Spinal Degenerative Disorder
Conditions
Brief summary
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.
Interventions
BEHAVIORALCBPT
Changing Behavior through Physical Therapy (CBPT) is a cognitive-behavioral based self-management program.
OTHEREducation
Patient education
Sponsors
Patient-Centered Outcomes Research Institute
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | Up to 12 months. | The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability. |
| Brief Pain Inventory (BPI) | Up to 12 months after spine surgery | The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome |
| 12-Item Short Form Health Survey (SF-12) | 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
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | Up to 12 months after spine surgery | Physical activity measured by a commercially available movement accelerometer |
Countries
United States
Participant flow
Recruitment details
838 participants assessed for eligibility. Of these 838, 513 participants were excluded. Of these 513 who were excluded, 222 did not meet inclusion criteria, 268 declined to participate, 23 were assessed too close to surgery to complete a preoperative assessment.
Pre-assignment details
248 participants were consented, enrolled, and randomized.
Participants by arm
| Arm | Count |
|---|---|
| CBPT Intervention Subjects participate in the cognitive behavioral physical therapy (CBPT) program focusing on a patient-oriented self-management approach to reduce pain and disability and improve physical activity and function, through reductions in fear of movement and increases in self-efficacy. Program consists of six weekly telephone sessions with a trained physical therapist. The first session is 45 minutes and the remaining 5 sessions are 30 minutes. Each subject will receive a binder to follow along with study therapist. | 124 |
| Education Intervention Subjects participate in an education program focusing on postoperative recovery. Sessions address benefits of physical therapy, proper biomechanics after surgery, importance of daily exercise, ways to promote healing, stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury. Treatment Group 2 is matched to the Treatment Group 1 in terms of session frequency, length and contact with the study therapist. Each subject will receive a binder to follow along with study therapist. | 124 |
| Total | 248 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | CBPT Intervention | Education Intervention | Total |
|---|---|---|---|
| Age, Continuous | 62.94 years STANDARD_DEVIATION 11.5 | 61.44 years STANDARD_DEVIATION 12.22 | 62.19 years STANDARD_DEVIATION 11.86 |
| Body Mass Index (BMI) | 32.18 kg/m^2 STANDARD_DEVIATION 6.12 | 32.59 kg/m^2 STANDARD_DEVIATION 7.01 | 32.39 kg/m^2 STANDARD_DEVIATION 6.57 |
| Comorbidities None | 53 Participants | 64 Participants | 117 Participants |
| Comorbidities One | 49 Participants | 38 Participants | 87 Participants |
| Comorbidities Two or more | 22 Participants | 22 Participants | 44 Participants |
| Current tobacco use | 18 Participants | 21 Participants | 39 Participants |
| Discharge location Home | 87 Participants | 88 Participants | 175 Participants |
| Discharge location Home with services | 20 Participants | 14 Participants | 34 Participants |
| Discharge location Inpatient rehabilitation facility | 14 Participants | 12 Participants | 26 Participants |
| Discharge location Skilled nursing facility | 3 Participants | 10 Participants | 13 Participants |
| Educational Level 12th grade, diploma or GED | 26 Participants | 32 Participants | 58 Participants |
| Educational Level Associate degree | 16 Participants | 11 Participants | 27 Participants |
| Educational Level College degree | 24 Participants | 19 Participants | 43 Participants |
| Educational Level Graduate degree | 20 Participants | 16 Participants | 36 Participants |
| Educational Level Less than 12th grade | 5 Participants | 3 Participants | 8 Participants |
| Educational Level Some college, no degree | 33 Participants | 43 Participants | 76 Participants |
| Insurance Status Military health plan (i.e., TRICARE) | 10 Participants | 7 Participants | 17 Participants |
| Insurance Status Private | 57 Participants | 68 Participants | 125 Participants |
| Insurance Status Public (i.e., Medicare, Medicaid) | 57 Participants | 49 Participants | 106 Participants |
| Length of Stay (LOS) | 3.01 days STANDARD_DEVIATION 1.82 | 3.6 days STANDARD_DEVIATION 3.32 | 3.31 days STANDARD_DEVIATION 2.69 |
| Marital Status Divorced | 15 Participants | 15 Participants | 30 Participants |
| Marital Status Living with Partner | 3 Participants | 3 Participants | 6 Participants |
| Marital Status Married | 81 Participants | 83 Participants | 164 Participants |
| Marital Status Separated | 0 Participants | 3 Participants | 3 Participants |
| Marital Status Single | 16 Participants | 7 Participants | 23 Participants |
| Marital Status Widowed | 9 Participants | 13 Participants | 22 Participants |
| Narcotics: yes | 49 Participants | 43 Participants | 92 Participants |
| Pain duration | 16.5 months | 24 months | 23 months |
| Prior spinal surgery | 32 Participants | 42 Participants | 74 Participants |
| Race/Ethnicity, Customized Non-White | 17 Participants | 16 Participants | 33 Participants |
| Race/Ethnicity, Customized White | 107 Participants | 108 Participants | 215 Participants |
| Revision Surgery | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Female | 60 Participants | 66 Participants | 126 Participants |
| Sex: Female, Male Male | 64 Participants | 58 Participants | 122 Participants |
| Spinal Levels One | 56 Participants | 55 Participants | 111 Participants |
| Spinal Levels Three or more | 21 Participants | 24 Participants | 45 Participants |
| Spinal Levels Two | 47 Participants | 45 Participants | 92 Participants |
| Surgery type Laminectomy with fusion | 73 Participants | 91 Participants | 164 Participants |
| Surgery type Laminectomy without fusion | 51 Participants | 33 Participants | 84 Participants |
| Working status Attending School | 2 Participants | 1 Participants | 3 Participants |
| Working status Disabled and/or retired due to illness | 35 Participants | 31 Participants | 66 Participants |
| Working status Elected not to work (e.g., Homemaker) | 0 Participants | 5 Participants | 5 Participants |
| Working status Employed | 45 Participants | 46 Participants | 91 Participants |
| Working status Looking for work | 1 Participants | 0 Participants | 1 Participants |
| Working status Retired (not due to illness) | 41 Participants | 41 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 124 |
| other Total, other adverse events | 0 / 124 | 0 / 124 |
| serious Total, serious adverse events | 0 / 124 | 0 / 124 |
Outcome results
Primary
12-Item Short Form Health Survey (SF-12)
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.
Time frame: Up to 12 months after spine surgery
Population: Number analyzed indicate the number of participants who completed the measure at each time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CBPT Intervention | 12-Item Short Form Health Survey (SF-12) | Physical Health: 6 Month | 39.31 units on a scale |
| CBPT Intervention | 12-Item Short Form Health Survey (SF-12) | Physical Health: 12 Month | 39.25 units on a scale |
| CBPT Intervention | 12-Item Short Form Health Survey (SF-12) | Physical Health: Preoperative | 27.84 units on a scale |
| CBPT Intervention | 12-Item Short Form Health Survey (SF-12) | Physical Health: 6 Week | 33.49 units on a scale |
| CBPT Intervention | 12-Item Short Form Health Survey (SF-12) | Mental Health: Preoperative | 49.69 units on a scale |
| CBPT Intervention | 12-Item Short Form Health Survey (SF-12) | Mental Health: 6 Week | 52.27 units on a scale |
| CBPT Intervention | 12-Item Short Form Health Survey (SF-12) | Mental Health: 6 Month | 54.02 units on a scale |
| CBPT Intervention | 12-Item Short Form Health Survey (SF-12) | Mental Health: 12 Month | 53.86 units on a scale |
| Education Intervention | 12-Item Short Form Health Survey (SF-12) | Mental Health: 12 Month | 53.23 units on a scale |
| Education Intervention | 12-Item Short Form Health Survey (SF-12) | Physical Health: 6 Month | 38.81 units on a scale |
| Education Intervention | 12-Item Short Form Health Survey (SF-12) | Mental Health: Preoperative | 48.54 units on a scale |
| Education Intervention | 12-Item Short Form Health Survey (SF-12) | Mental Health: 6 Month | 52.94 units on a scale |
| Education Intervention | 12-Item Short Form Health Survey (SF-12) | Physical Health: Preoperative | 27.8 units on a scale |
