Chronic Low Back Pain
Conditions
Keywords
Chronic Low Back Pain, cLBP, pain, acupressure
Brief summary
Almost one-third (30%) of persons 60 years and older suffer from cLBP and cause a significant negative impact on individuals and society in the U.S. The goal of managing cLBP is decreased pain and disability.To accomplish this, cLBP sufferers often use analgesics including opioids to decrease pain and facilitate activity, but the side effects caused by these medications are problematic. A better pain management strategy clearly needs to be developed. The investigators propose to test auricular point acupressure (APA), a non-invasive, easily administered, patient-controlled, and non-pharmacological strategy, to provide rapid, safe, and an innovative solution for chronic low back pain (cLBP) in older adults. APA involves an acupuncture-like stimulation of the ear without needles. With APA, small seeds are taped to specific ear points. The patient is taught to apply pressure to the seeds, with the thumb and index finger, three times a day (morning, noon, and evening) for three minutes each session to achieve pain relief. The investigators have developed a detailed APA protocol to teach health-care providers without experience in acupuncture and traditional Chinese Medicine that investigators can learn about APA in brief educational seminars as a treatment including the systematic identification of ear points (called auricular diagnosis). The investigators teach methods that enable patients to continue using APA to self-manage participants' pain. Brain imaging studies in acupuncture indicate that acupuncture can restore normal functional connectivity related to pain reduction. Studies suggest that stimulation of ear points (1) excites the somatotopic reflex system in the brain and that pathological brain patterns are electrically reset to stop the unwanted activation of spinal pain pathways, explaining the possible immediate pain relief that patients feel after APA and (2) cause a broad spectrum of systemic effects, such as vasodilation, by releasing endorphin to elicit short-term analgesic effects or neuropeptide-induced anti-inflammatory cytokines, which may explain long-term effects. The Ecological Momentary Assessment (EMA) smart phone app will be used to collect real-time cLBP outcomes and adherence to APA practice. Treatment and nonspecific psychological placebo effects will be measured via questionnaires for all participants. Neuro-transmitters is measured by inflammatory biomarkers. Blood samples will be collected for serum collection and a multiplex bead-based immunofluorescence assay performed to check for serum levels. Mini-Mental State Examination will be used to screen for cognitive function, also HRQoL, satisfaction, treatment beliefs and expectations, sleep, relaxation effects, catastrophizing and fear/avoidance, and placebo effects will be measured.
Interventions
OTHERTarget ear points related to chronic low back pain (T-APA)
Light touch using vaccaria seeds on specific points of the ear.
OTHERNon-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).
OTHEREnhanced Educational Control Group (CG-2)
No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
Sponsors
National Institute on Aging (NIA)
Johns Hopkins University
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 60 years or older * Able to read and write English * cLBP that has persisted at least 3 months and has pain on at least half of the days for the previous 6 months * Average intensity of pain ≥ 4 on a 11-point numerical pain scale in the previous week * Have intact cognition (Mini-Mental State Examination (MMSE) \> 24) * Willing to commit to up to 13-17 months as a study participant, depending on which group the participant is placed in * Able to apply pressure to the seeds with tapes on their ears
Exclusion criteria
* Malignant or autoimmune diseases (e.g., rheumatoid arthritis), in which the pain from the disease cannot be separated from the low back pain by the participant * Known acute compression fractures caused by osteoporosis, spinal stenosis, spondylolysis, or spondylolisthesis because these conditions may confound treatment effects or the interpretation of results * Sciatica with leg pain greater than back pain * Allergy to the tape * Use of some types of hearing aids (size may obstruct the placement of seeds) * Pain in other parts of the body that is more severe than the cLBP and which occurs daily or almost every day with at least moderate intensity or acute pain * Neurological disorders that could interfere with pain reporting or confound performance on the other outcomes, cerebral tumor, Alzheimer's disease (or other cognitive illnesses), prior stroke, or multiple sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity as Assessed by the Numeric Rating Scale (NRS) | Baseline | 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) |
| Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale | Baseline | 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). |
| Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ) | Baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression | Baseline | 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. |
| Memory as Assessed by the Stroop Test | Baseline | T-score will be reported, with a range of 0-100, with a higher score indicating better memory. |
| Relaxation as Assessed by Relaxation Response | Baseline | — |
| Number of Participants Who Use Opioids | Baseline | — |
| Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ) | Baseline | 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. |
| Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | Baseline | 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. |
| Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance | Baseline | 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. |
| APA Treatment Satisfaction as Assessed by Satisfaction Survey | immediately post intervention (1 month after baseline) | 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 |
| Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T-APA 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. | 92 |
| 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). | 91 |
| 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. | 89 |
| Total | 272 |
Baseline characteristics
| Characteristic | T-APA | Total | Enhanced Educational Control Group (CG-2) | NT-APA |
|---|---|---|---|---|
| Age, Continuous | 70.2 years STANDARD_DEVIATION 6.5 | 70.0 years STANDARD_DEVIATION 7 | 71.1 years STANDARD_DEVIATION 7.2 | 68.7 years STANDARD_DEVIATION 7.1 |
