Pilot Trial of Botulinum Toxin and Occupational Therapy for Writer's Cramp
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/17/2018 |
| Start Date: | December 3, 2013 |
| End Date: | September 13, 2016 |
Objective: Writer s cramp (WC) is a form of focal hand dystonia (FHD). Focal injections of
botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of
rehabilitative therapy can be useful. The hypothesis of this study is that BoNT together with
a specific type of occupational therapy will be better than BoNT alone for treating these
patients. Additionally, studies on WC were hampered by the lack of objective, validated
rating scales. In this pilot study, we will assess the value of a new scale compared with
older scales.
Study population: The study population will consist of 12 WC patients (accrual ceiling of
16).
Design: Patients will be randomized so that 6 patients will receive just BoNT therapy and 6
patients will receive BoNT therapy plus occupational therapy. The physical therapy will
involve specific exercises of finger movements in the direction opposite to the patient s own
dystonic movements, during the writing task. The movements will be isometric against splints
made to suit the individual patient. The final outcome will be assessed after 20 weeks of
treatment. Patients will be evaluated on several scales, including the writer s cramp rating
scale (WCRS) and writer s cramp impairment scale (WCIS), and will also be videotaped. The
primary outcome will be based on patient reported subjective scale and the secondary outcomes
will be assessed by four blinded raters of the videotapes, done both before and after
treatment.
Outcome measures: The primary outcome is to show additional improvement from baseline with
BoNT therapy plus occupational therapy compared to BoNT alone at 20 weeks using a
patient-rated subjective scale. The secondary outcomes are to show improvement in scores of
WCRS, WCIS, WCDS, and writing parameters with a new handwriting analysis program.
Additionally, the scores obtained from WCRS and WCIS will be compared.
botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of
rehabilitative therapy can be useful. The hypothesis of this study is that BoNT together with
a specific type of occupational therapy will be better than BoNT alone for treating these
patients. Additionally, studies on WC were hampered by the lack of objective, validated
rating scales. In this pilot study, we will assess the value of a new scale compared with
older scales.
Study population: The study population will consist of 12 WC patients (accrual ceiling of
16).
Design: Patients will be randomized so that 6 patients will receive just BoNT therapy and 6
patients will receive BoNT therapy plus occupational therapy. The physical therapy will
involve specific exercises of finger movements in the direction opposite to the patient s own
dystonic movements, during the writing task. The movements will be isometric against splints
made to suit the individual patient. The final outcome will be assessed after 20 weeks of
treatment. Patients will be evaluated on several scales, including the writer s cramp rating
scale (WCRS) and writer s cramp impairment scale (WCIS), and will also be videotaped. The
primary outcome will be based on patient reported subjective scale and the secondary outcomes
will be assessed by four blinded raters of the videotapes, done both before and after
treatment.
Outcome measures: The primary outcome is to show additional improvement from baseline with
BoNT therapy plus occupational therapy compared to BoNT alone at 20 weeks using a
patient-rated subjective scale. The secondary outcomes are to show improvement in scores of
WCRS, WCIS, WCDS, and writing parameters with a new handwriting analysis program.
Additionally, the scores obtained from WCRS and WCIS will be compared.
Objective: Writer s cramp (WC) is a form of focal hand dystonia (FHD). Focal injections of
botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of
rehabilitative therapy can be useful. The hypothesis of this study is that BoNT together with
a specific type of occupational therapy will be better than BoNT alone for treating these
patients. Additionally, studies on WC were hampered by the lack of objective, validated
rating scales. In this pilot study, we will assess the value of a new scale compared with
older scales.
Study population: The study population will consist of 12 WC patients (accrual ceiling of
16).
Design: Patients will be randomized so that 6 patients will receive just BoNT therapy and 6
patients will receive BoNT therapy plus occupational therapy. The physical therapy will
involve specific exercises of finger movements in the direction opposite to the patient s own
dystonic movements, during the writing task. The movements will be isometric against splints
made to suit the individual patient. The final outcome will be assessed after 20 weeks of
treatment. Patients will be evaluated on several scales, including the writer s cramp rating
scale (WCRS) and writer s cramp impairment scale (WCIS), and will also be videotaped. The
primary outcome will be based on patient reported subjective scale and the secondary outcomes
will be assessed by four blinded raters of the videotapes, done both before and after
treatment.
Outcome measures: The primary outcome is to show additional improvement from baseline with
BoNT therapy plus occupational therapy compared to BoNT alone at 20 weeks using a
patient-rated subjective scale. The secondary outcomes are to show improvement in scores of
WCRS, WCIS, WCDS, and writing parameters with a new handwriting analysis program.
Additionally, the scores obtained from WCRS and WCIS will be compared.
botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of
rehabilitative therapy can be useful. The hypothesis of this study is that BoNT together with
a specific type of occupational therapy will be better than BoNT alone for treating these
patients. Additionally, studies on WC were hampered by the lack of objective, validated
rating scales. In this pilot study, we will assess the value of a new scale compared with
older scales.
Study population: The study population will consist of 12 WC patients (accrual ceiling of
16).
Design: Patients will be randomized so that 6 patients will receive just BoNT therapy and 6
patients will receive BoNT therapy plus occupational therapy. The physical therapy will
involve specific exercises of finger movements in the direction opposite to the patient s own
dystonic movements, during the writing task. The movements will be isometric against splints
made to suit the individual patient. The final outcome will be assessed after 20 weeks of
treatment. Patients will be evaluated on several scales, including the writer s cramp rating
scale (WCRS) and writer s cramp impairment scale (WCIS), and will also be videotaped. The
primary outcome will be based on patient reported subjective scale and the secondary outcomes
will be assessed by four blinded raters of the videotapes, done both before and after
treatment.
Outcome measures: The primary outcome is to show additional improvement from baseline with
BoNT therapy plus occupational therapy compared to BoNT alone at 20 weeks using a
patient-rated subjective scale. The secondary outcomes are to show improvement in scores of
WCRS, WCIS, WCDS, and writing parameters with a new handwriting analysis program.
Additionally, the scores obtained from WCRS and WCIS will be compared.
- INCLUSION CRITERIA
1. be at least 18 years of age
2. have writer s cramp
3. patients are enrolled in 93-N-0202 and 85-N-0195
4. willing to be videotaped while writing
5. have normal hand function other than FHD
6. be willing to use therapeutic daily rehabilitative therapies as prescribed
7. have some positive subjective response to BoNT demonstrated on at least two prior
treatments
8. be able to comprehend and perform the daily activities required for those who are
involved in combined therapy.
EXCLUSION CRITERIA
1. BoNT administration within 3 months of participation
2. No response to BoNT
3. Unable to provide consent
4. Patients taking oral medications for WC including muscle relaxants or other
centrally-active medications such as antidepressants which may enhance tremors
5. Medical conditions that affect hand function, such as stroke, nerve entrapment,
tremor, parkinsonism, chorea, ataxia affecting the dominant hand
6. Unable to provide consent
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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