Trial Outcomes & Findings for Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure (NCT NCT03589703)
NCT ID: NCT03589703
Last Updated: 2024-04-24
Results Overview
Pain intensity as assessed by the NRS for worst pain in the past 7 days using a 0-10 scale (0 = "no pain" and 10 = "worst pain imaginable")
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
272 participants
Primary outcome timeframe
Baseline
Results posted on
2024-04-24
Participant Flow
Participant milestones
| Measure |
T-APA
Patients with active points related to chronic lower back pain (cLBP) will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Overall Study
STARTED
|
92
|
91
|
89
|
|
Overall Study
Completed Follow up 1 Month Post-intervention
|
81
|
68
|
71
|
|
Overall Study
COMPLETED
|
81
|
68
|
71
|
|
Overall Study
NOT COMPLETED
|
11
|
23
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure
Baseline characteristics by cohort
| Measure |
T-APA
n=92 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=91 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=89 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
68.7 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
71.1 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
70.0 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
59 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
218 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
92 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
31.3 kg/m^2
STANDARD_DEVIATION 8.5 • n=5 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 7.7 • n=7 Participants
|
30.6 kg/m^2
STANDARD_DEVIATION 7.0 • n=5 Participants
|
31.0 kg/m^2
STANDARD_DEVIATION 7.7 • n=4 Participants
|
|
Education Level
High School or Less
|
27 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Education Level
Some College
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Education Level
College or Higher
|
45 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Employment Status
Employed
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Employment Status
Unemployed or Retired
|
80 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
234 Participants
n=4 Participants
|
|
Employment Status
Unknown
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Severity of Comorbidity as Assessed by Charlson Comorbidity Index
|
1.3 score on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
1.0 score on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
1.0 score on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
1.1 score on a scale
STANDARD_DEVIATION 2.2 • n=4 Participants
|
|
Smoking Status
Current Smoker
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Smoking Status
Never Smoked
|
38 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Smoking Status
Previously Smoked
|
39 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselinePain intensity as assessed by the NRS for worst pain in the past 7 days using a 0-10 scale (0 = "no pain" and 10 = "worst pain imaginable")
Outcome measures
| Measure |
T-APA
n=92 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=91 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=89 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Pain Intensity as Assessed by the Numeric Rating Scale (NRS)
|
7.4 score on a scale
Standard Deviation 1.7
|
7.0 score on a scale
Standard Deviation 1.8
|
7.3 score on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm.
Pain intensity as assessed by the NRS for worst pain in the past 7 days using a 0-10 scale (0 = "no pain" and 10 = "worst pain imaginable")
Outcome measures
| Measure |
T-APA
n=81 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=72 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=69 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Pain Intensity as Assessed by the Numeric Rating Scale (NRS)
|
5.6 score on a scale
Standard Deviation 2.7
|
5.3 score on a scale
Standard Deviation 2.7
|
6.6 score on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: BaselinePain interference is assessed by the Brief Pain Inventory pain interference subscale, which uses a 0-10 scale (0 = "does not interfere" and 10 = "completely interferes").
Outcome measures
| Measure |
T-APA
n=92 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=91 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=89 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale
|
3.2 score on a scale
Standard Deviation 1.7
|
3.3 score on a scale
Standard Deviation 1.7
|
3.1 score on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm.
Pain interference is assessed by the Brief Pain Inventory pain interference subscale, which uses a 0-10 scale (0 = "does not interfere" and 10 = "completely interferes").
Outcome measures
| Measure |
T-APA
n=81 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=72 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=69 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale
|
2.7 score on a scale
Standard Deviation 1.9
|
2.5 score on a scale
Standard Deviation 1.6
|
2.9 score on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: BaselineThe Roland Morris Disability Questionnaire (RMDQ), 24-item measure, is used to assess the impact of back pain on their daily functioning. The score ranges from 0 (no disability) to 24 (maximum disability).
Outcome measures
| Measure |
T-APA
n=92 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=91 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=89 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)
|
12.4 score on a scale
Standard Deviation 5.3
|
12.6 score on a scale
Standard Deviation 6.2
|
12.0 score on a scale
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 18 in the Control arm.
The Roland Morris Disability Questionnaire (RMDQ), 24-item measure, is used to assess the impact of back pain on their daily functioning. The score ranges from 0 (no disability) to 24 (maximum disability).
