Trial Outcomes & Findings for Chronic Low Back Pain and Meditation (NCT NCT04034004)
NCT ID: NCT04034004
Last Updated: 2023-10-11
Results Overview
Numerical pain ratings (NRS) will be assessed while lying on the back and in response to the straight leg raise test (SLR). Pain ratings will be collected during SLR 1 and SLR 2 in the baseline, saline and naloxone sessions, respectively. The 11 point scan will include a minimum rating of "0" which is characterized as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable"." Higher numbers correspond to higher pain.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
88 participants
Primary outcome timeframe
Pain ratings were collected while lying supine and in response to the straight leg raise test. Collected twice, once in the first half and one in the second half of the baseline, saline infusion and naloxone infusion sessions. Up to 8 weeks total.
Results posted on
2023-10-11
Participant Flow
500 individuals were screened for eligibility through the UCSD Recruitment services and study flyers. Enrollment started in January 2021 and data collection was completed in December of 2022.
88 out of the 500 individuals were enrolled and participated in the baseline session. Seventeen out of the 88 were not randomized for the following reasons: Not responsive to straight leg raise test (n = 4), Intolerance to pain procedures (n = 3), Withdrew (n = 3), Scheduling issues (n = 1), Transportation issues (n = 1), Positive opioid test (n = 1), Inappropriate behavior (n = 1), Other pain management (n = 1), instruction incomprehension (n = 1) and Mindfulness experience (n = 1).
Participant milestones
| Measure |
Mindfulness Meditation and Saline First
After providing informed consent, 18 participants completed baseline testing.
Participants then completed a four session mindfulness meditation intervention where participants were taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation. One participant dropped out after the first intervention session.
After their respective intervention, these participants received IV saline in session 6. Two participants were dismissed because of trouble administering the IV.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
After a two day washout period, 15 participants returned to the clinic and performed the naloxone infusion in session 7.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also administered a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
|
Non Mindfulness Meditation and Saline First
After providing informed consent, 18 participants completed baseline testing. 2 participants withdrew from this session
Participants then completed a four session non-mindfulness meditation intervention where participants were taught to independently practice closing their eyes and take a deep breath every few minutes.
After their respective intervention, these participants received IV saline in session 6. One participants was dismissed because of trouble administering the IV.
After a two day washout period, 15 participants returned to the clinic and performed the naloxone infusion in session 7.
|
Mindfulness Meditation and Naloxone First
After providing informed consent, 17 participants participated in baseline testing. Two participants withdrew for scheduling issues after baseline.
Fifteen participants then completed a four session mindfulness meditation intervention where they were taught to focus on the changing sensations of the breath non-reactively
After their respective intervention, these 15 participants received IV naloxone in session 6
After a two day washout period, 15 participants returned to the clinic and performed the saline infusion in session 7.
|
Non Mindfulness Meditation and Naloxone First
After providing informed consent, 18 participants participated in baseline testing. Three participants withdrew for scheduling issues after baseline.
Fifteen participants then completed a four session non mindfulness meditation intervention where they were taught to independently take deep breaths.
After their respective intervention, these participants received IV naloxone in session 6. However, a study nurse unintentionally instructed a patient that naloxone was to be infused and thus the participant was dismissed.
After a two day washout period, 14 participants returned to the clinic and performed the saline infusion in session 7.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
17
|
18
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
4
|
Reasons for withdrawal
| Measure |
Mindfulness Meditation and Saline First
After providing informed consent, 18 participants completed baseline testing.
Participants then completed a four session mindfulness meditation intervention where participants were taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation. One participant dropped out after the first intervention session.
After their respective intervention, these participants received IV saline in session 6. Two participants were dismissed because of trouble administering the IV.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
After a two day washout period, 15 participants returned to the clinic and performed the naloxone infusion in session 7.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also administered a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
|
Non Mindfulness Meditation and Saline First
After providing informed consent, 18 participants completed baseline testing. 2 participants withdrew from this session
Participants then completed a four session non-mindfulness meditation intervention where participants were taught to independently practice closing their eyes and take a deep breath every few minutes.
After their respective intervention, these participants received IV saline in session 6. One participants was dismissed because of trouble administering the IV.
After a two day washout period, 15 participants returned to the clinic and performed the naloxone infusion in session 7.
|
Mindfulness Meditation and Naloxone First
After providing informed consent, 17 participants participated in baseline testing. Two participants withdrew for scheduling issues after baseline.
Fifteen participants then completed a four session mindfulness meditation intervention where they were taught to focus on the changing sensations of the breath non-reactively
After their respective intervention, these 15 participants received IV naloxone in session 6
After a two day washout period, 15 participants returned to the clinic and performed the saline infusion in session 7.
|
Non Mindfulness Meditation and Naloxone First
After providing informed consent, 18 participants participated in baseline testing. Three participants withdrew for scheduling issues after baseline.
Fifteen participants then completed a four session non mindfulness meditation intervention where they were taught to independently take deep breaths.
After their respective intervention, these participants received IV naloxone in session 6. However, a study nurse unintentionally instructed a patient that naloxone was to be infused and thus the participant was dismissed.
