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NCT01519115 · ClinicalTrials.gov registry record · NA
Comparison of Outcomes Between Early Physical Therapy Intervention and Usual Care Following Anterior Cervical Fusion Surgery
A NA study, sponsored by Texas Woman's University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT01519115: Completed NA study, sponsored by Texas Woman's University.
NCT01519115 is a NA study that has completed, run by Texas Woman's University. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01519115, a NA study, has completed, sponsored by Texas Woman's University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
Background: Early physical therapy (PT) intervention with emphasis on spinal stabilization has been shown to benefit individuals undergoing lumbar spinal surgery. Further, training cervical spine stabilizers (deep cervical flexors and cervical multifidus) has been shown to be effective in reducing neck pain, restoring cervical spinal function and mobility in many types of cervical spine dysfunction. However, the training of stabilizers has not been studied in individuals undergoing cervical spinal surgery, even though these individuals often have problems with residual pain and weakness after the surgery. Purpose: The purpose of this study is to compare the effectiveness of clinical outcomes between an early PT intervention and usual care in patients who have undergone anterior cervical spine fusion (ACF) surgery. A study hypothesis is that outcomes will be improved with early PT intervention. Methods: This study is a double-blinded randomized clinical trial with a two-factor (2x3) research design. The patients following ACF surgery will be randomly assigned in one of the two treatment groups: usual care and early intervention. Three outcome measures will be collected pre-operative for baseline, and then at 6-week and 12-week post-operative follow-up visits, including: (1) deep cervical flexor (DCF) strength as determined by the cranio-cervical flexion (CCF) performance test, (2) patient's perceived disability associated neck pain as determined by the Neck Disability Index (NDI) questionnaire, and (3) neck pain level using the numeric pain rating scale (NPRS). In addition, at 6 and 12 weeks, the global rate of change (GROC) scale will be obtained to determine the patient's perception of overall improvement as a result of surgery. The investigator performing the outcome measures will be blinded to group assignment, and therefore will not participate in treatment. After randomization, the usual care group will receive only one visit of PT for post-operative instruct
Primary Outcome
test described in protocol information
Interventions
- OTHER usual care
- OTHER early physical therapy intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-12 |
| Phase | NA |
What the finished NCT01519115 record still lists
NCT01519115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which usual care is the first listed.
NCT01519115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01519115 about?
NCT01519115 is a clinical study titled "Comparison of Outcomes Between Early Physical Therapy Intervention and Usual Care Following Anterior Cervical Fusion Surgery". Background: Early physical therapy (PT) intervention with emphasis on spinal stabilization has been shown to benefit individuals undergoing lumbar spinal surgery. Further, training cervical spine stabilizers (deep cervical flexors and cervical multifidus) has been shown to be effective in reducing n...
What is the current status of trial NCT01519115?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2013-07. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01519115?
The interventions under investigation include: usual care (OTHER), early physical therapy intervention (OTHER).
Who is sponsoring clinical trial NCT01519115?
This trial is sponsored by Texas Woman's University, which has 51 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01519115's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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