Pain
Conditions
Keywords
Mindfulness, Opioids, Pain, Naloxone
Brief summary
The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.
Detailed description
The purpose of this psychophysical and pharmacologic study is to determine if meditation induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during a pain evoking straight leg raise test in response to double-blind intravenous administration (IV) of naloxone/placebo-saline. The aim of this study is to determine if mindfulness-based analgesia is associated with the release of endogenous opioids.
Interventions
BEHAVIORALMeditation
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.
BEHAVIORALMindfulness
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.
DRUGNaloxone
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.
OTHERSaline
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Only the study physician, research coordinator, and research pharmacist will be aware of drug assignments. Research staff (nurses; research technicians) and the PI will be blinded to drug assignment.
Intervention model description
The study will employ a double blinded crossover factorial design. Baseline pain ratings will be assessed using visual analog scales obtained during three sessions where low back pain is induced. Study volunteers will participate in a four session (20min/session) meditation intervention. After meditation training, subjects will report to the UCSD Altman Clinical and Translational Research Institute across two separate experimental sessions. Half of the volunteers will be administered naloxone (opioid antagonist; 0.15 mg/kg bolus+ 0.1 mg/kg/hour infusion) and the other in the subsequent session will be administered IV placebo-saline, vice versa.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis * Participants must be between 18 and 65 years of age * Participants must rate their daily chronic pain intensity at a 3 or higher on 0-10 visual analog scale * Participants must have experienced their chronic low back pain for at least 3 months * Participants must have no prior meditative experience * Participants must be straight leg raise test positive
Exclusion criteria
* Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period * Participants must not be taking opioids * Participants must not be pregnant or nursing mothers * Participants must have not had back surgery within the last year before their enrollment into the study * Participants must have not had any other sensory or motor deficits that preclude participation in this study * Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, and a personal history of psychosis * Participants must not have any known allergies to naloxone or similar drugs * Participants must not have a history of syncope and/or fear of needles/blood
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Ratings | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing Scale | 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. |
| The Roland-Morris Disability Questionnaire (RMDQ) | 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. |
| Brief Pain Inventory (BPI) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| SF-12 Health Survey (SF-12) Physical Functioning | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Meditation 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. | 30 |
| Non-mindfulness Meditation 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. | 29 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | could not find vein to administer IV | 2 | 1 | 0 | 0 |
| Overall Study | nurse accidentally unblinded subject | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 | 3 |
Baseline characteristics
| Characteristic | Mindfulness Meditation | Total | Non-mindfulness Meditation |
|---|---|---|---|
| Age, Continuous age | 45 years STANDARD_DEVIATION 12 | 46 years STANDARD_DEVIATION 12 | 47 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 11 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 48 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Numerical pain ratings straight leg raise test | 4.83 units on a scale STANDARD_DEVIATION 2.21 | 5.12 units on a scale STANDARD_DEVIATION 2.34 | 5.41 units on a scale STANDARD_DEVIATION 2.46 |
| Numerical pain ratings supine | 3.60 units on a scale STANDARD_DEVIATION 2.08 | 4.14 units on a scale STANDARD_DEVIATION 2.22 | 4.69 units on a scale STANDARD_DEVIATION 2.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 45 Participants | 19 Participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 15 Participants | 29 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 36 |
| other Total, other adverse events | 0 / 35 | 0 / 36 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 |
Outcome results
Primary
Pain Ratings
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Meditation | Pain Ratings | baseline session: supine 1 | 3.60 units on a scale | Standard Deviation 2.08 |
| Mindfulness Meditation | Pain Ratings | baseline session: straight leg raise test 1 | 4.83 units on a scale | Standard Deviation 2.21 |
| Mindfulness Meditation | Pain Ratings | baseline session: supine 2 | 4.13 units on a scale | Standard Deviation 2.33 |
| Mindfulness Meditation | Pain Ratings | baseline session: straight leg raise test 2 | 5.15 units on a scale | Standard Deviation 2.4 |
| Mindfulness Meditation | Pain Ratings | saline session: supine 1 | 3.23 units on a scale | Standard Deviation 2.39 |
