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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 is a NA study that has completed, run by Texas Woman's University. The registered enrollment target is 40 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01519115
The ClinicalTrials.gov registry entry for NCT01519115 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas Woman's University, which has 51 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which usual care is the first listed.
NCT01519115 reports 0 study locations.
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.
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