Trial Outcomes & Findings for Collaborative Care for Older Adults With Back Pain (COCOA) (NCT NCT01312233)
NCT ID: NCT01312233
Last Updated: 2021-03-30
Results Overview
Adjusted mean changes in patient-rated LBP from baseline to week 12 were assessed. Average and worst LBP were rated on an 11 Numerical Rating Scale (NRS) point scale (0, no LBP; 10 worst LBP possible)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
131 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2021-03-30
Participant Flow
Participant milestones
| Measure |
Shared Care
Co-management of medical care and chiropractic care
Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care.
|
Dual Care
Unlinked co-occurrence of conventional medical care and chiropractic care
Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided.
|
Medical Care
Conventional medical care alone
Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral.
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
43
|
|
Overall Study
COMPLETED
|
42
|
44
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Collaborative Care for Older Adults With Back Pain (COCOA)
Baseline characteristics by cohort
| Measure |
Shared Care
n=44 Participants
Co-management of medical care and chiropractic care
Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care.
|
Dual Care
n=44 Participants
Unlinked co-occurrence of conventional medical care and chiropractic care
Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided.
|
Medical Care
n=43 Participants
Conventional medical care alone
Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
72.3 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
72.7 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
72.7 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
40 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
44 participants
n=7 Participants
|
43 participants
n=5 Participants
|
131 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: 9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up.
Adjusted mean changes in patient-rated LBP from baseline to week 12 were assessed. Average and worst LBP were rated on an 11 Numerical Rating Scale (NRS) point scale (0, no LBP; 10 worst LBP possible)
Outcome measures
| Measure |
Shared Care
n=42 Participants
Co-management of medical care and chiropractic care
Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care.
|
Dual Care
n=44 Participants
Unlinked co-occurrence of conventional medical care and chiropractic care
Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided.
|
Medical Care
n=36 Participants
Conventional medical care alone
Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral.
|
|---|---|---|---|
|
Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS)
NRS - Average LBP (adjusted mean change)
|
1.8 units on a scale
Interval 1.0 to 2.6
|
3.0 units on a scale
Interval 2.3 to 3.8
|
2.3 units on a scale
Interval 1.5 to 3.2
|
|
Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS)
NRS - Worst LBP (adjusted mean change)
|
2.1 units on a scale
Interval 1.3 to 2.9
|
2.9 units on a scale
Interval 2.1 to 3.6
|
2.3 units on a scale
Interval 1.5 to 3.1
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: 9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up.
Adjusted mean changes in patient-rated disability from baseline to week 12 were assessed using the 24-item RMDQ where 0 indicated no disability and 24 indicated severe disability.
Outcome measures
| Measure |
Shared Care
n=42 Participants
Co-management of medical care and chiropractic care
Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care.
|
Dual Care
n=44 Participants
Unlinked co-occurrence of conventional medical care and chiropractic care
Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided.
|
Medical Care
n=36 Participants
Conventional medical care alone
Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral.
|
|---|---|---|---|
|
Change From Baseline in Patient-Rated Disability, the 24-item Roland Morris Disability Questionnaire (RMDQ)
|
2.8 units on a scale
Interval 1.6 to 4.0
|
2.5 units on a scale
Interval 1.3 to 3.7
|
1.5 units on a scale
Interval 0.2 to 2.8
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: 9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up.
Physical function and Emotional Well-being (range 0-100). Higher scores indicate a better outcome.
Outcome measures
| Measure |
Shared Care
n=42 Participants
Co-management of medical care and chiropractic care
Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care.
|
Dual Care
n=44 Participants
Unlinked co-occurrence of conventional medical care and chiropractic care
Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided.
|
Medical Care
n=36 Participants
Conventional medical care alone
Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral.
|
|---|---|---|---|
|
Veterans-RAND 36-item Short-Form Health Survey (VR-36)
Physical Function - Baseline
|
50.0 units on a scale (0-100)
Standard Deviation 26.9
|
57.8 units on a scale (0-100)
Standard Deviation 23.6
|
65.0 units on a scale (0-100)
Standard Deviation 23.3
|
|
Veterans-RAND 36-item Short-Form Health Survey (VR-36)
Physical Function - 3 Months
|
58.8 units on a scale (0-100)
Standard Deviation 26.2
|
63.8 units on a scale (0-100)
Standard Deviation 25.4
|
65.6 units on a scale (0-100)
Standard Deviation 24.2
|
|
Veterans-RAND 36-item Short-Form Health Survey (VR-36)
Emotional Well-Being - Baseline
|
78.5 units on a scale (0-100)
Standard Deviation 13.1
|
80.4 units on a scale (0-100)
Standard Deviation 14.0
|
77.8 units on a scale (0-100)
Standard Deviation 13.3
|
|
Veterans-RAND 36-item Short-Form Health Survey (VR-36)
Emotional Well-Being - 3 Months
|
80.9 units on a scale (0-100)
Standard Deviation 14.1
|
82.4 units on a scale (0-100)
Standard Deviation 12.4
|
82.2 units on a scale (0-100)
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: 9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up.
