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Effect of Dry Needling Multifidus on Thickness of Transversus Abdominis in Healthy Individuals

Primary Purpose

Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dry needling

Sham needling

About this trial

This is an interventional basic science trial for Back Pain focused on measuring Back pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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'.

Exclusion Criteria:

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.

Sites / Locations

University of Nevada Las Vegas - Department of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Dry needling

Sham needling

Arm Description

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

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

Outcomes

Primary Outcome Measures

Thickness of transversus abdominis at rest and during contraction

Real time ultrasound measurement

Secondary Outcome Measures

Full Information

NCT ID

NCT01734577

First Posted

November 21, 2012

Last Updated

June 17, 2013

Sponsor

University of Nevada, Las Vegas

1. Study Identification

Unique Protocol Identification Number

NCT01734577

Brief Title

Effect of Dry Needling Multifidus on Thickness of Transversus Abdominis in Healthy Individuals

Official Title

The Effect of Trigger Point Dry Needling to the Multifidus Muscle on Resting and Contracted Thickness of Transversus Abdominis in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Nevada, Las Vegas

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Consenting adults will be taught how to contract their abdominal muscles, and to contract transversus abdominis in particular. They will then have real time ultrasound measurements of the resting and contracted thickness of their left transversus abdominis muscle. After this, they will receive actual or sham needling to their left multifidus muscle by another researchers blinded to the real time ultrasound measurements. After needling or sham intervention is complete, the original researchers will return to re-measure transversus abdominis. They will be blind to intervention allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain

Keywords

Back pain

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dry needling

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sham needling

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Dry needling

Intervention Description

Sterile monofilament needles

Intervention Type

Procedure

Intervention Name(s)

Sham needling

Intervention Description

Applicator tubes from the sterile monofilament needles

Primary Outcome Measure Information:

Title

Thickness of transversus abdominis at rest and during contraction

Description

Real time ultrasound measurement

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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'. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniella Morton, BSc

Organizational Affiliation

University of Nevada Las Vegas Physical Therapy

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sarah Buckingham, BSc

Organizational Affiliation

University of Nevada Las Vegas Physical Therapy

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Crystal Montoya, BSc

Organizational Affiliation

Univesity of Nevada Las Vegas Physical Therapy

Official's Role

Study Director

Facility Information:

Facility Name

University of Nevada Las Vegas - Department of Physical Therapy

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89154

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29187313

Citation

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.

Results Reference

derived

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Effect of Dry Needling Multifidus on Thickness of Transversus Abdominis in Healthy Individuals

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