Pain Intervention With Needling: Pilot Of Integrated Neuromodulation Techniques
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe University of Texas Medical Branch, Galveston
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Both males and females between the ages of 18 and 65 will be included in this study.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dry Needling
Other interventionDry 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
Other interventionDry 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
Other interventionDry 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.
Treatment groups
42 Participants
are divided into 3 treatment groupsGroup A: Dry Needling Only GroupExperimental treatment 1 intervention
Group B: Dry Needling Plus high-rate PENSExperimental treatment 1 intervention
Group C: Dry Needling Plus low-rate PENSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
one week, up to 3 months2
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.
Time frame
3 months, up to 2 years.Secondary outcomes
1
Physiological Activity Level Measured by ActiGraph for Phase 1 and Phase 2
Time spent in sedentary, low-intensity, and moderate-to-vigorous physical activity. Physical activity will be measured while enrolled in the study using the ActiGraph GT9X accelerometers. Higher = More activity (better).
Time frame
1 day (30-60 minutes)2
Physiological Activity Level Measured by Shimmer3 Galvanic Skin Response(GSR) +Unit for Phase 1 and Phase 2
Lower GSR often indicates less arousal.
Time frame
1 day (30-60 minutes)3
Physiological Activity Level Measured by Shimmer3 ECG Unit for Phase 1 and Phase 2
Beats per minute (BPM) will be collected and assessed from baseline while utilizing dry needling procedures.
Time frame
1 day (30-60 minutes)4
Physiological Activity Level Measured by Clario Opal for Phase 1 and Phase 2
Clario Opal-often called the Opal V2C® System-is a medical-grade wearable sensor solution that captures objective digital endpoints of mobility. It tracks gait, balance, and other functional mobility tasks using validated protocols and analytics. Higher gait speed/balance = better.
Time frame
1 day (30-60 minutes)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Medical Branch, Galveston
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov