Trial Outcomes & Findings for Postoperative Management for Degenerative Spinal Conditions (NCT NCT02184143)
NCT ID: NCT02184143
Last Updated: 2019-08-02
Results Overview
The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
248 participants
Primary outcome timeframe
Up to 12 months.
Results posted on
2019-08-02
Participant Flow
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.
248 participants were consented, enrolled, and randomized.
Participant milestones
| Measure |
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 received a binder to follow along with study therapist.
|
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 received a binder to follow along with study therapist.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
124
|
|
Overall Study
COMPLETED
|
114
|
117
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
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 received a binder to follow along with study therapist.
|
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 received a binder to follow along with study therapist.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Postoperative Management for Degenerative Spinal Conditions
Baseline characteristics by cohort
| Measure |
CBPT Intervention
n=124 Participants
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.
|
Education Intervention
n=124 Participants
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.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.94 years
STANDARD_DEVIATION 11.50 • n=5 Participants
|
61.44 years
STANDARD_DEVIATION 12.22 • n=7 Participants
|
62.19 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
107 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Marital Status
Single
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Marital Status
Married
|
81 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Marital Status
Separated
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Marital Status
Living with Partner
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Educational Level
Less than 12th grade
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Educational Level
12th grade, diploma or GED
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Educational Level
Some college, no degree
|
33 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Educational Level
Associate degree
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Educational Level
College degree
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Educational Level
Graduate degree
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Insurance Status
Private
|
57 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Insurance Status
Public (i.e., Medicare, Medicaid)
|
57 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Insurance Status
Military health plan (i.e., TRICARE)
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
32.18 kg/m^2
STANDARD_DEVIATION 6.12 • n=5 Participants
|
32.59 kg/m^2
STANDARD_DEVIATION 7.01 • n=7 Participants
|
32.39 kg/m^2
STANDARD_DEVIATION 6.57 • n=5 Participants
|
|
Current tobacco use
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Working status
Employed
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Working status
Retired (not due to illness)
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Working status
Disabled and/or retired due to illness
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Working status
Looking for work
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Working status
Elected not to work (e.g., Homemaker)
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Working status
Attending School
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Pain duration
|
16.5 months
n=5 Participants
|
24 months
n=7 Participants
|
23 months
n=5 Participants
|
|
Prior spinal surgery
|
32 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Comorbidities
None
|
53 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Comorbidities
One
|
49 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Comorbidities
Two or more
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Narcotics: yes
|
49 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Surgery type
Laminectomy without fusion
|
51 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Surgery type
Laminectomy with fusion
|
73 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Spinal Levels
One
|
56 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Spinal Levels
Two
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Spinal Levels
Three or more
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Revision Surgery
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Length of Stay (LOS)
|
3.01 days
STANDARD_DEVIATION 1.82 • n=5 Participants
|
3.6 days
STANDARD_DEVIATION 3.32 • n=7 Participants
|
3.31 days
STANDARD_DEVIATION 2.69 • n=5 Participants
|
|
Discharge location
Home
|
87 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Discharge location
Home with services
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Discharge location
Skilled nursing facility
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Discharge location
Inpatient rehabilitation facility
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months.Population: Number analyzed indicate the number of participants who completed the measure at each time point.
The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability.
Outcome measures
| Measure |
CBPT Intervention
n=124 Participants
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.
|
Education Intervention
n=124 Participants
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.
|
|---|---|---|
|
Oswestry Disability Index (ODI)
Preoperative
|
43.6 units on a scale
Interval 40.88 to 46.33
|
45.46 units on a scale
Interval 42.8 to 48.11
|
|
Oswestry Disability Index (ODI)
Baseline (6 weeks)
|
31.31 units on a scale
Interval 27.98 to 34.65
|
31.19 units on a scale
Interval 28.16 to 34.23
|
|
Oswestry Disability Index (ODI)
6 Months
|
24.06 units on a scale
Interval 20.68 to 27.43
|
24.33 units on a scale
Interval 21.34 to 27.32
|
|
Oswestry Disability Index (ODI)
12 Months
|
23.37 units on a scale
Interval 19.92 to 26.81
|
26.17 units on a scale
Interval 22.99 to 29.35
|
PRIMARY outcome
Timeframe: Up to 12 months after spine surgeryPopulation: Number analyzed indicate the number of participants who completed the measure at each time point.