Adjusted mean changes in patient-reported LBP bothersomeness on a 5 point scale index (1, not at all bothered; 5, extremely bothered) from baseline to week 12 were assessed.
Outcome measures
| Measure |
Shared Care
n=42 Participants
Co-management of medical care and chiropractic care
Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care.
|
Dual Care
n=44 Participants
Unlinked co-occurrence of conventional medical care and chiropractic care
Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided.
|
Medical Care
n=36 Participants
Conventional medical care alone
Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral.
|
|---|---|---|---|
|
Change From Baseline in Bothersomeness of Low Back Pain Symptoms
|
0.8 units on a scale
Interval 0.4 to 1.1
|
0.9 units on a scale
Interval 0.6 to 1.2
|
0.6 units on a scale
Interval 0.3 to 0.9
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up.
Percent of participants reporting levels of satisfaction for the information received regarding the cause of low back pain \[LBP\] (A), prognosis of LBP (B) and activities that hasten recovery (C), concern of MDs and Doctor of Chiropractic (DCs) during treatments (D), the quality of the treatment recommendations(E) and the overall care for LBP (F)
Outcome measures
| Measure |
Shared Care
n=42 Participants
Co-management of medical care and chiropractic care
Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care.
|
Dual Care
n=44 Participants
Unlinked co-occurrence of conventional medical care and chiropractic care
Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided.
|
Medical Care
n=36 Participants
Conventional medical care alone
Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral.
|
|---|---|---|---|
|
Patient Satisfaction With Care
(A) Cause of LBP · Good
|
10 Participants
|
7 Participants
|
8 Participants
|
|
Patient Satisfaction With Care
(A) Cause of LBP · Excellent
|
17 Participants
|
21 Participants
|
2 Participants
|
|
Patient Satisfaction With Care
(B) Prognosis of LBP · Poor
|
0 Participants
|
0 Participants
|
6 Participants
|
|
Patient Satisfaction With Care
(B) Prognosis of LBP · Fair
|
5 Participants
|
1 Participants
|
7 Participants
|
|
Patient Satisfaction With Care
(C) Activities that hasten recovery · Poor
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Patient Satisfaction With Care
(C) Activities that hasten recovery · Fair
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Patient Satisfaction With Care
(C) Activities that hasten recovery · Good
|
10 Participants
|
8 Participants
|
8 Participants
|
|
Patient Satisfaction With Care
(C) Activities that hasten recovery · Very Good
|
12 Participants
|
11 Participants
|
14 Participants
|
|
Patient Satisfaction With Care
(D) Concern of MDs and DCs during recovery · Good
|
6 Participants
|
1 Participants
|
8 Participants
|
|
Patient Satisfaction With Care
(D) Concern of MDs and DCs during recovery · Very Good
|
7 Participants
|
7 Participants
|
11 Participants
|
|
Patient Satisfaction With Care
(E) Quality of treatment recommendations · Fair
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Patient Satisfaction With Care
(E) Quality of treatment recommendations · Good
|
6 Participants
|
2 Participants
|
8 Participants
|
|
Patient Satisfaction With Care
(F) Overall Care for LBP · Fair
|
1 Participants
|
0 Participants
|
7 Participants
|
|
Patient Satisfaction With Care
(F) Overall Care for LBP · Good
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Patient Satisfaction With Care
(F) Overall Care for LBP · Very Good
|
14 Participants
|
8 Participants
|
17 Participants
|
|
Patient Satisfaction With Care
(F) Overall Care for LBP · Excellent
|
22 Participants
|
32 Participants
|
4 Participants
|
|
Patient Satisfaction With Care
(A) Cause of LBP · Poor
|
1 Participants
|
0 Participants
|
7 Participants
|
|
Patient Satisfaction With Care
(A) Cause of LBP · Fair
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Patient Satisfaction With Care
(A) Cause of LBP · Very Good
|
12 Participants
|
14 Participants
|
15 Participants
|
|
Patient Satisfaction With Care
(B) Prognosis of LBP · Good
|
10 Participants
|
10 Participants
|
6 Participants
|
|
Patient Satisfaction With Care
(B) Prognosis of LBP · Very Good
|
14 Participants
|
15 Participants
|
16 Participants
|
|
Patient Satisfaction With Care
(B) Prognosis of LBP · Excellent
|
13 Participants
|
18 Participants
|
1 Participants
|
|
Patient Satisfaction With Care
(C) Activities that hasten recovery · Excellent
|
18 Participants
|
24 Participants
|
3 Participants
|
|
Patient Satisfaction With Care
(D) Concern of MDs and DCs during recovery · Poor
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Patient Satisfaction With Care
(D) Concern of MDs and DCs during recovery · Fair
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Patient Satisfaction With Care
(D) Concern of MDs and DCs during recovery · Excellent
|
27 Participants
|
36 Participants
|
13 Participants
|
|
Patient Satisfaction With Care
(E) Quality of treatment recommendations · Poor
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Patient Satisfaction With Care
(E) Quality of treatment recommendations · Very Good
|
11 Participants
|
11 Participants
|
12 Participants
|
|
Patient Satisfaction With Care
(E) Quality of treatment recommendations · Excellent
|
25 Participants
|
30 Participants
|
8 Participants
|
|
Patient Satisfaction With Care
(F) Overall Care for LBP · Poor
|
0 Participants
|
0 Participants
|
4 Participants
|
Adverse Events
Shared Care
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Dual Care
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Medical Care
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Shared Care
n=44 participants at risk
Co-management of medical care and chiropractic care
Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care.
