Trial Outcomes & Findings for Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients (NCT NCT00830596)

NCT ID: NCT00830596

Last Updated: 2017-09-25

Results Overview

Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 221 participants
• Primary outcome timeframe: Baseline and 2 weeks
• Results posted on: 2017-09-25

Participant Flow

Participants with acute, subacute, or chronic low back pain were recruited from local communities.

Participant milestones

Measure	HVLA-SM High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation	LVVA-SM Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation	Sham Intervention Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation
Overall Study STARTED	74	74	73
Overall Study COMPLETED	72	72	67
Overall Study NOT COMPLETED	2	2	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients

Baseline characteristics by cohort

Measure	HVLA-SM n=74 Participants High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation	LVVA-SM n=74 Participants Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation	Sham Intervention n=73 Participants Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation	Total n=221 Participants Total of all reporting groups
Age, Continuous	44.1 years STANDARD_DEVIATION 10.6 • n=5 Participants	44.5 years STANDARD_DEVIATION 10.2 • n=7 Participants	44.4 years STANDARD_DEVIATION 10.5 • n=5 Participants	44.3 years STANDARD_DEVIATION 10.4 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	34 Participants n=7 Participants	33 Participants n=5 Participants	101 Participants n=4 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	40 Participants n=7 Participants	40 Participants n=5 Participants	120 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for:

Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction.

Outcome measures

Measure	HVLA-SM n=74 Participants High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation	LVVA-SM n=74 Participants Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation	Sham Intervention n=73 Participants Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation
Postural Sway Postural Sway_AP excursion - Hard (mm)	-.13 mm Interval -0.6 to 0.35	-0.26 mm Interval -0.75 to 0.22	-0.18 mm Interval -0.66 to 0.3
Postural Sway Postural Sway_ML excursion - Hard (mm)	-0.06 mm Interval -0.25 to 0.14	-0.06 mm Interval -0.26 to 0.14	-0.11 mm Interval -0.31 to 0.09
Postural Sway Postural Sway_AP excursion - Soft (mm)	-0.03 mm Interval -0.63 to 0.56	0.02 mm Interval -0.58 to 0.63	-0.26 mm Interval -0.87 to 0.34
Postural Sway Postural Sway_ML excursion - Soft (mm)	0.53 mm Interval 0.09 to 0.98	0.51 mm Interval 0.06 to 0.96	0.2 mm Interval -0.25 to 0.64

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Changes in sensorimotor function, as measured by postural sway speed in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for:

Sway Speed=overall center of pressure traveling distance divided by time.

Outcome measures

Measure	HVLA-SM n=74 Participants High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation	LVVA-SM n=74 Participants Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation	Sham Intervention n=73 Participants Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation
Postural Sway Speed Postural Sway_ Sway speed - Hard (mm/s)	0.02 mm/s Interval -1.14 to 1.18	-0.11 mm/s Interval -1.29 to 1.07	-0.23 mm/s Interval -1.4 to 0.94
Postural Sway Speed Postural Sway_Sway speed - Soft (mm/s)	-0.40 mm/s Interval -2.53 to 1.74	-1.71 mm/s Interval -3.87 to 0.46	-0.94 mm/s Interval -3.1 to 1.21

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for Response to sudden load [RTSL], ant. COP=anterior movement in center of pressure

Outcome measures

Measure	HVLA-SM n=74 Participants High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation	LVVA-SM n=74 Participants Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation	Sham Intervention n=73 Participants Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation
Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL	-4.7 mm Interval -7.9 to 1.5	-4.1 mm Interval -7.4 to 0.7	-5.8 mm Interval -9.2 to -2.4

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)

Outcome measures

Measure	HVLA-SM n=74 Participants High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation	LVVA-SM n=74 Participants Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation	Sham Intervention n=73 Participants Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation
Response to Sudden Load, Peak Muscle Response Per Side RTSL_Norm. peak muscle response - L (%)	-11.4 % muscle response Interval -21.7 to -1.2	5.2 % muscle response Interval -5.0 to 15.4	0.1 % muscle response Interval -10.0 to 10.2
Response to Sudden Load, Peak Muscle Response Per Side RTSL_Norm. peak muscle response - R (%)	3.4 % muscle response Interval -3.0 to 9.8	1.4 % muscle response Interval -5.2 to 8.0	-1.2 % muscle response Interval -7.8 to 5.3

