Feasibility of Near-infrared Spectroscopy to Measure Cortical Pain Pathway (Brain) Activation During Dry Needling

July 24, 2020 updated by: Army-Baylor University Doctoral Program in Physical Therapy
The benefit experienced by some patients when treated with dry needling,1 combined with the field-expedient nature of this intervention, make dry needling uniquely suited for the military healthcare environment. An improved understanding of the mechanism by which dry needling exerts its clinical benefits will allow clinicians to adopt more efficacious treatment strategies for Soldiers with chronic musculoskeletal pain. The proposed study will utilize functional near-infrared spectroscopy and structural health monitoring (SHM) to provide insight on the central and peripheral mechanisms of dry needling. Phase 1 will compare the cortical pain pathway response of thirty participants with non-traumatic shoulder pain receiving either true or sham dry needling. An additional 15 participants will be enrolled to receive true dry needling to determine if brain responses may be able to predict clinical improvement (responders versus non-responders) in phase 2. Since chronic pain after musculoskeletal injury is the leading cause of medical discharge from service and a primary source of disability in the U.S. military2,3, improved complementary and alternative treatment strategies have the potential to have a large impact on both military readiness and health care costs within the Armed Forces.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study supports a line of ongoing investigation aimed at improving the diagnosis, management, and treatment of chronic pain after musculoskeletal injury. Continued progress in this arena requires novel methods to measure central nervous system (brain) mechanism of action and its role in identification of the unique transition of musculoskeletal injury to chronic pain. The purpose of this study is to use near-infrared spectroscopy (NIRS) to measure changes along cortical pain pathways in the brain related to true and sham dry needling treatment.

Specific Aim #1: The investigators will compare the cortical pain pathway response during dry needling treatment to sham dry needling treatment using NIRS in two groups of patients with chronic shoulder pain.

The investigators hypothesize that decreased cortical activity will be seen in the dorsolateral prefrontal cortex (DLPFC) in those treated with true dry needling compared to those treated with sham dry needling.

Specific Aim #2: The investigators will evaluate whether the cortical pain pathway response (imaged using NIRS) during dry needling predicts 1-week improvement in shoulder muscle response, local hypoalgesia, and self-reported pain and disability in the group of patients that received true dry needling treatment. The investigators hypothesize that decreased cortical activity in the DLPFC will be associated with improvements in shoulder muscle response, local hypoalgesia, and self-reported pain and disability in those treated with true dry needling.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78234
        • Army Medical Department Center and Schools, Ft Sam Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

(all of the following) Active duty DoD beneficiary Age 18-50 years old Non-traumatic shoulder pain rated at least 4/10 on the Numeric Pain Rating Scale Right-handed

Exclusion Criteria:

