Health Coaching for Lower Back Pain

Recruiting at 1 trial location

Overseen By Amanda Priest

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Severe psychiatric, Substance use, others

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

Compensation: Varies

Number of Visits: 11

Duration: 3 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this two-group randomized trial is to determine the feasibility and acceptability of a remotely-delivered health coaching intervention offered in conjunction with usual care for patients with an acute exacerbation of chronic low back pain who present to the emergency department (ED). The main questions this feasibility trial aims to answer are: * Is our health coaching intervention and randomized trial methodology feasible to conduct? * Is our health coaching intervention acceptable to participants and ED providers? Participants will be randomized to one of two groups (usual ED care plus health coaching or usual ED care plus education) and complete outcome assessments at 3 and 6 months after ED discharge. Participants and ED providers will also complete an interview.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual care, but it's best to confirm with the trial organizers.

What data supports the effectiveness of the treatment Health Coaching for Lower Back Pain?

Research suggests that health coaching can help people with chronic low back pain by encouraging them to stay active and manage their symptoms better, potentially reducing the need for further medical care. ^{1 2 3 4 5}

Is health coaching safe for humans?

The research does not specifically address safety concerns, but health coaching is generally considered safe as it focuses on empowering individuals to manage their health and make lifestyle changes. ^{1 3 6 7 8}

How is the treatment Health Coaching unique for lower back pain?

Health Coaching is unique for lower back pain because it focuses on empowering patients to set and achieve personal health goals, helping them stay active and manage their symptoms after treatment. Unlike traditional treatments, it provides ongoing support to reduce the need for further medical care by integrating physical activity and self-management strategies. ^{1 2 3 9 10}

Research Team

Rogelio Coronado, PT, PhD

Principal Investigator

Vanderbilt University Medical Center

Kristin Archer, PhD, DPT

Principal Investigator

Vanderbilt University Medical Center

Sean Collins, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for patients who have had an acute episode of chronic low back pain and visited the emergency department. Participants should be willing to receive health coaching or education after discharge, and able to complete follow-ups at 3 and 6 months. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am 18 years old or older.

English-speaking

I am experiencing lower back pain.

Exclusion Criteria

I am currently hospitalized for a serious health issue.

In the opinion of the investigator has a severe psychiatric or behavioral diagnosis or substance use disorder that would interfere with the ability to perform the intervention and complete follow-up

Involved in litigation related to the LBP condition

Timeline

Screening

Participants are screened for eligibility to participate in the trial

During or shortly after ED visit

Treatment

Participants receive 8 calls from either a health coach or education provider

3 months

8 calls (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 3 and 6 months after ED discharge

Treatment Details

Interventions

• Health Coaching

Trial Overview The study is testing if a remotely-delivered health coaching program, along with usual care from the ED, can help people with chronic low back pain. It compares this approach to just getting educational materials plus usual care. The success will be measured by how feasible and acceptable these methods are.

Participant Groups

Group I: Usual ED Care plus Health Coaching Experimental Treatment 1 Intervention

Group II: Usual ED Care plus Education Active Control 1 Intervention

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Findings from Research

A systematic review of health coaching for low back pain included three RCTs and found that one study showed significant improvements in lifting capacity and exercise compliance for the health coaching group, indicating potential efficacy.

The overall quality of the evidence was rated as very low, highlighting the need for better-designed studies with clear protocols and measures of treatment fidelity to accurately assess the effectiveness of health coaching interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health coaching for low back pain: a systematic review of the literature. Holden, J., Davidson, M., O'Halloran, PD.[2018]

A study involving 374 adults with chronic low back pain will evaluate the effectiveness of a coordinated support system, which includes health coaching, compared to usual care after discharge from treatment.

The primary goal is to determine if this support system can reduce future healthcare utilization for low back pain over a 12-month period, potentially leading to better health outcomes and informing healthcare policy in Australia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a coordinated support system linking public hospitals to a health coaching service compared with usual care at discharge for patients with chronic low back pain: protocol for a randomised controlled trial. Ho, EK., Ferreira, ML., Bauman, A., et al.[2021]

Health coaching significantly reduces pain and disability in individuals with chronic low back pain (LBP), with notable mid-term pain reduction and improvements in both short-term and mid-term disability.

