Pain Intervention With Needling: Pilot Of Integrated Neuromodulation Techniques

Official title

PINPOINT Study: Pain Intervention With Needling: Pilot Of Integrated Neuromodulation Techniques

Overview

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.

Detailed description

Phase 1: Specific Aim 1 Once IRB approval is granted, the research team will initiate participant recruitment for Phase 1. This phase aims to recruit participants over a period of 4 months or until 12 participants are enrolled. Participants will be asked to wear comfortable clothing that allows them to move easily and allows access to the lumbar region.

Participants will be expected to participate in 3 sessions. Session 1 will last up to 120 minutes (2 hours), session 2 is expected to last up to 1 hour, and session 3 up to 120 minutes (2 hours). Depending on scheduling availability, participants can be expected to be a part of the study for 1 to 2 weeks. Each session will be at least 1 day apart (24 hours) to allow for their health systems to return to baseline.

Upon completion of data collection, the study team will aim to develop a protocol for publication and disseminate other relevant findings.

Phase 2: Specific Aim 2 Recruitment for Phase 2 will begin once the recruitment procedures for Phase 1 are reviewed with a goal of recruiting 30 participants, 10 in each group. Prior to beginning the study, participants will complete the informed consent for phase 2.

Participants will be block-randomized into one of three intervention groups. Participants in the intervention groups will be expected to participate in a baseline assessment, 6 intervention visits, a 2nd assessment, at least 2 weeks of wash out, a post-intervention assessment with a one-on-one interview, and a one- and three-month survey follow-up. Figure 2 outlines the flow of participation. Participants will be asked to wear comfortable clothing that allows them to move easily and allows access to the lumbar region.

Assessments and interventions are anticipated to be completed within 2 months. When including the follow-up surveys, the total time for participants in this phase to be in the study is anticipated to be 4 to 5 months. The proposed work for study 2 is anticipated to be completed in approximately 1 year with an additional 6 months for manuscript development.

Interventions

• Other 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.
• Other 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 curren
• Other 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

Primary outcome measures

• 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.]

Secondary outcome measures (12)

• Physiological Activity Level Measured by ActiGraph for Phase 1 and Phase 2 [Time frame: 1 day (30-60 minutes)]
• Physiological Activity Level Measured by Shimmer3 Galvanic Skin Response(GSR) +Unit for Phase 1 and Phase 2 [Time frame: 1 day (30-60 minutes)]
• Physiological Activity Level Measured by Shimmer3 ECG Unit for Phase 1 and Phase 2 [Time frame: 1 day (30-60 minutes)]
• Physiological Activity Level Measured by Clario Opal for Phase 1 and Phase 2 [Time frame: 1 day (30-60 minutes)]
• Michigan Visual Stress Test (M-VAST) for Phase 1 and Phase 2 [Time frame: 1 day (30-60 minutes)]
• Physical Assessment Measured by 6-minute walk test for Phase 1 and Phase 2 [Time frame: 1 day (30-60 minutes)]
• Self-Reported Outcome Measured by Numeric Pain Rating Scale for Phase 1 and Phase 2 [Time frame: 1 day (30-60 minutes)]
• Self-Reported Outcome Measured by PROMIS-29+2 for Phase 1 and Phase 2 [Time frame: 1 day (30-60 minutes)]
• Self-Reported Outcome Measured by Roland-Morris Disability Questionnaire for Phase 1 and Phase 2 [Time frame: 1 day (30-60 minutes)]
• Self-Reported Outcome Measured by Patient-Specific Functional Scale for Phase 1 and Phase 2 [Time frame: 1 day (30-60 minutes)]
• Self-Reported Outcome Measured by Complex Medical Symptoms Inventory for Phase 1 and Phase 2 [Time frame: 1 day (30-60 minutes)]
• Self-Reported Outcome Measured by World Health Organization Quality of Life Instrument for Phase 1 and Phase 2(WHOQOL) [Time frame: 1 day (30-60 minutes)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Texas Medical Branch, Galveston — Galveston

Identifiers

NCT: NCT07112404 · 25-0109 · K12NS130673

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