| Body Mass Index (BMI) | 31.3 kg/m^2 STANDARD_DEVIATION 8.5 | 31.0 kg/m^2 STANDARD_DEVIATION 7.7 | 30.6 kg/m^2 STANDARD_DEVIATION 7 | 31.1 kg/m^2 STANDARD_DEVIATION 7.7 |
| Education Level College or Higher | 45 Participants | 124 Participants | 41 Participants | 38 Participants |
| Education Level High School or Less | 27 Participants | 100 Participants | 37 Participants | 36 Participants |
| Education Level Some College | 20 Participants | 48 Participants | 11 Participants | 17 Participants |
| Employment Status Employed | 9 Participants | 33 Participants | 13 Participants | 11 Participants |
| Employment Status Unemployed or Retired | 80 Participants | 234 Participants | 75 Participants | 79 Participants |
| Employment Status Unknown | 3 Participants | 5 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 218 Participants | 67 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 50 Participants | 20 Participants | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants | 164 Participants | 55 Participants | 58 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 39 Participants | 97 Participants | 30 Participants | 28 Participants |
| Region of Enrollment United States | 92 Participants | 272 Participants | 89 Participants | 91 Participants |
| Severity of Comorbidity as Assessed by Charlson Comorbidity Index | 1.3 score on a scale STANDARD_DEVIATION 2.8 | 1.1 score on a scale STANDARD_DEVIATION 2.2 | 1.0 score on a scale STANDARD_DEVIATION 1.6 | 1.0 score on a scale STANDARD_DEVIATION 2.2 |
| Sex/Gender, Customized Female | 59 Participants | 174 Participants | 59 Participants | 56 Participants |
| Sex/Gender, Customized Male | 32 Participants | 96 Participants | 29 Participants | 35 Participants |
| Sex/Gender, Customized Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Smoking Status Current Smoker | 15 Participants | 47 Participants | 11 Participants | 21 Participants |
| Smoking Status Never Smoked | 38 Participants | 103 Participants | 39 Participants | 26 Participants |
| Smoking Status Previously Smoked | 39 Participants | 122 Participants | 39 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 91 | 0 / 89 |
| other Total, other adverse events | 69 / 92 | 48 / 91 | 0 / 89 |
| serious Total, serious adverse events | 0 / 92 | 0 / 91 | 0 / 89 |
Outcome results
Primary
Pain Intensity as Assessed by the Numeric Rating Scale (NRS)
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)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Pain Intensity as Assessed by the Numeric Rating Scale (NRS) | 7.4 score on a scale | Standard Deviation 1.7 |
| NT-APA | Pain Intensity as Assessed by the Numeric Rating Scale (NRS) | 7.0 score on a scale | Standard Deviation 1.8 |
| Enhanced Educational Control Group (CG-2) | Pain Intensity as Assessed by the Numeric Rating Scale (NRS) | 7.3 score on a scale | Standard Deviation 1.7 |
Primary
Pain Intensity as Assessed by the Numeric Rating Scale (NRS)
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Pain Intensity as Assessed by the Numeric Rating Scale (NRS) | 5.6 score on a scale | Standard Deviation 2.7 |
| NT-APA | Pain Intensity as Assessed by the Numeric Rating Scale (NRS) | 5.3 score on a scale | Standard Deviation 2.7 |
| Enhanced Educational Control Group (CG-2) | Pain Intensity as Assessed by the Numeric Rating Scale (NRS) | 6.6 score on a scale | Standard Deviation 2.2 |
Primary
Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale | 3.2 score on a scale | Standard Deviation 1.7 |
| NT-APA | Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale | 3.3 score on a scale | Standard Deviation 1.7 |
| Enhanced Educational Control Group (CG-2) | Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale | 3.1 score on a scale | Standard Deviation 1.6 |
Primary
Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale | 2.7 score on a scale | Standard Deviation 1.9 |
| NT-APA | Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale | 2.5 score on a scale | Standard Deviation 1.6 |
| Enhanced Educational Control Group (CG-2) | Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale | 2.9 score on a scale | Standard Deviation 1.7 |
Primary
Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ) | 12.4 score on a scale | Standard Deviation 5.3 |
| NT-APA | Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ) | 12.6 score on a scale | Standard Deviation 6.2 |
| Enhanced Educational Control Group (CG-2) | Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ) | 12.0 score on a scale | Standard Deviation 5.9 |
Primary
Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ) | 9.8 score on a scale | Standard Deviation 6.2 |
| NT-APA | Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ) | 9.6 score on a scale | Standard Deviation 6.6 |
| Enhanced Educational Control Group (CG-2) | Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ) | 10.5 score on a scale | Standard Deviation 5.8 |
Secondary
APA Treatment Satisfaction as Assessed by Satisfaction Survey
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | APA Treatment Satisfaction as Assessed by Satisfaction Survey | 2.29 score on a scale | Standard Deviation 1.088 |
| NT-APA | APA Treatment Satisfaction as Assessed by Satisfaction Survey | 2.10 score on a scale | Standard Deviation 0.953 |
Secondary
APA Treatment Satisfaction as Assessed by Satisfaction Survey
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | APA Treatment Satisfaction as Assessed by Satisfaction Survey | 2.04 score on a scale | Standard Deviation 0.993 |
| NT-APA | APA Treatment Satisfaction as Assessed by Satisfaction Survey | 2.16 score on a scale | Standard Deviation 1.047 |
Secondary
Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ) | 13.4 score on a scale | Standard Deviation 9 |
| NT-APA | Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ) | 14.8 score on a scale | Standard Deviation 8.8 |
| Enhanced Educational Control Group (CG-2) | Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ) | 15.2 score on a scale | Standard Deviation 8.4 |
Secondary
Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ) | 15.7 score on a scale | Standard Deviation 8.3 |
| NT-APA | Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ) | 17.0 score on a scale | Standard Deviation 8.8 |
| Enhanced Educational Control Group (CG-2) | Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ) | 15.6 score on a scale | Standard Deviation 8.6 |
Secondary
Memory as Assessed by the Stroop Test
T-score will be reported, with a range of 0-100, with a higher score indicating better memory.
