J Can Chiropr Assoc 2021 Apr; 65 (1): 32–49.

Table 4.
Evidence table for RCTs including quality rating, patient information, intervention and comparison group, dosage, adverse events reported and study conclusions.

Citation and quality^* Patient population, mean age, mean symptom duration Intervention Comparison group(s) Dosage Adverse event reported Conclusion

Gausel 2017⁸²
Acceptable N=56, pregnant women, less than 29 wks, with 1-sided PGP
Age (mean yrs): TG: 28.9
CG: 29.9
GA (mean wks): 23.1
Onset: Prior to 18–29 wks TG: SMT, mobs, STT, exercises and advice chosen by the chiropractor CG: UOBC TG: Number of treatments individualized by the chiropractor Reported: At follow-up appts, women were asked to recall any negative reactions. No serious or long-lasting adverse events were reported.
Although adverse events following SMT during pregnancy are rare, treatments should not be performed over a long period of time unless there is a positive response.
Future studies should track possible adverse events throughout the study. There were no statistically significant differences between the treatment group and control group with respect to sick leave, pain, disability or general health status.

Schwerla 2015⁸⁶
Acceptable n=80, postpartum women with nonspecific LBP or PGP; at least 3mo and 5/10 on VAS
Age (Mean wk): TG=33.9
CG=33.3
GA: TG= postpartum
CG= postpartum
Onset: Within the past 3 to 15 mo
Duration: TG: 9.8 mo
CG: 9.7 mo TG: OMT could include direct and indirect visceral and cranial techniques CG: No tx but told they were put on a wait list to be scheduled 2 mo later 8 wks
4 txs
40–60 min Reported: No serious adverse events were recorded during the study period.
Occasionally, participants complained of being tired following the intervention. OMT applied 4 times to postpartum women led to clinically relevant positive changes in pain intensity and functional disability.

Licciardone 2010⁸³
Acceptable n=146, pregnant women, third trimester with or without LBP
Age (Mean yrs)
TG=23.8
CG1=23.7
CG2=23.8
GA: Enrolled 28–30 wks
Onset: Not stated.
Duration: Not stated. TG: UOBC + OMT: Standardized OMT protocol during 3^rd trimester CG1: UOBC + SUT
CG2: UOBC Up to 7 treatment in conjunction with OB appointments at 30, 32, 34, 36, 37, 38 and 39 wks gestation
30 min No specific adverse events reported. But the authors stated that the study demonstrated important clinical benefits without any appreciable harms in back-specific functioning when OMT is provided as complementary therapy in the third trimester. OMT does halt or lessen back pain during the third trimester of pregnancy; however the possibility of minimally important harms cannot be ruled out.

Hensel 2016⁸⁷
Acceptable n=400, pregnant women, 3^rd trimester
Age (Mean yrs):
TG=24.0
CG1=24.1
CG2=24.7
GA: Enrolled at 30 wks
Onset: Not stated
Duration: Not stated TG: OMT= Usual care + standardized OMT protocol CG1: PUT
CG2: UOBC OMT and PUT groups provided 7 visits within 24 hours of OB visit
20 min
over 9 wks No specific adverse events reported.The authors did state that the OMT protocol did not increase the risk of precipitous labour, conversion to cesarean delivery or meconium-stained amniotic fluid
Although the OMT group experienced longer labour, there was no increased incidence of complications during delivery including perineal laceration, episiotomy or need for forceps or vacuum Those who received OMT protocol in addition to usual care had a slower rate of deterioration of their pain and back-specific functioning during the third trimester. The OMT protocol appears to be a safe and effective way to manage back pain and function during pregnancy.

Hensel 2016⁸⁵
Low n=400, pregnant women, 3^rd trimester
Age (Mean yrs): TG=24.1
CG1=24.1
CG2=24.8 TG: OMT= Usual care + standardized OMT protocol CG1: PUT
CG2: UOBC OMT and PUT groups provided 7 visits within 24 hours of OB visit
20 min
over 9 wks No specific adverse events reported. When using high-risk status and labour and delivery outcomes as an index for safety, no greater risk in the OMT group was found. The OMT protocol applied in the third trimester of pregnancy, is a safe intervention with respect to labour and delivery outcomes.

Peterson
2012⁶⁰
Acceptable n = 57, pregnant women with LBP and/or PGP reproducible by palpation
Age: TG1= 31.1
TG2=29.7
CG= 28.7
GA: TG1= 25.7
TG2= 27.0
CG=23.7
Onset: TG1=16.1
TG2=13.9
CG=11.6
Duration: During pregnancy TG1: SMT= HVLA for L/S and SI JT; blocks used to adjust Sacro Occiptial Technique Category II pelvis; activator to adjust pelvis
TG 2: NET= chiropractic mind-body technique; combines desensitization procedures with 5 element Chinese medicine + chiropractic adjustment CG: Individualized home exercises + Information All TGs: Paralleled prenatal care schedule; 1x/mo until 28 wks; 2x/mo until 36 wks; 1x/wk thereafter
CG: 5 x/wk
15 min Reported: Participants were asked at each assessment if they experienced any adverse events as a result of the intervention.
No adverse events were reported but the study participants in any group. However, 6% of SMT and exercise and 18% of NET participants produced soreness All 3 interventions appear to provide clinically meaningful improvements in function and pain intensity.

Licciardone
2013⁸⁴
Acceptable N= 144, pregnant women in 3rd trimester with or without LBP
Age: TG: 23.8
CG1: 23.7
CG2: 23.8
GA: enrolled between 28–30 wks
Onset: not stated
Duration: not stated TG: OMT + UOBC CG1: SUT + UOBC
CG2: UOBC Up to 7 treatment in conjunction with OB appointments at 30, 32, 34, 36, 37, 38 and 39 wks gestation
30 min No adverse events specifically reported. The authors did state that there was no SS between study groups in the rates of development of high-risk obstetric conditions or delivery prior to wk 39 OMT has medium to large treatment effects in preventing progressive back-specific dysfunction during the 3^rd trimester.

^* Modified Scottish Intercollegiate Guideline Network (SIGN) Quality RCT rating:
9–10 high quality, low risk of bias;
6–8 acceptable quality, moderate risk of bias;
3–5 low quality, high risk of bias; 0–2 or if item 1 and/or 3 are “no unacceptable quality (reject)
CG – control group;
GA – gestational age;
HVLA – high velocity low amplitude;
LBP – low back pain;
L/S – lumbar spine;
min – minute;
mo – month;
mobs – mobilization;
NET = neuroemotional technique;
OB – obstetrician;
OMT – osteopathic manipulative therapy;
PUT – placebo ultrasound therapy;
SI JT – sacroiliac joint;
SMT – spinal manipulative therapy;
SS = statistial significance;
STT – soft tissue therapy;
SUT – sham ultrasound therapy;
TG – treatment group;
tx – treatment;
txs – treatments;
UOBC – usual obstetric care;
wk – week;
wks – weeks;
x/ – times per;
yrs – years

Citation and quality^*	Patient population, mean age, mean symptom duration	Intervention	Comparison group(s)	Dosage	Adverse event reported	Conclusion


Gausel 2017⁸² Acceptable	N=56, pregnant women, less than 29 wks, with 1-sided PGP Age (mean yrs): TG: 28.9 CG: 29.9 GA (mean wks): 23.1 Onset: Prior to 18–29 wks	TG: SMT, mobs, STT, exercises and advice chosen by the chiropractor	CG: UOBC	TG: Number of treatments individualized by the chiropractor	Reported: At follow-up appts, women were asked to recall any negative reactions. No serious or long-lasting adverse events were reported. Although adverse events following SMT during pregnancy are rare, treatments should not be performed over a long period of time unless there is a positive response. Future studies should track possible adverse events throughout the study.	There were no statistically significant differences between the treatment group and control group with respect to sick leave, pain, disability or general health status.

Schwerla 2015⁸⁶ Acceptable	n=80, postpartum women with nonspecific LBP or PGP; at least 3mo and 5/10 on VAS Age (Mean wk): TG=33.9 CG=33.3 GA: TG= postpartum CG= postpartum Onset: Within the past 3 to 15 mo Duration: TG: 9.8 mo CG: 9.7 mo	TG: OMT could include direct and indirect visceral and cranial techniques	CG: No tx but told they were put on a wait list to be scheduled 2 mo later	8 wks 4 txs 40–60 min	Reported: No serious adverse events were recorded during the study period. Occasionally, participants complained of being tired following the intervention.	OMT applied 4 times to postpartum women led to clinically relevant positive changes in pain intensity and functional disability.