| Mindfulness Meditation | Pain Ratings | saline session: straight leg raise test 1 | 4.37 units on a scale | Standard Deviation 2.28 |
| Mindfulness Meditation | Pain Ratings | saline session: supine 2 | 3.90 units on a scale | Standard Deviation 2.45 |
| Mindfulness Meditation | Pain Ratings | saline session: straight leg raise 2 | 3.67 units on a scale | Standard Deviation 2.77 |
| Mindfulness Meditation | Pain Ratings | naloxone session: supine 1 | 3.30 units on a scale | Standard Deviation 2.23 |
| Mindfulness Meditation | Pain Ratings | naloxone session: straight leg raise 1 | 4.30 units on a scale | Standard Deviation 2.52 |
| Mindfulness Meditation | Pain Ratings | naloxone session: supine 2 | 3.73 units on a scale | Standard Deviation 2.46 |
| Mindfulness Meditation | Pain Ratings | naloxone session: straight leg raise 2 | 3.45 units on a scale | Standard Deviation 2.48 |
| Non Mindfulness Meditation | Pain Ratings | naloxone session: supine 2 | 5.18 units on a scale | Standard Deviation 2.58 |
| Non Mindfulness Meditation | Pain Ratings | baseline session: supine 1 | 4.69 units on a scale | Standard Deviation 2.25 |
| Non Mindfulness Meditation | Pain Ratings | saline session: supine 2 | 4.37 units on a scale | Standard Deviation 2.28 |
| Non Mindfulness Meditation | Pain Ratings | baseline session: straight leg raise test 1 | 5.41 units on a scale | Standard Deviation 2.46 |
| Non Mindfulness Meditation | Pain Ratings | naloxone session: straight leg raise 1 | 6.10 units on a scale | Standard Deviation 2.3 |
| Non Mindfulness Meditation | Pain Ratings | baseline session: supine 2 | 4.76 units on a scale | Standard Deviation 2.49 |
| Non Mindfulness Meditation | Pain Ratings | saline session: straight leg raise 2 | 5.32 units on a scale | Standard Deviation 2.84 |
| Non Mindfulness Meditation | Pain Ratings | baseline session: straight leg raise test 2 | 5.78 units on a scale | Standard Deviation 2.81 |
| Non Mindfulness Meditation | Pain Ratings | naloxone session: straight leg raise 2 | 5.52 units on a scale | Standard Deviation 2.68 |
| Non Mindfulness Meditation | Pain Ratings | saline session: supine 1 | 4.62 units on a scale | Standard Deviation 2.25 |
| Non Mindfulness Meditation | Pain Ratings | naloxone session: supine 1 | 4.82 units on a scale | Standard Deviation 2.34 |
| Non Mindfulness Meditation | Pain Ratings | saline session: straight leg raise test 1 | 5.75 units on a scale | Standard Deviation 2.4 |
Comparison: Pain ratings were collected while lying in the supine and after each straight leg rasise test (SLR 1; SLR 2). A 2 (group) X 2 (SLR 1-rest vs. SLR 2-meditation) X 2 (supine vs. SLR) X 3 (session) repeated measure mixed model ANOVA was conducted to determine if mindfulness and non-mindfulness meditation attenuate SLR induced pain through endogenous opioids. Simple effects tests tested significant main effects and interactions to test primary study hypotheses and between-group differences.p-value: 0.05Mixed Models Analysis
Secondary
Brief Pain Inventory (BPI)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Meditation | Brief Pain Inventory (BPI) | baseline BPI severity | 4.47 units on a scale | Standard Deviation 1.8 |
| Mindfulness Meditation | Brief Pain Inventory (BPI) | session 7 BPI severity | 3.94 units on a scale | Standard Deviation 1.84 |
| Mindfulness Meditation | Brief Pain Inventory (BPI) | baseline BPI interference | 4.40 units on a scale | Standard Deviation 2.73 |
| Mindfulness Meditation | Brief Pain Inventory (BPI) | session 7 BPI interference | 3.38 units on a scale | Standard Deviation 2.34 |
| Non Mindfulness Meditation | Brief Pain Inventory (BPI) | session 7 BPI interference | 4.57 units on a scale | Standard Deviation 2.8 |
| Non Mindfulness Meditation | Brief Pain Inventory (BPI) | baseline BPI severity | 5.22 units on a scale | Standard Deviation 1.91 |
| Non Mindfulness Meditation | Brief Pain Inventory (BPI) | baseline BPI interference | 5.17 units on a scale | Standard Deviation 2.5 |
| Non Mindfulness Meditation | Brief Pain Inventory (BPI) | session 7 BPI severity | 5.15 units on a scale | Standard Deviation 2.17 |
Secondary
Pain Catastrophizing Scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Meditation | Pain Catastrophizing Scale | Baseline PCS | 18.57 units on a scale | Standard Deviation 13.21 |
| Mindfulness Meditation | Pain Catastrophizing Scale | Session 7 PCS | 15.33 units on a scale | Standard Deviation 10.53 |
| Non Mindfulness Meditation | Pain Catastrophizing Scale | Baseline PCS | 20.83 units on a scale | Standard Deviation 12.85 |
| Non Mindfulness Meditation | Pain Catastrophizing Scale | Session 7 PCS | 18.48 units on a scale | Standard Deviation 13.43 |
Secondary
The Roland-Morris Disability Questionnaire (RMDQ)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Meditation | The Roland-Morris Disability Questionnaire (RMDQ) | baseline RMDQ | 12.86 units on a scale | Standard Deviation 5.61 |
| Mindfulness Meditation | The Roland-Morris Disability Questionnaire (RMDQ) | session 7 RMDQ | 12.03 units on a scale | Standard Deviation 5.71 |
| Non Mindfulness Meditation | The Roland-Morris Disability Questionnaire (RMDQ) | baseline RMDQ | 13.85 units on a scale | Standard Deviation 6.34 |
| Non Mindfulness Meditation | The Roland-Morris Disability Questionnaire (RMDQ) | session 7 RMDQ | 14.02 units on a scale | Standard Deviation 6.41 |
Post Hoc
Perceived Intervention Effectiveness Was Assessed With a VAS (0 = Not Effective at All; 10 = Most Effective Imaginable) for Each Intervention Session.