|
Dual Care
n=44 participants at risk
Unlinked co-occurrence of conventional medical care and chiropractic care
Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided.
|
Medical Care
n=43 participants at risk
Conventional medical care alone
Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Spine-related pain
|
65.9%
29/44 • Number of events 80 • 3 months
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.
|
75.0%
33/44 • Number of events 118 • 3 months
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.
|
4.7%
2/43 • Number of events 3 • 3 months
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.
|
|
Musculoskeletal and connective tissue disorders
Spine-related pain with radiation
|
15.9%
7/44 • Number of events 10 • 3 months
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.
|
25.0%
11/44 • Number of events 19 • 3 months
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.
|
7.0%
3/43 • Number of events 3 • 3 months
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.
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
25.0%
11/44 • Number of events 16 • 3 months
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.
|
40.9%
18/44 • Number of events 35 • 3 months
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.
|
2.3%
1/43 • Number of events 2 • 3 months
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.
|
|
Musculoskeletal and connective tissue disorders
Headache
|
4.5%
2/44 • Number of events 2 • 3 months
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.
|
4.5%
2/44 • Number of events 3 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Musculoskeletal and connective tissue disorders
General stiffness/tightness
|
4.5%
2/44 • Number of events 2 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm/cramp
|
0.00%
0/44 • 3 months
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.
|
4.5%
2/44 • Number of events 2 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Musculoskeletal and connective tissue disorders
Swelling
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Musculoskeletal and connective tissue disorders
Numbness/tingling
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
6.8%
3/44 • Number of events 4 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Musculoskeletal and connective tissue disorders
General soreness
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
11.4%
5/44 • Number of events 6 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Cardiac disorders
Pulmonary hypertension
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Cardiac disorders
Arrhythmia
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Cardiac disorders
Shortness of breath
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Cardiac disorders
Angina
|
4.5%
2/44 • Number of events 2 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/43 • Number of events 1 • 3 months
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.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Headache
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Tiredness/fatigue
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Dizziness/imbalance/vertigo
|
9.1%
4/44 • Number of events 6 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Nausea
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Upper respiratory infection
|
11.4%
5/44 • Number of events 5 • 3 months
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.
|
4.5%
2/44 • Number of events 3 • 3 months
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.
|
2.3%
1/43 • Number of events 1 • 3 months
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.
|
|
General disorders
Lower respiratory infection
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Sinus congestion/respiratory symptoms/allergy
|
9.1%
4/44 • Number of events 4 • 3 months
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.
|
9.1%
4/44 • Number of events 4 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Migraine
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
2.3%
1/44 • Number of events 2 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Abdominal pain
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Laceration
|
4.5%
2/44 • Number of events 2 • 3 months
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.
|
13.6%
6/44 • Number of events 7 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Swelling
|
2.3%
1/44 • Number of events 2 • 3 months
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.
|
4.5%
2/44 • Number of events 2 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Diarrhea
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
6.8%
3/44 • Number of events 3 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
General soreness
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Chipped tooth
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Allergic rash
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Shortness of breath
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Cold sore
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Fall
|
9.1%
4/44 • Number of events 5 • 3 months
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.
|
13.6%
6/44 • Number of events 6 • 3 months
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.
|
2.3%
1/43 • Number of events 1 • 3 months
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.
|
|
General disorders
Skin burning sensation
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Chest pain
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Tremor
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
2.3%
1/43 • Number of events 1 • 3 months
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.
|
|
General disorders
Constipation
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
GERD
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Skin allergic reaction
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Cough
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/44 • Number of events 1 • 3 months
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.
|
0.00%
0/43 • 3 months
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.
|
|
General disorders
Concussion
|
0.00%
0/44 • 3 months
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.
|
0.00%
0/44 • 3 months
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.
|
2.3%
1/43 • Number of events 1 • 3 months
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.
|
Additional Information
Christine M Goertz, DC, PhD (Study Principal Investigator)
Spine Institute for Quality
Phone: 301-335-0071
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place