CHARACTERISTICS OF THE INCLUDED STUDIES

Objectives/Scope

Type of primary
studies

Population

Intervention

Comparator

Outcomes

Notes

Zhang et al. 2011,¹² Canada

To evaluate the efficacy of BoNTA versus non-active injection or other treatment in reducing chronic musculoskeletal pain

Systematic review and meta-analysis of randomized controlled trials

RCTs only

A total of 21 trials, were included in the review; of which, 12 trials evaluated BoNTA for MPS, 8 of these 12 trials were included in the meta-analysis
Trials were published between 1994 and 2008
A total of 332 patients contributed to myofascial pain analysis

The review included trials on patients experiencing chronic musculoskeletal pain of all ages, gender and degree of severity

Intramuscular or subcutaneous BoNTA injections

Placebo
other non-active therapies, including exercise

Reduction in pain severity through the period of follow-up

Four of the included studies in the review were not included in the statistical analysis due to inadequate data reporting

The review included seven studies that are common with other systematic reviews (Gobel et al. 2006,¹⁷ Ojala et al. 2006,¹⁸ Qerama et al. 2006,¹⁹ Cheshire et al. 1994,²⁰ Wheeler et al. 2001,²¹ Ferrante et al. 2005,²² and Wheeler et al. 1998²³)

Zhou et al. 2014,¹¹ US

To evaluate the efficacy of BoNTA injection at active trigger points as a treatment for MPS

Systematic review of randomized controlled trials

Double-blinded RCTs only

A total of 8 trials, were included in the review
Trials were published between 1994 and 2006

The review included trials on patients with MPS

BoNTA injections into trigger points for pain

Saline
Bupivacaine

reduction in pain scores

The review included six studies that are common with other systematic reviews (Göbel et al. 2006,¹⁷ Qerama et al. 2006,¹⁹ Cheshire et al. 1994,²⁰ Wheeler et al. 2001,²¹ Ferrante et al. 2005,²² and Wheeler et al. 2001²³)

Soares et al. 2014,¹⁰ Brazil

To evaluate the effectiveness and safety of BoNTA in the treatment MPS

Systematic review of randomized controlled trials

RCTs only

A total of 4 trials, were included in the review
Trials were published between 2006 and 2010

Male and female adult patients of with a clinical diagnosis of MPS

Studies with MPS of the neck and head were excluded

BoNTA irrespective of dose

Placebo
alternative drug (unspecified)

Frequency, intensity and duration of pain, pressure pain tolerance, and pain relief Adverse events

The review included three studies that are common with other systematic reviews (Göbel et al. 2006,¹⁷ Ojala et al. 2006,¹⁸ Qerama et al. 2006,¹⁹)

Study Objectives and
Design

Inclusion Criteria, Sample Size, and
Patient Characteristics

Intervention, Comparator,
and Study Conduct

Outcomes

Nicol et al. 2014,¹³ US

To evaluate the analgesic effect of BoNTA directly into painful muscle groups in the treatment of cervical and shoulder girdle myofascial pain

Enriched protocol design was used, where subjects who were responders to BoNTA were entered in the second phase of the study which was randomized double-blind

Patients were assessed six and twelve weeks after randomization

Male and female patients in the age group 18 to 65 with myofascial pain of the neck and shoulders of at least 8 months duration were included
Patients had to have a Visual Numerical Scale pain score 4 or higher at baseline to be included
Patient with history of injection of BoNTA or with significant medical or psychiatric disease or were excluded
A total of 54 patients were randomized

Intervention:

BoNTA into each painful muscle, variable dose was used with a maximum dose of 300U, n=29

Comparator:

Placebo (Saline) into each painful muscle, n=25

pain intensity using a Visual Numerical Scale
health-related quality of life
disability
headache

Guarda-Nardini et al. 2011,¹⁴ Italy

To compare BoNTA injections with fascial manipulation in patients with TMD diagnosis of myofascial pain

Parallel design open label RCT

Patients were assessed at baseline and at three months

Adult patients with a research diagnostic criteria for TMD diagnosis of myofascial pain with or without limited opening and bilateral pain of at least six months duration were included
Patients with TMD diagnosis of arthralgia and/or osteoarthritis were excluded
A total of 30 patients were randomized

Intervention:

BoNTA (Dysport^®) 150U in the temporalis and masseter muscles.

