Pilot Trial of Botulinum Toxin and Occupational Therapy for Writer's Cramp
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): BoNT Injections; Occupational Therapy
Intervention type(s): Drug; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Occupational Therapy; Botulinum Toxin; Writer's Cramp