Using Structural Health Monitoring to Improve Diagnosis and Treatment of Low Back Injury in U.S. Service Members- Phase 2

NCT ID: NCT02352532

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-08-31

Brief Summary

The focus of this project is to evaluate the diagnostic utility of Shear Wave Elastography (SWE) in individuals after routine low back injury and begin an initial investigation of it's ability to effectively guide physical therapy treatment with dry-needling as a relevant treatment intervention.

Specific Aim #1: Evaluate the diagnostic utility of SWE in differentiating individuals with and without LBP. The investigators will also examine the interaction between tissue change and clinical improvement. The investigators hypothesize that individuals with LBP will have higher muscle stiffness (shear modulus) at rest and impaired (lower) stiffness during contraction than individuals without LBP.

Specific Aim #2: Evaluate the effectiveness of dry-needling in decreasing aberrant muscle stiffness in individuals with LBP. The investigators hypothesize that individuals with LBP that receive dry-needling will exhibit larger changes than both individuals with LBP that receive sham dry-needling and than individuals without LBP that receive dry-needling.

Specific Aim #3: Evaluate the effectiveness of dry-needling in decreasing pain and disability in individuals with LBP. The investigators hypothesize that individuals with LBP that receive dry-needling will exhibit larger improvements than individuals with LBP that receive sham dry-needling.

Detailed Description

Low back pain (LBP) is the second most frequent reason for health care visits and a leading cause of medical evacuation from theater. Traditional medical diagnosis based on static imaging strategies (e.g. MRI) has failed to improve management of this epidemic. Functional assessment of lumbar musculature using ultrasound imaging provides evidence of clinically relevant deficits in the lumbar multifidus (LM) muscle of patients with LBP, however such procedures are likely only valid within a narrow range of assessment conditions. Shear-Wave Elastography (SWE) is an evolving non-invasive ultrasound imaging technology capable of quantifying tissue stiffness (i.e., elasticity). Originally developed to improve diagnosis of soft tissue tumors, SWE is beginning to be used to as an alternative and more stable method of functional assessment of muscles.

This study will be the second project in a line of research aimed at improving the diagnosis, management, and treatment of patients with LBP using a new structural health monitoring technique called shear wave elastography (SWE). Since no previous studies had used SWE in the lumbar multifidus muscle, the initial project developed the measurement technique to be used with this device. We also established normative parameters, variance, and reliability estimates of SWE outcomes in asymptomatic individuals. A previous study, also performed at AMEDDC&S, found that individuals with LBP whom received dry needling to the lumbar multifidus muscle exhibited a reduction in pain and disability that was associated with an improved ability to contract the lumbar multifidus. The focus of this second project is to evaluate the diagnostic utility of SWE in individuals after routine low back injury and begin an initial investigation of it's ability to effectively guide physical therapy treatment with dry-needling as a relevant treatment intervention.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Low Back Pain - Dry Needling

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: OTHER

The dry-needling treatment will consist of inserting a sterile needle into needling the prone participant's lumbar multifidus and paraspinal muscles, 1-2 times each, in regions of local tenderness to palpation and/or regions with palpable trigger points. All needling treatment will be performed with FDA approved (FDA regulation # 880.5580) disposable 0.30 x 50-60 mm stainless steel Seirin J-type needles (Seirin, Japan). Each needle insertion will last approximately 5 seconds using a "pistoning" (in and out) technique.

Low Back Pain - Sham

Group Type: SHAM_COMPARATOR

Sham Needling

Intervention Type: OTHER

The sham dry-needling procedure will mimic the dry needling procedures by placing a sharp object in a needling guide tube against the skin (see figure). The sharp object will be rocked and twisted to simulate treatment, but will not pierce the skin. We have used this sham dry-needling technique in a previous study performed at AMEDDC\&S and have found it to be indistinguishable from real dry needling by the great majority of participants.

Asymmptomatic - Dry Needling

Group Type: ACTIVE_COMPARATOR

Dry Needling

Intervention Type: OTHER

The dry-needling treatment will consist of inserting a sterile needle into needling the prone participant's lumbar multifidus and paraspinal muscles, 1-2 times each, in regions of local tenderness to palpation and/or regions with palpable trigger points. All needling treatment will be performed with FDA approved (FDA regulation # 880.5580) disposable 0.30 x 50-60 mm stainless steel Seirin J-type needles (Seirin, Japan). Each needle insertion will last approximately 5 seconds using a "pistoning" (in and out) technique.

Interventions

Dry Needling

The dry-needling treatment will consist of inserting a sterile needle into needling the prone participant's lumbar multifidus and paraspinal muscles, 1-2 times each, in regions of local tenderness to palpation and/or regions with palpable trigger points. All needling treatment will be performed with FDA approved (FDA regulation # 880.5580) disposable 0.30 x 50-60 mm stainless steel Seirin J-type needles (Seirin, Japan). Each needle insertion will last approximately 5 seconds using a "pistoning" (in and out) technique.

Intervention Type: OTHER

Sham Needling

The sham dry-needling procedure will mimic the dry needling procedures by placing a sharp object in a needling guide tube against the skin (see figure). The sharp object will be rocked and twisted to simulate treatment, but will not pierce the skin. We have used this sham dry-needling technique in a previous study performed at AMEDDC\&S and have found it to be indistinguishable from real dry needling by the great majority of participants.

Intervention Type: OTHER

Other Intervention Names

Trigger point dry needling

Eligibility Criteria

Inclusion Criteria

• Between the age of 18 - 65 years
• Read and speak English well enough to provide informed consent and follow study instructions
• Active duty military or DOD beneficiary
• History of prior surgery to the lumbosacral spine
• Received manual therapy, acupuncture, or dry-needling interventions to the lumbosacral spine within the past 4 weeks
• Currently taking anticoagulant medications or those individuals with a medical history of bleeding disorder
• History of systemic inflammatory disease or other serious spinal pathology (e.g. annular tears of the intervertebral disc, spinal stenosis, fracture)
• Known pregnancy and/or inability to lie prone and fully elevate bilateral arms
• Presence of neurogenic LBP defined by either a positive ipsilateral or contralateral straight leg raise (reproduction of symptoms at <45°) or reflex, sensation, or strength deficits in a pattern consistent with nerve root compression
• Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease

Exclusion Criteria

• History of prior surgery to the lumbosacral spine
• Received manual therapy, acupuncture, or dry-needling interventions to the lumbosacral spine within the past 4 weeks
• Currently taking anticoagulant medications or those individuals with a medical history of bleeding disorder
• History of systemic inflammatory disease or other serious spinal pathology (e.g. annular tears of the intervertebral disc, spinal stenosis, fracture)
• Known pregnancy and/or inability to lie prone and fully elevate bilateral arms
• Presence of neurogenic LBP defined by either a positive ipsilateral or contralateral straight leg raise (reproduction of symptoms at <45°) or reflex, sensation, or strength deficits in a pattern consistent with nerve root compression
• Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Telemedicine & Advanced Technology Research Center (TATRC)

UNKNOWN

Sponsor Role: collaborator

Army Medical Department Center and Schools

UNKNOWN

Sponsor Role: collaborator

Baylor University

OTHER

Sponsor Role: lead

Responsible Party

Shane Koppenhaver

PT, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Army Medical Department Center and Schools

Fort Sam Houston, Texas, United States

Countries

United States

Other Identifiers

#10586012

Identifier Type: -

Identifier Source: org_study_id