Cervical Spine DegenerationFAST-PTNCT06202443
Function After Anterior Cervical Discectomy and Fusion Surgery: Timing of Physical Therapy
A study testing Early PT and Delayed PT in people with Cervical Spine Degeneration and ACDF Surgery, run by Vanderbilt University Medical Center at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Spine Degeneration, ACDF Surgery
- What is being tested?
- Early PT and Delayed PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Feb 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical treatment of a cervical degenerative condition using a 1- or 2-level ACDF procedure;
- English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
- Age 18-75 years of age (individuals older than 75 are more likely to experience respiratory and nervous system complications and death following ACDF)
Who cannot join
- Surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
- Undergoing cervical corpectomy;
- Prior history of cervical spine surgery in last 5 years;
- Diagnosis or presence of osteoporosis;
- Diagnosis or presence of severe psychiatric disorder such as schizophrenia or bipolar disorder;
- Documented history of alcohol and/or drug abuse;
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- Currently involved in litigation due to injury;
- Currently undergoing treatment for cancer;
- Patients not able to return for follow-up visits due to time and travel limitation or other reasons; and
- Unable to provide a stable telephone or physical address
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Booke Army Medical Center
Fort Sam Houston, Texas, 78234
Rachel Meyhew, 206-450-0075, rmayhew@genevausa.org
Daniel Rhon, PhD
- Recruiting
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Rachel Mayhew, 206-450-0075, rmayhew@genevausa.org
Daniel Rhon, PhD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Amanda Priest, 615-421-8336, amanda.priest@vumc.org
- Recruiting
Madigan Army Medical Center
Tacoma, Washington, 98431
Rachel Mayhew, 206-450-0075, rmayhew@genevausa.org
Daniel Rhon, PhD
About this study
Official title: Improving Surgical Outcomes With Early Physical Therapy After Anterior Cervical Discectomy and Fusion
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:
- Whether early PT participants will demonstrate greater improvements in outcomes compared to delayed PT participants.
- Whether improvements in handgrip strength, cervical endurance, and cervical range of motion will be associated with improvements in outcomes.
Participants will be randomized to one of two groups (early PT or delayed PT) and outcomes compared across groups.
Read the detailed description
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.
- Conditions
- Cervical Spine Degeneration, ACDF Surgery
- Being tested
- Early PT, Delayed PT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early PTOther
Physical therapy delivered within the first three months after surgery.
Delayed PTOther
Physical therapy delivered greater than 3 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Early PT |
| 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. Receives: Other: Delayed PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Neck Disability Index, 0-100 with higher scores indicating increased disability
Measured: 6 and 12 months after hospital discharge
Secondary outcomes (5)
Pain Intensity
Numeric Rating Scale, 0-10 with higher scores indicating increased pain intensity
Measured: 6 and 12 months after hospital discharge
Pain Interference
PROMIS, 0-100 with higher scores indicating increased pain interference
Measured: 6 and 12 months after hospital discharge
Physical Function
PROMIS, 0-100 with higher scores indicating better physical function
Measured: 6 and 12 months after hospital discharge
Opioid Utilization
MMEs
Measured: 6 and 12 months after hospital discharge
Return to work
Work Productivity and Activity Impairment Questionnaire
Measured: 6 and 12 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Spine DegenerationStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Kristin Archer, Vanderbilt University Medical Center
- Investigators
- Kristin Archer, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202443
- Sponsor's protocol ID
- 231031
- Acronym
- FAST-PT
- Status last verified
- Aug 2025
- First submitted
- 28 Dec 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31663795Coronado 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.
PubMed 31490861
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Surgical Outcomes With Early Physical Therapy After Anterior Cervical Discectomy and Fusion
- ClinicalTrials.gov ID
- NCT06202443
- Acronym / sponsor ID
- FAST-PT / 231031
- Conditions
- Cervical Spine Degeneration, ACDF Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether early PT participants will demonstrate greater improvements in outcomes compared to delayed PT participants.
- Whether improvements in handgrip strength, cervical endurance, and cervical range of motion will be associated with improvements in outcomes.
Participants will be randomized to one of two groups (early PT or delayed PT) and outcomes compared across groups.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Physical Therapy (PT) | Experimental | Other: Early PTPT 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 |
| Delayed Physical Therapy (PT) | Active comparator | Other: Delayed PTPT 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgical treatment of a cervical degenerative condition using a 1- or 2-level ACDF procedure;
- English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
- Age 18-75 years of age (individuals older than 75 are more likely to experience respiratory and nervous system complications and death following ACDF)
Key exclusion criteria (10 listed)
- Surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
- Undergoing cervical corpectomy;
- Prior history of cervical spine surgery in last 5 years;
- Diagnosis or presence of osteoporosis;
- Diagnosis or presence of severe psychiatric disorder such as schizophrenia or bipolar disorder;
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 |
|---|---|---|
| Early PTPhysical therapy delivered within the first three months after surgery. | Other | Early Physical Therapy (PT) |
| Delayed PTPhysical therapy delivered greater than 3 months after surgery. | Other | Delayed Physical Therapy (PT) |
Primary outcome
Disability
Time frame: 6 and 12 months after hospital discharge
Neck Disability Index, 0-100 with higher scores indicating increased disability
5 secondary outcomes
Pain Intensity
Time frame: 6 and 12 months after hospital discharge
Pain Interference
Time frame: 6 and 12 months after hospital discharge
Physical Function
Time frame: 6 and 12 months after hospital discharge
Opioid Utilization
Time frame: 6 and 12 months after hospital discharge
Return to work
Time frame: 6 and 12 months after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 31663795Coronado 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.
- Background: PubMed 31490861Coronado 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.
- Individual participant dataSharing planned: No
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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.
Kristin Archer, PhD principal investigator
Vanderbilt University Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early PT and Delayed PT in people with Cervical Spine Degeneration and ACDF Surgery, run by Vanderbilt University Medical Center at 4 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Priest (615-421-8336, amanda.priest@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: 6 and 12 months after hospital discharge). 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 NCT06202443, which also lists 2 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 27 Feb 2026.