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Table 3 Evidence table for randomized controlled trials of high- and acceptable quality stratified by condition

From: The global summit on the efficacy and effectiveness of spinal manipulative therapy for the prevention and treatment of non-musculoskeletal disorders: a systematic review of the literature

1st Author, Year, Study quality Participants, Case definition, Setting,
Number (n) enrolled
Interventions, Provider, Number (n) of subjects at baseline Control, Provider, Number (n) of subjects at baseline Follow-up Outcome measurements Results
Mean (95%CI)
Asthma
Balon 1998 [84]
Quality:
High Quality
Children, 7 to 16 yrs.; physician diagnosed mild or moderate asthma > 1 yr, use bronchodilator at least three times weekly, and confirmed by lung function testing.
Participants recruited through advertising.
Private chiropractic clinics in Ontario, Canada.
(n = 91)
SMT-HVLA determined and gentle soft-tissue therapy by chiropractor with usual medical care.
3x weekly for 4 weeks, 2x weekly for 4 weeks, then 1x weekly for 8 weeks, (range 20 to 36 Tx over 4-mths).
Chiropractors with 5 years of clinical experience
(n = 45)
Non-directional low amplitude, low velocity impulse to gluteals, scapulae and external occipital protuberance; and soft-tissue massage and gentle palpation; by chiropractor with usual medical care.
3x weekly for 4 weeks, 2x weekly for 4 weeks, then 1x weekly for 8 weeks, (range 20 to 36 Tx over 4-mths).
Chiropractors with 5 years of clinical experience
(n = 46)
2 and 4 mths Primary outcome: morning PEF prior to use of bronchodilator and frequency of morning PEF of < 85% of baseline.
Secondary outcomes: airway responsiveness; FEV1; daytime symptoms of asthma; need for inhaled beta-agonists; use of oral corticosteroids; Q of L; overall treatment satisfaction
Adverse events
NS between group differences
2 mths (mean between group differences):
PEF (% baseline): 2.1 (−3.9, 8.0)
FEV1(liters): − 0.28 (− 0.61, 0.05)
Overall Q of L: 0.29 (− 0.10, 0.69)
 Activity: 0.34 (− 0.13, 0.81)
 Symptoms: 0.29 (− 0.21, 0.78)
 Emotions: 0.26 (− 0.14, 0.66)
Change in symptoms: p = 0.59
Use of Beta-agonists: p = 0.55
4 mths (mean between group differences):
PEF: − 0.7 (− 6.7, 5.3)
FEV1(liters): − 0.28 (− 0.61, 0.04)
Overall Q of L: 0.32 (− 0.12, 0.75)
 Activity: 0.42 (− 0.10, 0.93)
 Symptoms: 0.15 (− 0.39, 0.69)
 Emotions: 0.29 (− 0.15, 0.73)
Change in symptoms: p = 0.84
Use of Beta-agonists: p = 0.35
Between group differences in days with PEF < 85%: − 2.9 (− 11.1, 5.3)
Mean satisfaction-Intervention: 6.22/7.0
Mean satisfaction-Control: 6.46/7.0
No adverse events, apart from exacerbations of asthma.
Infantile Colic
Olafsdottir 2001 [87]
Quality:
Acceptable
Infants (born at term with a birth weight > 2.5 Kg; appropriate gain in weight, height and head circumference) recruited in Bergen, Norway from public health clinics the paediatric outpatient clinic at the University Hospital, general
practitioners, chiropractors, and from direct referrals from parents who were informed
about the project at the maternity units in Bergen and by the media from April 1998 to December 1999.
Infantile colic defined as ≥3 h crying/day, 3 days per week for the last 3 weeks.
(n = 100)
SMT and mobilization determined by treating chiropractor by areas of dysfunction identified by palpation; dysfunctional articulations manipulated and mobilized using light fingertip pressure.
Counselling and support on feeding, baby care, and family interaction.
3 sessions with intervals of 2–5 days over 8 days by a licensed chiropractor
(n = 46)
Infants held by a nurse for 10 min (the approximate time of treatment) after being partially undressed in a similar way as treated infants.
Counselling and support on feeding, baby care, and family interaction.
