Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model

Unger, Mark D.; Barr, Jackilyn N.; Brower, Jacob A.; Kingston, Joseph C.; Heller, Gregory R.; Palmer, Joy L.

doi:10.1186/s12906-023-04230-2

BMC Complementary Medicine and Therapies

Table 2 Characteristics of studies that passed methodological review

From: Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model

Study reference number	Study design^a	Patients in OMT group (n)	Mean OMT encounters per patient	Female^b (% of all subjects)	Age^b (mean yr ± sd)	Indication for OMT	Duration of OMT encounter and techniques performed^c	Approach to AE/AEO grading
[22]	Pilot	10	1	70.0	45.0 ± 15.0	• Headache ≥ 3 months after mild TBI	• 4 techniques/encounter • Non-protocolized: ME, MFR, CS, Suboccipital release	• No AEs/AEOs detected during post-OMT interval assessments
[6]	Observational	884	2	76.0	51.8 ± 15.8	• SD	• “Real world” office visits • Non-protocolized: HVLA, CS, FPR, ME, ART, Still, MFR, ST, Visceral, OCMM, Indirect, Functional, BLT, LAS	• 5-point scale • POW • Retrospective chart review to grade AEs: mild, moderate, serious
[23]	RCT	29	1	62.0	29.0 ± 8.0	• Musculoskeletal neck pain < 3 wk • SD	• Up to 5 min/encounter • Non-protocolized: HVLA, ME, ST	• POW
[24]	Pilot	10	1	100	47.0 ± 10.0	• Chronic asthma	• 10–15 min/encounter • Protocolized: BLT, Still, Direct, MFR	• POW
[11]	RCT	18	5	44.0	68.0 ± 8.0	• COPD	• 5–10 min/encounter • Protocolized: Lymphatic pump, Rib raising, MFR	• POW
[9]	RCT	17	1	56.0	69.6 ± 6.6	• COPD • SD	• 20 min/encounter • Non-protocolized + Protocolized: MFR, HVLA, ME, ST, Rib raising, Suboccipital decompression, Lymphatic pump	• POW
[25]	RCT	9	12	20.0	72 ± 11.3	• Motor function, balance in PD	• 30 min/encounter • Protocolized: Park-OMM protocol	• POW
[10]	RCT	7	9	86.0	82.3 ± 4.7	• Influenza vaccine recipients • SD	• 15 min/encounter • Non-protocolized + Protocolized: ME, CS, MFR, Direct, ART, Paraspinal inhibition, Rib raising, Lymphatic pump, Splenic pump	• POW
[26]	Feasibility	6	3	73.1	52.5 ± 11.8	• Peripheral vertigo > 3 mo • SD	• 45 min/encounter • Non-protocolized: CS, MFR, BLT, ST, HVLA, ART	• No AEs/AEOs detected during post-OMT interval assessments
[19]	RCT	27	4	76.0	42.1 ± 13.5	• Neck pain > 3 mo • SD	• 30 min/encounter • Protocolized: HVLA, ST, ME, MFR, ART	• POW • 2-point NRS increase = AE • CTCAE grades
[27]	Feasibility	11	6	82.0	50.5 ± NR	• Pain in FM • SD	• 30 min/encounter • Non-protocolized: MFR, ME, CS, FPR, LAS, HVLA, OCMM	• Survey items • POW • Side effect severity: mild, moderate, severe
[28]	Pilot	18	4	62.5	64.5 ± NR	• Peripheral vertigo > 3 mo • SD	• 4 techniques/encounter • Non-protocolized: ME, CS, MFR, BLT	• Survey items • POW • Mild, moderate, severe
[29]	RCT	191	6	63.0	41.0, 29–51 (median, IQR)	• Low back pain ≥ 3 mo • SD	• 15 min/encounter • Non-protocolized: HVLA, ART, ST, MFR, ME	• Description of clinical signs

Legend: ^aAll studies that passed methodological review were found to be prospective and interventional with the exception of [6] which was observational. Additional design traits are listed as reported. ^bGender and age distributions were calculated for patients enrolled in the OMT group for all studies except [27] where gender and age data were reported for all patients regardless of treatment group. ^cThe OMT duration and techniques represent the OMT intervention described in the methods section of each study. AE Adverse event, AEO Adverse event outcome, ART Articulatory, BLT Balanced ligamentous tension, COPD Chronic obstructive pulmonary disease, CS Counterstrain, CTCAE Common Terminology Criteria for Adverse Events, FM Fibromyalgia, FPR Facilitated positional release, HVLA High-velocity, low amplitude, LAS Ligamentous articular strain, ME Muscle energy, MFR Myofascial release, NR Not reported, NRS Numerical rating scale, OCMM Osteopathic cranial manipulative medicine, OMM Osteopathic manipulative medicine, OMT Osteopathic manipulative treatment, OSE Osteopathic structural exam, PD Parkinson’s disease, POW Patient’s own words, RCT Randomized controlled trial, SD Somatic dysfunction, ST Soft tissue, TBI Traumatic brain injury

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ISSN: 2662-7671

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