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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204055
• Other study ID #: 878_Severino
• Status: Recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Whitworth University
• Contact: Dominic J Severino, PT,DPT
• Phone: 5097774687
• Email: dseverino[@]whitworth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: November 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Whitworth University	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Whitworth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index	self reported questionnaire that is used to measure a patient's permanent functional disability.	Baseline, week 1, week 2 and week 3
Secondary	Fear-Avoidance Beliefs Questionnaire	self reported questionnaire that is used to measure a patient's fear associated with movement and/or work	Baseline, week 1, week 2 and week 3
Secondary	11 point Numeric Pain-Rating Scale	self reported scale that is used to rate subjective intensity of back and leg pain	Baseline, week 1, week 2 and week 3