Early PT
OtherPhysical therapy delivered within the first three months after surgery.
NCT Number: NCT06202443
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Tripler Army Medical Center, Honolulu, Hawaii, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Physical therapy delivered within the first three months after surgery.
Physical therapy delivered greater than 3 months after surgery.
Time frame: 6 and 12 months after hospital discharge
Neck Disability Index, 0-100 with higher scores indicating increased disability
Time frame: 6 and 12 months after hospital discharge
Numeric Rating Scale, 0-10 with higher scores indicating increased pain intensity
Time frame: 6 and 12 months after hospital discharge
PROMIS, 0-100 with higher scores indicating increased pain interference
Time frame: 6 and 12 months after hospital discharge
PROMIS, 0-100 with higher scores indicating better physical function
Time frame: 6 and 12 months after hospital discharge
MMEs
Time frame: 6 and 12 months after hospital discharge
Work Productivity and Activity Impairment Questionnaire
Contact information is provided by the study sponsor or research team.
Vanderbilt University Medical Center
Other
Improving Surgical Outcomes With Early Physical Therapy After Anterior Cervical Discectomy and Fusion
Acronym: FAST-PT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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