Physical Activity Program for Post-Low Back Surgery Patients

Overseen By Carol A Mancuso, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Disqualifiers: Cardiopulmonary symptoms

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help individuals who have undergone low back surgery become more active. Many patients remain inactive post-surgery due to concerns about pain or re-injury. The study will compare two groups: one will receive a booklet, a device to track movement, and encouragement, while the other will receive only the booklet. The program includes an educational component to enhance self-efficacy, boosting patients' confidence in their ability to stay active. It suits those who have had back surgery and feel ready to walk more, provided they have not developed new heart or lung issues since their surgery. As an unphased trial, this study offers a unique opportunity to contribute to research that may improve recovery strategies for future patients.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for post-low back surgery patients?

Research has shown that education and self-confidence programs are safe for patients recovering from low back surgery. Studies have found that providing patients with an educational booklet and support helps them engage more in their recovery without risk. These programs also enhance patients' confidence in managing their health, known as self-efficacy.

Further research indicates that adding counseling to these programs can improve health outcomes after surgery. Participants in these programs often felt better and more in control of their recovery. Importantly, these methods focus on helping patients manage their recovery safely and effectively.

Overall, these treatments are well-tolerated, with no reports of harmful side effects. Patients in these studies gained more knowledge about their condition and felt more empowered to participate in their recovery process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support recovery after low back surgery. Unlike traditional methods that may only focus on physical rehabilitation exercises, this trial includes educational aspects and self-efficacy enhancement. The Education/Self-efficacy approach is particularly interesting as it combines a physical activity booklet with a movement monitoring device and encouragement, aiming to empower patients to take control of their recovery. By emphasizing self-efficacy, this approach could lead to more confident and sustained physical activity, potentially improving long-term outcomes for patients.

What evidence suggests that this program is effective for increasing physical activity in post-low back surgery patients?

Research has shown that education and self-confidence programs can aid recovery after lower back surgery. Resilience and confidence in managing pain are linked to improved recovery over a year. In this trial, one group will receive an Education/Self-efficacy intervention, which includes a booklet about physical activity, a movement monitoring device, and encouragement. Another group will receive education alone, consisting of a booklet about physical activity. Previous studies have found that guided rehabilitation improved quality of life and belief in one's ability to succeed after surgery. Specifically, a booklet based on research for spinal surgery patients was well-received in another study. This type of educational material can help patients better understand their condition and recovery process. Overall, these approaches show promise in helping patients become more active and manage their recovery effectively. ^{4 6 7 8 9}

Who Is on the Research Team?

Carol A Mancuso, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

This trial is for individuals who have had lumbar surgery due to spine degeneration and are now cleared by their surgeon to increase walking. It's not suitable for those with new heart or lung symptoms post-surgery.

Inclusion Criteria

I had back surgery for a degenerative condition and my doctor says it's safe for me to walk more.

Exclusion Criteria

I have experienced new heart or lung symptoms since my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postoperative stabilization

Participants are monitored until deemed orthopedically stable to increase walking

Approximately 3 months

Intervention

Participants receive a multi-component intervention to increase lifestyle walking

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Education
• Education/Self-efficacy

Trial Overview The study tests a program designed to encourage patients to walk more as part of their daily routine, starting several months after they've recovered from low back surgery.

How Is the Trial Designed?

Group I: Education/Self-efficacy Active Control 1 Intervention

Booklet about physical activity, movement monitoring device, encouragement

Group II: Education Active Control 1 Intervention

Booklet about physical activity

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Published Research Related to This Trial

The Preoperative Spinal Education (POSE) program significantly reduced the length of hospital stay (LOS) for spinal fusion surgery patients, with the Attend-POSE group having a median LOS of 3 days compared to 5 days for the pre-POSE group.

POSE was safe, as it did not increase complication or readmission rates, and helped patients feel better prepared and less anxious about their surgery, although only 43% of eligible patients chose to participate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preoperative Spinal Education intervention for spinal fusion surgery designed using the Rehabilitation Treatment Specification System is safe and could reduce hospital length of stay, normalize expectations, and reduce anxiety : a prospective cohort study. Edwards, R., Gibson, J., Mungin-Jenkins, E., et al.[2022]

Individual patient education for managing acute and subacute low back pain (LBP) showed moderate evidence of being more effective than placebo education in reducing pain and improving physical function, although the effects were not clinically significant.

The education was also found to improve short-term quality of life and reduce sick leave compared to noneducational interventions, suggesting that while the direct impact on pain may be minimal, patient education remains a valuable component of LBP management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual Patient Education for Managing Acute and/or Subacute Low Back Pain: Little Additional Benefit for Pain and Function Compared to Placebo. A Systematic Review With Meta-analysis of Randomized Controlled Trials. Piano, L., Ritorto, V., Vigna, I., et al.[2022]

Psychoeducation before spinal surgery significantly reduces the consumption of postoperative analgesics, indicating that informed patients may experience less pain after surgery.

Involving a psychologist in surgical care not only enhances patients' physical and mental recovery but also lowers rehabilitation costs, highlighting the importance of addressing patients' fears and anxieties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of surgical psychoeducation on the outcome of spinal surgery]. Sütő, J., Klekner, Á., Nagy, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3535244/

Patients' views on an education booklet following spinal ... This study evaluated an evidence-based education booklet developed for patients undergoing spinal surgery which was used as a treatment intervention.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10775701/

The Impact of Preoperative Adaptive Training on ... Our study reveals that preoperative adaptive training stabilizes intraoperative blood pressure fluctuations in lumbar disc herniation surgeries.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468781225001134

Survey of rehabilitation practice for patients undergoing ... This study highlights considerable variation in access to and content of rehabilitation for patients undergoing lumbar surgery in the UK.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0003999324009420

The Effect of Graded Activity and Pain Education After ... The secondary outcomes were reduction in time spent in sedentary behavior at 12 months and changes from baseline to 3-, 6-, and 12 months on disability, pain, ...

5. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-024-07419-9

The impact of nursing interventions on the rehabilitation ... This study aimed to investigate the impact of nursing interventions on the rehabilitation outcomes of patients after lumbar spine surgery.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11730817/

Exploring strategies to enhance patient safety in spine surgery This review highlights the critical need for ongoing evaluation and refinement of safety protocols in spine surgery.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11015628/

The effects of psychological distress after surgery in ... The aim of this study was to evaluate the psychological distress pre-operatively, at 3, 6, and 12 months in patients who underwent lumbar spine fusion surgery.

8. sciencedirect.com sciencedirect.com/science/article/pii/S266654842500040X

Therapeutic exercise following lumbar spine surgery This review provides the most current evidence regarding the safety and effectiveness of therapeutic exercise following lumbar spine surgery.

9. mdpi.com mdpi.com/2227-9032/7/1/48

The Effect of Preoperative Education on Psychological ... Factors associated with anxiety and depression both before and after spine surgery are reported to be a greater experience of pain, the need for ...