Postoperative Management for Degenerative Spinal Conditions
Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02184143
Collaborator
Patient-Centered Outcomes Research Institute (Other)
248
2
2
41
124
3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
248 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions
Study Start Date
:
Aug 1, 2014
Actual Primary Completion Date
:
Nov 1, 2017
Actual Study Completion Date
:
Jan 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CBPT intervention CBPT program consisting of weekly phone calls. |
Behavioral: CBPT
Changing Behavior through Physical Therapy (CBPT) is a cognitive-behavioral based self-management program.
|
| Active Comparator: Education intervention Education program consisting of weekly phone calls. |
Other: Education
Patient education
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Physical Activity [Up to 12 months after spine surgery]
Physical activity measured by a commercially available movement accelerometer
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins School of Medicine | Baltimore | Maryland | United States | 21287 |
| 2 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Vanderbilt University Medical Center
- Patient-Centered Outcomes Research Institute
Investigators
- Principal Investigator: Kristin R Archer, PT, PhD, Vanderbilt University
Study Documents (Full-Text)
More Information
Publications
- Archer KR, Devin CJ, Vanston SW, Koyama T, Phillips SE, Mathis SL, George SZ, McGirt MJ, Spengler DM, Aaronson OS, Cheng JS, Wegener ST. Cognitive-Behavioral-Based Physical Therapy for Patients With Chronic Pain Undergoing Lumbar Spine Surgery: A Randomized Controlled Trial. J Pain. 2016 Jan;17(1):76-89. doi: 10.1016/j.jpain.2015.09.013. Epub 2015 Oct 23. Erratum in: J Pain. 2017 Apr;18(4):477.
- Archer KR, Motzny N, Abraham CM, Yaffe D, Seebach CL, Devin CJ, Spengler DM, McGirt MJ, Aaronson OS, Cheng JS, Wegener ST. Cognitive-behavioral-based physical therapy to improve surgical spine outcomes: a case series. Phys Ther. 2013 Aug;93(8):1130-9. doi: 10.2522/ptj.20120426. Epub 2013 Apr 18.
Responsible Party:
Kristin Archer,
Associate Professor,
Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT02184143
Other Study ID Numbers:
- 140057
First Posted:
Jul 9, 2014
Last Update Posted:
Aug 2, 2019
Last Verified:
Jun 1, 2019
Study Results
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 Detail | 248 participants were consented, enrolled, and randomized. |
| Arm/Group Title | CBPT Intervention | Education Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 124 | 124 |
| COMPLETED | 114 | 117 |
| NOT COMPLETED | 10 | 7 |
Baseline Characteristics
| Arm/Group Title | CBPT Intervention | Education Intervention | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 of all reporting groups |
| Overall Participants | 124 | 124 | 248 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
62.94
(11.50)
|
61.44
(12.22)
|
62.19
(11.86)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
60
48.4%
|
66
53.2%
|
126
50.8%
|
| Male |
64
51.6%
|
58
46.8%
|
122
49.2%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
107
86.3%
|
108
87.1%
|
215
86.7%
|
| Non-White |
17
13.7%
|
16
12.9%
|
33
13.3%
|
| Marital Status (Count of Participants) | |||
| Single |
16
12.9%
|
7
5.6%
|
23
9.3%
|
| Married |
81
65.3%
|
83
66.9%
|
164
66.1%
|
| Widowed |
9
7.3%
|
13
10.5%
|
22
8.9%
|
| Divorced |
15
12.1%
|
15
12.1%
|
30
12.1%
|
| Separated |
0
0%
|
3
2.4%
|
3
1.2%
|
| Living with Partner |
3
2.4%
|
3
2.4%
|
6
2.4%
|
| Educational Level (Count of Participants) | |||
| Less than 12th grade |
5
4%
|
3
2.4%
|
8
3.2%
|
| 12th grade, diploma or GED |
26
21%
|
32
25.8%
|
58
23.4%
|
| Some college, no degree |
33
26.6%
|
43
34.7%
|
76
30.6%
|
| Associate degree |
16
12.9%
|
11
8.9%
|
27
10.9%
|
| College degree |
24
19.4%
|
19
15.3%
|
43
17.3%
|
| Graduate degree |
20
16.1%
|
16
12.9%
|
36
14.5%
|
| Insurance Status (Count of Participants) | |||
| Private |
57
46%
|
68
54.8%
|
125
50.4%
|
| Public (i.e., Medicare, Medicaid) |
57
46%
|
49
39.5%
|
106
42.7%
|
| Military health plan (i.e., TRICARE) |
10
8.1%
|
7
5.6%
|
17
6.9%
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
32.18
(6.12)
|
32.59
(7.01)
|
32.39
(6.57)
|
| Current tobacco use (Count of Participants) | |||
| Count of Participants [Participants] |
18
14.5%
|
21
16.9%
|
39
15.7%
|
| Working status (Count of Participants) | |||
| Employed |
45
36.3%
|
46
37.1%
|
91
36.7%
|
| Retired (not due to illness) |
41
33.1%
|
41
33.1%
|
82
33.1%
|
| Disabled and/or retired due to illness |
35
28.2%
|
31
25%
|
66
26.6%
|
| Looking for work |
1
0.8%
|
0
0%
|
1
0.4%
|
| Elected not to work (e.g., Homemaker) |
0
0%
|
5
4%
|
5
2%
|
| Attending School |
2
1.6%
|
1
0.8%
|
3
1.2%
|
| Pain duration (months) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [months] |
