A Phase 1 interventional study of Exercise and transcranial direct current stimulation in Headaches Posttraumatic and Neck Pain, sponsored by San Diego State University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by San Diego State University · Phase 1, Interventional, and Treatment
The goal of this prospective case series is to assess the feasibility of intervention and assessment protocols for telehealth intervention with mindfulness-based exercise, transcranial direct current stimulation, and their combination in Veterans with peristent post-traumatic headache. The main questions it aims to answer are:
What percentage of patients complete pre- and post- assessment measures? Are patients adherent to and satisfied with each intervention? What are potential adverse effects of treatment? How responsive are patient-reported outcome measures and biomarkers of brain connectivity, muscle health, and pain sensitivity to change following treatment?
Participants will complete 18 telehealth sessions with a physical therapist (3x/wk for 6 weeks) with one of the following interventions:
Participants will complete the following assessments before and after intervention:
192 studies on the registry are indexed under Post-Traumatic Headache; 54 are open to participants now.
This study's enrollment of 18 is below the median of 44 across 169 interventional studies indexed under Post-Traumatic Headache.
Browse Post-Traumatic Headache studies →San Diego State University is the lead sponsor of 149 studies on the registry; 43 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Progressive resistance exercise program to improve motor control, strength, and endurance of craniocervical and scapular muscles performed with guided mindfulness instruction
Behavioral: Exercise
Anodal stimulation applied over the left primary motor cortex for 20 minutes at 2 mA
Device: transcranial direct current stimulation
CSE performed concurrently with tDCS
Behavioral: Exercise · Device: transcranial direct current stimulation
30-min supervised (via telehealth) progressive resistance exercise program performed with guided mindfulness. Cervicoscapular exercises include: warm up/flexibility, craniocervical flexion, craniocervical extension, scapular protraction, scapular retraction.
Also known as: mindfulness
20 minutes of supervised (via telehealth) direct current anodal stimulation over the left primary motor cortex with cathodal stimulation over the right prefrontal cortex at 2 mA
Participant retention
Percent of enrolled participants who complete the post-intervention assessment for each treatment arm as measured by assessment attendance logs in REDCap
Time frame: From enrollment to the post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Treatment adherence
Percent of prescribed treatment sessions completed by participants who are retained in each treatment arm as measured by treatment attendance logs in REDCap
Time frame: From first to last treatment session completed (18 sessions, ~6-weeks)
Treatment satisfaction
Median Global Rating of Perceived Satisfaction for each treatment arm (reverse-scored range: 1 "extremely dissatisfied" to 7 "extremely satisfied")
Time frame: From first treatment session to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Treatment duration
Average number of weeks required to complete 18 prescribed treatment sessions for participants retained in each treatment arm as measured by treatment attendance logs in REDCap
Time frame: From first to last treatment session completed (~ 6 weeks)
Perceived improvement
Median Global Rating of Perceived Improvement for each treatment arm (reverse-scored range: 1 "very much worse" to 7 "very much improved")
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
PROMIS headache intensity, measurement responsiveness
Within-group effect size (Hedge's g) for pre-post intervention change in PROMIS Pain Intensity v2.0 T-score for headache, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
PROMIS neck pain intensity, measurement responsiveness
Within-group effect size (Hedge's g) for pre-post intervention change in PROMIS Pain Intensity v2.0 T-score for neck pain, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Headache Impact Test-6, measurement responsiveness
Within-group effect size (Hedge's g) for pre-post intervention change in Short-Form Headache Impact Test-6 score, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Neck Pain and Disability Scale, measurement responsiveness
Within-group effect size (Hedge's g) for pre-post intervention change in Neck Pain and Disability Scale score, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Fraction, Obliquus Capitis Inferior
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Obliquus Capitis Inferior muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Fraction, Rectus Capitis Posterior Major
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Rectus Capitis Posterior Major muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Fraction, Rectus Capitis Posterior Minor
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Rectus Capitis Posterior Minor muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Fraction, Longus Colli/Capitis C2/3
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Longus Colli/Capitis muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Fraction, Longus Colli/Capitis C5/6
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Longus Colli/Capitis muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Fraction, Sternocleidomastoid C2/3
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Sternocleidomastoid muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Fraction, Sternocleidomastoid C5/6
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Sternocleidomastoid muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Fraction, Multifidi C3
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Multifidi muscle at vertebral level C3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Fraction, Multifidi C6
Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Multifidi muscle at vertebral level C6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Total Muscle Volume, Obliquus Capitis Inferior
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Obliquus Capitis Inferior muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Total Muscle Volume, Rectus Capitis Posterior Major
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Rectus Capitis Posterior Major muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Total Muscle Volume, Rectus Capitis Posterior Minor
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Rectus Capitis Posterior Minor muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Total Muscle Volume, Longus Colli/Capitis C2/3
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Longus Colli/Capitis muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Total Muscle Volume, Longus Colli/Capitis C5/6
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Longus Colli/Capitis muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Total Muscle Volume, Sternocleidomastoid C2/3
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Sternocleidomastoid muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Total Muscle Volume, Sternocleidomastoid C5/6
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Sternocleidomastoid muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Total Muscle Volume, Multifidi C3
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Multifidi muscle at vertebral level C3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Total Muscle Volume, Multifidi C6
Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Multifidi muscle at vertebral level C6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Free Muscle Volume, Obliquus Capitis Inferior
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Obliquus Capitis Inferior muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Free Muscle Volume, Rectus Capitis Posterior Major
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Rectus Capitis Posterior Major muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Free Muscle Volume, Rectus Capitis Posterior Minor
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Rectus Capitis Posterior Minor muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Free Muscle Volume, Longus Colli/Capitis C2/3
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Longus Colli/Capitis muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Free Muscle Volume, Longus Colli/Capitis C5/6
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Longus Colli/Capitis muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Free Muscle Volume, Sternocleidomastoid C2/3
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Sternocleidomastoid muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Free Muscle Volume, Sternocleidomastoid C5/6
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Sternocleidomastoid muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Free Muscle Volume, Multifidi C3
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Multifidi muscle at vertebral level C3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Fat Free Muscle Volume, Multifidi C6
Within-group effect size (Hedge's g) for pre-post intervention change in fat free muscle volume of the Multifidi muscle at vertebral level C6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-Cerebellum (left)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and cerebellum (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-Cerebellum (right)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and cerebellum (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-DLPFC (left)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and dorsolateral prefrontal cortex (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-DLPFC (right)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and dorsolateral prefrontal cortex (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-M1 (left)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and primary motor cortex (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-M1 (right)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and primary motor cortex (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-S1 (left)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and primary sensory cortex (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-S1 (right)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and primary sensory cortex (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-SMA (left)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and supplementary motor area (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-SMA (right)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and supplementary motor area (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-Thalamus (left)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and thalamus (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-Thalamus (right)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and thalamus (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-TPJ (left)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and temporoparietal junction (left side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-TPJ (right)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and temporoparietal junction (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-MCC (right)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and middle cingulate cortex (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Resting State Functional Connectivity, PAG-PCC (right)
Within-group effect size (Hedge's g) for pre-post intervention change in resting state functional connectivity between the periaqueductal gray and posterior cingulate cortex (right side) measured with functional magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Pressure Pain Threshold, Trapezius (left)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the trapezius muscle (left side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Pressure Pain Threshold, Trapezius (right)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the trapezius muscle (right side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Pressure Pain Threshold, Temporalis (left)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the temporalis muscle (left side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Pressure Pain Threshold, Temporalis (right)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the temporalis muscle (right side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Pressure Pain Threshold, Frontalis (left)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the frontalis muscle (left side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Pressure Pain Threshold, Frontalis (right)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the frontalis muscle (right side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Pressure Pain Threshold, Neck (left)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the C3 spinous process (left side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Pressure Pain Threshold, Neck (right)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the C3 spinous process (right side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Pressure Pain Threshold, Forearm (right)
Within-group effect size (Hedge's g) for pre-post intervention change in pressure pain threshold measured with a handheld algometer over the forearm flexor muscles (right side), where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
PROMIS Anxiety, measurement responsiveness
Within-group effect size (Hedge's g) for pre-post intervention change in PROMIS Anxiety Short Form 8a T-score for severity of anxiety symptoms, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
PROMIS Depression, measurement responsiveness
Within-group effect size (Hedge's g) for pre-post intervention change in PROMIS Depression Short Form 8a T-score for severity of depressive symptoms, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
PCL-5, measurement responsiveness
Within-group effect size (Hedge's g) for pre-post intervention change in Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 score for severity of PTSD symptoms, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large"
Time frame: From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks)
Plan to share: Yes — The datasets generated and analyzed during this study will not be made publicly available due to data sharing policies at VASDHS. Deidentified IPD and supporting information are available from the primary contact (Dr. Monroe) upon written request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD and supporting information will be available 3 months after publication of primary endpoints up to 3 years after the study end date.
Access criteria: Investigators with scientific interest may request deidentified IPD and supporting information by emailing a written request for information to the primary study contact (Dr. Monroe) at ksmonroe@sdsu.edu.
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