The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome
Outcome measures
| Measure |
CBPT Intervention
n=124 Participants
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.
|
Education Intervention
n=124 Participants
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.
|
|---|---|---|
|
Brief Pain Inventory (BPI)
Back Pain: 6 Week
|
3.15 units on a scale
Interval 2.69 to 3.6
|
3.14 units on a scale
Interval 2.74 to 3.54
|
|
Brief Pain Inventory (BPI)
Back Pain: 6 Month
|
2.82 units on a scale
Interval 2.39 to 3.24
|
2.69 units on a scale
Interval 2.28 to 3.1
|
|
Brief Pain Inventory (BPI)
Back Pain: Preoperative
|
6.79 units on a scale
Interval 6.4 to 7.18
|
6.64 units on a scale
Interval 6.22 to 7.06
|
|
Brief Pain Inventory (BPI)
Back Pain: 12 Month
|
2.95 units on a scale
Interval 2.46 to 3.43
|
2.83 units on a scale
Interval 2.38 to 3.27
|
|
Brief Pain Inventory (BPI)
Leg Pain: Preoperative
|
6.63 units on a scale
Interval 6.2 to 7.06
|
6.38 units on a scale
Interval 5.92 to 6.83
|
|
Brief Pain Inventory (BPI)
Leg Pain: 6 Week
|
2.32 units on a scale
Interval 1.88 to 2.75
|
2.35 units on a scale
Interval 1.9 to 2.81
|
|
Brief Pain Inventory (BPI)
Leg Pain: 6 Month
|
2.23 units on a scale
Interval 1.77 to 2.69
|
2.45 units on a scale
Interval 1.98 to 2.91
|
|
Brief Pain Inventory (BPI)
Leg Pain: 12 Month
|
2.35 units on a scale
Interval 1.87 to 2.83
|
2.81 units on a scale
Interval 2.28 to 3.34
|
PRIMARY outcome
Timeframe: Up to 12 months after spine surgeryPopulation: Number analyzed indicate the number of participants who completed the measure at each time point.
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.
Outcome measures
| Measure |
CBPT Intervention
n=124 Participants
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.
|
Education Intervention
n=124 Participants
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.
|
|---|---|---|
|
12-Item Short Form Health Survey (SF-12)
Physical Health: Preoperative
|
27.84 units on a scale
Interval 26.19 to 29.5
|
27.8 units on a scale
Interval 26.22 to 29.38
|
|
12-Item Short Form Health Survey (SF-12)
Physical Health: 6 Week
|
33.49 units on a scale
Interval 31.61 to 35.36
|
33.55 units on a scale
Interval 31.99 to 35.1
|
|
12-Item Short Form Health Survey (SF-12)
Physical Health: 6 Month
|
39.31 units on a scale
Interval 37.11 to 41.5
|
38.81 units on a scale
Interval 36.86 to 40.77
|
|
12-Item Short Form Health Survey (SF-12)
Physical Health: 12 Month
|
39.25 units on a scale
Interval 36.82 to 41.69
|
37.43 units on a scale
Interval 35.21 to 39.64
|
|
12-Item Short Form Health Survey (SF-12)
Mental Health: Preoperative
|
49.69 units on a scale
Interval 47.55 to 51.84
|
48.54 units on a scale
Interval 46.23 to 50.86
|
|
12-Item Short Form Health Survey (SF-12)
Mental Health: 6 Week
|
52.27 units on a scale
Interval 50.25 to 54.29
|
51.89 units on a scale
Interval 49.75 to 54.02
|
|
12-Item Short Form Health Survey (SF-12)
Mental Health: 6 Month
|
54.02 units on a scale
Interval 52.46 to 55.58
|
52.94 units on a scale
Interval 50.84 to 55.03
|
|
12-Item Short Form Health Survey (SF-12)
Mental Health: 12 Month
|
53.86 units on a scale
Interval 52.01 to 55.71
|
53.23 units on a scale
Interval 51.38 to 55.08
|
SECONDARY outcome
Timeframe: Up to 12 months after spine surgeryPopulation: Number analyzed indicate the number of participants who completed the measure at each time point.
Physical activity measured by a commercially available movement accelerometer
Outcome measures
| Measure |
CBPT Intervention
n=124 Participants
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.
|
Education Intervention
n=124 Participants
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.
|
|---|---|---|
|
Physical Activity
Mean Activity Counts/Minute: 12 months
|
474.29 Mean Activity Counts/Minute
Interval 427.66 to 520.92
|
480.42 Mean Activity Counts/Minute
Interval 440.48 to 520.36
|
|
Physical Activity
Mean Activity Counts/Minute: 6 weeks
|
432.17 Mean Activity Counts/Minute
Interval 390.69 to 473.66
|
421.77 Mean Activity Counts/Minute
Interval 386.08 to 457.45
|
|
Physical Activity
Mean Activity Counts/Minute: 6 months
|
484.29 Mean Activity Counts/Minute
Interval 443.08 to 525.51
|
487.93 Mean Activity Counts/Minute
Interval 440.9 to 534.97
|
Adverse Events
CBPT Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place