Differences in Mechanistic Measures (Oxytocin and Cortisol) of Therapeutic Alliance Between A Talk-Based Therapy and Soft-Tissue Mobilization in Individuals With Chronic Spinal Pain

Not Applicable

Not yet recruiting

• Conditions: Spine; Low Back Pain; Neck Pain

• Registration Number: NCT06987786
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Recruitment at Duke University: Recruitment will follow a well-versed, successful process at Duke University. MaestroCare will be used to identify, recruit, and conduct this research study. Participants will be invited to participate in this study via a MyChart patient portal invitation sent by a clinical research coordinator (CRC). The CRC will screen participants for eligibility via telephone encounter. Prior to obtaining consent, participants will be screened for medical conditions that may influence hormone levels during the study (e.g., Cushing's Syndrome, Addison's Disease, etc.), use of medications (e.g., steroids, antidepressants, or hormonal treatments) that could influence the results, and exclude participants if necessary, and previously diagnosed conditions or factors known to affect cortisol or oxytocin levels, such as chronic stress disorders, hormonal imbalances, or pregnancy. After obtaining consent and prior to treatment, the study will screen for potential STM contraindications or other clinical safety considerations (i.e., infection, skin lesions, etc) using a limited systems-screening to rule out pertinent clinical contraindications to STM (e.g., radiculopathy, fracture, etc.).

Participants: Individuals with CSP (3 months or greater), 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 will be eligible for the study. The study operationally defines chronic pain using the International Association of the Study of Pain (IASP) pragmatic criteria of pain lasting for 3 months or more that cannot be attributed to another diagnosis or condition.

Variables: In addition to pertinent demographics and patient characteristics, the study will capture baseline PROMIS pain interference, pain intensity, depression, and physical function values. Onsite, to improve the likelihood that hormone related changes are not influenced by external factors, the study will capture a Perceived Stress Scale (PSS), which measures subjective stress levels, State-Trait Anxiety Inventory (STAI), which assesses temporary and long-term anxiety states, blood pressure and pulse prior to each visit. For the PSS, a score of 27 or above is typically considered high. For the STAI, a score above 60 is often considered high, signaling significant anxiety. If individuals score high in either measure, the participants will be rescheduled. Those with Blood pressure: ≥140/90 mmHg and a heart rate \>100bpm will be asked to reschedule.

The study's primary variables of interest in the study involve cortisol and oxytocin levels. The study will capture 525 μL salivary concentrations of oxytocin and cortisol through a SalivaBio Oral Swab (SOS) Method. Testing will be completed with Salimetrics Assay Kits. The study will also capture the self-report WAI short-form and the PROMIS pain interference, pain intensity, and physical function measures at baseline and after completion of both visits.

Interventions: After describing the study design and purpose, participants will be randomized into a single treatment of STM-first or a single treatment of ER-first. All treatments will be provided by Dr. Cook, a licensed physical therapist with 35 years of clinical experience and fellowship-level training in STM (e.g., manual therapies) and a 2.5-year post-professional, certification-level training in chronic pain management/psychologically informed practice. A designated clinical research coordinator (CRC) and Dr. Cook will be responsible for screening of each applicant to ensure the participants are appropriate and safe for study inclusion.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-07-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cortisol changes	Day 1 and day 15	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	Day 1 and day 15	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.

Secondary Outcome Measures

Name	Time	Method
Therapeutic alliance	Day 1 and day 15	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	Day 1 and day 15	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	Day 1 and day 15	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	Day 1 and day 15	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.
PROMIS physical function	Day 1 and day 15	The PROMIS Physical Function 4 scale is measured using a series of questions assessing a person's ability to perform various physical tasks, with responses scored on a 5-point Likert scale. The raw score from these responses is then converted to a standardized T-score on a scale of 0 to 100, with a mean of 50 and a standard deviation of 10. The total score is the final T-score.

Trial Locations

Locations (1)

CORE 2200 West Main Street; 🇺🇸 Durham, North Carolina, United States