After a two day washout period, 14 participants returned to the clinic and performed the saline infusion in session 7.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
3
|
|
Overall Study
could not find vein to administer IV
|
2
|
1
|
0
|
0
|
|
Overall Study
nurse accidentally unblinded subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Chronic Low Back Pain and Meditation
Baseline characteristics by cohort
| Measure |
Mindfulness Meditation
n=30 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
|
Non-mindfulness Meditation
n=29 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
age
|
45 years
STANDARD_DEVIATION 12 • n=5 Participants
|
47 years
STANDARD_DEVIATION 13 • n=7 Participants
|
46 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Numerical pain ratings
straight leg raise test
|
4.83 units on a scale
STANDARD_DEVIATION 2.21 • n=5 Participants
|
5.41 units on a scale
STANDARD_DEVIATION 2.46 • n=7 Participants
|
5.12 units on a scale
STANDARD_DEVIATION 2.34 • n=5 Participants
|
|
Numerical pain ratings
supine
|
3.60 units on a scale
STANDARD_DEVIATION 2.08 • n=5 Participants
|
4.69 units on a scale
STANDARD_DEVIATION 2.25 • n=7 Participants
|
4.14 units on a scale
STANDARD_DEVIATION 2.22 • n=5 Participants
|
PRIMARY outcome
Timeframe: Pain ratings were collected while lying supine and in response to the straight leg raise test. Collected twice, once in the first half and one in the second half of the baseline, saline infusion and naloxone infusion sessions. Up to 8 weeks total.Numerical pain ratings (NRS) will be assessed while lying on the back and in response to the straight leg raise test (SLR). Pain ratings will be collected during SLR 1 and SLR 2 in the baseline, saline and naloxone sessions, respectively. The 11 point scan will include a minimum rating of "0" which is characterized as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable"." Higher numbers correspond to higher pain.
Outcome measures
| Measure |
Mindfulness Meditation
n=30 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
|
Non Mindfulness Meditation
n=29 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
|
|---|---|---|
|
Pain Ratings
saline session: supine 1
|
3.23 units on a scale
Standard Deviation 2.39
|
4.62 units on a scale
Standard Deviation 2.25
|
|
Pain Ratings
saline session: straight leg raise test 1
|
4.37 units on a scale
Standard Deviation 2.28
|
5.75 units on a scale
Standard Deviation 2.40
|
|
Pain Ratings
saline session: supine 2
|
3.90 units on a scale
Standard Deviation 2.45
|
4.37 units on a scale
Standard Deviation 2.28
|
|
Pain Ratings
saline session: straight leg raise 2
|
3.67 units on a scale
Standard Deviation 2.77
|
5.32 units on a scale
Standard Deviation 2.84
|
|
Pain Ratings
naloxone session: supine 1
|
3.30 units on a scale
Standard Deviation 2.23
|
4.82 units on a scale
Standard Deviation 2.34
|
|
Pain Ratings
naloxone session: straight leg raise 1
|
4.30 units on a scale
Standard Deviation 2.52
|
6.10 units on a scale
Standard Deviation 2.30
|
|
Pain Ratings
naloxone session: supine 2
|
3.73 units on a scale
Standard Deviation 2.46
|
5.18 units on a scale
Standard Deviation 2.58
|
|
Pain Ratings
naloxone session: straight leg raise 2
|
3.45 units on a scale
Standard Deviation 2.48
|
5.52 units on a scale
Standard Deviation 2.68
|
|
Pain Ratings
baseline session: supine 1
|
3.60 units on a scale
Standard Deviation 2.08
|
4.69 units on a scale
Standard Deviation 2.25
|
|
Pain Ratings
baseline session: straight leg raise test 1
|
4.83 units on a scale
Standard Deviation 2.21
|
5.41 units on a scale
Standard Deviation 2.46
|
|
Pain Ratings
baseline session: supine 2
|
4.13 units on a scale
Standard Deviation 2.33
|
4.76 units on a scale
Standard Deviation 2.49
|
|
Pain Ratings
baseline session: straight leg raise test 2
|
5.15 units on a scale
Standard Deviation 2.40
|
5.78 units on a scale
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: The Pain Catastrophizing Scale was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare change in Pain Catastrophizing Scale from baseline to session 7.This is a 13-item questionnaire with 3 subscales assessing rumination, magnification, and helplessness in patients. A numeric value between 0 (not at all) and 4 (all the time) is provided in response to each statement. Scores on this assessment range from 0 to 52, with higher values reflecting more salient impacts of pain on one's day to day experience. The total range is from 0 - 52.
Outcome measures
| Measure |
Mindfulness Meditation
n=30 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
|
Non Mindfulness Meditation
n=29 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
|
|---|---|---|
|
Pain Catastrophizing Scale
Baseline PCS
|
18.57 units on a scale
Standard Deviation 13.21
|
20.83 units on a scale
Standard Deviation 12.85
|
|
Pain Catastrophizing Scale
Session 7 PCS
|
15.33 units on a scale
Standard Deviation 10.53
|
18.48 units on a scale
Standard Deviation 13.43
|
SECONDARY outcome
Timeframe: The Roland-Morris Disability Questionnaire was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare RMDQ from baseline to session 7.The Roland-Morris Questionnaire (RMDQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMDQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. Higher scores indicate greater disability. Total RMDQ scores are used before and after each intervention by group. The range of scores is from 0 - 24.
