Back PainNCT06693453
Effects of Electronic Acupuncture Combined With Dry Cupping Therapy in Treating Back Pain Due to Lumbar Spondylosis
A study testing Electroacupuncture and Dry cupping in people with Back Pain, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to learn if Electroacupuncture combined with Dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Electroacupuncture and Dry cupping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals, male and female, 18-70 years of age.
- Report pain intensity between 3 and 7 according to the pain numerical rating scale.
- ODI disability index ≥10%.
- Patients diagnosed with lower back pain due to Qi stagnation and blood stasis syndrome (diagnosed by a Traditional Medicine Doctor) with clinical signs: stabbing, fixed lower back pain, worse at night, stiffness in the lumbar region, difficulty bending forward, extending, or rotating. The tongue is dark purple, possibly with blood stasis spots, and the pulse is wiry and tight or hesitant.
Who cannot join
- Have previously performed cupping therapy in some body segment;
- Present neurological, vestibular, visual or auditory deficits that make assessments impossible;
- Being in the gestational period;
- Having severe spinal disease (including fractures, tumour, inflammatory diseases, or tumours);
- Have undergone previous spinal surgery;
- Present with radiating or sacroiliac back pain; another rheumatic disease such as fibromyalgia,or ankylosing spondylitis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Ho Chi Minh University of Medicine and Phamacy, Ho Chi Minh City,
Ho Chi Minh City
About this study
Official title: Evaluating the Effects of Electronic Acupuncture Combined With Dry Cupping Therapy in Treating Back Pain Due to Lumbar Spondylosis in the qi Stagnation and Blood Stasis Pattern: A Randomized Clinical Trial
The goal of this clinical trial is to learn if Electroacupuncture combined with Dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern. I
The main questions it aims to answer are:
Read more
- Does Electroacupuncture combined with Dry cupping therapy reduces pain on Visual Analog Scale (VAS) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern?
- Dose Electroacupuncture combined with Dry cupping therapy improving the daily activities on Oswestry Disability index (ODI) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern?
- What medical problems do participants have when taking Electroacupuncture combined with Dry cupping therapy ? Researchers will compare dry cupping to a sham dry cupping (a sham cupping device was developed by establishing a small hole to reduce the negative pressure after suction such that inner pressure could not be maintained in the cup) to see if dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern.
Patients with back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern will be registered for this study. They will be treated with a combination of Electroacupuncture combined with Dry cupping therapy.
The intervention period is two weeks. Electronic acupuncture will be performed once a day for 2 weeks. Dry cupping therapy will be performed every 4 days for 2 weeks. Data on the Visual Analog Scale (VAS), Oswestry Disability index (ODI), and side effects of Electroacupuncture and Dry cuppingwill be recorded before the study and weekly for 2 weeks.
Read the detailed description
The goal of this clinical trial is to learn if Electroacupuncture combined with Dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern. I
The main questions it aims to answer are:
- Does Electroacupuncture combined with Dry cupping therapy reduces pain on Visual Analog Scale (VAS) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern?
- Dose Electroacupuncture combined with Dry cupping therapy improving the daily activities on Oswestry Disability index (ODI) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern?
- What medical problems do participants have when taking Electroacupuncture combined with Dry cupping therapy ? Researchers will compare dry cupping to a sham dry cupping (a sham cupping device was developed by establishing a small hole to reduce the negative pressure after suction such that inner pressure could not be maintained in the cup) to see if dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern.
Patients with back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern will be registered for this study. They will be treated with a combination of Electroacupuncture combined with Dry cupping therapy.
The intervention period is two weeks. Electronic acupuncture will be performed once a day for 2 weeks. Dry cupping therapy will be performed every 4 days for 2 weeks. Data on the Visual Analog Scale (VAS), Oswestry Disability index (ODI), and side effects of Electroacupuncture and Dry cuppingwill be recorded before the study and weekly for 2 weeks.
