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Meta-Analysis
. 2010 Sep 8;2010(9):CD008271.
doi: 10.1002/14651858.CD008271.pub2.

Botulinum toxin for shoulder pain

Jasvinder A Singh  1 , Patrick M Fitzgerald
Affiliations
Meta-Analysis

Botulinum toxin for shoulder pain

Jasvinder A Singh et al. Cochrane Database Syst Rev. .

Abstract

Background: Recent evidence suggests an anti-nociceptive effect of botulinum toxin.

Objectives: To compare the efficacy and safety of botulinum toxin in comparison to placebo or other treatment options for shoulder pain.

Search strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), Ovid MEDLINE, CINAHL (via EBSCOhost), Ovid SPORTDiscus, EMBASE and Science Citation Index.

Selection criteria: Randomized controlled trials (RCTs) comparing botulinum toxin with placebo or active treatment in people with shoulder pain were included.

Data collection and analysis: For continuous measures we calculated mean difference (MD), and for categorical measures risk ratio (RR) (with 95% confidence interval (CI)).

Main results: Six RCTs with 164 patients were included. Five RCTs in participants with post-stroke shoulder pain indicated that compared with placebo, a single intramuscular injection of botulinum toxin A significantly reduced pain at three to six months post-injection (MD -1.2 points, 95% CI -2.4 to -0.07; 0 to 10 point scale) but not at one month (MD -1.1 points, 95% CI -2.9 to 0.7). Shoulder external rotation was increased at one month (MD 9.8 degrees , 95% CI 0.2 to 19.4) but not at three to six months. Shoulder abduction, external rotation or spasticity did not differ between groups, nor did the number of adverse events (RR 1.46, 95% CI 0.6 to 24.3).One RCT in arthritis-related shoulder pain indicated that botulinum toxin reduced pain severity (MD -2.0, 95% CI -3.7 to -0.3; 10 point scale) and shoulder disability with a reduction in Shoulder Pain and Disability Index score (MD -13.4, 95% CI -24.9 to -1.9; 100 point scale) when compared with placebo. Shoulder abduction was improved (MD 13.8 degrees, 95% CI 3.2 to 44.0). Serious adverse events did not differ between groups (RR 0.35, 95% CI: 0.11, 1.12).

Authors' conclusions: The results should be interpreted with caution due to few studies with small sample sizes and high risk of bias. Botulinum toxin A injections seem to reduce pain severity and improve shoulder function and range of motion when compared with placebo in patients with shoulder pain due to spastic hemiplegia or arthritis. It is unclear if the benefit of pain relief in post-stroke shoulder pain at three to six months but not at one month is due to limitations of the evidence, which includes small sample sizes with imprecise estimates, or a delayed onset of action. More studies with safety data are needed.

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Conflict of interest statement

JS: speaker honoraria from Abbott pharmaceuticals; research grants from Amgen, Allergan, Takeda and Savient pharmaceuticals; consultant fee from Savient and URL pharmaceuticals; travel grants from Allergan and Wyeth pharmaceuticals.

PF: none.

The review included one study by a review author (JS). Selection of studies for inclusion as well as abstraction of all data were done independently by the two review authors (JS, PF). In addition, the abstracted data were checked for accuracy by another individual (KM).

