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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

After the physical examination has been performed, each participant will be randomized to receive IMDN or SIMDN. Randomization will be completed by use of a computer-generated list of random numbers that will designate group assignment. The PI will inform the study PTs of the participants group assignment. The list will be maintained by a research assistant who is not involved with participant recruitment, examination or treatment. Participants will be blinded to group assignment.

Study Groups

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Intramuscular Dry-Needling

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

Group Type EXPERIMENTAL

Intramuscular Dry-Needling

Intervention Type OTHER

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 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

Group Type SHAM_COMPARATOR

Intramuscular Dry-Needling

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes