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NCT02177617 · ClinicalTrials.gov registry record · Phase 4
Neurotoxin and Physical Therapy
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT02177617: Completed Phase 4 study, sponsored by University of Florida.
NCT02177617 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02177617, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study aims to compare Botox injections without Physical Therapy sessions to Botox injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms and quality of life more than Botox alone. It is also expected that Botox combined with Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after Botox injection.
Primary Outcome
The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is a measure of symptoms, pain, and disability related to Cervical Dystonia. The total TWSTRS scale includes a global outcome score (total score) and scores on each of 3 subscales for severity (0-35), disability (0-30), and pain (0-20), which are summed together for a total score (0-85), with higher scores indicating greater impairment. The TWSTRS is completed by a neurologist who visually assesses the patient's symptoms, and asks t
Interventions
- BEHAVIORAL Physical Therapy
- PROCEDURE Transcranial magnetic stimulation (TMS)
- DRUG Botox injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-12 |
| Est. Completion | 2017-01-07 |
| Phase | Phase 4 |
What the finished NCT02177617 record still lists
NCT02177617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Physical Therapy is the first listed.
NCT02177617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02177617 about?
NCT02177617 is a clinical study titled "Neurotoxin and Physical Therapy". This study aims to compare Botox injections without Physical Therapy sessions to Botox injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms and quality of life more than...
What is the current status of trial NCT02177617?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2014-12. Estimated completion is 2017-01-07.
What interventions are being tested in trial NCT02177617?
The interventions under investigation include: Physical Therapy (BEHAVIORAL), Transcranial magnetic stimulation (TMS) (PROCEDURE), Botox injection (DRUG).
Who is sponsoring clinical trial NCT02177617?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02177617's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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