Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review

Martha Funabashi; Lindsay M. Gorrell; Katherine A. Pohlman; Andrea Bergna; Nicola R. Heneghan

doi:10.1371/journal.pone.0270671

Table 1

Inclusion and exclusion criteria.

Category Inclusion Criteria Exclusion Criteria
Language ▪ English, Portuguese, Italian

Participants ▪ Adults (average age 18 to 65 years old) ▪ Pediatric population (average age < 18 years old)
▪ Primary musculoskeletal condition (e.g., back pain, neck pain, cervicogenic / tension-type headache, temporomandibular joint pain, etc.) ▪ Older adults (average age > 65 years old)
▪ Secondary musculoskeletal condition (e.g., shoulder pain due to surgery/cancer, etc.) ▪ Non-musculoskeletal conditions (e.g., neurological conditions [e.g., migraine, stroke, etc.], pulmonary, cardiac, rheumatological conditions, etc.)
▪ Participants seeking medical management for a musculoskeletal condition (e.g., fracture, arthroplasty, etc.)

Intervention ▪ Spinal or peripheral joint manipulation or mobilization used as the primary intervention (i.e., forces applied directly to skin overlying a joint) ▪ Pharmacological or surgical interventions
▪ Other interventions, such as active interventions (e.g., exercise, active stretching, etc.), ancillary procedures (e.g., taping, heat, ice, ultrasound, laser, etc.), other manual therapy modalities (e.g., massage therapy, acupressure, soft tissue therapy, etc.), as primary interventions, with manipulation or mobilization being secondary
▪ Multimodal intervention including manipulation or mobilization (e.g., exercise + manipulation or mobilization, etc.)
▪ Indirect joint manipulation or mobilization (e.g., fascial mobilization, muscle energy technique, etc.)
▪ Manipulation under anesthesia
▪ Early mobilization (e.g., Continuous Passive Movement, early mobilization after surgery, mobilization of Intensive Care Unit patients, etc.)
▪ Manipulation or mobilization with a mechanical device (e.g., Activator™, Impulse™, robotic manipulation or mobilization, Cox tables, etc.)

Outcomes ▪ Adverse events definition ▪ Adverse event report, but without an adverse event definition
▪ Classification (i.e., symptom severity, onset, duration, need for unplanned additional remedial or medical care, etc.) ▪ Adverse event reports, but with no mention of manipulation or mobilization
Study design ▪ Peer-reviewed publication (e.g., literature reviews, meta-analyses, clinical practice guidelines, experimental studies, clinical studies, qualitative studies, observational studies, surveys, case series and reports, study protocols, etc.) ▪ Editorials, conference proceedings, commentaries, letter to the editor, expert opinion, secondary sources (e.g., textbooks, etc.)
▪ Case reports that do not mention the terms “adverse event”, “complication”, “side effect”, “adverse reaction”, etc. or do not imply the condition being an adverse event to manipulation or mobilization

Category	Inclusion Criteria	Exclusion Criteria
Language	▪ English, Portuguese, Italian

Participants	▪ Adults (average age 18 to 65 years old)	▪ Pediatric population (average age < 18 years old)
	▪ Primary musculoskeletal condition (e.g., back pain, neck pain, cervicogenic / tension-type headache, temporomandibular joint pain, etc.)	▪ Older adults (average age > 65 years old)
	▪ Secondary musculoskeletal condition (e.g., shoulder pain due to surgery/cancer, etc.)	▪ Non-musculoskeletal conditions (e.g., neurological conditions [e.g., migraine, stroke, etc.], pulmonary, cardiac, rheumatological conditions, etc.)
		▪ Participants seeking medical management for a musculoskeletal condition (e.g., fracture, arthroplasty, etc.)

Intervention	▪ Spinal or peripheral joint manipulation or mobilization used as the primary intervention (i.e., forces applied directly to skin overlying a joint)	▪ Pharmacological or surgical interventions
		▪ Other interventions, such as active interventions (e.g., exercise, active stretching, etc.), ancillary procedures (e.g., taping, heat, ice, ultrasound, laser, etc.), other manual therapy modalities (e.g., massage therapy, acupressure, soft tissue therapy, etc.), as primary interventions, with manipulation or mobilization being secondary
	▪ Multimodal intervention including manipulation or mobilization (e.g., exercise + manipulation or mobilization, etc.)
		▪ Indirect joint manipulation or mobilization (e.g., fascial mobilization, muscle energy technique, etc.)
		▪ Manipulation under anesthesia
		▪ Early mobilization (e.g., Continuous Passive Movement, early mobilization after surgery, mobilization of Intensive Care Unit patients, etc.)
		▪ Manipulation or mobilization with a mechanical device (e.g., Activator™, Impulse™, robotic manipulation or mobilization, Cox tables, etc.)

Outcomes	▪ Adverse events definition	▪ Adverse event report, but without an adverse event definition
Outcomes	▪ Classification (i.e., symptom severity, onset, duration, need for unplanned additional remedial or medical care, etc.)	▪ Adverse event reports, but with no mention of manipulation or mobilization
Study design	▪ Peer-reviewed publication (e.g., literature reviews, meta-analyses, clinical practice guidelines, experimental studies, clinical studies, qualitative studies, observational studies, surveys, case series and reports, study protocols, etc.)	▪ Editorials, conference proceedings, commentaries, letter to the editor, expert opinion, secondary sources (e.g., textbooks, etc.)
Study design		▪ Case reports that do not mention the terms “adverse event”, “complication”, “side effect”, “adverse reaction”, etc. or do not imply the condition being an adverse event to manipulation or mobilization