Tags

Type your tag names separated by a space and hit enter

Prospective assessment of tizanidine for spasticity due to acquired brain injury.

Abstract

OBJECTIVE

To determine if orally delivered tizanidine will control spastic hypertonia due to acquired brain injury.

DESIGN

Randomized, double-blind, placebo-controlled, crossover design, with 2 8-week treatment arms separated by a 1-week washout period at baseline. Patients were randomly assigned to receive tizanidine or a matching placebo.

SETTING

Tertiary care outpatient and inpatient rehabilitation center attached to a university hospital.

PARTICIPANTS

Seventeen persons recruited in a consecutive manner, 9 of whom had suffered a stroke and 8 a traumatic brain injury, and had more than 6 months of intractable spastic hypertonia.

INTERVENTION

Over a 6-week period, subjects were slowly titrated up to their maximum tolerated dose (up to 36 mg/d). Following a 1-week drug taper and 1-week period in which no study drug was administered, patients were then crossed over to the other study medication following an identical titration regime.

MAIN OUTCOME MEASURES

Subjects were evaluated for dose and effect throughout the trial as well as for side effects. Data for Ashworth rigidity scores, spasm scores, deep tendon reflex scores, and motor strength were collected on the affected upper extremity (UE) and lower extremity (LE). Differences over time were assessed via descriptive statistics, Friedman's analysis, and Wilcoxon's signed-rank. Data are reported as the mean +/- 1 standard deviation.

RESULTS

Following 4 weeks of treatment when subjects reached their maximal tolerated dosage, the average LE Ashworth score on the affected side decreased from 2.3 +/- 1.4 to 1.7 +/- 1.1 (p <.0001). The spasm score decreased from 1.0 +/- 0.9 to 0.5 +/- 0.8 (p =.0464), while the reflex score was not statistically significant decreasing from 2.2 +/- 1.0 to 2.0 +/- 1.1 (p =.0883). The average UE Ashworth score on the affected side decreased from 1.9 +/- 1.1 to 1.5 +/- 0.9 (p <.0001). There was no significant change in the UE spasm and reflex scores. While there were positive placebo effects on motor tone, the active drug was still significantly better than placebo for decreasing LE tone (p =.0006) and UE tone (p =.0007). With a reduction in motor tone, there was an increase in motor strength (p =.0089). The average dosage at 4 weeks was 25.2mg/d.

CONCLUSION

Tizanidine is effective in decreasing the spastic hypertonia associated with acquired brain injury, which is dose-dependent. There are limitations on its use due to side effects related to drowsiness.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Department of Physical Medicine and Rehabilitation, University of Alabama School of Medicine, Birmingham, AL, USA. JMeythal@uab.edu

    , ,

    Source

    MeSH

    Administration, Oral
    Adult
    Aged
    Brain Injuries
    Clonidine
    Cross-Over Studies
    Dose-Response Relationship, Drug
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Muscle Hypertonia
    Muscle Relaxants, Central
    Muscle Spasticity
    Prospective Studies
    Reflex, Abnormal
    Severity of Illness Index
    Sleep Stages
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    11552184

    Citation

    Meythaler, J M., et al. "Prospective Assessment of Tizanidine for Spasticity Due to Acquired Brain Injury." Archives of Physical Medicine and Rehabilitation, vol. 82, no. 9, 2001, pp. 1155-63.
    Meythaler JM, Guin-Renfroe S, Johnson A, et al. Prospective assessment of tizanidine for spasticity due to acquired brain injury. Arch Phys Med Rehabil. 2001;82(9):1155-63.
    Meythaler, J. M., Guin-Renfroe, S., Johnson, A., & Brunner, R. M. (2001). Prospective assessment of tizanidine for spasticity due to acquired brain injury. Archives of Physical Medicine and Rehabilitation, 82(9), pp. 1155-63.
    Meythaler JM, et al. Prospective Assessment of Tizanidine for Spasticity Due to Acquired Brain Injury. Arch Phys Med Rehabil. 2001;82(9):1155-63. PubMed PMID: 11552184.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Prospective assessment of tizanidine for spasticity due to acquired brain injury. AU - Meythaler,J M, AU - Guin-Renfroe,S, AU - Johnson,A, AU - Brunner,R M, PY - 2001/9/12/pubmed PY - 2001/10/5/medline PY - 2001/9/12/entrez SP - 1155 EP - 63 JF - Archives of physical medicine and rehabilitation JO - Arch Phys Med Rehabil VL - 82 IS - 9 N2 - OBJECTIVE: To determine if orally delivered tizanidine will control spastic hypertonia due to acquired brain injury. DESIGN: Randomized, double-blind, placebo-controlled, crossover design, with 2 8-week treatment arms separated by a 1-week washout period at baseline. Patients were randomly assigned to receive tizanidine or a matching placebo. SETTING: Tertiary care outpatient and inpatient rehabilitation center attached to a university hospital. PARTICIPANTS: Seventeen persons recruited in a consecutive manner, 9 of whom had suffered a stroke and 8 a traumatic brain injury, and had more than 6 months of intractable spastic hypertonia. INTERVENTION: Over a 6-week period, subjects were slowly titrated up to their maximum tolerated dose (up to 36 mg/d). Following a 1-week drug taper and 1-week period in which no study drug was administered, patients were then crossed over to the other study medication following an identical titration regime. MAIN OUTCOME MEASURES: Subjects were evaluated for dose and effect throughout the trial as well as for side effects. Data for Ashworth rigidity scores, spasm scores, deep tendon reflex scores, and motor strength were collected on the affected upper extremity (UE) and lower extremity (LE). Differences over time were assessed via descriptive statistics, Friedman's analysis, and Wilcoxon's signed-rank. Data are reported as the mean +/- 1 standard deviation. RESULTS: Following 4 weeks of treatment when subjects reached their maximal tolerated dosage, the average LE Ashworth score on the affected side decreased from 2.3 +/- 1.4 to 1.7 +/- 1.1 (p <.0001). The spasm score decreased from 1.0 +/- 0.9 to 0.5 +/- 0.8 (p =.0464), while the reflex score was not statistically significant decreasing from 2.2 +/- 1.0 to 2.0 +/- 1.1 (p =.0883). The average UE Ashworth score on the affected side decreased from 1.9 +/- 1.1 to 1.5 +/- 0.9 (p <.0001). There was no significant change in the UE spasm and reflex scores. While there were positive placebo effects on motor tone, the active drug was still significantly better than placebo for decreasing LE tone (p =.0006) and UE tone (p =.0007). With a reduction in motor tone, there was an increase in motor strength (p =.0089). The average dosage at 4 weeks was 25.2mg/d. CONCLUSION: Tizanidine is effective in decreasing the spastic hypertonia associated with acquired brain injury, which is dose-dependent. There are limitations on its use due to side effects related to drowsiness. SN - 0003-9993 UR - https://www.unboundmedicine.com/medline/citation/11552184/Prospective_assessment_of_tizanidine_for_spasticity_due_to_acquired_brain_injury_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0003-9993(01)73950-0 DB - PRIME DP - Unbound Medicine ER -