NCT01734577

Brief Summary

Intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of musculoskeletal pain. The mechanisms of action remain unknown, and this study will examine for a neurophysiological effect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

10 months

First QC Date

November 21, 2012

Last Update Submit

June 17, 2013

Conditions

Keywords

Back pain

Outcome Measures

Primary Outcomes (1)

  • Thickness of transversus abdominis at rest and during contraction

    Real time ultrasound measurement

    1 day

Study Arms (2)

Dry needling

ACTIVE COMPARATOR

Monofilament needles will be inserted into each subject's left multifidus muscle and stimulated mechanically for a local twitch response

Procedure: Dry needling

Sham needling

SHAM COMPARATOR

Monofilament tubes will be pressed into the left multifidus muscle and mechanically manipulated to give the sensation that needling is occuring.

Procedure: Sham needling

Interventions

Dry needlingPROCEDURE

Sterile monofilament needles

Dry needling
Sham needlingPROCEDURE

Applicator tubes from the sterile monofilament needles

Sham needling

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age, absence of back pain or symptoms for greater than 6 months and ability to perform DCC. Subjects must also report they are comfortable with being 'needled'.

You may not qualify if:

  • Presence of back pain or symptoms within the last 6 months, history of: abdominal or spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia, active ankylosing spondylitis. If a subject reports a fear of needles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada Las Vegas - Department of Physical Therapy

Las Vegas, Nevada, 89154, United States

Location

Related Publications (1)

  • Puentedura EJ, Buckingham SJ, Morton D, Montoya C, Fernandez de Las Penas C. Immediate Changes in Resting and Contracted Thickness of Transversus Abdominis After Dry Needling of Lumbar Multifidus in Healthy Participants: A Randomized Controlled Crossover Trial. J Manipulative Physiol Ther. 2017 Oct;40(8):615-623. doi: 10.1016/j.jmpt.2017.06.013.

MeSH Terms

Conditions

Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Daniella Morton, BSc

    University of Nevada Las Vegas Physical Therapy

    STUDY DIRECTOR
  • Sarah Buckingham, BSc

    University of Nevada Las Vegas Physical Therapy

    STUDY DIRECTOR
  • Crystal Montoya, BSc

    Univesity of Nevada Las Vegas Physical Therapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Emilio J. Puentedura

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 27, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations