NCT00804089

Brief Summary

The purpose of this study is to compare the therapeutic effects of acupuncture using traditional acupoints and Ashi points with myofascial trigger points superficial dry needling and acupressure, followed by postisometric stretching of the appropriate muscles, in the treatment of patients with chronic mechanical low back pain.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Last Updated

December 8, 2008

Status Verified

December 1, 2008

Enrollment Period

3 months

First QC Date

December 5, 2008

Last Update Submit

December 5, 2008

Conditions

Keywords

Low Back Pain, ChronicAcupunctureDry NeedlingAcupressureAcupuncture PointsTrigger Points, Myofascial

Study Arms (3)

1

EXPERIMENTAL

Traditional needle acupuncture

Procedure: Traditional needle acupuncture

2

ACTIVE COMPARATOR

Myofascial trigger point dry needling

Procedure: Myofascial trigger point dry needling

3

ACTIVE COMPARATOR

Myofascial trigger point acupressure

Procedure: Myofascial trigger point acupressure

Interventions

Traditional needle acupuncture using traditional meridian acupoints and Ashi (tender) points

1

Superficial dry needling of myofascial trigger points found in the muscles related to low back pain, followed by their postisometric stretching

2

Blunt needle acupressure of myofascial trigger points found in the muscles related to low back pain, followed by their postisometric stretching

3

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of mechanical lower back pain for at least three months.
  • The chronic mechanical lower back pain is the chief complaint, with or without leg pain.
  • The lower back pain is disabling to the degree that affects the patient's routine job and/or his or her lifestyle.

You may not qualify if:

  • Patients with tumor, infection, major trauma to the spine causing fracture or disruption of the major ligaments, or cauda equina syndrome.
  • Patients with neurological signs of spinal nerve compression.
  • Patients having undergone spinal surgery, facet joint block and/or corticoid injection.
  • Patients with general contraindications for acupuncture or acupressure treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Social Security Hospital

Ibarra, Imbabura, Ecuador

RECRUITING

Social Security Hospital

Ambato, Tungurahua Province, Ecuador

RECRUITING

MeSH Terms

Conditions

Low Back PainBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Sergiy Voznesenskyy, Ph.D. B.P.T.

    Hermano Miguel Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergiy Voznesenskyy, Ph.D. B.P.T.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

December 1, 2008

Primary Completion

March 1, 2009

Last Updated

December 8, 2008

Record last verified: 2008-12

Locations