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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dry Needling

Sham Needling

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Dry Needling, Shear Wave Elastography, Ultrasound

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Army Medical Department Center and Schools

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Low Back Pain - Dry Needling

Low Back Pain - Sham

Asymmptomatic - Dry Needling

Arm Description

Outcomes

Primary Outcome Measures

Change in muscle stiffness and activation utilizing shear-wave elastography after dry needling - one week follow-up

SWE images of the lumbar multifidus and paraspinal muscles will be acquired at rest and during sub-maximal isometric contraction. All SWE images will be obtained using a Supersonic Aixplorer ultrasound system with a 50mm 10-2 MHz linear array. The sub-maximal contraction of the lumbar multifidus will be elicited by a contralateral arm lift maneuver while holding a small hand weight following techniques outlined in our previous work.42 The weight used will depend on the participant's body weight and will elicit approximately 30% of the MVC of the lumbar multifidus muscle as previously shown by fine wire EMG.43 Participants weighing less than 68 kg (150 lbs) will use .68 kg (1.5 lbs), those between 68-90 kg (150-200 lbs) will use .91 kg (2 lbs), and those greater than 91 kg (200 lbs) will use 1.36 kg (3 lbs). Participants will be instructed as follows: "lift your arm approximately 2 inches (5 cm) off the table".

Change in pain pressure threshold utilizing pressure algometry after dry needling

Pressure algometry will used in the current study to determine the most painful spinal level at baseline and as a secondary outcome measure, pain pressure threshold (PPT), to assess abnormalities in nociceptive processing or hyperalgisia 37,38. PPT measures have been found to be highly reliable,39-41 especially when taken by the same rater (ICC=0.94-.097) 40. A digital pressure algometer (Wagner Force Ten FDX, Wagner Instruments, Greenwich, CT) will be used to measure PPT in the lumbar multifidus and paraspinal muscles on the side that the participant reported as more symptomatic. The pressure algometer will held by the examiner directly perpendicular to the muscle belly, approximately 1.5 cm lateral to the spinous process. The algometer will be advanced at a rate of approximately 5N/sec. and participants are instructed to verbally signal when they first perceive the force exerted as painful. PPT at each location will taken three times and averaged to reduce variability. Pressure

Change in muscle stiffness and activation utilizing shear-wave elastography after dry needling.

Change in pain pressure threshold utilizing pressure algometry after dry needling - 1 week follow-up

Secondary Outcome Measures

Change in Numerical Pain Rating Scale

The numeric pain rating scale (NPRS) will be used to assess the participant's pain levels. The participant will grade his/her pain on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).The NPRS has been shown to be a reliable, generalizable, and internally consistent measure of clinical and experimental pain intensity in individuals with musculoskeletal disorders.33,34 A 2-point change on the NPRS is required to be clinically meaningful.

Change in function and disability utilizing a physical exam

Participants with current LBP will undergo a standardized clinical examination based the Treatment Based Classification System.31 Patients without current LBP will undergo an abbreviated examination primarily focused on sociodemographic

Change in Oswestry Disability Index

The Oswestry Disability Index (ODI) is a LBP-specific subjective measure of disability. Users are asked to rate the difficulty of performing 10 functional tasks on a scale of 0 to 5 with different descriptors for each task. A total score out of 100 is calculated by summing each score and doubling the total. The answers provide a score between 0 and 100, with higher scores representing more disability. It has been shown to have excellent test-retest reliability (ICC2,1=.90), good validity, and superior responsiveness compared to other leading disability scales.32

Full Information

NCT ID

NCT02352532

First Posted

January 26, 2015

Last Updated

July 20, 2017

Sponsor

Baylor University

Collaborators

Telemedicine & Advanced Technology Research Center (TATRC), Army Medical Department Center and Schools

1. Study Identification

Unique Protocol Identification Number

NCT02352532

Brief Title

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

Acronym

SWE/DN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baylor University

Collaborators

Telemedicine & Advanced Technology Research Center (TATRC), Army Medical Department Center and Schools

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Dry Needling, Shear Wave Elastography, Ultrasound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Back Pain - Dry Needling

Arm Type

Experimental

Arm Title

Low Back Pain - Sham

Arm Type

Sham Comparator

Arm Title

Asymmptomatic - Dry Needling

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Dry Needling

Other Intervention Name(s)

Trigger point dry needling

Intervention Description

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

Intervention Name(s)

Sham Needling

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in muscle stiffness and activation utilizing shear-wave elastography after dry needling - one week follow-up

Description

Time Frame

7 days

Title

Change in pain pressure threshold utilizing pressure algometry after dry needling

Description

Time Frame

5 minutes

Title

Change in muscle stiffness and activation utilizing shear-wave elastography after dry needling.

Description

Time Frame

5 minutes

Title

Change in pain pressure threshold utilizing pressure algometry after dry needling - 1 week follow-up

Description

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Change in Numerical Pain Rating Scale

Description

Time Frame

7 days

Title

Change in function and disability utilizing a physical exam

Description

Time Frame

7 days

Title

Change in Oswestry Disability Index

Description

Time Frame

7 days

Other Pre-specified Outcome Measures:

Title

Global Rate of Change

Description

The global rating of change (GRC) assesses subjective perception of overall change and the importance of that change. A 15-point Likert type scale ranging from -7 (very great deal worse) to +7 (a very great deal better) and a 6-point Likert type scale ranging from 1 (a tiny bit important) to 6 (a very great important) will be used.

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Army Medical Department Center and Schools

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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