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

NCT04170803 | Completed Early Phase 1

• 2 other identifiers: C.2018.057d40037-0010-0001-0208
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Pain; Chronic Pain; Musculoskeletal Injury

Keywords

Chronic Pain; Musculoskeletal Injury; Functional near-infrared spectroscopy; Structural health monitoring; Dry needling

Outcome Measures

Primary Outcomes (2)

• Change in Functional Near-Infrared Spectroscopy

  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

  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 Outcomes (5)

• 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

Study Arms (2)

True Dry Needling

EXPERIMENTAL

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

Sham Dry Needling

SHAM COMPARATOR

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

Interventions

Dry Needling DEVICE

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

Also known as: Trigger point dry needling, functional dry needling

True Dry Needling

Sham Dry Needling OTHER

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

Also known as: Placebo Treatment

Sham Dry Needling

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Army-Baylor University Doctoral Program in Physical Therapy: lead
• Brooke Army Medical Center: collaborator

Study Sites (1)

Army Medical Department Center and Schools, Ft Sam Houston

San Antonio, Texas, 78234, United States

Location

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MeSH Terms

Conditions

Shoulder Pain; Chronic Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; 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: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: November 20, 2019
• Study Start: January 8, 2019
• Primary Completion: July 9, 2019
• Study Completion: July 24, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

US (1)