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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Intramuscular Dry-Needling

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 Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominic J Severino, PT,DPT; Phone Number: 5097774687; Email: dseverino@whitworth.edu

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99251
      • Recruiting
      • Whitworth University
      • Contact: Dominic Severino; Phone Number: 509-777-4687; Email: dseverino@whitworth.edu
      • Contact: Email: dseverino@whitworth.edu
      • Principal Investigator: Dominic Severino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intramuscular Dry-Needling; (IMDN) is a minimally invasive procedure where a solid filament needle is inserted into a myofascial trigger point.	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.
Sham Comparator: Sham Intramuscular Dry-Needling; ). Park sham acupuncture needles (AcuPrime) will be used to perform sham needling for this group. The sham needle functions by allowing the blunted needle to cause a pricking sensation when pushed against the skin, but does not penetrate. This will allow the patient to perceive that the needle is entering the skin while also maintaining therapist-patient contact and interaction time	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Whitworth University
• Investigators: Principal Investigator: Dominic Severino, PT,DPT, Whitworth University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Low Back Pain; Myofascial Pain; Dry-Needling; Treatment Based Classification
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 878_Severino

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No