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

NCT06204055 | Unknown

• 1 other identifier: 878_Severino
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low Back Pain; Dry-Needling; Myofascial Pain; Treatment Based Classification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fear-Avoidance Beliefs Questionnaire

  Baseline, week 1, week 2 and week 3

• 11 point Numeric Pain-Rating Scale

  Baseline, week 1, week 2 and week 3

Study Arms (2)

Intramuscular Dry-Needling

EXPERIMENTAL

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

Other: Intramuscular Dry-Needling

Sham Intramuscular Dry-Needling

SHAM COMPARATOR

). 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

Interventions

Intramuscular Dry-Needling 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.

Intramuscular Dry-Needling; Sham Intramuscular Dry-Needling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Whitworth University: lead

Study Sites (1)

Whitworth University

Spokane, Washington, 99251, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dominic Severino, PT,DPT

  Whitworth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominic J Severino, PT,DPT

CONTACT

5097774687; dseverino@whitworth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)