Outcome measures
| Measure |
T-APA
n=81 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=72 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=71 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)
|
9.8 score on a scale
Standard Deviation 6.2
|
9.6 score on a scale
Standard Deviation 6.6
|
10.5 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
T-APA
n=92 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=91 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=89 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Number of Participants Who Use Opioids
|
44 Participants
|
45 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected for 17 in the T-APA arm, 29 in the NT-APA arm, and 20 in the control arm.
Outcome measures
| Measure |
T-APA
n=75 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=62 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=69 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Number of Participants Who Use Opioids
|
25 Participants
|
22 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: immediately post intervention (1 month after baseline)Population: Data were not collected for 11 in the T-APA arm and 17 in the NT-APA arm. These data were not collected for any of the 89 in the control arm, as they did not receive the APA treatment.
Satisfaction is assessed using a 5-point numeric rating scale: 1. \- Completely satisfied 2. \- Somewhat satisfied 3. \- Neither satisfied nor dissatisfied 4. \- Somewhat dissatisfied 5. \- Very dissatisfied
Outcome measures
| Measure |
T-APA
n=81 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=74 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
APA Treatment Satisfaction as Assessed by Satisfaction Survey
|
2.04 score on a scale
Standard Deviation 0.993
|
2.16 score on a scale
Standard Deviation 1.047
|
—
|
SECONDARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected for 17 in the T-APA arm and 29 in the NT-APA arm. These data were not collected for any of the 89 in the control arm, as they did not receive the APA treatment.
Satisfaction is assessed using a 5-point numeric rating scale: 1. \- Completely satisfied 2. \- Somewhat satisfied 3. \- Neither satisfied nor dissatisfied 4. \- Somewhat dissatisfied 5. \- Very dissatisfied
Outcome measures
| Measure |
T-APA
n=75 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=62 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
APA Treatment Satisfaction as Assessed by Satisfaction Survey
|
2.29 score on a scale
Standard Deviation 1.088
|
2.10 score on a scale
Standard Deviation 0.953
|
—
|
SECONDARY outcome
Timeframe: BaselineThe Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, anxiety. The raw score on the anxiety subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater anxiety. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, an anxiety T-score of 40 is one SD better than average in terms of anxiety. A T-score below 55 is indicative of anxiety within normal limits.
Outcome measures
| Measure |
T-APA
n=92 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=91 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=89 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety
|
51.0 T-score
Standard Deviation 8.9
|
53.1 T-score
Standard Deviation 10.8
|
51.8 T-score
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm.
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, anxiety. The raw score on the anxiety subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater anxiety. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, an anxiety T-score of 40 is one SD better than average in terms of anxiety. A T-score below 55 is indicative of anxiety within normal limits.
Outcome measures
| Measure |
T-APA
n=81 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=72 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=69 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety
|
49.0 T-score
Standard Deviation 9.5
|
48.8 T-score
Standard Deviation 9.4
|
51.5 T-score
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: BaselineThe Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, depression. The raw score on the depression subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater depression. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a depression T-score of 40 is one SD better than average in terms of depression. A T-score below 55 is indicative of depression within normal limits.
Outcome measures
| Measure |
T-APA
n=92 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=91 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=89 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression
|
50.3 T-score
Standard Deviation 9.6
|
52.7 T-score
Standard Deviation 9.0
|
50.5 T-score
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm.
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, depression. The raw score on the depression subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater depression. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a depression T-score of 40 is one SD better than average in terms of depression. A T-score below 55 is indicative of depression within normal limits.
Outcome measures
| Measure |
T-APA
n=81 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=72 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=69 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression
|
49.1 T-score
Standard Deviation 8.7
|
48.9 T-score
Standard Deviation 8.3
|
49.6 T-score
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: BaselineThe Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, sleep disturbance. The raw score on the sleep disturbance subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater sleep disturbance. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a sleep disturbance T-score of 40 is one SD better than average in terms of sleep disturbance. A T-score below 55 is indicative of sleep disturbance within normal limits.
Outcome measures
| Measure |
T-APA
n=92 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=91 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=89 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance
|
56.0 T-score
Standard Deviation 4.1
|
56.0 T-score
Standard Deviation 3.3
|
55.5 T-score
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm.
