NCT03685864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

October 12, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2023

Completed
Last Updated

April 10, 2024

Status Verified

November 1, 2023

Enrollment Period

5.2 years

First QC Date

September 25, 2018

Last Update Submit

April 9, 2024

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • VAS

    The patients will be asked to mark, on a 10 cm VAS (0, absence of bothersomeness; 10, the worst bothersomeness imaginable)

    2 week

Secondary Outcomes (2)

  • Oswestry Disability Index (ODI)

    2 week

  • EQ-5D

    2 week

Study Arms (2)

Suture Embedding Acupuncture

EXPERIMENTAL

Suture Embedding Acupuncture 1 time for two weeks, total 3 times.

Other: Suture Embedding Acupuncture

Sham acupuncture

SHAM COMPARATOR

Sham Acupuncture 1 time for two weeks, total 3 times.

Other: Sham Acupuncture

Interventions

Suture Embedding AcupunctureOTHER

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.

Suture Embedding Acupuncture
Sham AcupunctureOTHER

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

Sham acupuncture

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 or herbal medicine to treat LBP within one month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei medical university hospital

Taipei, 110, Taiwan

Location

Related Publications (3)

  • Fan Z. Observation on 105 cases of duodenal bulbar ulcer treated by combined therapy of catgut embedding and Chinese drugs. J Tradit Chin Med. 2001 Jun;21(2):111-5. No abstract available.

    PMID: 11498898BACKGROUND

  • Cho YJ, Song YK, Cha YY, Shin BC, Shin IH, Park HJ, Lee HS, Kim KW, Cho JH, Chung WS, Lee JH, Song MY. Acupuncture for chronic low back pain: a multicenter, randomized, patient-assessor blind, sham-controlled clinical trial. Spine (Phila Pa 1976). 2013 Apr 1;38(7):549-57. doi: 10.1097/BRS.0b013e318275e601.

    PMID: 23026870BACKGROUND

  • Manheimer E, White A, Berman B, Forys K, Ernst E. Meta-analysis: acupuncture for low back pain. Ann Intern Med. 2005 Apr 19;142(8):651-63. doi: 10.7326/0003-4819-142-8-200504190-00014.

    PMID: 15838072BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chien-Huang Lin, PhD

    Taipei Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician, Department of Orthopedics

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 26, 2018

Study Start

October 12, 2018

Primary Completion

December 13, 2023

Study Completion

December 13, 2023

Last Updated

April 10, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)