The goal of this randomized cross-over mechanistic trial is to compare pre- and post-level cortisol and oxytocin changes in patients with chronic spine pain who receive either a hand's on (massage) or a hand's off (talk-based) approach. The study plans to address two primary aims.
Specific Aim One: Directly compare pre- and post-session oxytocin and cortisol levels across two sessions of massage and talk-based therapy. Hypothesis 1: It is expected that in both treatments, oxytocin will increase and cortisol will decrease, demonstrating no significant between-group differences in hormone levels.
Specific Aim Two: The study plans to compare pre- and post-session oxytocin and cortisol change scores a therapeutic alliance (TA) scale change scores and PROMIS patient-reported outcomes associated with pain, depression, and disability. Hypothesis 2a: It is projected that there will be moderate +/- relationships (R\>.4) between the therapeutic alliance change score and oxytocin and cortisol levels, suggesting that the hormones moderately reflect the construct associated with TA. Hypothesis 2b: It is expected that there will be weak (R\>.1) +/-relationships between hormone measures and PROMIS pain/disability/depression measures, which reflects similar findings to preliminary work.
Participants will participant in a massage based treatment and a talk-based treatment approach. Participants will also complete patient report outcomes and will receive a total of four salivary swabs.
Individuals with chronic spine pain (3 months or greater) (and);
who are 18 years of age and older (and)
who experience persistent pain of ≥3 on a 10-point scale for the majority of days during the previous 3-months
Participants with medical conditions that may influence hormone levels during the study (e.g., Cushing's Syndrome, Addison's Disease, etc.) (or),
Use of medications (e.g., steroids, antidepressants, or hormonal treatments) that could influence the results (or)
Previously diagnosed conditions or factors known to affect cortisol or oxytocin levels, such as chronic stress disorders, hormonal imbalances, or pregnancy.
participants have infection, skin lesions, (or)
Crossover
Massage
Other interventionSoft tissue mobilization (STM), also known as massage, is a form of manual therapy. STM consists of many different categories of treatment, but all involve a "hand's on" application. During the session, the Dr. Cook will use techniques such as kneading, stretching, and deep tissue manipulation to target the affected areas. The total time of application will be 30 minutes. This "hands-on" approach is theorized to reduce muscle tension, improve blood circulation, and promote relaxation. STM stimulates the release of endorphins and serotonin, which are natural painkillers and mood enhancers.
Talk-based therapy
Other interventionTalk based therapy includes an innovative, evidence-based psychosocial therapy designed to provide rapid and effective pain management for individuals suffering from chronic pain. This single-session, intervention equips patients with essential pain relief skills through a combination of cognitive behavioral therapy (CBT) techniques, mindfulness principles, and pain neuroscience education. The program focuses on teaching patients how to identify and reframe distressing thoughts, practice relaxation techniques, and develop personalized pain management plans.
Cortisol changes
The study will capture 525 μL salivary concentrations cortisol through a SalivaBio Oral Swab (SOS) Method. Testing will be completed with Salimetrics Assay Kits.
Oxytocin changes
The study will capture 525 μL salivary concentrations of oxytocin through a SalivaBio Oral Swab (SOS) Method. Testing will be completed with Salimetrics Assay Kits.
Therapeutic alliance
Working Alliance Inventory (WAI) short-form. The Working Alliance Inventory (WAI) measures three important aspects of the therapeutic alliance: 1. Agreement about the therapeutic tasks, 2. Agreement about the therapeutic goals, and 3. The affective bond between clinician and client. The WAI short-form is scored by adding up individual item responses, which are rated on a 5-point Likert scale (1=rarely or never to 5=always). The Working Alliance Inventory-Short (WAI-S) has a total score ranging from 12 to 84. A higher score indicates a stronger working alliance between a patient and therapist.
PROMIS pain interference
The PROMIS Pain Interference (PROMIS-PI) measure assesses the extent to which pain affects a person's daily life, specifically their ability to engage in social, cognitive, emotional, physical, and recreational activities. It's a widely used instrument within the PROMIS (Patient-Reported Outcomes Measurement Information System) initiative, a set of tools for measuring patient-reported outcomes in various health conditions. The PROMIS Pain Interference (PI) scale, particularly the 4-item short form (4a), measures how much pain interferes with an individual's activities over the past 7 days. Each question is answered on a 5-point scale (1=never to 5=almost always), and the total score is calculated by summing the individual item scores. For the 4-item short form, the total raw score range is 4 to 20, with higher scores indicating greater pain interference. PROMIS also uses a T-score metric, where the mean is 50 and the standard deviation is 10.
PROMIS Pain intensity
The PROMIS Pain Intensity measure assesses how much pain a person is experiencing. It uses a numeric rating scale (NRS) where individuals rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). The PROMIS Pain Intensity measure is part of the broader Patient-Reported Outcomes Measurement Information System (PROMIS) initiative, which aims to develop standardized, reliable, and valid tools for measuring patient-reported outcomes.
PROMIS Depression
The PROMIS Depression measure is a tool used to assess depression, specifically focusing on affective and cognitive symptoms like sadness, guilt, and self-criticism. It's part of the Patient-Reported Outcomes Measurement Information System (PROMIS), a collection of measures designed to evaluate patient-reported outcomes. PROMIS Depression 4 scale measures depression severity using a four-item questionnaire. Each item is rated on a scale, and the total score is the sum of these ratings, ranging from 4 to 20. Higher scores indicate more severe depression. It's important to note that PROMIS scales, including the 4-item depression scale, also use a T-score system, which is a standardized score with a mean of 50 and a standard deviation of 10.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
