Neurotoxin and Physical Therapy
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Orthopedic, Women's Studies |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/28/2018 |
| Start Date: | December 2014 |
| End Date: | January 7, 2017 |
Synergistic Effects of 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 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.
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.
The study will recruit primary cervical dystonia patients (age 18-80) who are stable on
Allergan botulinum toxin type A (Botox). Patients will be randomized to receive their typical
Botox injection alone, or with physical therapy.
At Baseline, disease characteristics (as measured by the Toronto Western Spasmodic
Torticollis Rating Scale, or TWSTRS, and the Clinical Global Impression of Severity, or CGIS)
will be measured, along with quality of life (from the Short Health 36 Survey Form 36, or
SF-36). One subscale of the TWSTRS will be videotaped to be later evaluated by blinded
movement disorder specialists. A pain scale will also be completed and range of head motion
will be measured using a device similar to a protractor (called a goniometer). An
individualized Botox injection will be administered, as well as transcranial magnetic
stimulation (TMS) to measure neuroplasticity, or the ability of the brain to make new
connections. If randomized to receive physical therapy, participants will also receive
instructions to perform physical therapy exercises five times per week by a physical
therapist who specializes in movement disorders. The investigator will call weekly to check
how the participant is doing with the exercise program.
The same procedures outlined above will also be performed at 5 weeks past baseline, and at 12
weeks (except for the Botox injection, which will only be given at baseline and 12 weeks).
Allergan botulinum toxin type A (Botox). Patients will be randomized to receive their typical
Botox injection alone, or with physical therapy.
At Baseline, disease characteristics (as measured by the Toronto Western Spasmodic
Torticollis Rating Scale, or TWSTRS, and the Clinical Global Impression of Severity, or CGIS)
will be measured, along with quality of life (from the Short Health 36 Survey Form 36, or
SF-36). One subscale of the TWSTRS will be videotaped to be later evaluated by blinded
movement disorder specialists. A pain scale will also be completed and range of head motion
will be measured using a device similar to a protractor (called a goniometer). An
individualized Botox injection will be administered, as well as transcranial magnetic
stimulation (TMS) to measure neuroplasticity, or the ability of the brain to make new
connections. If randomized to receive physical therapy, participants will also receive
instructions to perform physical therapy exercises five times per week by a physical
therapist who specializes in movement disorders. The investigator will call weekly to check
how the participant is doing with the exercise program.
The same procedures outlined above will also be performed at 5 weeks past baseline, and at 12
weeks (except for the Botox injection, which will only be given at baseline and 12 weeks).
Inclusion Criteria:
- Aged 18-80 with a diagnosis of Cervical Dystonia, which will be confirmed by a
movement disorders specialist
- Positive response to at least two prior treatments with Botox as indicated by an
improvement in Clinical Global Improvement Scale.
- Received last dose of Botox a minimum of 12 weeks prior to baseline visit.
Exclusion Criteria:
- Any conditions that would contraindicate transcranial magnetic stimulation (for
example, pregnancy or epilepsy)
- Any secondary, fixed, post-traumatic, or psychogenic dystonia
We found this trial at
1
site
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
Click here to add this to my saved trials
