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

Overview

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.

Interventions

• Other Massage
  Soft 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 stimul
• Other Talk-based therapy
  Talk 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 relaxat

Primary outcome measures

• Cortisol changes [Time frame: Day 1 and day 15]
• Oxytocin changes [Time frame: Day 1 and day 15]

Secondary outcome measures (5)

• Therapeutic alliance [Time frame: Day 1 and day 15]
• PROMIS pain interference [Time frame: Day 1 and day 15]
• PROMIS Pain intensity [Time frame: Day 1 and day 15]
• PROMIS Depression [Time frame: Day 1 and day 15]
• PROMIS physical function [Time frame: Day 1 and day 15]

Eligibility criteria

Inclusion Criteria include:

• 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

(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).

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Exclusion Criteria include:

• 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.

(After obtaining consent and prior to treatment), the study will screen for potential massage contraindications or other clinical safety considerations and will exclude if:

• participants have infection, skin lesions, (or)
• Fractures in the region of the massage

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• CORE 2200 West Main Street — Durham

Identifiers

NCT: NCT06987786 · Pro00118076

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