Actively Recruiting
PINPOINT Study: Pain Intervention With Needling: Pilot Of Integrated Neuromodulation Techniques
Led by The University of Texas Medical Branch, Galveston · Updated on 2026-03-16
42
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Medical Branch, Galveston
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how three different dry needling treatments affect pain and quality of life in people with chronic low back pain. Dry needling involves inserting very thin needles into muscles to reduce pain, improve muscle activation, increase blood flow, and support nervous system function. The study includes two phases: a short initial phase with healthy adults and a longer phase with people experiencing chronic low back pain. In phase 1, healthy participants will attend three sessions over 1 to 2 weeks to test the procedure's feasibility. In phase 2, participants with chronic low back pain will be randomly assigned to one of three groups: dry needling alone, dry needling plus high-rate electrical nerve stimulation, or dry needling plus low-rate electrical nerve stimulation. They will undergo six intervention visits, assessments before and after treatment, a washout period, an interview, and follow-up surveys lasting up to 4 to 5 months. Participants will wear comfortable clothing to allow access to the lower back and undergo various assessments including pain rating scales, physical tests like a 6-minute walk, and physiological monitoring using devices measuring skin response and heart activity. The study monitors acceptability, feasibility, and outcomes related to pain, quality of life, and function. Follow-up surveys occur at one and three months after treatment to assess lasting effects, with the entire study expected to finish around 2027.
CONDITIONS
Brief Title
Pain Intervention With Needling: Pilot Of Integrated Neuromodulation Techniques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Healthy adults with no lumbar region pain for more than 1 day in the past 3 months (Phase 1)
- Adults with chronic low back pain lasting at least 3 months
- Pain present at least 75% of days in the past 3 months (Phase 2)
- Both males and females are eligible
You will not qualify if you...
- Currently receiving medical treatments for lumbar conditions beyond routine physician follow-up
- Previous lumbar surgeries causing structural abnormalities that affect needle placement (e.g., lumbar fusion or scoliosis rod placement)
- Experiencing radicular symptoms past the knee or electrical in nature
- Having neurological conditions or cognitive deficits requiring assistance
- Conditions affecting sensory processing such as peripheral neuropathy, skin conditions, or circulatory disorders
- Taking anticoagulants or having compromised immune system
- Local or systemic infection, active tumor, history of lymph node removal, autoimmune disease
- Allergy to metals like nickel or chromium
- History of cosmetic procedures in the lumbar area
- Pregnancy or osteoporosis
- Non-English speakers due to communication needs during procedures
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 months for Phase 2; 1 to 2 weeks for Phase 1
Participants in Phase 1 take part in up to 3 sessions over 1 to 2 weeks involving dry needling interventions. In Phase 2, participants are randomized into one of three groups and complete a baseline assessment, 6 intervention visits with dry needling (with or without electrical nerve stimulation), and a post-intervention assessment including a one-on-one interview.
Phase 1: 3 sessions at least 1 day apart; Phase 2: 1 baseline assessment, 6 intervention visits, 1 post-intervention assessment
Duration - Approximately 3 months
After treatment, participants complete a washout period of at least 2 weeks followed by one- and three-month survey follow-ups to assess outcomes and experiences.
Survey follow-ups at 1 month and 3 months post-intervention
Trial Site Locations
Total: 1 location
1
University of Texas Medical Branch, Galveston
Galveston, Texas, United States, 77555
Actively Recruiting
Research Team
R
Ryan Pontiff, PT, DPT, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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