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

Launched by DUKE UNIVERSITY · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to understand how two different types of therapy—massage therapy and talk-based therapy—affect hormone levels in people suffering from chronic spinal pain, such as low back or neck pain. The researchers want to see if these therapies can change levels of two important hormones: oxytocin, which is linked to feelings of bonding and trust, and cortisol, which is related to stress. By measuring these hormones before and after each type of therapy, the study aims to find out if one method is more effective than the other and how they relate to the quality of the therapeutic relationship between the patient and the therapist.

To participate in this study, individuals must be at least 18 years old and have experienced chronic spine pain for three months or longer, with a pain level of at least 3 on a scale of 10 most days. Participants will try both therapies during the study and will be asked to complete questionnaires about their pain and well-being. Additionally, they will provide saliva samples to measure their hormone levels. It's important to note that individuals with certain medical conditions or those taking specific medications that might affect hormone levels will not be eligible to participate.

Gender

ALL

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).
• • -
• 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