Licciardone 2010⁸³ Acceptable	n=146, pregnant women, third trimester with or without LBP Age (Mean yrs) TG=23.8 CG1=23.7 CG2=23.8 GA: Enrolled 28–30 wks Onset: Not stated. Duration: Not stated.	TG: UOBC + OMT: Standardized OMT protocol during 3^rd trimester	CG1: UOBC + SUT CG2: UOBC	Up to 7 treatment in conjunction with OB appointments at 30, 32, 34, 36, 37, 38 and 39 wks gestation 30 min	No specific adverse events reported. But the authors stated that the study demonstrated important clinical benefits without any appreciable harms in back-specific functioning when OMT is provided as complementary therapy in the third trimester.	OMT does halt or lessen back pain during the third trimester of pregnancy; however the possibility of minimally important harms cannot be ruled out.

Hensel 2016⁸⁷ Acceptable	n=400, pregnant women, 3^rd trimester Age (Mean yrs): TG=24.0 CG1=24.1 CG2=24.7 GA: Enrolled at 30 wks Onset: Not stated Duration: Not stated	TG: OMT= Usual care + standardized OMT protocol	CG1: PUT CG2: UOBC	OMT and PUT groups provided 7 visits within 24 hours of OB visit 20 min over 9 wks	No specific adverse events reported.The authors did state that the OMT protocol did not increase the risk of precipitous labour, conversion to cesarean delivery or meconium-stained amniotic fluid Although the OMT group experienced longer labour, there was no increased incidence of complications during delivery including perineal laceration, episiotomy or need for forceps or vacuum	Those who received OMT protocol in addition to usual care had a slower rate of deterioration of their pain and back-specific functioning during the third trimester. The OMT protocol appears to be a safe and effective way to manage back pain and function during pregnancy.

Hensel 2016⁸⁵ Low	n=400, pregnant women, 3^rd trimester Age (Mean yrs): TG=24.1 CG1=24.1 CG2=24.8	TG: OMT= Usual care + standardized OMT protocol	CG1: PUT CG2: UOBC	OMT and PUT groups provided 7 visits within 24 hours of OB visit 20 min over 9 wks	No specific adverse events reported. When using high-risk status and labour and delivery outcomes as an index for safety, no greater risk in the OMT group was found.	The OMT protocol applied in the third trimester of pregnancy, is a safe intervention with respect to labour and delivery outcomes.

Peterson 2012⁶⁰ Acceptable	n = 57, pregnant women with LBP and/or PGP reproducible by palpation Age: TG1= 31.1 TG2=29.7 CG= 28.7 GA: TG1= 25.7 TG2= 27.0 CG=23.7 Onset: TG1=16.1 TG2=13.9 CG=11.6 Duration: During pregnancy	TG1: SMT= HVLA for L/S and SI JT; blocks used to adjust Sacro Occiptial Technique Category II pelvis; activator to adjust pelvis TG 2: NET= chiropractic mind-body technique; combines desensitization procedures with 5 element Chinese medicine + chiropractic adjustment	CG: Individualized home exercises + Information	All TGs: Paralleled prenatal care schedule; 1x/mo until 28 wks; 2x/mo until 36 wks; 1x/wk thereafter CG: 5 x/wk 15 min	Reported: Participants were asked at each assessment if they experienced any adverse events as a result of the intervention. No adverse events were reported but the study participants in any group. However, 6% of SMT and exercise and 18% of NET participants produced soreness	All 3 interventions appear to provide clinically meaningful improvements in function and pain intensity.

Licciardone 2013⁸⁴ Acceptable	N= 144, pregnant women in 3rd trimester with or without LBP Age: TG: 23.8 CG1: 23.7 CG2: 23.8 GA: enrolled between 28–30 wks Onset: not stated Duration: not stated	TG: OMT + UOBC	CG1: SUT + UOBC CG2: UOBC	Up to 7 treatment in conjunction with OB appointments at 30, 32, 34, 36, 37, 38 and 39 wks gestation 30 min	No adverse events specifically reported. The authors did state that there was no SS between study groups in the rates of development of high-risk obstetric conditions or delivery prior to wk 39	OMT has medium to large treatment effects in preventing progressive back-specific dysfunction during the 3^rd trimester.