Postoperative Management for Degenerative Spinal Conditions

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Increasing Long-Term Physical Activity After Lumbar Spine Surgery

NCT02611427

Lumbar Spine Degenerative Changes

ACTIVE_NOT_RECRUITING NA

Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users

NCT06294834

Paraplegia Paralysis, Legs

ACTIVE_NOT_RECRUITING NA

Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching

NCT05424172

Spinal Cord Injuries

RECRUITING NA

Improving Self-Management Skills Among People With Spinal Cord Injury

NCT03140501

Spinal Cord Injuries Self-Management Mobile Application

UNKNOWN NA

Clinical Trial to Evaluate One-to-one Peer Mentoring

NCT02274649

Injuries, Spinal Cord

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Degenerative Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBPT intervention

CBPT program consisting of weekly phone calls.

Group Type EXPERIMENTAL

CBPT

Intervention Type BEHAVIORAL

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

Education intervention

Education program consisting of weekly phone calls.

Group Type ACTIVE_COMPARATOR

Education

Intervention Type OTHER

Patient education

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBPT

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

Intervention Type BEHAVIORAL

Education

Patient education

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. 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)
2. 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)
3. Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor
4. Presence of back and/or lower extremity pain \< 3 months indicating no history of chronic pain
5. 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
6. Presence of schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic disorder and Delusional disorder
7. Patients not able to return to clinic for standard follow-up visits with surgeon due to time and travel limitation
8. Patients having surgery under a workman's compensation claim
9. 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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No