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OpenTrials
Completed

NCT Number: NCT02184143

Postoperative Management for Degenerative Spinal Conditions

The overall objective of this study is to conduct a two-group randomized control trial (RCT) to compare which of two treatments provided by telephone - a cognitive-behavioral based physical therapy (CBPT) program focusing on self-management strategies or an education program about postoperative recovery - are more effective for improving patient-centered outcomes in older adults recovering from lumbar spine surgery for degenerative conditions. Our central hypothesis is that the CBPT intervention focusing on self-management will decrease pain and disability and improve general health, physical activity and physical function in community-dwelling adults undergoing spine surgery, through reductions in fear of movement and increases in pain self-efficacy.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Radiographic evidence of lumbar spinal stenosis secondary to degenerative changes
  • Surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis procedures
  • English speaking due to feasibility of employing study personnel to deliver and assess the study intervention
  • Age older than 21 years (younger individuals do not typically have a lumbar degenerative condition).

Exclusion criteria

  • Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy (individuals having these minimally invasive surgical techniques tend to have a less severe case of lumbar degeneration and a shorter recovery time than individuals having arthrodesis or laminectomy without arthrodesis)
  • Patients having surgery for spinal deformity as the primary indication (patients with spinal deformity as the primary spinal disorder tend to have a different recovery trajectory compared to the inclusion population)
  • Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor
  • Presence of back and/or lower extremity pain < 3 months indicating no history of chronic pain
  • History of neurological disorder or disease, resulting in moderate to severe movement dysfunction. Including but not limited to Parkinson's disease, Multiple Sclerosis, Epilepsy, Brain tumors, Huntington's disease, Alzheimer's disease, Muscular Dystrophy, Stroke, Autonomic Nervous System disorders, Traumatic Brain Injury, Cerebral Palsy, and Amyotrophic Lateral Sclerosis
  • Presence of schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic disorder and Delusional disorder
  • Patients not able to return to clinic for standard follow-up visits with surgeon due to time and travel limitation
  • Patients having surgery under a workman's compensation claim
  • Unable to provide a stable address and access to a telephone indicating the inability to participate in either the telephone-based CBPT or education program.

Treatment and study plan

CBPT

Behavioral

Changing Behavior through Physical Therapy (CBPT) is a cognitive-behavioral based self-management program.

Education

Other

Patient education

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: Up to 12 months.

    The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability.

  2. Brief Pain Inventory (BPI)

    Time frame: Up to 12 months after spine surgery

    The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome

  3. 12-Item Short Form Health Survey (SF-12)

    Time frame: Up to 12 months after spine surgery

    The SF-12 is a measure of general physical and mental health. The SF-12 is scored from 0 to 100, with higher scores indicating better health.

Secondary outcomes

  1. Physical Activity

    Time frame: Up to 12 months after spine surgery

    Physical activity measured by a commercially available movement accelerometer

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jul 9, 2014
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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