Time frame: Baseline
Population: Data were not collected from any participant for this outcome measure.
Secondary
Memory as Assessed by the Stroop Test
T-score will be reported, with a range of 0-100, with a higher score indicating better memory.
Time frame: 1 month post completion of the treatment (2 months after baseline)
Population: Data were not collected from any participant for this outcome measure.
Secondary
Number of Participants Who Use Opioids
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T-APA | Number of Participants Who Use Opioids | 25 Participants |
| NT-APA | Number of Participants Who Use Opioids | 22 Participants |
| Enhanced Educational Control Group (CG-2) | Number of Participants Who Use Opioids | 17 Participants |
Secondary
Number of Participants Who Use Opioids
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T-APA | Number of Participants Who Use Opioids | 44 Participants |
| NT-APA | Number of Participants Who Use Opioids | 45 Participants |
| Enhanced Educational Control Group (CG-2) | Number of Participants Who Use Opioids | 32 Participants |
Secondary
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | 14.1 score on a scale | Standard Deviation 12.7 |
| NT-APA | Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | 13.9 score on a scale | Standard Deviation 11.8 |
| Enhanced Educational Control Group (CG-2) | Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | 13.8 score on a scale | Standard Deviation 12.7 |
Secondary
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | 15.7 score on a scale | Standard Deviation 12.4 |
| NT-APA | Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | 19.1 score on a scale | Standard Deviation 14.2 |
| Enhanced Educational Control Group (CG-2) | Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | 15.9 score on a scale | Standard Deviation 12.4 |
Secondary
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety | 49.0 T-score | Standard Deviation 9.5 |
| NT-APA | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety | 48.8 T-score | Standard Deviation 9.4 |
| Enhanced Educational Control Group (CG-2) | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety | 51.5 T-score | Standard Deviation 10 |
Secondary
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety | 51.0 T-score | Standard Deviation 8.9 |
| NT-APA | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety | 53.1 T-score | Standard Deviation 10.8 |
| Enhanced Educational Control Group (CG-2) | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety | 51.8 T-score | Standard Deviation 9.9 |
Secondary
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression | 50.3 T-score | Standard Deviation 9.6 |
| NT-APA | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression | 52.7 T-score | Standard Deviation 9 |
| Enhanced Educational Control Group (CG-2) | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression | 50.5 T-score | Standard Deviation 9.1 |
Secondary
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression | 49.1 T-score | Standard Deviation 8.7 |
| NT-APA | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression | 48.9 T-score | Standard Deviation 8.3 |
| Enhanced Educational Control Group (CG-2) | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression | 49.6 T-score | Standard Deviation 9.6 |
Secondary
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | 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 |
| NT-APA | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance | 55.9 T-score | Standard Deviation 5 |
| Enhanced Educational Control Group (CG-2) | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance | 55.9 T-score | Standard Deviation 3.3 |
Secondary
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-APA | 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 |
| NT-APA | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance | 56.0 T-score | Standard Deviation 3.3 |
| Enhanced Educational Control Group (CG-2) | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance | 55.5 T-score | Standard Deviation 4 |
Secondary
Relaxation as Assessed by Relaxation Response
Time frame: Baseline
Population: Data were not collected from any participant for this outcome measure.
Secondary
Relaxation as Assessed by Relaxation Response
Time frame: 1 month post completion of the treatment (2 months after baseline)
Population: Data were not collected from any participant for this outcome measure.