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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBPT intervention | Experimental | CBPT program consisting of weekly phone calls. |
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| Education intervention | Active Comparator | Education program consisting of weekly phone calls. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBPT | Behavioral | Changing Behavior through Physical Therapy (CBPT) is a cognitive-behavioral based self-management program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) | The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability. | Up to 12 months. |
| Brief Pain Inventory (BPI) | The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome | Up to 12 months after spine surgery |
| 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. | Up to 12 months after spine surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Physical activity measured by a commercially available movement accelerometer | Up to 12 months after spine surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin R Archer, PT, PhD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21287 | United States | ||
| Vanderbilt University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23599351 | Background | 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. | |
| 26476267 | Background |
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248 participants were consented, enrolled, and randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oswestry Disability Index (ODI) | The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability. | Number analyzed indicate the number of participants who completed the measure at each time point. | Posted | Mean | 95% Confidence Interval | units on a scale | Up to 12 months. |
|
Adverse event data collected over 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Archer | Vanderbilt University Medical Center | (615) 322-2732 | kristin.archer@Vanderbilt.Edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2014 | Mar 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Education | Other | Patient education |
|
| Nashville |
| Tennessee |
| 37232 |
| United States |
| 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. |
| 25273991 | Derived | Archer KR, Coronado RA, Haug CM, Vanston SW, Devin CJ, Fonnesbeck CJ, Aaronson OS, Cheng JS, Skolasky RL, Riley LH 3rd, Wegener ST. A comparative effectiveness trial of postoperative management for lumbar spine surgery: changing behavior through physical therapy (CBPT) study protocol. BMC Musculoskelet Disord. 2014 Oct 1;15:325. doi: 10.1186/1471-2474-15-325. |
| Death |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Educational Level | Count of Participants | Participants |
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| Insurance Status | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Current tobacco use | Count of Participants | Participants |
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| Working status | Count of Participants | Participants |
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| Pain duration | Median | Inter-Quartile Range | months |
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| Prior spinal surgery | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
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| Narcotics: yes | Count of Participants | Participants |
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| Surgery type | Count of Participants | Participants |
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| Spinal Levels | Count of Participants | Participants |
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| Revision Surgery | Count of Participants | Participants |
|
| Length of Stay (LOS) | Mean | Standard Deviation | days |
|
| Discharge location | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | Brief Pain Inventory (BPI) | The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome | Number analyzed indicate the number of participants who completed the measure at each time point. | Posted | Mean | 95% Confidence Interval | units on a scale | Up to 12 months after spine surgery |
|
|
|
| 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. | Number analyzed indicate the number of participants who completed the measure at each time point. | Posted | Mean | 95% Confidence Interval | units on a scale | Up to 12 months after spine surgery |
|
|
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| Secondary | Physical Activity | Physical activity measured by a commercially available movement accelerometer | Number analyzed indicate the number of participants who completed the measure at each time point. | Posted | Mean | 95% Confidence Interval | Mean Activity Counts/Minute | Up to 12 months after spine surgery |
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| 0 |
| 124 |
| 0 |
| 124 |
| 0 |
| 124 |
| EG001 | 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. | 0 | 124 | 0 | 124 | 0 | 124 |
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| Back Pain: 6 Week |
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| Back Pain: 6 Month |
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| Back Pain: 12 Month |
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| Leg Pain: Preoperative |
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| Leg Pain: 6 Week |
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| Leg Pain: 6 Month |
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| Leg Pain: 12 Month |
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| Physical Health: 6 Week |
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| Physical Health: 6 Month |
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| Physical Health: 12 Month |
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| Mental Health: Preoperative |
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| Mental Health: 6 Week |
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| Mental Health: 6 Month |
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| Mental Health: 12 Month |
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| Mean Activity Counts/Minute: 6 months |
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| Mean Activity Counts/Minute: 12 months |
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