Massage vs Talk-Based Therapy for Spine Pain

(COTHA Trial)

Overseen By Chad E Cook, principal investigator, PT, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Steroids, Antidepressants, Hormonal treatments

Disqualifiers: Cushing's, Addison's, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Chad E Cook

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults aged 18+ with chronic spine pain lasting over 3 months, who consistently rate their pain at least a 3 out of 10. It's not suitable for those with conditions or on medications that affect hormone levels, such as Cushing's Syndrome or Addison's Disease, and those with skin infections or fractures where the massage would be applied.

Inclusion Criteria

I have had chronic back pain for 3 months or more.

I have had pain of 3 or more on a scale of 10 for most days in the last 3 months.

Exclusion Criteria

I have no infections, skin issues, or fractures where I would get a massage.

I am not on medications like steroids, antidepressants, or hormones that could affect the study.

Previously diagnosed conditions or factors known to affect cortisol or oxytocin levels (e.g., chronic stress disorders, hormonal imbalances, or pregnancy)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Treatment

Participants receive either talk-based therapy or massage therapy, followed by a 2-week washout period, then crossover to the other treatment

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in oxytocin and cortisol levels, as well as therapeutic alliance and PROMIS outcomes

2 weeks

2 visits (in-person)

Treatment Details

Interventions

• Massage
• Talk-based therapy

Trial Overview The study compares the effects of massage (hands-on) versus talk-based therapy (hands-off) on hormone changes in people with chronic spinal pain. It measures oxytocin and cortisol before and after sessions to see if there are differences between the two therapies in improving patient-reported outcomes related to pain, depression, and disability.

Participant Groups

Group I: Talk-based therapy, then massage Experimental Treatment 2 Interventions

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

Group II: Massage, then talk-based therapy Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+