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

Not Applicable

Recruiting

• Conditions: Low Back Pain

• Registration Number: NCT06204055
• Lead Sponsor: Whitworth University

Brief 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.

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-08
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	Baseline, week 1, week 2 and week 3	self reported questionnaire that is used to measure a patient's permanent functional disability.

Secondary Outcome Measures

Name	Time	Method
Fear-Avoidance Beliefs Questionnaire	Baseline, week 1, week 2 and week 3	self reported questionnaire that is used to measure a patient's fear associated with movement and/or work
11 point Numeric Pain-Rating Scale	Baseline, week 1, week 2 and week 3	self reported scale that is used to rate subjective intensity of back and leg pain

Trial Locations

Locations (1)

Whitworth University; 🇺🇸 Spokane, Washington, United States