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, sleep disturbance. The raw score on the sleep disturbance subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater sleep disturbance. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a sleep disturbance T-score of 40 is one SD better than average in terms of sleep disturbance. A T-score below 55 is indicative of sleep disturbance within normal limits.
Outcome measures
| Measure |
T-APA
n=81 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=72 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=69 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance
|
55.3 T-score
Standard Deviation 3.4
|
55.9 T-score
Standard Deviation 5.0
|
55.9 T-score
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: BaselineThe fear-avoidance beliefs questionnaire (FABQ) focuses on participant's beliefs about how physical activity and work affect their pain. The questionnaire consists of 16 items in which a participant rates their agreement with each statement on a 7-point Likert scale where 0 = completely disagree and 6 =completely agree. The total score ranges from 0 to 96. A higher score indicates more strongly held fear-avoidance beliefs.
Outcome measures
| Measure |
T-APA
n=92 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=91 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=89 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)
|
15.7 score on a scale
Standard Deviation 8.3
|
17.0 score on a scale
Standard Deviation 8.8
|
15.6 score on a scale
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected for 11 in the T-APA arm, 29 in the NT-APA arm, and 21 in the Control arm.
The fear-avoidance beliefs questionnaire (FABQ) focuses on participant's beliefs about how physical activity and work affect their pain. The questionnaire consists of 16 items in which a participant rates their agreement with each statement on a 7-point Likert scale where 0 = completely disagree and 6 =completely agree. The total score ranges from 0 to 96. A higher score indicates more strongly held fear-avoidance beliefs.
Outcome measures
| Measure |
T-APA
n=81 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=62 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=68 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)
|
13.4 score on a scale
Standard Deviation 9.0
|
14.8 score on a scale
Standard Deviation 8.8
|
15.2 score on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: BaselineThe PCS was included to detect exaggerated and negative interpretations of pain. It is a self-report scale that consists of13 items. Participants were asked to reflect on past painful experiences and to indicate to which degree he/she experienced symptoms such as helplessness or rumination when feeling pain. This is a 0-4 Likert scale (score sum 0-52) with responses ranging from "not at all" to "all the time," with higher scores indicate stronger catastrophizing.
Outcome measures
| Measure |
T-APA
n=92 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=91 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=89 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
|
15.7 score on a scale
Standard Deviation 12.4
|
19.1 score on a scale
Standard Deviation 14.2
|
15.9 score on a scale
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 21 in the Control arm.
The PCS was included to detect exaggerated and negative interpretations of pain. It is a self-report scale that consists of13 items. Participants were asked to reflect on past painful experiences and to indicate to which degree he/she experienced symptoms such as helplessness or rumination when feeling pain. This is a 0-4 Likert scale (score sum 0-52) with responses ranging from "not at all" to "all the time," with higher scores indicate stronger catastrophizing.
Outcome measures
| Measure |
T-APA
n=81 Participants
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=72 Participants
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=68 Participants
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
|
14.1 score on a scale
Standard Deviation 12.7
|
13.9 score on a scale
Standard Deviation 11.8
|
13.8 score on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data were not collected from any participant for this outcome measure.
T-score will be reported, with a range of 0-100, with a higher score indicating better memory.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected from any participant for this outcome measure.
T-score will be reported, with a range of 0-100, with a higher score indicating better memory.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Data were not collected from any participant for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month post completion of the treatment (2 months after baseline)Population: Data were not collected from any participant for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
T-APA
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
NT-APA
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Enhanced Educational Control Group (CG-2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
T-APA
n=92 participants at risk
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear.
|
NT-APA
n=91 participants at risk
The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.
These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.
Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
|
Enhanced Educational Control Group (CG-2)
n=89 participants at risk
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
|
|---|---|---|---|
|
General disorders
Itching/Discomfort on the ear where the seed was placed
|
75.0%
69/92 • Number of events 183 • from start of intervention to end of intervention (4 weeks)
|
52.7%
48/91 • Number of events 112 • from start of intervention to end of intervention (4 weeks)
|
0.00%
0/89 • from start of intervention to end of intervention (4 weeks)
|
Additional Information
Nada Lukkahatai, PhD, MSN, RN, CNE, FAAN
Johns Hopkins University
Phone: 410-614-5297
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place