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

NCT02284724 | Completed

• 1 other identifier: 1202-4059
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (2)

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

  Using real-time ultrasound imaging to measure thickness in milimeters

  Immediate

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

  Using real-time ultrasound imaging to measure thickness in milimeters

  Immediate

Secondary Outcomes (2)

• Numeric Pain Rating Scale 10 point pain scale

  Immediate and 48 hours later

• Oswestry Disability Index

  48 hours later

Study Arms (2)

Needling

EXPERIMENTAL

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

Procedure: Dry Needling

Sham

OTHER

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

Procedure: Sham Needling

Interventions

Dry Needling PROCEDURE

Needling

Sham Needling PROCEDURE

Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada Las Vegas - Department of Physical Therapy

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 6, 2014
• Study Start: November 1, 2014
• Primary Completion: May 30, 2018
• Study Completion: June 30, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

US (1)