| Education Intervention | 12-Item Short Form Health Survey (SF-12) | Mental Health: 6 Week | 51.89 units on a scale |
| Education Intervention | 12-Item Short Form Health Survey (SF-12) | Physical Health: 6 Week | 33.55 units on a scale |
| Education Intervention | 12-Item Short Form Health Survey (SF-12) | Physical Health: 12 Month | 37.43 units on a scale |
Primary
Brief Pain Inventory (BPI)
The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome
Time frame: Up to 12 months after spine surgery
Population: Number analyzed indicate the number of participants who completed the measure at each time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CBPT Intervention | Brief Pain Inventory (BPI) | Back Pain: Preoperative | 6.79 units on a scale |
| CBPT Intervention | Brief Pain Inventory (BPI) | Back Pain: 6 Week | 3.15 units on a scale |
| CBPT Intervention | Brief Pain Inventory (BPI) | Back Pain: 6 Month | 2.82 units on a scale |
| CBPT Intervention | Brief Pain Inventory (BPI) | Back Pain: 12 Month | 2.95 units on a scale |
| CBPT Intervention | Brief Pain Inventory (BPI) | Leg Pain: Preoperative | 6.63 units on a scale |
| CBPT Intervention | Brief Pain Inventory (BPI) | Leg Pain: 6 Week | 2.32 units on a scale |
| CBPT Intervention | Brief Pain Inventory (BPI) | Leg Pain: 6 Month | 2.23 units on a scale |
| CBPT Intervention | Brief Pain Inventory (BPI) | Leg Pain: 12 Month | 2.35 units on a scale |
| Education Intervention | Brief Pain Inventory (BPI) | Leg Pain: 12 Month | 2.81 units on a scale |
| Education Intervention | Brief Pain Inventory (BPI) | Back Pain: Preoperative | 6.64 units on a scale |
| Education Intervention | Brief Pain Inventory (BPI) | Leg Pain: Preoperative | 6.38 units on a scale |
| Education Intervention | Brief Pain Inventory (BPI) | Back Pain: 6 Week | 3.14 units on a scale |
| Education Intervention | Brief Pain Inventory (BPI) | Leg Pain: 6 Month | 2.45 units on a scale |
| Education Intervention | Brief Pain Inventory (BPI) | Back Pain: 6 Month | 2.69 units on a scale |
| Education Intervention | Brief Pain Inventory (BPI) | Leg Pain: 6 Week | 2.35 units on a scale |
| Education Intervention | Brief Pain Inventory (BPI) | Back Pain: 12 Month | 2.83 units on a scale |
Primary
Oswestry Disability Index (ODI)
The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability.
Time frame: Up to 12 months.
Population: Number analyzed indicate the number of participants who completed the measure at each time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CBPT Intervention | Oswestry Disability Index (ODI) | Preoperative | 43.6 units on a scale |
| CBPT Intervention | Oswestry Disability Index (ODI) | Baseline (6 weeks) | 31.31 units on a scale |
| CBPT Intervention | Oswestry Disability Index (ODI) | 6 Months | 24.06 units on a scale |
| CBPT Intervention | Oswestry Disability Index (ODI) | 12 Months | 23.37 units on a scale |
| Education Intervention | Oswestry Disability Index (ODI) | 12 Months | 26.17 units on a scale |
| Education Intervention | Oswestry Disability Index (ODI) | Preoperative | 45.46 units on a scale |
| Education Intervention | Oswestry Disability Index (ODI) | 6 Months | 24.33 units on a scale |
| Education Intervention | Oswestry Disability Index (ODI) | Baseline (6 weeks) | 31.19 units on a scale |
Secondary
Physical Activity
Physical activity measured by a commercially available movement accelerometer
Time frame: Up to 12 months after spine surgery
Population: Number analyzed indicate the number of participants who completed the measure at each time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CBPT Intervention | Physical Activity | Mean Activity Counts/Minute: 6 weeks | 432.17 Mean Activity Counts/Minute |
| CBPT Intervention | Physical Activity | Mean Activity Counts/Minute: 6 months | 484.29 Mean Activity Counts/Minute |
| CBPT Intervention | Physical Activity | Mean Activity Counts/Minute: 12 months | 474.29 Mean Activity Counts/Minute |
| Education Intervention | Physical Activity | Mean Activity Counts/Minute: 6 weeks | 421.77 Mean Activity Counts/Minute |
| Education Intervention | Physical Activity | Mean Activity Counts/Minute: 6 months | 487.93 Mean Activity Counts/Minute |
| Education Intervention | Physical Activity | Mean Activity Counts/Minute: 12 months | 480.42 Mean Activity Counts/Minute |