3 sessions with intervals of 2–5 days over 8 days by a nurse
(n = 40)
8–14 days post-intervention Parent’s global perceived improvement (“getting worse”, “no improvement”, “some improvement”, “marked improvement”, “completely well”)
Crying time (hours/day)
No Improvement in SMT group vs. control group (marked improvement or completely well)
Relative Risk =0.97 (95% CI: 0.59, 1.60)
Crying time (hours/day):
SMT/mobilization vs. Control
1st visit: − 0.6 (− 1.47, 0.27)
2nd visit: − 0.5 (− 1.34, 0.37)
3rd visit: − 0.3 (− 1.17, 0.57)
Hypertension
Goertz 2016 [81]
Quality:
High Quality
Adults (21–75 yrs), recruited from the community through targeted direct mailers, American Heart Association events, and press releases in Iowa, USA.
Hypertension with systolic blood pressure ranging from 135 to 159 mmHg or diastolic blood pressure ranging from 85 to 99 mmHg and misalignment of either or both of the first 2 cervical spinal segments based on standardized radiography.
Research clinic of the Palmer Center for Chiropractic Research,
Davenport, IA
(n = 51)
Toggle recoil consisting of HVLA thrust delivered to the C1 and/or C2 vertebra with participants in a side-lying position on the treatment table.
2 sessions/week over 6 weeks
Chiropractors with > 5 years’ experience trained in toggle recoil SMT
(n = 24)
Sham manipulation consisting of no thrust delivered to the participant’s head or neck.
Delivered at 1st session and then for 4–8 visits at random intervals over 6 weeks
Chiropractors with > 5 years’ experience trained in toggle recoil SMT
(n = 27)
Immediately after intervention and 6 weeks Primary outcome: Blood pressure
Secondary outcome: SF–36 (Pain and General Health Sub-Scales), Perceived Stress Scale
Adverse events
NS difference in blood pressure change between groups following the intervention.
CRUDE:
Mean difference change score
3 weeks:
Systolic BP: − 0.3 (− 6.2, –5.3)
Diastolic BP − 0.3 (− 4.0, –3.5)
6 weeks:
Systolic BP: 3.5 (− 1.9, –8.9)
Diastolic BP: 1.5 (− 2.1, –5.0)
ADJUSTED (age, sex, BMI, baseline BP):
Mean difference change score
3 weeks:
Systolic BP: 0.9 (− 5.0, –6.9)
Diastolic BP: 1.0 (− 2.8, –4.9)
6 weeks:
Systolic BP: 4.8 (− 0.4, –10.0)
Diastolic BP: 2.3 (− 1.2, –5.8)
SF-36: Pain:
Mean change (95% CI)
SMT vs. Sham: 0.6 (− 2.18, 3.38)
SF-36: General Health:
Mean change (95% CI)
SMT vs. Sham: − 1.1 (− 3.18, 0.98)
Perceived Stress Scale
Mean change (95% CI)
SMT vs. Sham: 0.1 (− 1.70, 1.90)
Adverse events included 4 related to study treatments: 3 headaches, 1 neck and upper thoracic pain. Three additional: foot numbness and tingling after a neck examination, fainting episode 24 h after treatment, mild nausea and vertigo at first treatment.
Ward 2015 [80]
Quality:
Acceptable
Adults (18–65 yrs), recruited via online advertisements and word-of-mouth in Texas, USA.
Proof of high blood pressure (hypertension medications) or initial blood pressure reading > 140/90 mmHg.
(n = 50)
Supine diversified anterior upper thoracic SMT to the T1–4 region with a HVLA thrust of the upper body of the chiropractor over the participant’s chest to achieve cavitation of the T1–4 segments of the thoracic spine.
1 session by chiropractor with 20 years of experience and 15 years of SMT technique teaching experience at
Texas Chiropractic College
(n = 25)
Participants’ arms folded across their chest for a few seconds and then the chiropractor unfolded the arms.
1 session by chiropractor with 20 years of experience and 15 years of SMT technique teaching experience at
Texas Chiropractic College
(n = 25)
1- and 10-min post-intervention Bilateral blood pressure
Arterial pressure
Heart rate
Adverse events not assessed
NS differences in mean blood pressure change between groups.
