Trial Outcomes & Findings for Integrative Medicine Consultation for Patients With Pain or Fatigue (NCT NCT01058265)
NCT ID: NCT01058265
Last Updated: 2012-02-24
Results Overview
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.
COMPLETED
NA
47 participants
3 months
2012-02-24
Participant Flow
Participant milestones
| Measure |
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.
|
Standard
Standard general medical evaluation.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
25
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
| Measure |
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.
|
Standard
Standard general medical evaluation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
12
|
Baseline Characteristics
Integrative Medicine Consultation for Patients With Pain or Fatigue
Baseline characteristics by cohort
| Measure |
Integrative
n=22 Participants
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.
|
Standard
n=25 Participants
Standard general medical evaluation.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
43.4 Year
n=99 Participants
|
51.8 Year
n=107 Participants
|
44.7 Year
n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Reason for appointment
Fatigue
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Reason for appointment
Pain
|
6 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Reason for appointment
Both
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Weight
|
70.5 kg
STANDARD_DEVIATION 17.8 • n=99 Participants
|
76.1 kg
STANDARD_DEVIATION 24.6 • n=107 Participants
|
73.6 kg
STANDARD_DEVIATION 21.7 • n=206 Participants
|
|
Height
|
168.4 cm
STANDARD_DEVIATION 8.1 • n=99 Participants
|
161.3 cm
STANDARD_DEVIATION 20.3 • n=107 Participants
|
164.6 cm
STANDARD_DEVIATION 16.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsIt 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.
Outcome measures
| Measure |
Integrative
n=11 Participants
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.
|
Standard
n=13 Participants
Standard general medical evaluation.
|
|---|---|---|
|
Short Form 36 (SF-36) Physical Component Summary (PCS)
|
36.2 Scores on a scale
Interval 22.2 to 44.1
|
39.0 Scores on a scale
Interval 32.2 to 43.3
|
PRIMARY outcome
Timeframe: 3 monthsIt 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.
Outcome measures
| Measure |
Integrative
n=11 Participants
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.
|
Standard
n=13 Participants
Standard general medical evaluation.
|
|---|---|---|
|
Short Form 36 (SF-36) Mental Component Summary (MCS)
|
45.2 Scores on a scale
Interval 36.4 to 50.8
|
47.9 Scores on a scale
Interval 35.2 to 57.3
|
Adverse Events
Integrative
Standard
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