Recruiting

Dry Needling

Sponsor:

Texas Woman's University

Code:

NCT05111691

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Dry needling

Study Details

Brief summary:

The investigators plan to use a pre-test post-test research design to investigate whether dry needling (DN) has an effect on cortical excitability in patients with chronic low back pain (CLBP), specifically in patients who have developed central sensitization (CS). Therefore, the primary purpose of this study is to examine the immediate effects of a single session of DN on cortical excitability and neurosensory responses in patients CLBP. There are two specific aims: 1) to examine whether a single session of DN will change cortical excitability corresponding to the lumbar multifidus (LM) muscle, and 2) to examine whether a single session of DN will change neurosensory responses to the stimuli applied to the LM muscles.

The investigators also are interested in exploring whether DN has a differential effect on cortical excitability in patients with CLBP who have developed CS vs. those who have not developed CS. Therefore, the secondary purpose of the study is to compare the immediate effects of a single session of DN on cortical excitability between patients with CLBP who have developed central sensitization (CS) and those who do not have CS. The specific aim is to compare cortical excitability corresponding to the LM in participants with and without CS after a single session of DN.

Conditions

Low Back Pain

Study ID

NCT05111691

Start date

Mar 1, 2022

Status verified date

Jun, 2022

Completion date

May 31, 2023

Anticipated

Primary completion date

May 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults 18-65 years of age
  • Have chronic low back pain primarily in the L4-5 area that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months

Exclusion Criteria:

  • Systemic joint disease (e.g. rheumatoid arthritis, psoriasis arthritis)
  • Fracture
  • Infection
  • Tumor
  • Neurological disorders (e.g., radiculopathy, myelopathy, cauda equina syndrome)
  • Cancer
  • Raynaud's disease
  • Pregnancy, previous low back surgery
  • Immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus)
  • Bleeding disorders (e.g. hemophilia)
  • Use of anti-coagulants (e.g. Coumadin)
  • A history of significant head trauma
  • An electrical, magnetic, or mechanical implantation (e.g. cardiac pacemakers or intracerebral vascular clip)
  • A metal implantation in the head and neck areas,
  • A history of seizures or unexplained loss of consciousness
  • An immediate family member with epilepsy
  • Use of seizure threshold lowering medicine
  • Current abuse of alcohol or drugs
  • A history of psychiatric illness requiring medication controls
  • Inability to maintain the testing and treatment positions (i.e., slightly leaning forward while sitting and prone-lying) for 15 minutes at a time

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dry needling

Two needles will be inserted on or near the most tender point of the low back. Two additional needles will be inserted on the opposite side at the level of the most tender point regardless of unilateral or bilateral low back pain (LBP). After piercing the skin, the needle will be directed toward the spinous process in a slight inferior-medial angle (approximately 20-30°). Once the needle is inserted, the treating investigator will use a ultrasound scanner to visualize the needle placement and to confirm that needle has reached the deeper layer of the lumbar multifidus (LM) muscle.

Once the needle placement is confirmed, it will be pulled slightly in and out within the muscle and redirected in small angles for 10 seconds after insertion. The needles will stay (in situ) in the LM for approximately 10 minutes after the insertion and then will be withdrawn.

Interventions

Dry needling

Dry needling

Primary outcome measure

  • Amplitude of motor evoked potential [ Time Frame: Before and immediately after the intervention ]
  • Intracortical facilitation [ Time Frame: Before and immediately after the intervention ]
  • Short-interval intracortical inhibition [ Time Frame: Before and immediately after the intervention ]

Central Contacts and Locations

Central contacts

Sharon Wang-Price

2146897715swang@twu.edu

Jason Zafereo

2146481002Jason.Zafereo@UTSouthwestern.edu

Locations

Texas Woman's University

Recruiting

Dallas, Texas, United States, 75235

Contacts

Sharon Wang-Price, PhD

214-689-7715swang@twu.edu

More Information

Sponsor

Texas Woman's University

Last update posted

Jul 6, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Woman's University on 2022-07-06.