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Suture Embedding Acupuncture for Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03685864
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Meng-Huang Wu, Taipei Medical University Hospital

Brief Summary:
Chronic low back pain (cLBP) is a common public health issue, and it is one of the main causes of disability among adults of working age. Suture embedding acupuncture is one of the most often used interventions for the treatments of cLBP. The investigators will investigate the efficacy and safety of suture embedding acupuncture for cLBP in this single center, parallel, randomized, sham-controlled clinical trial.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Suture Embedding Acupuncture Other: Sham Acupuncture Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Suture Embedding Acupuncture for Chronic Low Back Pain: A Randomized, Sham-Controlled Clinical Trial
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Suture Embedding Acupuncture
Suture Embedding Acupuncture 1 time for two weeks, total 3 times.
Other: Suture Embedding Acupuncture
Suture Embedding Acupuncture at 8 acupoints (both sides of BL23, BL24, BL25, BL37). Receiving intervention 1 time in 2 weeks, and total receive 3 times.

Sham Comparator: Sham acupuncture
Sham Acupuncture 1 time for two weeks, total 3 times.
Other: Sham Acupuncture
Sham Acupuncture at 8 acupoints (both sides of BL23, BL24, BL25, BL37). Receiving intervention 1 time in 2 weeks, and total receive 3 times.




Primary Outcome Measures :
  1. VAS [ Time Frame: 2 week ]
    The patients will be asked to mark, on a 10 cm VAS (0, absence of bothersomeness; 10, the worst bothersomeness imaginable)


Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 2 week ]
    The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel

  2. EQ-5D [ Time Frame: 2 week ]

    In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    In evaluation part, the respondents evaluate their overall health status using the visual analogue scale.




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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cLBP lasting for at least the last 3 months.
  • 10-cm visual analogue scale (VAS) for bothersomeness of LBP exceeding 4.
  • Nonspecific and uncomplicated LBP that was intact on neurological examination.

Exclusion Criteria:

  • Sciatic pain. (i.e., if a patient reported typical radiating pain in the leg as well as one or more neurological indications of nerve root tension or neurological deficit.)
  • Pain mainly below the knee.
  • Serious spinal disorders including malignancy, vertebral fracture, spinal infection, inflammatory spondylitis and cauda equine compression.
  • History of previous spinal surgery or scheduled surgery to address a chronic disease that could interfere with treatment effects. (e.g., cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, dementia, and epilepsy)
  • Acupuncture treatment of LBP during the previous month.
  • Conditions that could compromise the safety of acupuncture. (e.g., clotting disorders, taking anticoagulant agent, pregnancy, and seizure disorders)
  • Severe psychiatric or psychological disorder.
  • Use of corticosteroids, narcotics, muscle relaxants, or herbal medicine to treat LBP within one month.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685864


Contacts
Contact: Meng-Huang Wu, PhD 886 2 27372181 ext 3740 alumni@tmu.edu.tw
Contact: Chien-Huang Lin

Locations
Taiwan
Taipei medical university hospital Recruiting
Taipei, Taiwan, 110
Contact: Meng-Huang Wu, PhD         
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
Study Chair: Chien-Huang Lin, PhD Taipei Medical University

Publications:
Responsible Party: Meng-Huang Wu, Attending physician, Department of Orthopedics, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT03685864     History of Changes
Other Study ID Numbers: N201807035
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms