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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The goal of this two-group randomized clinical trial is to examine the effects of early postoperative PT compared to delayed postoperative PT for improving outcomes after hospital discharge for ACDF surgery.
The main question this clinical trial aims to answer are:
Participants will be randomized to one of two groups (early PT or delayed PT) and outcomes compared across groups.
This study is a prospective randomized controlled trial of early PT (within 3 months after surgery) versus delayed PT (greater than 3 months after surgery) in adults following ACDF surgery for degenerative conditions. The central hypothesis is that an early PT program will be effective in improving disability, pain, physical function, opioid use and return to work/duty. 76 participants will be enrolled and randomized (38 patients per randomized group), with 64 (85%) expected to be retained in the trial at the 12-month follow-up. Eligible patients undergoing ACDF surgery for a degenerative condition will be randomized to one of two groups (early PT or delayed PT). Patients will be enrolled prior to surgery, asked to complete a preoperative questionnaire prior to surgery and then randomized. Patients randomized to one of the PT groups will have their first PT visit scheduled for them by study staff prior to surgery. This visit will occur at approximately 2 weeks after hospital discharge for the early PT group and approximately 3 months after hospital discharge for the delayed PT group. All randomized patients will be asked to participate in follow-up visits approximately 3-, 6- and 12-months after hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Physical Therapy (PT) | Experimental | PT will be delivered two times a week for 8 weeks by a licensed physical therapist. Participants will start PT approximately 2 weeks after hospital discharge |
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| Delayed Physical Therapy (PT) | Active Comparator | PT will be delivered two times a week for 8 weeks by a licensed physical therapist. Participants will start PT approximately 3 months after hospital discharge. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early PT | Other | Physical therapy delivered within the first three months after surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disability | Neck Disability Index, 0-100 with higher scores indicating increased disability | 6 and 12 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Numeric Rating Scale, 0-10 with higher scores indicating increased pain intensity | 6 and 12 months after hospital discharge |
| Pain Interference | PROMIS, 0-100 with higher scores indicating increased pain interference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Priest | Contact | 615-421-8336 | amanda.priest@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Kristin Archer, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tripler Army Medical Center | Recruiting | Honolulu | Hawaii | 96859 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31663795 | Background | Coronado RA, Devin CJ, Pennings JS, Aaronson OS, Haug CM, Van Hoy EE, Vanston SW, Archer KR. Safety and feasibility of an early telephone-supported home exercise program after anterior cervical discectomy and fusion: a case series. Physiother Theory Pract. 2021 Oct;37(10):1096-1108. doi: 10.1080/09593985.2019.1683921. Epub 2019 Oct 30. | |
| 31490861 |
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| Delayed PT | Other | Physical therapy delivered greater than 3 months after surgery. |
|
| 6 and 12 months after hospital discharge |
| Physical Function | PROMIS, 0-100 with higher scores indicating better physical function | 6 and 12 months after hospital discharge |
| Opioid Utilization | MMEs | 6 and 12 months after hospital discharge |
| Return to work | Work Productivity and Activity Impairment Questionnaire | 6 and 12 months after hospital discharge |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Booke Army Medical Center | Recruiting | Fort Sam Houston | Texas | 78234 | United States |
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| Madigan Army Medical Center | Recruiting | Tacoma | Washington | 98431 | United States |
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| Coronado RA, Devin CJ, Pennings JS, Vanston SW, Fenster DE, Hills JM, Aaronson OS, Schwarz JP, Stephens BF, Archer KR. Early Self-directed Home Exercise Program After Anterior Cervical Discectomy and Fusion: A Pilot Study. Spine (Phila Pa 1976). 2020 Feb 15;45(4):217-225. doi: 10.1097/BRS.0000000000003239. |