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

November 14, 2024 updated by: NGUYEN THI THUY AN, University of Medicine and Pharmacy at Ho Chi Minh City

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:

  • 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • Ho Chi Minh University of Medicine and Phamacy, Ho Chi Minh City,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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)
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale (VAS)
Time Frame: baseline and week 2
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.
baseline and week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

October 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1099/HDDD-DHYD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Back Pain

Clinical Trials on Electroacupuncture and Sham Dry cupping

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe