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Prospective study on the use of bolus intrathecal baclofen for spastic hypertonia due to acquired brain injury.
Arch Phys Med Rehabil 1996; 77(5):461-6AP

Abstract

OBJECTIVE

To determine if the intrathecal delivery of baclofen will decrease spastic hypertonia caused by brain injury.

PATIENTS

Eleven patients more than 1 year after their brain injury with disabling lower extremity spastic hypertonia.

SETTING

University tertiary care outpatient rehabilitation clinic.

DESIGN

Patients were a consecutive sample randomized in a double blind, placebo-controlled crossover study.

INTERVENTIONS

Bolus intrathecal injection of either normal saline or 50 micrograms baclofen.

MAIN OUTCOME MEASURES

Data for Ashworth rigidity scores, spasm scores, and deep tendon reflex scores were collected for both the upper extremities (UE) and lower extremities (LE). Changes over time were assessed via Friedman's test. Differences between the placebo and active drug at any given time were assessed via Wilcoxon signed-rank.

RESULTS

Four hours after injection with the active drug (maximum effect) the average LE Ashworth score decreased from 4.2 +/- 0.8 (SD) to 2.2 +/- 0.6 (p = .0033), spasm score from 3.1 +/- 1.0 to 1.0 +/- 0.7 (p = .0032), and reflex score from 3.3 +/- 0.5 to 1.0 +/- 1.3 (p = .0033). The average UE Ashworth score decreased from 3.3 +/- 1.3 to 1.9 +/- 0.8 (p = .0033), spasm score from 1.8 +/- 1.3 to 0.6 +/- 1.0 (p = .007), and reflex score from 2.7 +/- 0.5 to 1.7 +/- 0.6 (p = .0111). No trend was observed over time with placebo administration. There were significant reductions in the average for LE Ashworth (p < .0001), spasm (p < .0001), and reflex (p < .0001) scores and for UE Ashworth (p < .0001) and spasm (p < .0004) scores observed over 4 hours (maximum effect) with active drug administration. No significant differences were noted between the active drug and placebo groups before administration in LE and UE Ashworth, spasm, or reflex scores. There were significant differences between the active drug and placebo groups at 4 hours after administration for LE and UE Ashworth, spasm, and reflex scores (p < or = .0272).

CONCLUSION

Intrathecal injection of baclofen is capable of reducing the spastic hypertonia associated with brain injury.

Authors+Show Affiliations

Department of Rehabilitation Medicine, University of Alabama-Birmingham School of Medicine 35233-7330, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

8629922

Citation

Meythaler, J M., et al. "Prospective Study On the Use of Bolus Intrathecal Baclofen for Spastic Hypertonia Due to Acquired Brain Injury." Archives of Physical Medicine and Rehabilitation, vol. 77, no. 5, 1996, pp. 461-6.
Meythaler JM, DeVivo MJ, Hadley M. Prospective study on the use of bolus intrathecal baclofen for spastic hypertonia due to acquired brain injury. Arch Phys Med Rehabil. 1996;77(5):461-6.
Meythaler, J. M., DeVivo, M. J., & Hadley, M. (1996). Prospective study on the use of bolus intrathecal baclofen for spastic hypertonia due to acquired brain injury. Archives of Physical Medicine and Rehabilitation, 77(5), pp. 461-6.
Meythaler JM, DeVivo MJ, Hadley M. Prospective Study On the Use of Bolus Intrathecal Baclofen for Spastic Hypertonia Due to Acquired Brain Injury. Arch Phys Med Rehabil. 1996;77(5):461-6. PubMed PMID: 8629922.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prospective study on the use of bolus intrathecal baclofen for spastic hypertonia due to acquired brain injury. AU - Meythaler,J M, AU - DeVivo,M J, AU - Hadley,M, PY - 1996/5/1/pubmed PY - 1996/5/1/medline PY - 1996/5/1/entrez SP - 461 EP - 6 JF - Archives of physical medicine and rehabilitation JO - Arch Phys Med Rehabil VL - 77 IS - 5 N2 - OBJECTIVE: To determine if the intrathecal delivery of baclofen will decrease spastic hypertonia caused by brain injury. PATIENTS: Eleven patients more than 1 year after their brain injury with disabling lower extremity spastic hypertonia. SETTING: University tertiary care outpatient rehabilitation clinic. DESIGN: Patients were a consecutive sample randomized in a double blind, placebo-controlled crossover study. INTERVENTIONS: Bolus intrathecal injection of either normal saline or 50 micrograms baclofen. MAIN OUTCOME MEASURES: Data for Ashworth rigidity scores, spasm scores, and deep tendon reflex scores were collected for both the upper extremities (UE) and lower extremities (LE). Changes over time were assessed via Friedman's test. Differences between the placebo and active drug at any given time were assessed via Wilcoxon signed-rank. RESULTS: Four hours after injection with the active drug (maximum effect) the average LE Ashworth score decreased from 4.2 +/- 0.8 (SD) to 2.2 +/- 0.6 (p = .0033), spasm score from 3.1 +/- 1.0 to 1.0 +/- 0.7 (p = .0032), and reflex score from 3.3 +/- 0.5 to 1.0 +/- 1.3 (p = .0033). The average UE Ashworth score decreased from 3.3 +/- 1.3 to 1.9 +/- 0.8 (p = .0033), spasm score from 1.8 +/- 1.3 to 0.6 +/- 1.0 (p = .007), and reflex score from 2.7 +/- 0.5 to 1.7 +/- 0.6 (p = .0111). No trend was observed over time with placebo administration. There were significant reductions in the average for LE Ashworth (p < .0001), spasm (p < .0001), and reflex (p < .0001) scores and for UE Ashworth (p < .0001) and spasm (p < .0004) scores observed over 4 hours (maximum effect) with active drug administration. No significant differences were noted between the active drug and placebo groups before administration in LE and UE Ashworth, spasm, or reflex scores. There were significant differences between the active drug and placebo groups at 4 hours after administration for LE and UE Ashworth, spasm, and reflex scores (p < or = .0272). CONCLUSION: Intrathecal injection of baclofen is capable of reducing the spastic hypertonia associated with brain injury. SN - 0003-9993 UR - https://www.unboundmedicine.com/medline/citation/8629922/Prospective_study_on_the_use_of_bolus_intrathecal_baclofen_for_spastic_hypertonia_due_to_acquired_brain_injury_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0003-9993(96)90034-9 DB - PRIME DP - Unbound Medicine ER -