Outcome measures
| Measure |
Mindfulness Meditation
n=30 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
|
Non Mindfulness Meditation
n=29 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
|
|---|---|---|
|
The Roland-Morris Disability Questionnaire (RMDQ)
baseline RMDQ
|
12.86 units on a scale
Standard Deviation 5.61
|
13.85 units on a scale
Standard Deviation 6.34
|
|
The Roland-Morris Disability Questionnaire (RMDQ)
session 7 RMDQ
|
12.03 units on a scale
Standard Deviation 5.71
|
14.02 units on a scale
Standard Deviation 6.41
|
SECONDARY outcome
Timeframe: Administered at the baseline, post-intervention session 6 and post-intervention session 7. Outcome measurements will compare in BPI severity and interference from baseline to session 7.Pain severity and interference: impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. Higher scores indicate higher chronic pain. BPI severity and interference scales are used and collected before and after each intervention. Higher BPI severity indicate higher chronic pain severity. Higher BPI interference scores indicate higher chronic pain interference.The scoring scale for severity and interference range from 0 - 10, respectively.
Outcome measures
| Measure |
Mindfulness Meditation
n=30 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
|
Non Mindfulness Meditation
n=29 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
|
|---|---|---|
|
Brief Pain Inventory (BPI)
baseline BPI severity
|
4.47 units on a scale
Standard Deviation 1.80
|
5.22 units on a scale
Standard Deviation 1.91
|
|
Brief Pain Inventory (BPI)
session 7 BPI severity
|
3.94 units on a scale
Standard Deviation 1.84
|
5.15 units on a scale
Standard Deviation 2.17
|
|
Brief Pain Inventory (BPI)
baseline BPI interference
|
4.40 units on a scale
Standard Deviation 2.73
|
5.17 units on a scale
Standard Deviation 2.50
|
|
Brief Pain Inventory (BPI)
session 7 BPI interference
|
3.38 units on a scale
Standard Deviation 2.34
|
4.57 units on a scale
Standard Deviation 2.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 weeks. Administered at visit 1, 6 and 7. Outcome measurements will compare SF-12 health survey from baseline to session 7.This is a 12-item version of the SF-12 item Health Survey designed to assess general mental and physical functioning, and overall health-related quality of life. We used the physical functioning SF-12 scale and collected this information before and after each intervention and by group. The total range of scores is from 0 - 100. The minimum total score is 0 and the maximum score is 100. Higher scores indicate better functioning.
Outcome measures
| Measure |
Mindfulness Meditation
n=30 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
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Non Mindfulness Meditation
n=29 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
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|---|---|---|
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SF-12 Health Survey (SF-12) Physical Functioning
baseline SF physical functioning
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52.50 units on a scale
Standard Deviation 28.88
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49.17 units on a scale
Standard Deviation 29.71
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SF-12 Health Survey (SF-12) Physical Functioning
session 7 SF physical functioning
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39.66 units on a scale
Standard Deviation 33.08
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44.83 units on a scale
Standard Deviation 33.66
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POST_HOC outcome
Timeframe: Delivered after completion of each of the 4 meditation intervention sessions. Up to 8 weeks.Outcome measures
| Measure |
Mindfulness Meditation
n=30 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
|
Non Mindfulness Meditation
n=29 Participants
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Mindfulness: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Naloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
Saline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
Meditation: A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
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|---|---|---|
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Perceived Intervention Effectiveness Was Assessed With a VAS ("0" = Not Effective at All; "10" = Most Effective Imaginable) for Each Intervention Session.
intervention 1 effectiveness
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4.83 units on a scale
Standard Deviation 3.08
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5.13 units on a scale
Standard Deviation 2.63
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Perceived Intervention Effectiveness Was Assessed With a VAS ("0" = Not Effective at All; "10" = Most Effective Imaginable) for Each Intervention Session.
intervention 2 effectiveness
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4.05 units on a scale
Standard Deviation 2.45
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5.17 units on a scale
Standard Deviation 2.84
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Perceived Intervention Effectiveness Was Assessed With a VAS ("0" = Not Effective at All; "10" = Most Effective Imaginable) for Each Intervention Session.
intervention 3 effectiveness
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4.21 units on a scale
Standard Deviation 2.72
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5.21 units on a scale
Standard Deviation 2.49
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Perceived Intervention Effectiveness Was Assessed With a VAS ("0" = Not Effective at All; "10" = Most Effective Imaginable) for Each Intervention Session.
intervention 4 effectiveness
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4.51 units on a scale
Standard Deviation 2.88
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5.40 units on a scale
Standard Deviation 2.75
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Adverse Events
Mindfulness Meditation During Pain Testing, Saline and Naloxone Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-mindfulness Meditation During Pain Testing, Saline and Naloxone Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place