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)

Outcome measures

Measure	HVLA-SM n=74 Participants High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation	LVVA-SM n=74 Participants Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation	Sham Intervention n=73 Participants Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation
Response to Sudden Load Response Times RTSL_Response start time - L (ms)	-18.3 ms Interval -54.2 to 17.7	-42.8 ms Interval -82.4 to -3.2	-19.8 ms Interval -53.0 to 13.3
Response to Sudden Load Response Times RTSL_Response start time R (ms)	-5.9 ms Interval -25.1 to 13.2	-17.1 ms Interval -38.4 to 4.3	-20.8 ms Interval -38.9 to -2.7
Response to Sudden Load Response Times RTSL_Peak response time - L (ms)	-14.6 ms Interval -49.6 to 20.3	-25.2 ms Interval -63.7 to 13.3	-28.5 ms Interval -60.7 to 3.7
Response to Sudden Load Response Times RTSL_Peak response time - R (ms)	-18.1 ms Interval -30.5 to -5.8	-2.2 ms Interval -15.9 to 11.6	1.9 ms Interval -9.9 to 13.8

Adverse Events

HVLA-SM*

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

LVVA-SM*

Serious events: 0 serious events

Other events: 57 other events

Deaths: 0 deaths

Sham Intervention*

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HVLA-SM* n=74 participants at risk High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation	LVVA-SM* n=74 participants at risk Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation	Sham Intervention* n=73 participants at risk Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation
General disorders Tooth/facial pain	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/73 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
General disorders Numbness/tingling	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/74 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/73 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
General disorders Gastrointestinal symptoms	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/74 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	0.00% 0/73 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
General disorders Migraine	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/73 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
General disorders Insect bite	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/74 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	0.00% 0/73 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
Musculoskeletal and connective tissue disorders Spine-related pain	62.2% 46/74 • Number of events 92 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	73.0% 54/74 • Number of events 124 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	52.1% 38/73 • Number of events 70 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
Musculoskeletal and connective tissue disorders Spine-related pain with radiation	10.8% 8/74 • Number of events 9 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	20.3% 15/74 • Number of events 20 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	20.5% 15/73 • Number of events 17 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
Musculoskeletal and connective tissue disorders Extremity pain	17.6% 13/74 • Number of events 17 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	17.6% 13/74 • Number of events 24 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	17.8% 13/73 • Number of events 18 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
Musculoskeletal and connective tissue disorders Headache	4.1% 3/74 • Number of events 4 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/74 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	5.5% 4/73 • Number of events 5 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
Musculoskeletal and connective tissue disorders General stiffness/tightness	10.8% 8/74 • Number of events 8 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	8.1% 6/74 • Number of events 6 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	9.6% 7/73 • Number of events 10 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
Musculoskeletal and connective tissue disorders Transient muscle weakness	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/74 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	0.00% 0/73 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
Musculoskeletal and connective tissue disorders Tenderness	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/74 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/73 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
Musculoskeletal and connective tissue disorders Muscle spasm/cramp	2.7% 2/74 • Number of events 2 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	5.4% 4/74 • Number of events 5 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	2.7% 2/73 • Number of events 2 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
Musculoskeletal and connective tissue disorders Muscle pain	5.4% 4/74 • Number of events 4 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/74 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/73 • Number of events 2 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
General disorders Tiredness/fatigue	1.4% 1/74 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/74 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	0.00% 0/73 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
General disorders Dizziness/imbalance/vertigo	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/74 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	4.1% 3/73 • Number of events 4 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
General disorders Nausea	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	0.00% 0/74 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/73 • Number of events 1 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
General disorders Sinus congestion/respiratory symptoms/allergy	2.7% 2/74 • Number of events 2 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	8.1% 6/74 • Number of events 6 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	2.7% 2/73 • Number of events 2 • 2 weeks Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.

Additional Information

Christine Goertz, DC, PhD, Principal Investigator

Palmer College of Chiropractic

Phone: (563) 884-5150

Email: christine.goertz@palmer.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place