Pain Intervention With Needling: Pilot Of Integrated Neuromodulation Techniques

NCT07112404 | Recruiting

• 2 other identifiers: 25-0109K12NS130673
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Assess the acceptability and feasibility of the protocol- Phase 1 Healthy Participants

  Acceptability and feasibility will be assessed through an interview and retention records at the end of the study.

  one week, up to 3 months

• Assess the acceptability and feasibility of the protocol- Phase 2 Those with Chronic Low Back Pain

  Acceptability and feasibility will be assessed through an interview and retention records at the end of the study.

  3 months, up to 2 years.

Secondary Outcomes (19)

• Physiological Activity Level Measured by ActiGraph for Phase 1 and Phase 2

  1 day (30-60 minutes)

• Physiological Activity Level Measured by Shimmer3 Galvanic Skin Response(GSR) +Unit for Phase 1 and Phase 2

  1 day (30-60 minutes)

• Physiological Activity Level Measured by Shimmer3 ECG Unit for Phase 1 and Phase 2

  1 day (30-60 minutes)

• Physiological Activity Level Measured by Clario Opal for Phase 1 and Phase 2

  1 day (30-60 minutes)

• Michigan Visual Stress Test (M-VAST) for Phase 1 and Phase 2

  1 day (30-60 minutes)

Study Arms (3)

Dry Needling Only Group

EXPERIMENTAL

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

Other: Dry Needling

Dry Needling Plus high-rate PENS

EXPERIMENTAL

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

Other: Dry needling with high-rate PENS

Dry Needling Plus low-rate PENS

EXPERIMENTAL

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

Other: Dry needling with low-rate PENS

Interventions

Dry Needling OTHER

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 Only Group

Dry needling with high-rate PENS OTHER

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 Plus high-rate PENS

Dry needling with low-rate PENS OTHER

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.

Dry Needling Plus low-rate PENS

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Pain; Back Pain; Low Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Ryan Pontiff, PT, DPT, PhD

CONTACT

409-772-0310; rypontif@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 8, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)