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

260 Participants Needed

Trial Summary

What is the purpose of this trial?

After recuperating from low back surgery patients often perpetuate a sedentary lifestyle because they are concerned about injury and recurrent pain. The objective of this study is to test the feasibility of a program to increase lifestyle walking starting several months after low back surgery.

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 data supports the effectiveness of the treatment Education, Educational Intervention, Coping Education, Mental Health Education, Education/Self-efficacy for post-low back surgery patients?

Research shows that education and counseling interventions can improve health outcomes after spine surgery by increasing patient involvement in their recovery. Additionally, preoperative education programs have been found to reduce hospital stays and anxiety for spinal surgery patients. ^{1 2 3 4 5}

Is the Physical Activity Program for Post-Low Back Surgery Patients safe?

Research on similar educational interventions for spinal surgery patients suggests they are generally safe and can help reduce anxiety and hospital stay length, as well as improve recovery by reducing pain medication use. ^{1 2 3 4 6}

How is the Education/Self-efficacy treatment unique for post-low back surgery patients?

The Education/Self-efficacy treatment is unique because it focuses on teaching patients how to manage their recovery and cope with anxiety, which can lead to reduced pain and faster recovery. Unlike traditional treatments that may focus solely on physical rehabilitation, this approach empowers patients with knowledge and coping strategies to improve their mental and physical well-being after surgery. ^{2 4 6 7 8}

Research Team

Carol A Mancuso, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Effectiveness of Computer Assisted Training of Patients Undergoing Lumbar Disc Herniation Surgery. [2020]

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

Telephone-Based Intervention to Improve Rehabilitation Engagement After Spinal Stenosis Surgery: A Prospective Lagged Controlled Trial. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Patients' views on an education booklet following spinal surgery. [2021]

4. England 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. [2022]

5. United States 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. [2022]

6. Hungary pubmed.ncbi.nlm.nih.gov

[The effect of surgical psychoeducation on the outcome of spinal surgery]. [2023]

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

An evaluation of the effectiveness of cardiac teaching during hospitalization. [2007]

8. England pubmed.ncbi.nlm.nih.gov

A comparative effectiveness trial of postoperative management for lumbar spine surgery: changing behavior through physical therapy (CBPT) study protocol. [2021]