16.5
|
24
|
23
|
| Prior spinal surgery (Count of Participants) | |||
| Count of Participants [Participants] |
32
25.8%
|
42
33.9%
|
74
29.8%
|
| Comorbidities (Count of Participants) | |||
| None |
53
42.7%
|
64
51.6%
|
117
47.2%
|
| One |
49
39.5%
|
38
30.6%
|
87
35.1%
|
| Two or more |
22
17.7%
|
22
17.7%
|
44
17.7%
|
| Narcotics: yes (Count of Participants) | |||
| Count of Participants [Participants] |
49
39.5%
|
43
34.7%
|
92
37.1%
|
| Surgery type (Count of Participants) | |||
| Laminectomy without fusion |
51
41.1%
|
33
26.6%
|
84
33.9%
|
| Laminectomy with fusion |
73
58.9%
|
91
73.4%
|
164
66.1%
|
| Spinal Levels (Count of Participants) | |||
| One |
56
45.2%
|
55
44.4%
|
111
44.8%
|
| Two |
47
37.9%
|
45
36.3%
|
92
37.1%
|
| Three or more |
21
16.9%
|
24
19.4%
|
45
18.1%
|
| Revision Surgery (Count of Participants) | |||
| Count of Participants [Participants] |
17
13.7%
|
18
14.5%
|
35
14.1%
|
| Length of Stay (LOS) (days) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [days] |
3.01
(1.82)
|
3.6
(3.32)
|
3.31
(2.69)
|
| Discharge location (Count of Participants) | |||
| Home |
87
70.2%
|
88
71%
|
175
70.6%
|
| Home with services |
20
16.1%
|
14
11.3%
|
34
13.7%
|
| Skilled nursing facility |
3
2.4%
|
10
8.1%
|
13
5.2%
|
| Inpatient rehabilitation facility |
14
11.3%
|
12
9.7%
|
26
10.5%
|
Outcome Measures
| Title | Oswestry Disability Index (ODI) |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed indicate the number of participants who completed the measure at each time point. |
| Arm/Group Title | CBPT Intervention | Education Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 124 | 124 |
| Preoperative |
43.6
|
45.46
|
| Baseline (6 weeks) |
31.31
|
31.19
|
| 6 Months |
24.06
|
24.33
|
| 12 Months |
23.37
|
26.17
|
| Title | Brief Pain Inventory (BPI) |
|---|---|
| Description | The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome |
| Time Frame | Up to 12 months after spine surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed indicate the number of participants who completed the measure at each time point. |
| Arm/Group Title | CBPT Intervention | Education Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 124 | 124 |
| Back Pain: Preoperative |
6.79
|
6.64
|
| Back Pain: 6 Week |
3.15
|
3.14
|
| Back Pain: 6 Month |
2.82
|
2.69
|
| Back Pain: 12 Month |
2.95
|
2.83
|
| Leg Pain: Preoperative |
6.63
|
6.38
|
| Leg Pain: 6 Week |
2.32
|
2.35
|
| Leg Pain: 6 Month |
2.23
|
2.45
|
| Leg Pain: 12 Month |
2.35
|
2.81
|
| Title | 12-Item Short Form Health Survey (SF-12) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed indicate the number of participants who completed the measure at each time point. |
| Arm/Group Title | CBPT Intervention | Education Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 124 | 124 |
| Physical Health: Preoperative |
27.84
|
27.8
|
| Physical Health: 6 Week |
33.49
|
33.55
|
| Physical Health: 6 Month |
39.31
|
38.81
|
| Physical Health: 12 Month |
39.25
|
37.43
|
| Mental Health: Preoperative |
49.69
|
48.54
|
| Mental Health: 6 Week |
52.27
|
51.89
|
| Mental Health: 6 Month |
54.02
|
52.94
|
| Mental Health: 12 Month |
53.86
|
53.23
|
| Title | Physical Activity |
|---|---|
| Description | Physical activity measured by a commercially available movement accelerometer |
| Time Frame | Up to 12 months after spine surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed indicate the number of participants who completed the measure at each time point. |
| Arm/Group Title | CBPT Intervention | Education Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 124 | 124 |
| Mean Activity Counts/Minute: 6 weeks |
432.17
|
421.77
|
| Mean Activity Counts/Minute: 6 months |
484.29
|
487.93
|
| Mean Activity Counts/Minute: 12 months |
474.29
|
480.42
|
Adverse Events
| Time Frame | Adverse event data collected over 12 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | CBPT Intervention | Education Intervention | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| CBPT Intervention | Education Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/124 (0%) | 0/124 (0%) | ||
Serious Adverse Events |
||||
| CBPT Intervention | Education Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/124 (0%) | 0/124 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| CBPT Intervention | Education Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/124 (0%) | 0/124 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Kristin Archer |
|---|---|
| Organization | Vanderbilt University Medical Center |
| Phone | (615) 322-2732 |
| kristin.archer@Vanderbilt.Edu |
Responsible Party:
Kristin Archer,
Associate Professor,
Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT02184143
Other Study ID Numbers:
- 140057
First Posted:
Jul 9, 2014
Last Update Posted:
Aug 2, 2019
Last Verified:
Jun 1, 2019