Spinal Degenerative DisorderNCT02184143

Postoperative Management for Degenerative Spinal Conditions

A study testing CBPT and Education in people with Spinal Degenerative Disorder, run by Vanderbilt University Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 90 years
Conditions the study is for: Spinal Degenerative Disorder
What is being tested?: CBPT and Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 248 participants
Where: 2 sitesUnited States
Study dates: Aug 2014to Jan 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions

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.

Conditions: Spinal Degenerative Disorder
Being tested: CBPT, Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02184143
Study group	Role	What they receive
CBPT intervention	Experimental	CBPT program consisting of weekly phone calls. Receives: Behavioral: CBPT
Education intervention	Active comparator	Education program consisting of weekly phone calls. Receives: Other: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

Oswestry Disability Index (ODI)
The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability.
Measured: Up to 12 months.
Brief Pain Inventory (BPI)
The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome
Measured: 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.
Measured: Up to 12 months after spine surgery

Secondary outcomes (1)

Physical Activity
Physical activity measured by a commercially available movement accelerometer
Measured: Up to 12 months after spine surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Jan 2018

First posted9 Jul 2014 (estimated)
Study startAug 2014
Primary completionNov 2017
Study completionJan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Spinal Degenerative DisorderStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02184143
Sponsor's protocol ID: 140057
Status last verified: Jun 2019
First submitted: 2 Jul 2014
Last updated: 2 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 23599351
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.
PubMed 26476267
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.
PubMed 25273991

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions
ClinicalTrials.gov ID: NCT02184143
Acronym / sponsor ID: 140057
Conditions: Spinal Degenerative Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 248 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: Aug 2014
Primary completion: Nov 2017 (actual)
Study completion: Jan 2018 (actual)
First posted: 9 Jul 2014 (estimated)
Results: Posted 2 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CBPT intervention	Experimental	Behavioral: CBPTCBPT program consisting of weekly phone calls.
Education intervention	Active comparator	Other: EducationEducation program consisting of weekly phone calls.

Who may qualify

Ages: 21 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBPTChanging Behavior through Physical Therapy (CBPT) is a cognitive-behavioral based self-management program.	Behavioural	CBPT intervention
EducationPatient education	Other	Education intervention

Primary outcome

Oswestry Disability Index (ODI)
Time frame: 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)
Time frame: 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)
Time frame: 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.

1 secondary outcome

Physical Activity
Time frame: Up to 12 months after spine surgery

Results and safety

Results posted to the registry on 2 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CBPT Intervention	124	114
Education Intervention	124	117

Primary outcome: Oswestry Disability Index (ODI)

Time frame: Up to 12 months.. Mean (95% Confidence Interval). Unit: units on a scale

Measure	CBPT Intervention n = 124	Education Intervention n = 124
Preoperative	43.6 (40.88 to 46.33)	45.46 (42.80 to 48.11)
Baseline (6 weeks)	31.31 (27.98 to 34.65)	31.19 (28.16 to 34.23)
6 Months	24.06 (20.68 to 27.43)	24.33 (21.34 to 27.32)
12 Months	23.37 (19.92 to 26.81)	26.17 (22.99 to 29.35)

Population analysed: Number analyzed indicate the number of participants who completed the measure at each time point.

Primary outcome: Brief Pain Inventory (BPI)

Time frame: Up to 12 months after spine surgery. Mean (95% Confidence Interval). Unit: units on a scale

Measure	CBPT Intervention n = 124	Education Intervention n = 124
Back Pain: Preoperative	6.79 (6.4 to 7.18)	6.64 (6.22 to 7.06)
Back Pain: 6 Week	3.15 (2.69 to 3.6)	3.14 (2.74 to 3.54)
Back Pain: 6 Month	2.82 (2.39 to 3.24)	2.69 (2.28 to 3.1)
Back Pain: 12 Month	2.95 (2.46 to 3.43)	2.83 (2.38 to 3.27)
Leg Pain: Preoperative	6.63 (6.2 to 7.06)	6.38 (5.92 to 6.83)
Leg Pain: 6 Week	2.32 (1.88 to 2.75)	2.35 (1.9 to 2.81)
Leg Pain: 6 Month	2.23 (1.77 to 2.69)	2.45 (1.98 to 2.91)
Leg Pain: 12 Month	2.35 (1.87 to 2.83)	2.81 (2.28 to 3.34)

Population analysed: Number analyzed indicate the number of participants who completed the measure at each time point.

Primary outcome: 12-Item Short Form Health Survey (SF-12)

Time frame: Up to 12 months after spine surgery. Mean (95% Confidence Interval). Unit: units on a scale

Measure	CBPT Intervention n = 124	Education Intervention n = 124
Physical Health: Preoperative	27.84 (26.19 to 29.5)	27.8 (26.22 to 29.38)
Physical Health: 6 Week	33.49 (31.61 to 35.36)	33.55 (31.99 to 35.1)
Physical Health: 6 Month	39.31 (37.11 to 41.5)	38.81 (36.86 to 40.77)
Physical Health: 12 Month	39.25 (36.82 to 41.69)	37.43 (35.21 to 39.64)
Mental Health: Preoperative	49.69 (47.55 to 51.84)	48.54 (46.23 to 50.86)
Mental Health: 6 Week	52.27 (50.25 to 54.29)	51.89 (49.75 to 54.02)
Mental Health: 6 Month	54.02 (52.46 to 55.58)	52.94 (50.84 to 55.03)
Mental Health: 12 Month	53.86 (52.01 to 55.71)	53.23 (51.38 to 55.08)

Population analysed: Number analyzed indicate the number of participants who completed the measure at each time point.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data collected over 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBPT Intervention	0 of 124 (0%)	0 of 124 (0%)	0 of 124
Education Intervention	0 of 124 (0%)	0 of 124 (0%)	0 of 124

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23599351Archer 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.
Background: PubMed 26476267Archer 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.
Derived from this study: PubMed 25273991Archer 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kristin R Archer, PT, PhD principal investigator

Vanderbilt University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CBPT and Education in people with Spinal Degenerative Disorder, run by Vanderbilt University Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Disability Index (ODI) (time frame: Up to 12 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02184143, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.