- Conditions
- Back Pain
- Being tested
- Electroacupuncture and Dry cupping, Electroacupuncture and Sham Dry cupping
- Keywords
- Back Pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture and Dry cuppingOther
This group will perform electroacupuncture for 20 minutes daily (10 sessions over 2 weeks) and dry cupping for 7 minutes every 4 days (3 sessions over 2 weeks)
Electroacupuncture and Sham Dry cuppingOther
This group will perform Electroacupuncture for 20 minutes daily (10 sessions over 2 weeks) and Sham Dry cupping for 7 minutes every 4 days (3 sessions over 2 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Sham Group | Sham comparator | Sham Coparator: 38 patients were treated with acupuncture using Khanh Phong 20x15 needles inserted into specific acupuncture points. Afterward, the acupuncture needles were connected to electrodes to administer electrical stimulation through the KWD808-1 electroacupuncture machine. The Sham group will receive placebo dry cupping therapy using two size 1 acrylic cups (internal diameter 4.5 cm), with a distance of 3 cm between each cup, placed parallel to the spine, bilaterally along the boundaries of acupoints BL17, BL23, and B25. This group will undergo placebo dry cupping therapy for 7 minutes, every 4 days (3 sessions over 2 weeks). However, the cups will be prepared with small holes <2 mm in diameter to release the negative pressure within seconds. Double-sided tape will be used to ensure the cups remain attached and in contact with the skin. Receives: Other: Electroacupuncture and Sham Dry cupping |
| Intervention Group | Experimental | 38 patients were treated with acupuncture using Khanh Phong 20x15 needles inserted into specific acupuncture points. Afterward, the acupuncture needles were connected to electrodes to administer electrical stimulation through the KWD808-1 electroacupuncture machine. Dry cupping will be applied using 6 size 1 acrylic cups (internal diameter 4.5 cm), with a distance of 3 cm between each cup, parallel to the spine, bilaterally according to the boundaries of acupoints BL17, BL23, and B25. This group will perform electroacupuncture for 20 minutes daily (10 sessions over 2 weeks) and dry cupping for 10 minutes every 4 days (3 sessions over 2 weeks). Receives: Other: Electroacupuncture and Dry cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disability - ODI
The Oswestry Disability Index (ODI) questionnaire will be used to analyze disability in people with low back pain.This instrument contains 10 items that assess the impact of low back pain on various functional activities. Values range from 0 to 5, with the highest value indicating greater disability. The final result is the sum of all items. The validated version in Portuguese is used.
Measured: baseline and week 2
Secondary outcomes (1)
Change in Visual Analog Scale (VAS)
Pain will be measured using the Visual Analog Scale (VAS). Patients will be asked to circle a number from 0 to 10, where 0 represents "no pain" and 10 represents "the worst possible pain.
Measured: baseline and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Jan 2024
- Primary completion30 Oct 2024
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NGUYEN THI THUY AN, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693453
- Sponsor's protocol ID
- 1099/HDDD-DHYD
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Electronic Acupuncture Combined With Dry Cupping Therapy in Treating Back Pain Due to Lumbar Spondylosis in the qi Stagnation and Blood Stasis Pattern: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06693453
- Acronym / sponsor ID
- 1099/HDDD-DHYD
- Conditions
- Back Pain
- Keywords
- Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 18 Nov 2024 (actual)
- 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.
The goal of this clinical trial is to learn if Electroacupuncture combined with Dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern. I
The main questions it aims to answer are:
- Does Electroacupuncture combined with Dry cupping therapy reduces pain on Visual Analog Scale (VAS) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern?
- Dose Electroacupuncture combined with Dry cupping therapy improving the daily activities on Oswestry Disability index (ODI) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern?
- What medical problems do participants have when taking Electroacupuncture combined with Dry cupping therapy ? Researchers will compare dry cupping to a sham dry cupping (a sham cupping device was developed by establishing a small hole to reduce the negative pressure after suction such that inner pressure could not be maintained in the cup) to see if dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern.
Patients with back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern will be registered for this study. They will be treated with a combination of Electroacupuncture combined with Dry cupping therapy.
The intervention period is two weeks. Electronic acupuncture will be performed once a day for 2 weeks. Dry cupping therapy will be performed every 4 days for 2 weeks. Data on the Visual Analog Scale (VAS), Oswestry Disability index (ODI), and side effects of Electroacupuncture and Dry cuppingwill be recorded before the study and weekly for 2 weeks.
Detailed description
The goal of this clinical trial is to learn if Electroacupuncture combined with Dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern. I
The main questions it aims to answer are:
- Does Electroacupuncture combined with Dry cupping therapy reduces pain on Visual Analog Scale (VAS) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern?
- Dose Electroacupuncture combined with Dry cupping therapy improving the daily activities on Oswestry Disability index (ODI) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern?
