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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different therapies—massage and talk-based therapy—affect hormone levels in people with chronic spine pain. The researchers aim to determine if these treatments can alter levels of stress and bonding hormones, specifically cortisol and oxytocin. Participants will experience both treatments and provide feedback on their pain, mood, and ability to perform daily activities. This trial suits individuals who have experienced spine pain for at least three months and face significant discomfort most days. As an unphased trial, it offers a unique opportunity to explore innovative therapies that could enhance quality of life.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications like steroids, antidepressants, or hormonal treatments, as they could affect the study results.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that massage therapy is generally safe and well-tolerated. A review of studies found that unwanted effects from massage are rare and usually mild, such as temporary soreness or discomfort. Studies have also shown that massage can effectively reduce back pain.

Talk-based therapies, including mindfulness and cognitive behavioral therapy (CBT), are also considered safe. Research indicates these therapies improve pain and function without significant risks. As non-invasive treatments, they do not involve entering the body, reducing the chance of harmful effects.

Both treatments offer safe options for managing spine pain. Participants should experience minimal risk during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for spine pain, such as medications and physical therapy, focus on relieving symptoms or improving mobility. However, researchers are excited about exploring massage and talk-based therapy because they offer a more holistic approach. Massage therapy can help reduce muscle tension and improve circulation, potentially offering immediate relief. Talk-based therapy provides a mental and emotional support component, which can be crucial since spine pain often affects mental well-being. By alternating these therapies, researchers hope to uncover new insights into how combining physical and psychological treatments might offer more comprehensive relief from spine pain.

What evidence suggests that this trial's treatments could be effective for spine pain?

This trial will compare the effects of massage therapy and talk-based therapy for spine pain. Research has shown that massage therapy can help with chronic back pain, with some studies finding benefits lasting up to six months. In one study, 63% of participants who received comprehensive massage therapy reported being pain-free after one month. Another study found that massage was as effective as treatments like spinal manipulation.

Talk-based therapies, such as cognitive behavioral therapy (CBT), have also been shown to reduce chronic low back pain. These therapies can lessen pain and reduce the need for pain medications like opioids. A year-long study found that mindfulness-based therapy and CBT significantly reduced pain and improved function in people with chronic back pain. Both treatments offer promising options for managing spine pain, and participants in this trial will experience both therapies in different sequences to evaluate their effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Chad E Cook

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

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

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3772691/

The effectiveness of massage therapy for the treatment ... The findings from this RCT, of low methodological quality (38%), indicated that massage therapy was less effective than spinal manipulative ...

2. amtamassage.org amtamassage.org/about/position-statements/massage-therapy-can-be-effective-for-low-back-pain/

Massage Therapy Can Be Effective for Low Back Pain Massage therapy may be effective for treatment of chronic back pain, with benefits lasting at least 6 months.

3. cmaj.ca cmaj.ca/content/162/13/1815

Effectiveness of massage therapy for subacute low-back pain At 1-month follow-up 63% of subjects in the comprehensive massage therapy group reported no pain as compared with 27% of the soft-tissue ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0885392498001298

Massage Therapy for Low Back Pain: A Systematic Review One of these studies suggests that massage is superior to no treatment. Two trials imply that it is equally effective as spinal manipulation or transcutaneous ...

5. academic.oup.com academic.oup.com/painmedicine/article/18/7/1394/3069964

Results of a Repeated Measures Cohort Study | Pain Medicine The Kentucky Pain Research and Outcomes Study evaluated massage impact on pain, disability, and health-related quality of life for primary care ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4145795/

Adverse Events of Massage Therapy in Pain-Related ... This review is an evaluation of the frequency and severity of adverse events (AEs) reported mainly for pain-related massage between 2003 and 2013.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12779300/

A review of the evidence for the effectiveness, safety, and cost ... Conclusions: Initial studies have found massage to be effective for persistent back pain. Spinal manipulation has small clinical benefits that are equivalent to ...

8. bmj.com bmj.com/content/364/bmj.l689

Benefits and harms of spinal manipulative therapy for the ... SMT produces similar effects to recommended therapies for chronic low back pain but results in clinically better effects for short term ...

9. journals.lww.com journals.lww.com/md-journal/fulltext/2020/03200/clinical_outcomes_and_cost_effectiveness_of.30.aspx

Clinical outcomes and cost-effectiveness of massage chair... The results of our study suggest that both clinic-based physiotherapy and mechanical massage chair demonstrate effectiveness in pain control, patient ...

10. medicalsciencepulse.com medicalsciencepulse.com/article/01.3001.0015.8755/en

Effectiveness of massage therapy in reducing back pain ... Conclusions: Massage therapy resulted in a reduction of spinal pain in older adults. Massage is an effective form of therapy for reducing back pain in older ...