Control vs SMT -Mean difference (95% CI)
Right systolic BP
1 min: 3.4 (− 4.06, 10.86)
10 min: 2.9 (− 4.01, 9.81)
Right diastolic BP
1 min: 2 (− 2.49, 6.49)
10 min: − 0.2 (− 4.69, 4.29)
Left systolic BP
1 min: − 1.8 (− 8.67, 5.07)
10 min: 4 (− 3.39, 11.39)
Left diastolic BP
1 min: − 0.6 (− 5.51, 4.31)
10 min: 1 (− 3.75, 5.75)
Pulse pressure
1 min: 1.3 (− 3.84, 6.44)
10 min: 3.1 (− 1.51, 7.71)
Mean arterial pressure
1 min: 2.5 (− 2.62, 7.62)
10 min: 0.9 (− 4.08, 5.88)
Heart rate
1 min: 1.1 (− 2.97, 5.17)
10 min: 1 (− 3.12, 5.12)
Dysmenorrhea
Hondras 1999 [37]
Quality:
High Quality
Women, 18–45 yrs.; sexually active, non-pregnant, good general health, regular menstrual cycles accompanied by moderate to severe pain; diagnosis of primary dysmenorrhea recruited through local advertisements in
Chicago metropolitan newspapers.
National College Chiropractic Center outpatient clinic, Chicago, USA.
(n = 138)
SMT-HVLA > 750 N to all clinically relevant levels from T10-L5 and sacroiliac joints, bilaterally.
3x/week beginning the week before expected onset of menstruation for next two cycles (cycles 3 and 4)
Chiropractors practicing at National College Chiropractic Center
(n = 69)
LFM-high-velocity, short-lever, low amplitude thrust between 200 to 400 N to L2–3 vertebral by chiropractor
Chiropractors practicing at National College Chiropractic Center
(n = 69)
4 menstrual cycles Primary outcome: Pain intensity (VAS)
Secondary outcome: MDQ
Adverse events
NS between group differences at any follow-up menstrual cycle for pain intensity (p = 0.65) or menstrual distress (p = 0.78)
2 women in the LFM group and 3 women in the SMT group reported soreness in the low back region 24–48 h following intervention at 1 visit.
Migraine
Chaibi 2017 [82]
Quality:
Acceptable
Adults (18–70 yrs) recruited from Akershus University Hospital, general practitioners and media advertisements in Akershus and Oslo Counties, Norway.
Migraine diagnosed according to the ICHD-II (ICHD, 2004) and with ≥ one migraine attack per month.
Akershus University Hospital, Norway
(n = 104)a
Gonstead method, specific contact, HVLA, short-lever SMT with no post-adjustment recoil that was directed to spinal biomechanical dysfunction (full spinal column approach)
12 sessions over 3 mths
Experienced chiropractor
(n = 34)
Sham SMT consisting of a broad, non-specific contact, low velocity, low amplitude sham push maneuver
12 sessions over 3 mths
Experienced chiropractor
(n = 34)
Immediately after treatment, 3, 6 and 12 mths. Primary outcome: Number of migraine days per mth
Secondary outcomes: migraine duration, migraine intensity and headache index, medicine consumption and adverse events
Significant differences in mean change in migraine days favoring sham treatments. No difference in secondary outcomes.
Sham vs. CSMT
Migraine days
Post-treatment: − 1.6 (− 3.09, − 0.10)
3 months: − 1.7 (− 3.28, − 0.12)
6 months: − 0.8 (− 2.50, 0.90)
12 months: − 2.1(− 3.84, − 0.36)
Duration
Post-treatment: − 1.1 (− 3.19, 0.98)
3 months: − 1.2 (− 3.51, 1.10)
6 months: 2.0 (− 0.38, 4.38)
12 months: − 1.5 (− 4.05, 1.04)
Intensity
Post-treatment: − 0.1 (− 1.06, 0.86)
3 months: − 0.5 (− 1.49, 0.49)
6 months: 0.4 (− 0.77, 1.57)
12 months: − 1.1 (− 2.34, 0.14)
Headache Index
Post-treatment: − 170.4 (− 346.30, 5.50)
3 mths: − 143.4 (− 323.24, 35.45)
6 mths: − 115.2 (− 296.07, 65.67)
12 mths: − 232.9 (− 429.06, − 36.74)
NS difference in medicine consumption
Minor, transient adverse events [local tenderness and neck pain] were more commonly reported in CSMT (73/355) than sham SMT group (29/348). There were no severe or serious AEs reported.
  1. FEV1 forced expiratory volume in 1 s, HVLA high velocity, low amplitude, mths months, NS non-significant, PEF peak expiratory flow, Q of L quality of life, SMT spinal manipulative therapy, Tx treatment, yrs years, LFM low force mimic, MDQ Moos’ menstrual distress questionnaire, VAS visual analog scale, AE adverse events
  2. aResults only reported from intervention (SMT) and sham group