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

NCT06987786 | Not Yet Recruiting DMC

• 1 other identifier: Pro00118076
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine; Low Back Pain; Neck Pain

Keywords

Oxytocin; Cortisol; spinal pain

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1 and day 15

• 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.

  Day 1 and day 15

Secondary Outcomes (5)

• Therapeutic alliance

  Day 1 and day 15

• PROMIS pain interference

  Day 1 and day 15

• PROMIS Pain intensity

  Day 1 and day 15

• PROMIS Depression

  Day 1 and day 15

• PROMIS physical function

  Day 1 and day 15

Study Arms (2)

Massage, then talk-based therapy

EXPERIMENTAL

Subjects will be randomized to receive massage for one session, then will receive talk-based therapy after a two week washout period.

Other: Massage; Other: Talk-based therapy

Talk-based therapy, then massage

EXPERIMENTAL

Subjects will be randomized to receive talk-based therapy first, then after a 2 week wash out period will receive a massage threatment

Other: Massage; Other: Talk-based therapy

Interventions

Massage OTHER

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 stimulates the release of endorphins and serotonin, which are natural painkillers and mood enhancers.

Massage, then talk-based therapy; Talk-based therapy, then massage

Talk-based therapy OTHER

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 relaxation techniques, and develop personalized pain management plans.

Massage, then talk-based therapy; Talk-based therapy, then massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

CORE 2200 West Main Street

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Low Back Pain; Neck Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Chad E Cook

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chad E Cook, principal investigator, PT, PHD

CONTACT

19196848905; chad.cook@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This proposal involves a randomized, cross-over mechanistic clinical trial that includes a cohort of participants with chronic spine pain. A randomized, cross-over mechanistic trial is useful because it allows each participant to serve as their own control, reducing variability and increasing the statistical power to detect treatment effects.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 23, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)