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

NCT02352532 | Completed

• 1 other identifier: #10586012
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Dry Needling; Shear Wave Elastography; Ultrasound

Outcome Measures

Primary Outcomes (4)

• 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".

  7 days

• 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

  5 minutes

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

  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".

  5 minutes

• Change in pain pressure threshold utilizing pressure algometry after dry needling - 1 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".

  7 days

Secondary Outcomes (3)

• Change in Numerical Pain Rating Scale

  7 days

• Change in function and disability utilizing a physical exam

  7 days

• Change in Oswestry Disability Index

  7 days

Other Outcomes (1)

• Global Rate of Change

  7 days

Study Arms (3)

Low Back Pain - Dry Needling

EXPERIMENTAL

Other: Dry Needling

Low Back Pain - Sham

SHAM COMPARATOR

Other: Sham Needling

Asymmptomatic - Dry Needling

ACTIVE COMPARATOR

Other: Dry Needling

Interventions

Dry Needling 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.

Also known as: Trigger point dry needling

Asymmptomatic - Dry Needling; Low Back Pain - Dry Needling

Sham Needling 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.

Low Back Pain - Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor University: lead
• Telemedicine & Advanced Technology Research Center (TATRC): collaborator
• Army Medical Department Center and Schools: collaborator

Study Sites (1)

Army Medical Department Center and Schools

Fort Sam Houston, Texas, 78209, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)