For knee osteoarthritis (OA), health coaching also leads to significant long-term improvements in functional disability, although there is no evidence available for its effectiveness in hip OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Coaching for Low Back Pain and Hip and Knee Osteoarthritis: A Systematic Review with Meta-Analysis. Prior, JL., Vesentini, G., Michell De Gregorio, JA., et al.[2023]

Health coaching (HC) significantly reduced HbA1c levels in type 2 diabetes patients compared to health education (HE), with reductions of 0.8% in Turkey and 0.4% in Denmark, indicating its effectiveness in diabetes management.

Patients in the HC group also experienced a greater reduction in periodontal treatment needs compared to those in the HE group, highlighting the broader health benefits of HC beyond just diabetes control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new complementary approach for oral health and diabetes management: health coaching. Cinar, AB., Freeman, R., Schou, L.[2022]

This systematic review aims to evaluate the effectiveness of health coaching (HC) interventions for adults with chronic conditions, synthesizing studies published in the last four years to assess patient improvement and coaching characteristics.

If health coaching is found to be effective, it could lead to broader public health applications and integration into current management strategies for chronic diseases, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials. Yang, J., Bauer, BA., Lindeen, SA., et al.[2023]

Health coaching significantly reduced outpatient and total healthcare expenditures for high-risk participants, with estimated savings of $286 and $412 per person per month, respectively.

While health coaching did not impact emergency room costs, it did lead to a significant decrease in the probability of incurring inpatient expenditures, highlighting its potential effectiveness in managing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective is health coaching in reducing health services expenditures? Jonk, Y., Lawson, K., O'Connor, H., et al.[2022]

In a study involving 14,584 patients with prediabetes, the highest uptake rate for wellness coaching appointments was achieved through secured email messages (3.0%), compared to letters and telephone messages, indicating that digital outreach may be more effective.

Overall, only 1.9% of patients engaged with wellness coaching, but factors such as age and gender influenced participation, with older patients and women being more likely to make appointments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wellness Coaching for People With Prediabetes: A Randomized Encouragement Trial to Evaluate Outreach Methods at Kaiser Permanente, Northern California, 2013. Xiao, H., Adams, SR., Goler, N., et al.[2019]

Health coaching significantly improved various health outcomes, including stress levels, healthy eating, exercise, and overall quality of life, with 89% of participants achieving at least one health goal within 6 months.

Despite only 7% of eligible candidates participating, those with higher chronic disease burdens were more likely to engage, indicating that health coaching may be particularly beneficial for individuals with complex health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of Telephonic Health Coaching on Health Outcomes in a High-risk Population. Lawson, KL., Jonk, Y., O'Connor, H., et al.[2022]

A training program was created for health professionals across various specialties to effectively manage and reduce low back pain in patients, aiming to alleviate both disability and healthcare costs.

The program is designed to be accessible for NHS nurses, enabling them to implement the training regardless of their location, thus promoting widespread improvement in patient care for low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a CBT approach to manage low back pain. Richmond, H.[2021]

A pilot study involving 68 participants with chronic low back pain showed that a patient-centered physical activity intervention, supported by health coaching and mobile health tools, is feasible and well-accepted, with high participant satisfaction (average score of 8.7 out of 10).

The intervention group experienced a 38% reduction in care-seeking rates compared to standard care, suggesting potential benefits in reducing the need for additional medical attention, although the results were not statistically significant and further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Mobile-health, health coaching, and physical activity to reduce the burden of chronic low back pain trial (IMPACT): a pilot randomised controlled trial. Amorim, AB., Pappas, E., Simic, M., et al.[2020]

References

1. India pubmed.ncbi.nlm.nih.gov

Health coaching for low back pain: a systematic review of the literature. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a coordinated support system linking public hospitals to a health coaching service compared with usual care at discharge for patients with chronic low back pain: protocol for a randomised controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Health Coaching for Low Back Pain and Hip and Knee Osteoarthritis: A Systematic Review with Meta-Analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A new complementary approach for oral health and diabetes management: health coaching. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

How effective is health coaching in reducing health services expenditures? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Wellness Coaching for People With Prediabetes: A Randomized Encouragement Trial to Evaluate Outreach Methods at Kaiser Permanente, Northern California, 2013. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The impact of Telephonic Health Coaching on Health Outcomes in a High-risk Population. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Using a CBT approach to manage low back pain. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Integrating Mobile-health, health coaching, and physical activity to reduce the burden of chronic low back pain trial (IMPACT): a pilot randomised controlled trial. [2020]