Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-01 @ 4:55 PM
Study NCT ID:
NCT07112404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Intervention With Needling: Pilot Of Integrated Neuromodulation Techniques
Sponsor:
The University of Texas Medical Branch, Galveston
Organization:
Study Overview
Official Title:
PINPOINT Study: Pain Intervention With Needling: Pilot Of Integrated Neuromodulation Techniques
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PINPOINT
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K12NS130673 | NIH | None | https://reporter.nih.gov/quic… | View |