Table 27 Botulinum Neurotoxin for Reducing Spasticity

Author Year

Country
Research Design

Score
Total Sample Size

Methods Outcome

Richardson et al. 2000

England

RCT

PEDro=9

N=52

Population: Injury etiology: stroke=23, head injury=12, SCI=6, other=11.

Intervention: EMG guided injection of BTX-A with doses and specific muscles injected based on clinical judgment.

Outcome Measures: Modified Ashworth Scale (MAS), Passive range of motion (ROM), Subjective rating of Problem Severity, 9-hole peg test (upper limb problems only), Timed 10 m walk test (10MWT) (lower limb problems only), Goal Attainment Scale (GAS), Rivermead Motor Assessment Scale (RMA) at 3, 6, 9 and 12 wk.

1.     Spasticity was significantly reduced for active tx versus placebo (as shown by MAS aggregate scores) (p<0.02). The main reduction for both tx and placebo groups occurred between baseline and 3 wk with little further improvement thereafter. tx group had more marked reduction than placebo group.

2.     ROM was significantly improved for both groups but significantly more for treatment versus placebo group (p<0.03). As with MAS most marked changes were between baselines and 3 wk.

3.     In general, the various functional measures showed no systematic significant differences other than Subjective Rating of Problem Severity with aggregate outcome scores significantly better for active Tx versus placebo (p<0.025).

Spiegl 2014

Germany

Pre-Post

N=9

Population: Mean age: 40.0 yr; Gender: males=9, females=0; Level of severity: AIS A=8, AIS B=0, AIS C=1.

Intervention: Patients received botulinum toxin A injections (800-2000 U) to the affected muscles of the lower extremities after ≥3 mo of unsuccessful physiotherapeutic and oral antispastic therapy. Following injection, patients received intensive physiotherapy of the affected muscles for 3 day.

Outcome Measures: Modified Ashworth Scale (MAS) at 2wk and 2 yr; Difficulties during mobilization, Adverse events.

1.     MAS scores 2 wk post injection decreased to ≤2 in 6 patients with a mean reduction of 1.9.

2.     MAS scores 2wk post injection showed no change in 2 patients.

3.     Decreases in spasticity were observed 2-5 days post injection with the peak decrease observed at a mean of 2 wk post injection.

4.     MAS scores at 2 yr post injection were ≤2 in 3 patients and ≤3 in 3 patients with a mean increase of 0.6 from 2 wk to 2 yr.

5.     Difficulties during mobilization were reduced in 5 patients in areas including getting dressed or transferring to wheelchair.

6.     Adverse events were reported by 2 patients with 1 patient reporting decreased mobility due to muscle weakness for 3 mo post injection and the other reporting general muscle weakness for 3 days post injection.

7.     No infections or allergic reactions were observed in patients post injection.

8.     The positive effect in 6 patients lasted >7 mo before decreasing in all patients.

Bernuz et al. 2012

France

Pre-Post

N=15

Population: Mean age: 43.0 yr; Gender: males=14, females=1; Mean time since injury: 10 yr; Level of injury: cervical=7, thoracic=7, lumbar=1; Level of severity: AIS D=15.

Intervention: Injection of 200 UI of Botulinum Toxin (BoNT A) distributed in 2 points in the rectus femoris (RF) muscles.

Outcome Measures: Isokinetic peak torque (seated and supine) during passive stretch (10 deg/sec, 90 deg/sec, 150 deg/sec) and voluntary contraction (60 deg/sec), Angle at peak torque (seated and supine) during passive stretch (10 deg/sec, 90 deg/sec, 150 deg/sec) and voluntary contraction (60 deg/sec), Modified Tardieu Scale (MTS), Peak knee flexion, Gait velocity, Stride length, Swing phase, 6-minute walking test (6MWT), Timed stair climbing, Discomfort.

1.     Peak torque during voluntary contraction decreased significantly (p=0.0004).

2.     The angle at peak torque during passive stretch at 90 deg/s increased significantly (p=0.03).

3.     The MTS grade decreased significantly (p<0.05) and the MTS angle increased significantly (p<0.01).

4.     Peak knee angle during flexion, and the knee flexion velocity at toe-off increased significantly (both p<0.05).

·       Significant treatment increases in gait velocity (p<0.01), stride length (p<0.01), and swing phase (p<0.01).

5.     No significant change in the 6MWT was found.

6.     The Timed stair climbing decreased significantly (p<0.05).

7.     Main discomfort decreased significantly (p=0.001).

Palazon-Garcia et al. 2018

Spain

Case Series

N=90

Population: SCI (n=90): Etiology: Trauma=87, Familial spastic paraparesis=3; Mean age=41.92yr (range=18-77); Gender: males=65, females=25; Level of injury: C=51, T=23, L=13; Mean time since injury=NR; AIS scale: A=20, B=11, C=14, D=44, E=1.

Intervention: This retrospective study examined spasticity outcomes in patients injected with botulinum toxin. Muscles injected include the flexor carpi radialis, flexor digitorum profundus, biceps brachii, quadriceps, soleus, and tibialis posterior.     

Outcome Measures: modified Ashworth Scale (mAS).

1.     Muscle tone as measured by the mAS fell from 2.38 to 1.18 post injection when considering only the injected muscles. Mean improvement in tone, as measured by the mAS was 1.3 points per muscle.

Hecht et al. 2008

Germany

Case Series

NInitial=19,

NFinal=11

 

Population: Hereditary spastic paraplegia (HSP): Mean age: 41.6 yr; Gender: males=14, females=5; Mean time since injury: 18.5 yr.

Intervention: Injection of BTX-A with doses and specific muscles injected based on clinical judgment.

Outcome Measures: Ashworth Scale (AS), Global Subjective Assessment (GSA).

1.  17 patients had a one point improvement on the AS, one improved by three points, and one was not scored.

2.   Of the 17, those with GSA improvement continued BTX-A treatment (n=11).

3.   10 of the continuing 11 patients participated in physical therapy concurrently with BTX-A injections.

4.   Adverse effects: muscle weakness (n=3), pain during walking (n=1) & CK elevation (n=1).

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