NCT01049074

Brief Summary

Hypothesis: Acupuncture procedure of He's Santong Methods could be an option to treat nonspecific low back pain.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
534

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable low-back-pain

Geographic Reach
2 countries

2 active sites

Status
unknown

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

Study Start

First participant enrolled

November 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

March 19, 2010

Status Verified

November 1, 2008

Enrollment Period

2 years

First QC Date

January 13, 2010

Last Update Submit

March 18, 2010

Conditions

Low Back Pain

Keywords

Low Back PainAcupunctureRCT

Outcome Measures

Primary Outcomes (1)

  • Score of SF-36

    4 weeks, 8 weeks, 12 weeks, 24 weeks

Secondary Outcomes (1)

  • Oswestry Disability Index (ODI)

    4 weeks, 8 weeks, 12 weeks, 24 weeks

Study Arms (2)

Verus acupuncture

EXPERIMENTAL
Other: Acupuncture Treatment

Sham acupuncture

SHAM COMPARATOR
Other: Sham acupuncture

Interventions

Acupuncture TreatmentOTHER

Acupuncture is a technique of inserting and manipulating fine needles into specific points on the body to relieve pain or for therapeutic purposes.

Verus acupuncture
Sham acupunctureOTHER

Sham acupuncture is inserting needles superficially, without manipulating, into specific points on the body.

Sham acupuncture

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient who is suffering the Non-specific Low Back Pain which meets the diagnostic criterion of posterior ramus of lumbar spinal nerve syndrome.
  • The patient who is from 18 to 79 years old.
  • The patient who can comprehensively understand and fill in the questionnaires about the disease.
  • The patient who suffered problems no less than 12 weeks.
  • The patient who have not the other diseases which can result in back pain.
  • The patient who received the clear examinations of X-ray, CT scan or MRI.
  • The patient who wrote the informed consents.

You may not qualify if:

  • The patient whose low back pain is the consequences of spondyloschisis, Spondylolysis, osteoarthritis, osteoporosis, internal disease, metastatic tumor.
  • The patient who have the hemorrhagic disease such as hemophilia.
  • The patient who have the spinal diseases which have not been diagnosed clearly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing TCM Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology

Lasi, Romania

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Linpeng Wang, M.D.

    Beijing TCM Hospital

    STUDY CHAIR

  • Stratulat Ioan Sorin, M.D.

    Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Chen, M.D.

CONTACT

86-10-52176636chenpenger@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

November 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2011

Last Updated

March 19, 2010

Record last verified: 2008-11

Locations

RO(1)CN(1)