NCT07112404 Pain Intervention With Needling: Pilot Of Integrated Neuromodulation Techniques
| NCT ID | NCT07112404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Medical Branch, Galveston |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2025-10-23 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07112404 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07112404 currently recruiting?
Yes, NCT07112404 is actively recruiting participants. Contact the research team at rypontif@utmb.edu for enrollment information.
Where is the NCT07112404 trial being conducted?
This trial is being conducted at Galveston, United States.
Who is sponsoring the NCT07112404 clinical trial?
NCT07112404 is sponsored by The University of Texas Medical Branch, Galveston. The trial plans to enroll 42 participants.