Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT07112404
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07112404
Study Brief:
Protocol Section:
NCT07112404