  • Anticoagulant medication use Bleeding disorders Shoulder pain referred from cervical spine Full-thickness rotator cuff tears Known pregnancy Inability to lie prone Left- or mixed-handed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: True Dry Needling
Active duty DoD beneficiaries, with shoulder pain will be recruited from Army Medical Department Center and School (AMEDDC&S) and the Brooke Army Medical Center (BAMC) Outpatient Physical Therapy Clinic who meet inclusion and exclusion criteria. The TDN treatment will consist of a trained investigator inserting a needle through the participant's skin, into the infraspinatus muscle using FDA approved (FDA regulation # 880.5580) disposable 0.25 x 40 mm stainless steel Seirin J-type needles (Seirin, Japan). Each shoulder will undergo this treatment. Each needle insertion will last approximately 2-3 seconds using the "sparrow pecking" (in and out) technique to the depth of the scapula at 3 locations in the infraspinatus muscle on the affected (painful) side. When detectable, the needle insertion will specifically target palpably painful and/or "taut" bands of tissue. Immediately after use, all needles will be disposed of in approved sharps containers.
Device: Dry Needling
The participant will undergo true or sham dry needling treatment with simultaneous monitoring using the NIRS head cap.
Other Names:
  • Trigger point dry needling
  • functional dry needling
SHAM_COMPARATOR: Sham Dry Needling
The sham dry-needling procedure will mimic the dry needling procedures by placing a blunted instrument in a needling guide tube against the skin. 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 previous studies performed at AMEDDC&S and have found it to be indistinguishable from real dry needling by the great majority of participants..
Other: Sham Dry Needling
The participant randomized to the "sham" group will undergo placebo dry needling which is functionally mimicking trigger point dry needling
Other Names:
  • Placebo Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Near-Infrared Spectroscopy
Time Frame: Pre-, During intervention (real-time for approximately 3-5 minutes), directly after intervention, 1 week after intervention
NIRS is a technology that uses low levels (less than 4mW/mm2 at 800nm) of non-ionizing, near-infrared, diffuse light to measure spectroscopic absorption changes. It will be used to non-invasively measures hemodynamic changes in the brain. An 8-channel NIRS instrument will be used to measure changes in the intensity of visible red to near-infrared light (760 and 850 nm) between sources and detectors that are placed on the scalp. Changes in intensity will be converted to optical density (absorption) and then the modified Beer-Lambert law will be applied to convert the data from optical density to change in oxy- and deoxyhemoglobin concentration.
Pre-, During intervention (real-time for approximately 3-5 minutes), directly after intervention, 1 week after intervention
Change in Muscle Stiffness using the MyotonPro
Time Frame: Pre-, directly after intervention, and 1 week after intervention
the MyotonPRO, a research only device, (Myoton AS, Tallinn, Estonia) by applying a mechanical impulse to the skin, which is transmitted to the underlying soft tissue and muscle (0.58 N for 15 ms). 33 The oscillation of the muscle is recorded by an accelerometer located at the probe end. Measures will be taken at the same three locations in each infraspinatus muscle as the dry needling.
Pre-, directly after intervention, and 1 week after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement test
Time Frame: Pre-, directly after intervention, and 1 week after intervention
The Hawkins-Kennedy Test - shoulder flexion and internal rotation
Pre-, directly after intervention, and 1 week after intervention
Change in Pain Pressure Threshold
Time Frame: Pre-, directly after intervention, and 1 week after intervention
is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgisia.34 We will use a digital pressure algometer (Wagner Force 25 FDX, Wagner Instruments, Greenwich, CT) to measure PPT, and will operationally define it as the minimal amount of pressure that produces pain or discomfort. Pressure algometry has been found to be highly reliable, especially when using the same rater (ICC=0.94-.097)
Pre-, directly after intervention, and 1 week after intervention
The Global Rate of Change Score
Time Frame: directly after intervention and 1 week after intervention
The GRC assesses subjective perception of overall change on a 15-point Likert type scale ranging from 1 (very great deal worse) to 15 (a very great deal better).38
directly after intervention and 1 week after intervention
Change in Numerical Pain Rating Scale
Time Frame: Pre-, directly after intervention, and 1 week after intervention
will also be used to quantify clinical changes in pain. Pain during a comparable sign39 will be additionally assessed at baseline, immediately after needling, and during the follow up visit. Participants will report a simple physical maneuver that could reproduce their primary shoulder symptoms, such as shoulder flexion with internal rotation or the Hawkins-Kennedy test. Participants will then be asked to perform this maneuver and report their pain intensity using an 11-point NPRS from 0 to 10. Previous work has reported the MCID of the NPRS in patients with shoulder pain to be 1.1 points.
Pre-, directly after intervention, and 1 week after intervention
Pain and Shoulder Disability - The Penn Shoulder Score
Time Frame: Pre-,directly after intervention, and 1 week after intervention
: The Penn Shoulder Score will be used as the primary measure of clinical outcome. This 100-point shoulder-specific self-report questionnaire consists of 3 subscales of pain, satisfaction, and function. A maximum score of 100 indicates no disability, no pain, and high satisfaction with the function of the shoulder. When aggregated, the questionnaire has demonstrated high test-retest reliability (ICC=0.94), internally consistency (Cronbach alpha = 0.93), and responsiveness in patients with shoulder pain. The minimal clinically important difference (MCID) for improvement has been reported at 11.4 points.37
Pre-,directly after intervention, and 1 week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Army-Baylor University Doctoral Program in Physical Therapy

Collaborators

Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2019

Primary Completion (ACTUAL)

July 9, 2019

Study Completion (ACTUAL)

July 24, 2020

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (ACTUAL)

November 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2018.057d
  • 40037-0010-0001-0208 (OTHER: The Geneva Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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