- What medical problems do participants have when taking Electroacupuncture combined with Dry cupping therapy ? Researchers will compare dry cupping to a sham dry cupping (a sham cupping device was developed by establishing a small hole to reduce the negative pressure after suction such that inner pressure could not be maintained in the cup) to see if dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern.
Patients with back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern will be registered for this study. They will be treated with a combination of Electroacupuncture combined with Dry cupping therapy.
The intervention period is two weeks. Electronic acupuncture will be performed once a day for 2 weeks. Dry cupping therapy will be performed every 4 days for 2 weeks. Data on the Visual Analog Scale (VAS), Oswestry Disability index (ODI), and side effects of Electroacupuncture and Dry cuppingwill be recorded before the study and weekly for 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Group | Sham comparator | Other: Electroacupuncture and Sham Dry cuppingSham Coparator: 38 patients were treated with acupuncture using Khanh Phong 20x15 needles inserted into specific acupuncture points. Afterward, the acupuncture needles were connected to electrodes to administer electrical stimulation through the KWD808-1 electroacupuncture machine. The Sham group will receive placebo dry cupping therapy using two size 1 acrylic cups (internal diameter 4.5 cm), with a distance of 3 cm between each cup, placed parallel to the spine, bilaterally along the boundaries of acupoints BL17, BL23, and B25. This group will undergo placebo dry cupping therapy for 7 minutes, every 4 days (3 sessions over 2 weeks). However, the cups will be prepared with small holes <2 mm in diameter to release the negative pressure within seconds. Double-sided tape will be used to ensure the cups remain attached and in contact with the skin. |
| Intervention Group | Experimental | Other: Electroacupuncture and Dry cupping38 patients were treated with acupuncture using Khanh Phong 20x15 needles inserted into specific acupuncture points. Afterward, the acupuncture needles were connected to electrodes to administer electrical stimulation through the KWD808-1 electroacupuncture machine. Dry cupping will be applied using 6 size 1 acrylic cups (internal diameter 4.5 cm), with a distance of 3 cm between each cup, parallel to the spine, bilaterally according to the boundaries of acupoints BL17, BL23, and B25. This group will perform electroacupuncture for 20 minutes daily (10 sessions over 2 weeks) and dry cupping for 10 minutes every 4 days (3 sessions over 2 weeks). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals, male and female, 18-70 years of age.
- Report pain intensity between 3 and 7 according to the pain numerical rating scale.
- ODI disability index ≥10%.
- Patients diagnosed with lower back pain due to Qi stagnation and blood stasis syndrome (diagnosed by a Traditional Medicine Doctor) with clinical signs: stabbing, fixed lower back pain, worse at night, stiffness in the lumbar region, difficulty bending forward, extending, or rotating. The tongue is dark purple, possibly with blood stasis spots, and the pulse is wiry and tight or hesitant.
Key exclusion criteria (6 listed)
- Have previously performed cupping therapy in some body segment;
- Present neurological, vestibular, visual or auditory deficits that make assessments impossible;
- Being in the gestational period;
- Having severe spinal disease (including fractures, tumour, inflammatory diseases, or tumours);
- Have undergone previous spinal 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 |
|---|---|---|
| Electroacupuncture and Dry cuppingThis group will perform electroacupuncture for 20 minutes daily (10 sessions over 2 weeks) and dry cupping for 7 minutes every 4 days (3 sessions over 2 weeks) | Other | Intervention Group |
| Electroacupuncture and Sham Dry cuppingThis group will perform Electroacupuncture for 20 minutes daily (10 sessions over 2 weeks) and Sham Dry cupping for 7 minutes every 4 days (3 sessions over 2 weeks) | Other | Sham Group |
Primary outcome
Change in Disability - ODI
Time frame: baseline and week 2
The Oswestry Disability Index (ODI) questionnaire will be used to analyze disability in people with low back pain.This instrument contains 10 items that assess the impact of low back pain on various functional activities. Values range from 0 to 5, with the highest value indicating greater disability. The final result is the sum of all items. The validated version in Portuguese is used.
1 secondary outcome
Change in Visual Analog Scale (VAS)
Time frame: baseline and week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Dry cupping in people with Back Pain, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 6 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: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact An Thi Thuy Nguyen (0773030312, nguyenan27011997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disability - ODI (time frame: baseline and week 2). 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 18 Nov 2024.