Time frame: Delivered after completion of each of the 4 meditation intervention sessions. Up to 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Meditation | Perceived Intervention Effectiveness Was Assessed With a VAS (0 = Not Effective at All; 10 = Most Effective Imaginable) for Each Intervention Session. | intervention 3 effectiveness | 4.21 units on a scale | Standard Deviation 2.72 |
| Mindfulness Meditation | Perceived Intervention Effectiveness Was Assessed With a VAS (0 = Not Effective at All; 10 = Most Effective Imaginable) for Each Intervention Session. | intervention 1 effectiveness | 4.83 units on a scale | Standard Deviation 3.08 |
| Mindfulness Meditation | Perceived Intervention Effectiveness Was Assessed With a VAS (0 = Not Effective at All; 10 = Most Effective Imaginable) for Each Intervention Session. | intervention 4 effectiveness | 4.51 units on a scale | Standard Deviation 2.88 |
| Mindfulness Meditation | Perceived Intervention Effectiveness Was Assessed With a VAS (0 = Not Effective at All; 10 = Most Effective Imaginable) for Each Intervention Session. | intervention 2 effectiveness | 4.05 units on a scale | Standard Deviation 2.45 |
| Non Mindfulness Meditation | Perceived Intervention Effectiveness Was Assessed With a VAS (0 = Not Effective at All; 10 = Most Effective Imaginable) for Each Intervention Session. | intervention 4 effectiveness | 5.40 units on a scale | Standard Deviation 2.75 |
| Non Mindfulness Meditation | Perceived Intervention Effectiveness Was Assessed With a VAS (0 = Not Effective at All; 10 = Most Effective Imaginable) for Each Intervention Session. | intervention 2 effectiveness | 5.17 units on a scale | Standard Deviation 2.84 |
| Non Mindfulness Meditation | Perceived Intervention Effectiveness Was Assessed With a VAS (0 = Not Effective at All; 10 = Most Effective Imaginable) for Each Intervention Session. | intervention 3 effectiveness | 5.21 units on a scale | Standard Deviation 2.49 |
| Non Mindfulness Meditation | Perceived Intervention Effectiveness Was Assessed With a VAS (0 = Not Effective at All; 10 = Most Effective Imaginable) for Each Intervention Session. | intervention 1 effectiveness | 5.13 units on a scale | Standard Deviation 2.63 |
Other Pre-specified
SF-12 Health Survey (SF-12) Physical Functioning
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.
Time frame: Up to 8 weeks. Administered at visit 1, 6 and 7. Outcome measurements will compare SF-12 health survey from baseline to session 7.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Meditation | SF-12 Health Survey (SF-12) Physical Functioning | baseline SF physical functioning | 52.50 units on a scale | Standard Deviation 28.88 |
| Mindfulness Meditation | SF-12 Health Survey (SF-12) Physical Functioning | session 7 SF physical functioning | 39.66 units on a scale | Standard Deviation 33.08 |
| Non Mindfulness Meditation | SF-12 Health Survey (SF-12) Physical Functioning | baseline SF physical functioning | 49.17 units on a scale | Standard Deviation 29.71 |
| Non Mindfulness Meditation | SF-12 Health Survey (SF-12) Physical Functioning | session 7 SF physical functioning | 44.83 units on a scale | Standard Deviation 33.66 |