Clinical trial NCT06204055: The Derivation of a Clinical Prediction Rule to Identify Those With Low Back Pain Who Will Respond Favorably to Intramuscular Dry-needling
Official title: The Derivation of a Clinical Prediction Rule to Identify Those With Low Back Pain Who Will
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Dry-Needling
Myofascial Pain
Treatment Based Classification
Lead sponsor: Whitworth University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.

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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: Baseline, week 1, week 2 and week 3
Secondary outcomes:
measure: Fear-Avoidance Beliefs Questionnaire
timeFrame: Baseline, week 1, week 2 and week 3
measure: 11 point Numeric Pain-Rating Scale
timeFrame: Baseline, week 1, week 2 and week 3
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Whitworth University
state: Washington
Study officials:
affiliation: Whitworth University
name: Dominic Severino, PT,DPT
role: PRINCIPAL_INVESTIGATOR
References: