinical Trial, Pilot Study Saudi Arabia, 2015
- ClinicalTrials.gov ID
- NCT02631382
- Acronym / sponsor ID
- NCCAM - TRIAL - CUPPING2
- Conditions
- Low Back Pain
- Keywords
- wet cupping Saudi Arabia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Center for Complementary and Alternative Medicine, Saudi ArabiaOther government
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Dec 2015 (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.
Randomized clinical trial to compare the effectiveness and safety of double (traditional) versus single (Asian) cupping techniques in chronic low back pain.
Detailed description
Chronic Low Back Pain is a very common pain disorder in the primary care. As in many chronic pain conditions, patients are usually asking for alternative options, especially local traditional and therapies including wet cupping, to replace the long-term use of painkillers. The majority of the wet cupping trials conducted abroad used different techniques, which is different from our local traditional wet cupping technique. This study can identify the technique that is more efficacious in reducing pain, prolonging the pain relieve period, and decrease patient dependence on painkillers in chronic low back pain.The aim of this study is to compare the effectiveness and safety of double (traditional) versus single (Asian) cupping techniques in chronic low back pain. This a randomized comparative effectiveness pilot clinical trial. After taking written informed consent, patient with chronic low back pain will be randomized into two groups, one group to receive wet cupping therapy with the Traditional double technique, the other group to receive it with the Asian single technique. Numeric Rating Scale, Present Pain Intensity and Oswestry Disability Questionnaire will be used to measure the outcome before and after the intervention, one week after the intervention, then two weeks after. Wilcoxon rank sum test for the continuous dependent data analysis and the analysis of covariance ANCOVA, to compare both groups mean scores will be used. The outcome baseline for each score will be used as the covariate. Chi square or Fisher's exact test will be used to compare categorical data with Minimal Clinical Improvement Difference within and between the two groups.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wet cupping : double cupping | Experimental | Procedure: wet cuppingwet cupping: (traditional cupping technique): cupping (suction) - Scarification - cupping (suction) |
| wet cupping: single cupping | Experimental | Procedure: wet cuppingwet cupping:(Asian cupping): Puncture by needles then cupping (suction): |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and Female
- Age equal or more than 18 years up to 60 years
- Chronic low back pain (at least the duration ≥ 3 months)
- Not on anti-inflammatory or pain killers for the last 15 days.
Key exclusion criteria (11 listed)
- Patients received wet-cupping therapy before in the last three months
- Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, and cauda equinal syndrome)
- Patients who are inappropriate to the wet cupping treatment (AIDS, Hepatitis, Tuberculosis, Syphilis. The referring physicians will be advised to exclude those patients)
- Patients currently receiving any anticoagulant, antiplatelet medications
- Anemia, thrombocytopenia, Coagulopathy or Hemorrhagic disease like hemophilia
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: Hijamah, wet cupping deviceIn double cupping (traditional technique): Cupping (suction) then scarification then cupping (suction). In single cupping (Asian): puncture using auto lancet then cupping (suction). In both techniques 4 out of 6 acupoints (BL23, BL24, BL25 bilateral) will be selected. | Procedure or surgery | wet cupping : double cupping, wet cupping: single cupping |
Primary outcome
Pain Numeric rating scale (NRS) before and after intervention
Time frame: 14 DAYS
numeric pain scale to be measured before intervention then two weeks after
3 secondary outcomes
pain: McGill, Persistent Pain Intensity (PPI)
Time frame: 14 days
functioning (Disability) using the Oswestry Disability Questionnaire (ODQ)
Time frame: 14 days
the Safety of the two wet cupping techniques, by collecting safety data after two weeks of the intervention
Time frame: up to 14 days
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 22 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Sulaiman AlEidi, MBBS principal investigator
NCCAM , MOH, Riyadh, Saudi Arabia
Mohamed Khalil, MD study chair
NCCAM.MOH
Ashry Gad Mohamed, MD study chair
King Saud University
2 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 Low Back Pain, run by National Center for Complementary and Alternative Medicine, Saudi Arabia at 2 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 4 inclusion and 11 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Pain Numeric rating scale (NRS) before and after intervention (time frame: 14 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2016.