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RecruitingNCT06693453Updated Nov 18, 2024

Effects of Electronic Acupuncture Combined With Dry Cupping Therapy in Treating Back Pain Due to Lumbar Spondylosis

An interventional study of Electroacupuncture and Dry cupping and Electroacupuncture and Sham Dry cupping in Back Pain, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-18.

Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2024, registered Nov 2024).
  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Back Pain

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Keywords

  • Back Pain
03

In context

Back Pain

2,389 studies on the registry are indexed under Back Pain; 282 are open to participants now.

This study's planned enrollment of 76 is above the median of 60 across 1,952 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 121 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
76 participants (estimated)

Study arms

  • Sham comparator
    Sham Group

    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.

    Other: Electroacupuncture and Sham Dry cupping

  • Experimental
    Intervention Group

    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).

    Other: Electroacupuncture and Dry cupping

Interventions

  • OtherElectroacupuncture and Dry cupping

    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)

  • OtherElectroacupuncture and Sham Dry cupping

    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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: baseline and week 2

07

Study locations

1 of 1 sites recruiting
  • Ho Chi Minh University of Medicine and Phamacy, Ho Chi Minh City,
    Ho Chi Minh City, Vietnam
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Oct 2024, 9 months.

Of 933 non-industry interventional studies with no phase under Back Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's 9 months is close to that.

Counting every sponsor, half of 997 studies reached it within 11 months; a quarter within 5 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2024
First posted
Nov 18, 2024
StartActual
Jan 1, 2024
Primary completionActual
Oct 30, 2024
CompletionEst.
Nov 30, 2024
Last update
Nov 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06693453
Responsible party
NGUYEN THI THUY AN (Principal Investigator, University of Medicine and Pharmacy at Ho Chi Minh City) — Principal investigator
First posted
Nov 18, 2024
Start date
Jan 1, 2024
Primary completion
Oct 30, 2024
Completion
Nov 30, 2024 (estimated)
Last update
Nov 18, 2024

Study contacts

An Thi Thuy Nguyen
Contact
nguyenan27011997@gmail.com
0773030312

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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