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

NCT06693453 | Recruiting DMC

• 1 other identifier: 1099/HDDD-DHYD
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain

Keywords

Back Pain

Outcome Measures

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.

  baseline and week 2

Secondary Outcomes (1)

• Change in Visual Analog Scale (VAS)

  baseline and week 2

Study Arms (2)

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.

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).

Other: Electroacupuncture and Dry cupping

Interventions

Electroacupuncture and Dry cupping OTHER

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)

Intervention Group

Electroacupuncture and Sham Dry cupping OTHER

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)

Sham Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Ho Chi Minh University of Medicine and Phamacy, Ho Chi Minh City,

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Back Pain

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

An Thi Thuy Nguyen

CONTACT

0773030312; nguyenan27011997@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

VN (1)