Identifying patients with low back pain who may benefit from dry needling treatment
The Derivation of a Clinical Prediction Rule to Identify Those With Low Back Pain Who Will
This study is testing if a new tool can help doctors find out which patients with low back pain are likely to benefit from dry needling treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Whitworth University Academic / other |
| Locations | 1 site (Spokane, Washington) |
| Trial ID | NCT06204055 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a clinical prediction rule (CPR) to identify patients with low back pain (LBP) who are likely to respond positively to intramuscular dry needling (IMDN). It will involve a randomized controlled trial comparing IMDN to a sham treatment, with assessments of patient-reported outcomes and clinical measures of pain at multiple time points. The second phase will analyze demographic and clinical variables to find strong predictors of treatment outcomes using logistic regression. The goal is to create a tool that clinicians can use to better select patients for IMDN therapy.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 60 with non-traumatic low back pain and an Oswestry Disability Index score of at least 20.
Not a fit: Patients who are pregnant, taking narcotic pain medication, have had prior lumbosacral spine surgery, or have a BMI greater than 35 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help clinicians more effectively identify patients who will benefit from dry needling, potentially improving pain management for those with low back pain.
How similar studies have performed: Other studies have explored dry needling for pain management, but this specific predictive approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females between the ages of 18 and 60 years with non-traumatic low back pain between the 12th rib and the buttock region. * Participants must also report an Oswestry Disability Index score of at least 20/100 points. Exclusion Criteria: * Participants must be able to speak and read English. * Individuals who are currently pregnant, currently taking pain narcotic medication or have had a prior surgery in the lumbosacral spine * Those participants whose BMI is greater than 35
Where this trial is running
Spokane, Washington
- Whitworth University — Spokane, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Dominic Severino, PT,DPT — Whitworth University
- Study coordinator: Dominic J Severino, PT,DPT
- Email: dseverino@whitworth.edu
- Phone: 5097774687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.