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Dry Needling to the Multifidus Muscle in Subjects With Low Back Pain

Primary Purpose

Low Back Pain, Mechanical

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Needling
Sham Needling
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age, current symptoms of mechanical low back pain or any symptoms experienced within the last 6 months, and ability to perform DCC.
  • Subjects must also report they are comfortable with being 'needled', that is, they should not express a fear of needles and being needled.
  • If subjects express fear of needles or being needled, they will be excluded from the study.

Exclusion Criteria:

  • History of: abdominal or spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia, active ankylosing spondylitis, anticoagulant therapy, hemophilia, lymphedema, and cancer.
  • If a subject reports a fear of needles.
  • History of adverse reaction to needling (or injection) in the past.

Sites / Locations

  • University of Nevada Las Vegas - Department of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Needling

Sham

Arm Description

Insertion of solid mono-filament needle into lumbar multifidus muscle at both sides of L4/5 segment

The plastic tube containing the mono-filament needle will be pressed into the skin over the lumbar multifidus muscle at both sides of L4/5 segment - without insertion through the skin

Outcomes

Primary Outcome Measures

Resting thickness transversus abdominis Using real-time ultrasound imaging to measure thickness in milimeters
Using real-time ultrasound imaging to measure thickness in milimeters
Contracted thickness transversus abdominis Using real-time ultrasound imaging to measure thickness in milimeters
Using real-time ultrasound imaging to measure thickness in milimeters

Secondary Outcome Measures

Numeric Pain Rating Scale 10 point pain scale
10 point pain scale
Oswestry Disability Index
Patient reported outcome measure

Full Information

First Posted
November 3, 2014
Last Updated
October 22, 2018
Sponsor
University of Nevada, Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT02284724
Brief Title
Dry Needling to the Multifidus Muscle in Subjects With Low Back Pain
Official Title
The Effect of Trigger Point Dry Needling to the Multifidus Muscle on Resting and Contracted Thickness of Transversus Abdominis in Subjects With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (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
No

5. Study Description

Brief Summary
To examine for differences in contraction thickness of the transversus abdominis muscle in symptomatic subjects with mechanical lower back pain following the application of dry needling to the lumbar multifidus muscles.
Detailed Description
Consenting subjects will be pre-screened for contraindications for dry needling and whether or not they meet the criteria for low back pain. Following acceptance and prior to intervention sessions, subjects will complete a pre-participation questionnaire. This will be used to check for any needle phobia or previous adverse reactions to needling in prospective subjects and analyze potential confounding variables within the subjects participating. Once consented and accepted into the study, subjects will be taught the deep corset contraction (DCC), which is the isolated co-contraction of bilateral transversus abdominis and the deep fibers of lumbar multifidus. Following DCC training, the subject will have a real-time ultrasound transducer applied to the lateral abdominal wall in order to image the three abdominal muscle layers external oblique, internal oblique and transversus abdominis. A relaxed state measure will be taken from the ultrasound image. Subjects will then perform the DCC and a second measure of the abdominal muscles will be taken. A percentage thickness change will be calculated. Prior to treatment, subjects will have been randomly assigned to one of 2 intervention ordered groups: 1) Dry needling: subjects will be placed prone and dry needling to the bilateral multifidus muscles will be performed. Subjects will sense light pressure and their skin will be penetrated by the needle. 2) Sham needling: subjects will be placed prone and the plastic tubes which house the needles for dry needling will be pressed into the bilateral multifidus muscles.Subjects will sense light pressure, but their skin will not be penetrated. All needling and sham needling interventions will be performed under "clean needle" conditions using appropriate skin preparation and use of clean protective gloves by the PI. The needles used will be single-use disposable acupuncture-style needles which come in a plastic tube for easy insertion. Dry needling techniques are techniques that many practicing therapists use for various musculoskeletal conditions, and are also taught by the PI as part of the requirements for the Doctor of Physical Therapy degree. For this study, all needling and sham needling interventions will be performed by the PI who has over 27 years experience in such interventions. Immediately following the needling or sham needling, the real-time ultrasound will be reapplied to measure thickness of the abdominal muscles in the relaxed state and contracted state using the DCC, and percent changes will be calculated. Measurements will be collected by one of three independent researchers who will be blinded to the intervention. An average of 3 measurements will be used to calculate the percent thickness change after the treatment. In addition, the PI performing the needling will remain blinded to ultrasound measurements. Subjects will then be contacted by phone 48 hours as well as one week after the intervention was given in which they will verbally complete questionnaires regarding their degree of pain and level of disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Needling
Arm Type
Experimental
Arm Description
Insertion of solid mono-filament needle into lumbar multifidus muscle at both sides of L4/5 segment
Arm Title
Sham
Arm Type
Other
Arm Description
The plastic tube containing the mono-filament needle will be pressed into the skin over the lumbar multifidus muscle at both sides of L4/5 segment - without insertion through the skin
Intervention Type
Procedure
Intervention Name(s)
Dry Needling
Intervention Type
Procedure
Intervention Name(s)
Sham Needling
Primary Outcome Measure Information:
Title
Resting thickness transversus abdominis Using real-time ultrasound imaging to measure thickness in milimeters
Description
Using real-time ultrasound imaging to measure thickness in milimeters
Time Frame
Immediate
Title
Contracted thickness transversus abdominis Using real-time ultrasound imaging to measure thickness in milimeters
Description
Using real-time ultrasound imaging to measure thickness in milimeters
Time Frame
Immediate
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale 10 point pain scale
Description
10 point pain scale
Time Frame
Immediate and 48 hours later
Title
Oswestry Disability Index
Description
Patient reported outcome measure
Time Frame
48 hours later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age, current symptoms of mechanical low back pain or any symptoms experienced within the last 6 months, and ability to perform DCC. Subjects must also report they are comfortable with being 'needled', that is, they should not express a fear of needles and being needled. If subjects express fear of needles or being needled, they will be excluded from the study. Exclusion Criteria: History of: abdominal or spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia, active ankylosing spondylitis, anticoagulant therapy, hemophilia, lymphedema, and cancer. If a subject reports a fear of needles. History of adverse reaction to needling (or injection) in the past.
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

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Dry Needling to the Multifidus Muscle in Subjects With Low Back Pain

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