Comparator:

Fascial manipulation technique

Pain assessed using VAS
Jaw range of motion

Benecke et al. 2011,¹⁵ Germany

To evaluate the efficacy and tolerability BoNTA for the treatment of upper back MPS using standardized fixed location injections

Parallel design double-blind RCT

Patients were followed-up for 12 weeks after treatment

Patients in the age group 18 to 70 with MPS affecting cervical muscles of the back and shoulder and with moderate to severe intensity were included
Patient with history of injection of BoNTA for pain or had concurrent muscle disease, or had severe concomitant disease, or had specific back pain disorder were excluded
A total of 154 patients were randomized

Intervention:

BoNTA (Dysport^®) 400U, n=81

Comparator:

Placebo (Saline), n=72

Intervention and the comparator were injected into 10 fixed locations in predetermined injection sited in the head, neck, and shoulder

Proportion of patients with mild or no pain at week 5
Change in pain intensity
Duration of pain
Number of pain free days per week
Time to reduction in pain
Safety

Ernberg et al. 2011,¹⁶ Sweden and Denmark

To compare BoNTA with isotonic saline for the treatment of persistent myofascial TMD pain.

Randomized double-blind Cross-over design

Patients were followed-up for three months after treatment

Adult patients with a research diagnostic criteria for TMD diagnosis of myofascial pain with pain that persisted for at least 6 months in spite of conservative treatment were included
Patients with systemic inflammatory connective tissue diseases, fibromyalgia, pain of dental origin, whiplash-associated disorder, neuropathic pain or neurological disorders, or use aminoglycoside antibiotics, or muscle relaxants were excluded
A total of 21 patients were randomized

Intervention:

BoNTA (Botox^®) the total dose of BoNTA was 50 U per muscle, if both muscles were treated a maximum dose of 100U received by the patient.

Comparator:

Isotonic saline

Pain
Physical function
Emotional function
Global improvement
Side effects

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Botulinum Toxin A for Myofascial Pain Syndrome: A Review of the Clinical Effectiveness [Internet].

APPENDIX 2CHARACTERISTICS OF THE INCLUDED STUDIES

Table A2.1Characteristics of the Included Systematic Reviews and Meta-analyses

Table A2.2Characteristics of the Included Randomized Controlled Trials

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Objectives/Scope	Type of primary studies	Population	Intervention	Comparator	Outcomes	Notes
Zhang et al. 2011,¹² Canada
To evaluate the efficacy of BoNTA versus non-active injection or other treatment in reducing chronic musculoskeletal pain Systematic review and meta-analysis of randomized controlled trials	RCTs only A total of 21 trials, were included in the review; of which, 12 trials evaluated BoNTA for MPS, 8 of these 12 trials were included in the meta-analysis Trials were published between 1994 and 2008 A total of 332 patients contributed to myofascial pain analysis	The review included trials on patients experiencing chronic musculoskeletal pain of all ages, gender and degree of severity	Intramuscular or subcutaneous BoNTA injections	Placebo other non-active therapies, including exercise	Reduction in pain severity through the period of follow-up	Four of the included studies in the review were not included in the statistical analysis due to inadequate data reporting The review included seven studies that are common with other systematic reviews (Gobel et al. 2006,¹⁷ Ojala et al. 2006,¹⁸ Qerama et al. 2006,¹⁹ Cheshire et al. 1994,²⁰ Wheeler et al. 2001,²¹ Ferrante et al. 2005,²² and Wheeler et al. 1998²³)
Zhou et al. 2014,¹¹ US
To evaluate the efficacy of BoNTA injection at active trigger points as a treatment for MPS Systematic review of randomized controlled trials	Double-blinded RCTs only A total of 8 trials, were included in the review Trials were published between 1994 and 2006	The review included trials on patients with MPS	BoNTA injections into trigger points for pain	Saline Bupivacaine	reduction in pain scores	The review included six studies that are common with other systematic reviews (Göbel et al. 2006,¹⁷ Qerama et al. 2006,¹⁹ Cheshire et al. 1994,²⁰ Wheeler et al. 2001,²¹ Ferrante et al. 2005,²² and Wheeler et al. 2001²³)
Soares et al. 2014,¹⁰ Brazil
To evaluate the effectiveness and safety of BoNTA in the treatment MPS Systematic review of randomized controlled trials	RCTs only A total of 4 trials, were included in the review Trials were published between 2006 and 2010	Male and female adult patients of with a clinical diagnosis of MPS Studies with MPS of the neck and head were excluded	BoNTA irrespective of dose	Placebo alternative drug (unspecified)	Frequency, intensity and duration of pain, pressure pain tolerance, and pain relief Adverse events	The review included three studies that are common with other systematic reviews (Göbel et al. 2006,¹⁷ Ojala et al. 2006,¹⁸ Qerama et al. 2006,¹⁹)