Figures

1
1
Study selection flow chart
1.1
1.1. Analysis
Comparison 1 Intramuscular botulinum toxin versus placebo in patients with shoulder spasticity, Outcome 1 Pain (0‐10 cm visual analog scale or verbal rating scale).
1.2
1.2. Analysis
Comparison 1 Intramuscular botulinum toxin versus placebo in patients with shoulder spasticity, Outcome 2 Spasticity on Modified Ashworth Scale (0‐5 scale; higher=worse spasticity).
1.3
1.3. Analysis
Comparison 1 Intramuscular botulinum toxin versus placebo in patients with shoulder spasticity, Outcome 3 Passive shoulder flexion (0‐180; higher=better function).
1.4
1.4. Analysis
Comparison 1 Intramuscular botulinum toxin versus placebo in patients with shoulder spasticity, Outcome 4 Passive shoulder abduction (0‐180; higher=better function).
1.5
1.5. Analysis
Comparison 1 Intramuscular botulinum toxin versus placebo in patients with shoulder spasticity, Outcome 5 Shoulder external rotation (0‐90; higher=better function).
1.6
1.6. Analysis
Comparison 1 Intramuscular botulinum toxin versus placebo in patients with shoulder spasticity, Outcome 6 Number of adverse events.
2.1
2.1. Analysis
Comparison 2 Intramuscular botulinum toxin versus intra‐articular triamcinolone in shoulder spasticity: 12 weeks, Outcome 1 Change in pain on 0‐10 Numeric Rating Scale (higher=more pain).
2.2
2.2. Analysis
Comparison 2 Intramuscular botulinum toxin versus intra‐articular triamcinolone in shoulder spasticity: 12 weeks, Outcome 2 Change in physician global rating scale (0‐4; 4=maximum improvement).
2.3
2.3. Analysis
Comparison 2 Intramuscular botulinum toxin versus intra‐articular triamcinolone in shoulder spasticity: 12 weeks, Outcome 3 Change in passive shoulder flexion(0‐180; higher=better function).
2.4
2.4. Analysis
Comparison 2 Intramuscular botulinum toxin versus intra‐articular triamcinolone in shoulder spasticity: 12 weeks, Outcome 4 Change in passive shoulder abduction (0‐180; higher=better function).
2.5
2.5. Analysis
Comparison 2 Intramuscular botulinum toxin versus intra‐articular triamcinolone in shoulder spasticity: 12 weeks, Outcome 5 Change in passive shoulder external rotation (0‐90; higher=better function).
2.6
2.6. Analysis
Comparison 2 Intramuscular botulinum toxin versus intra‐articular triamcinolone in shoulder spasticity: 12 weeks, Outcome 6 Change in passive shoulder internal rotation (0‐90; higher=better function).
2.7
2.7. Analysis
Comparison 2 Intramuscular botulinum toxin versus intra‐articular triamcinolone in shoulder spasticity: 12 weeks, Outcome 7 Change in Muscle spasticity on Modified Ashworth Scale.
3.1
3.1. Analysis
Comparison 3 Intra‐articular botulinum toxin versus placebo in patients with end‐stage arthritis: 4 weeks, Outcome 1 Pain on 0‐10 Visual Analog Scale (0‐10 cm; higher=worse pain).
3.2
3.2. Analysis
Comparison 3 Intra‐articular botulinum toxin versus placebo in patients with end‐stage arthritis: 4 weeks, Outcome 2 SPADI Disability Subscale Score (0‐100; higher=worse function).
3.3
3.3. Analysis
Comparison 3 Intra‐articular botulinum toxin versus placebo in patients with end‐stage arthritis: 4 weeks, Outcome 3 SPADI Pain Subscale Score (0‐100; higher=worse pain).
3.4
3.4. Analysis
Comparison 3 Intra‐articular botulinum toxin versus placebo in patients with end‐stage arthritis: 4 weeks, Outcome 4 Active Shoulder flexion (0‐180; higher=better function).
3.5
3.5. Analysis
Comparison 3 Intra‐articular botulinum toxin versus placebo in patients with end‐stage arthritis: 4 weeks, Outcome 5 Active shoulder abduction (0‐180; higher=better function).
3.6
3.6. Analysis
Comparison 3 Intra‐articular botulinum toxin versus placebo in patients with end‐stage arthritis: 4 weeks, Outcome 6 McGill Total Pain Score (0‐45; higher=worse pain).
3.7
3.7. Analysis
Comparison 3 Intra‐articular botulinum toxin versus placebo in patients with end‐stage arthritis: 4 weeks, Outcome 7 McGill Sensory Dimension Pain Score (0‐33; higher=worse).
3.8
3.8. Analysis
Comparison 3 Intra‐articular botulinum toxin versus placebo in patients with end‐stage arthritis: 4 weeks, Outcome 8 McGill Affective Dimension Pain Score (0‐12; higher=worse pain).
3.9
3.9. Analysis
Comparison 3 Intra‐articular botulinum toxin versus placebo in patients with end‐stage arthritis: 4 weeks, Outcome 9 Serious adverse events.
3.10
3.10. Analysis
Comparison 3 Intra‐articular botulinum toxin versus placebo in patients with end‐stage arthritis: 4 weeks, Outcome 10 Number of patients with 1 or more serious adverse events.
3.11
3.11. Analysis
Comparison 3 Intra‐articular botulinum toxin versus placebo in patients with end‐stage arthritis: 4 weeks, Outcome 11 Death.
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Update of

References

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