NCT02184143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 2, 2019

Completed
Last Updated

August 2, 2019

Status Verified

June 1, 2019

Enrollment Period

3.3 years

First QC Date

July 2, 2014

Results QC Date

March 1, 2018

Last Update Submit

June 26, 2019

Conditions

Spinal Degenerative Disorder

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (1)

  • Physical Activity

    Up to 12 months after spine surgery

Study Arms (2)

CBPT intervention

EXPERIMENTAL

CBPT program consisting of weekly phone calls.

Behavioral: CBPT

Education intervention

ACTIVE COMPARATOR

Education program consisting of weekly phone calls.

Other: Education

Interventions

CBPTBEHAVIORAL

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

CBPT intervention
EducationOTHER

Patient education

Education intervention

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (3)

  • 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.

    PMID: 23599351BACKGROUND

  • 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.

    PMID: 26476267BACKGROUND

  • 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.

    PMID: 25273991DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Kristin Archer
Organization
Vanderbilt University Medical Center
kristin.archer@Vanderbilt.Edu
(615) 322-2732

Study Officials

  • Kristin R Archer, PT, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 9, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

August 2, 2019

Results First Posted

August 2, 2019

Record last verified: 2019-06

Locations

US(2)