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

Whitworth University

Status: Enrolling

Conditions: Low Back Pain

Treatments: Other: Intramuscular Dry-Needling

Study type: Interventional

Funder types: Other

Identifiers

NCT06204055

878_Severino

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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85 participants in 2 patient groups

Intramuscular Dry-Needling

Experimental group

Description:

(IMDN) is a minimally invasive procedure where a solid filament needle is inserted into a myofascial trigger point.

Treatment:

Other: Intramuscular Dry-Needling

Sham Intramuscular Dry-Needling

Sham Comparator group

Description:

). 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

Treatment:

Other: Intramuscular Dry-Needling