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Effects of Two Different Dry-Needling Techniques for Low Back Pain

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ClinicalTrials.gov Identifier: NCT03970486
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Sharon Wang-Price, Texas Woman's University

Brief Summary:
Although dry-needling with or without manipulation has shown to be a useful technique to reduce pain in patients with low back pain (LBP), it is unclear which of these two dry-needling techniques would have a greater effect on the lumboscaral multifidus (LM) muscle activation, which is essential in LBP rehabilitation. Therefore, the purposes of the study are: 1) to investigate whether or not dry-needling would change muscle activity of the LM muscles in asymptomatic healthy adults and in individuals with LBP, respectively, and 2) to compare the effects of two dry-needling techniques on LM muscle activation and pressure pain threshold (PPT) in asymptomatic healthy adults and individuals with LBP, respectively.

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Dry needling Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned into two dry needling treatment groups.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Two Different Dry-Needling Techniques on Lumbar Multifidus Muscle Activation and Pressure Pain Threshold in Healthy Adults and Patients With Low Back Pain
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Needle Manipulation
Participant will receive dry needling intervention with manipulation.
Procedure: Dry needling
For the needle manipulation technique, the needle will be pulled in and out (sparrow pecking) and redirected in small angles (coning) for 5-10 seconds. For the in situ technique, the needles will stay (in situ) in the left and right lumbar multifidus muscles for 10 minutes after the insertion of the needle.

Active Comparator: In Situ
Participant will receive dry needling intervention without manipulation.
Procedure: Dry needling
For the needle manipulation technique, the needle will be pulled in and out (sparrow pecking) and redirected in small angles (coning) for 5-10 seconds. For the in situ technique, the needles will stay (in situ) in the left and right lumbar multifidus muscles for 10 minutes after the insertion of the needle.




Primary Outcome Measures :
  1. Change of Muscle activity [ Time Frame: Before intervention, immediately after intervention and one week after intervention ]
    An electroencephalographic (EMG) system with 4 wireless surface electrodes will be used to obtain muscle activities of the right and left lumbar multifidus muscles at the L5 and S2 levels.

  2. Change of Pressure pain threshold [ Time Frame: Before intervention, immediately after intervention and one week after intervention ]
    A hand-held computerized pressure algometer will be used to determine the pressure pain threshold on the same 4 sites of EMG recording.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English-speaking adults and are 18 years of age or older.
  • For asymptomatic healthy adults: no existing low back pain (LBP) and no LBP in the past 6 months.
  • For individuals with LBP: existing LBP near the L5-S1 level with an average pain intensity score ≥ 2/10 in the past 24 hours (numeric pain rating scale of 0-10, 0 being no pain, 10 being unbearable pain)

Exclusion Criteria (for both the asymptomatic healthy and patients with low back pain groups) :

  • Bleeding disorders (e.g. hemophilia)
  • Use of anti-coagulants (e.g. Coumadin)
  • Previous low back surgery, systemic joint disease (e.g. rheumatoid arthritis)
  • Cancer of the lower quadrant,
  • Neurological disorders
  • Allergic reaction to adhesive tape
  • Inability to obtain testing positions (prone lying)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970486


Contacts
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Contact: Sharon Wang-Price, PhD 2146897715 swang@twu.edu

Locations
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United States, Texas
Texas Woman's University Recruiting
Dallas, Texas, United States, 75235
Contact: Sharon Wang-Price, PhD    214-689-7715    swang@twu.edu   
Sponsors and Collaborators
Texas Woman's University
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Sharon Wang-Price Texas Woman's University

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Responsible Party: Sharon Wang-Price, Professor, Texas Woman's University
ClinicalTrials.gov Identifier: NCT03970486     History of Changes
Other Study ID Numbers: 19750
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms