NCT06204055

The Derivation of a Clinical Prediction Rule to Identify Those With Low Back Pain Who Will Respond Favorably to Intramuscular Dry-needling

The Derivation of a Clinical Prediction Rule to Identify Those With Low Back Pain Who Will

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Whitworth University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate specific clinical characteristics, amongst those with low back pain, that identify patient appropriateness for Intermuscular Dry-Needling (IMDN) and to develop a prediction tool that can be used by clinicians.

Detailed description

The aim of the CPR is to identify patients with LBP who are likely to benefit from IMDN. Improvement of patient-reported outcomes and clinical measures of pain are the outcomes being predicted by the model. The CPR will be developed in a double-phase design. The first phase will be an RCT, 2 x 3 group (IMDN or Sham) by time (pretest, post-treatment week 1, post-treatment week 2, posttest, follow-up) with repeated measures on timeframe. This design will establish if improvement of patient reported outcomes and clinical measures of pain are achieved because of the IMDN treatment. Furthermore, each group will receive the same type and volume of lumbar and hip stretching exercises in conjunction with their assigned needling regimen. The second phase will utilize logistic regression analysis to identify associations between the groups' demographic, historical, clinical variables and short-term pain and disability outcomes. This type of analysis will be able to identify strong predictors of the treatment outcome. Various processes will be used to determine optimal model fit for analysis.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Intramuscular Dry-Needling	It is a minimally invasive procedure where a solid filament needle is inserted deeply into a myofascial trigger point (MTrP) within a muscle in an attempt to abate it and illicit a desired treatment effect.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-08-01
• Completion: 2024-11-01
• First posted: 2024-01-12
• Last updated: 2024-01-12

Locations

1 site across 1 country: United States