Fatigue, Pain
Conditions
Brief summary
Patients with a diagnosis of chronic fatigue or pain benefit minimally from a conventional medical evaluation yet consume a large amount of medical resources and time. The question is to see if patients with a diagnosis of chronic pain or fatigue benefit from an Integrative Medicine medical evaluation conducted by physician who has additional training in Integrative Medicine. Patients who call for a general medical examination with a complaint of chronic fatigue or pain will be set up with the integrative medical specialist or standard general medical evaluation.
Interventions
OTHERIntegrative
Integrative Medicine medical evaluation.
OTHERStandard
Standard general medical evaluation.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients seeking a medical evaluation for a primary complaint of pain or fatigue.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form 36 (SF-36) Physical Component Summary (PCS) | 3 months | It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Physical Component Summary ranges from 0 to 100, and higher score indicates better physical condition. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison. |
| Short Form 36 (SF-36) Mental Component Summary (MCS) | 3 months | It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Mental Component Summary ranges from 0 to 100, and higher score indicates better mental health status. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Integrative Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes. | 22 |
| Standard Standard general medical evaluation. | 25 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 12 |
Baseline characteristics
| Characteristic | Total | Standard | Integrative |
|---|---|---|---|
| Age Continuous | 44.7 Year | 51.8 Year | 43.4 Year |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 21 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 164.6 cm STANDARD_DEVIATION 16.2 | 161.3 cm STANDARD_DEVIATION 20.3 | 168.4 cm STANDARD_DEVIATION 8.1 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other/Unknown | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 42 Participants | 22 Participants | 20 Participants |
| Reason for appointment Both | 4 Participants | 3 Participants | 1 Participants |
| Reason for appointment Fatigue | 23 Participants | 8 Participants | 15 Participants |
| Reason for appointment Pain | 20 Participants | 14 Participants | 6 Participants |
| Sex: Female, Male Female | 38 Participants | 21 Participants | 17 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 5 Participants |
| Weight | 73.6 kg STANDARD_DEVIATION 21.7 | 76.1 kg STANDARD_DEVIATION 24.6 | 70.5 kg STANDARD_DEVIATION 17.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 25 |
| serious Total, serious adverse events | 0 / 22 | 0 / 25 |
Outcome results
Primary
Short Form 36 (SF-36) Mental Component Summary (MCS)
It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Mental Component Summary ranges from 0 to 100, and higher score indicates better mental health status. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Integrative | Short Form 36 (SF-36) Mental Component Summary (MCS) | 45.2 Scores on a scale |
| Standard | Short Form 36 (SF-36) Mental Component Summary (MCS) | 47.9 Scores on a scale |
Comparison: The null hypothesis is that there is no difference in MCS between two groups.p-value: 0.817Wilcoxon (Mann-Whitney)
Primary
Short Form 36 (SF-36) Physical Component Summary (PCS)
It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Physical Component Summary ranges from 0 to 100, and higher score indicates better physical condition. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Integrative | Short Form 36 (SF-36) Physical Component Summary (PCS) | 36.2 Scores on a scale |
| Standard | Short Form 36 (SF-36) Physical Component Summary (PCS) | 39.0 Scores on a scale |
Comparison: The null hypothesis is that there is no difference in PCS between two groups.p-value: 0.487Wilcoxon (Mann-Whitney)