Recruiting

Dry Needling

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT07112404

Conditions

Pain

Back Pain

Lower Back Pain

Quality of Life

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Dry Needling

Dry needling with high-rate PENS

Dry needling with low-rate PENS

Study Details

Brief summary:

The study will be conducted on site in Galveston, Texas, United States. Study-related assessments and procedures will be performed at the designated clinical study site by qualified study personnel in accordance with the study protocol and applicable regulatory requirements.

The study's purpose is to determine the effects of three different dry needling sessions on pain and quality of life for those with chronic low back pain. Dry needling is a therapeutic procedure in which a very thin, monofilament needle is inserted through the skin to reach a target tissue like a muscle to help reduce pain, improve muscle activation, and increase blood flow. Dry needling has also been shown to improve nervous system function.

Conditions

Pain

Back Pain

Lower Back Pain

Quality of Life

Study ID

NCT07112404

Start date

Oct 23, 2025

Status verified date

Aug, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Both males and females between the ages of 18 and 65 will be included in this study.

Phase 1 Inclusion criteria

\- Healthy adults who report no pain for more than 1 day in the past 3 months in their lumbar region. Lumbar region will include posterior lumber musculature, lumbar spine, sacroiliac pain, or superior gluteal area pain.

Phase 2 Inclusion criteria

  • Adults experiencing chronic low back pain. Chronic low back pain will be identified as having pain the lumbar region for at least 3 months. The pain may be constant or episodic in nature.
  • Participants will be included if they experience pain at least 75% of the days in the past 3 months. All pain levels will be included. Lumbar region will include posterior lumber musculature, lumbar spine, sacroiliac pain, or superior gluteal area pain.

Exclusion Criteria:

  • Individuals who are currently seeking any form of medical treatment for lumbar conditions beyond routine physician follow-up appointments in order to avoid confounding variables, regardless of pain-free status. These may include, but are not limited to, seeking treatment from a chiropractor, acupuncturist, or massage therapist or medical procedures such as injections into the lumbar region for pain.
  • Additionally, those with previous lumbar surgeries or those with previous major injuries to the lumbar spine that may have resulted in structural abnormalities that may compromise needle placement will be excluded. If surgical procedures did not alter structural alignment, then it will be allowed. For example, an approved procedure may include discectomy or nerve ablation, while a not approved procedure would include a lumbar fusion or scoliosis rod placement.
  • Additionally, if a person is experiencing radicular symptoms from a back injury, despite not feeling the symptoms in the lumbar region, will not be considered. Radicular symptoms will be defined as those present past the knee and/or electrical in nature. Individuals with neurological conditions or those who need the services of another due to cognitive deficits will not be considered for this study.
  • Furthermore, as this study relies on an intact sensory system, participants with conditions that may affect sensory processing (e.g., peripheral neuropathy, skin conditions, or circulatory disorders) will be excluded through careful screening.

Additional exclusion criteria

  • Will include the following conditions identified as contraindications for dry needling: those with impaired sensitivity, taking anticoagulants, a compromised immune system, a local or systemic infection, an active tumor, history of lymph node removal, history of autoimmune disease, allergy to metals such as nickel or chromium, history of cosmetic procedures in the area, pregnant individuals, or osteoporosis.
  • Non-English-speaking subjects will be excluded from the study due to the need to understand any communication while dry-needling procedures are taking place.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dry Needling Only Group

This group will receive dry needling only. The group will receive the dry needling at visits 2-7.

experimental: Dry Needling Plus high-rate PENS

This grouping will receive dry needling plus high-rate PENS. The group will receive the dry needling at visits 2-7.

experimental: Dry Needling Plus low-rate PENS

This grouping will receive dry needling plus low-rate PENS. The group will receive the dry needling at visits 2-7.

Interventions

Dry Needling

Dry needling is a therapeutic technique where thin, solid filiform needles are inserted into trigger points, tight muscle bands, or areas of muscle tension without injecting any medication. The procedure aims to release muscle knots, reduce pain, and improve muscle function by stimulating the body's natural healing response.

Dry needling with high-rate PENS

Dry needling is a therapeutic technique where thin, solid filiform needles are inserted into trigger points, tight muscle bands, or areas of muscle tension without injecting any medication. The procedure aims to release muscle knots, reduce pain, and improve muscle function by stimulating the body's natural healing response.

When combined with high-rate percutaneous electrical nerve stimulation (PENS), the needles serve as electrodes for delivering a controlled, high-frequency electrical current directly to the targeted tissues. This electrical stimulation further modulates pain signals, promotes muscle relaxation, and can enhance the effectiveness of dry needling, especially for persistent pain and neuromuscular dysfunction.

Dry needling with low-rate PENS

Dry needling is a therapeutic technique where thin, solid filiform needles are inserted into trigger points, tight muscle bands, or areas of muscle tension without injecting any medication. The procedure aims to release muscle knots, reduce pain, and improve muscle function by stimulating the body's natural healing response.

When combined with low-rate percutaneous electrical nerve stimulation (PENS), the needles serve as electrodes for delivering a controlled, low-frequency electrical current directly to the targeted tissues. This electrical stimulation further modulates pain signals, promotes muscle relaxation, and can enhance the effectiveness of dry needling, especially for persistent pain and neuromuscular dysfunction.

Primary outcome measure

  • Assess the acceptability and feasibility of the protocol- Phase 1 Healthy Participants [ Time Frame: one week, up to 3 months ]
  • Assess the acceptability and feasibility of the protocol- Phase 2 Those with Chronic Low Back Pain [ Time Frame: 3 months, up to 2 years. ]

Central Contacts and Locations

Central contacts

Ryan Pontiff, PT, DPT, PhD

409-772-0310rypontif@utmb.edu

Locations

University of Texas Medical Branch, Galveston

Recruiting

Galveston, Texas, United States, 77555

Contacts

Ryan Pontiff, PT,DPT,PhD

409-772-0310rypontif@utmb.edu

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2026-08-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.