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

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

Patrocinadores

Patrocinador principal: Army-Baylor University Doctoral Program in Physical Therapy

Colaborador: Brooke Army Medical Center

Fuente Army-Baylor University Doctoral Program in Physical Therapy
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio January 8, 2019
Fecha de Terminación July 24, 2020
Fecha de finalización primaria July 9, 2019
Fase Early Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change in Functional Near-Infrared Spectroscopy Pre-, During intervention (real-time for approximately 3-5 minutes), directly after intervention, 1 week after intervention
Change in Muscle Stiffness using the MyotonPro Pre-, directly after intervention, and 1 week after intervention
Resultado secundario
Medida Periodo de tiempo
Movement test Pre-, directly after intervention, and 1 week after intervention
Change in Pain Pressure Threshold Pre-, directly after intervention, and 1 week after intervention
The Global Rate of Change Score directly after intervention and 1 week after intervention
Change in Numerical Pain Rating Scale Pre-, directly after intervention, and 1 week after intervention
Pain and Shoulder Disability - The Penn Shoulder Score Pre-,directly after intervention, and 1 week after intervention
Inscripción 18
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Dry Needling

Descripción: The participant will undergo true or sham dry needling treatment with simultaneous monitoring using the NIRS head cap.

Etiqueta de grupo de brazo: True Dry Needling

Tipo de intervención: Other

Nombre de intervención: Sham Dry Needling

Descripción: The participant randomized to the "sham" group will undergo placebo dry needling which is functionally mimicking trigger point dry needling

Etiqueta de grupo de brazo: Sham Dry Needling

Otro nombre: Placebo Treatment

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 50 Years

Voluntarios Saludables: No

Ubicación
Instalaciones: Army Medical Department Center and Schools, Ft Sam Houston
Ubicacion Paises

United States

Fecha de verificación

July 2020

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: True Dry Needling

Tipo: Experimental

Descripción: 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.

Etiqueta: Sham Dry Needling

Tipo: Sham Comparator

Descripción: 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..

Datos del paciente Undecided
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: This study will be a randomized controlled trial. A convenience sample will be recruited from the Army Medical Department Center and School and the Brooke Army Medical Center (BAMC) Outpatient Physical Therapy Clinic using fliers and word of mouth. A computer-generated table of random numbers will be used to accomplish the group assignment. Thirty participants with shoulder pain will be randomized to receive either true or sham dry needling (Aim #1). An additional 15 participants will be recruited to receive true dry needling (Aim #2). Pre- and post-treatment and 1-week follow-up measurements will be recorded using the MyotonPRO and NIRS, in addition to measures of local hypoalgesia and self-reported pain and disability.

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Outcomes Assessor)

Fuente: ClinicalTrials.gov