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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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

3 months

Results posted on

2012-02-24

Participant Flow

Participant milestones

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

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

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=5 Participants
51.8 Year
n=7 Participants
44.7 Year
n=5 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
21 Participants
n=7 Participants
38 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
4 Participants
n=7 Participants
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=5 Participants
21 Participants
n=7 Participants
41 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/Ethnicity, Customized
White
20 Participants
n=5 Participants
22 Participants
n=7 Participants
42 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Other/Unknown
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Reason for appointment
Fatigue
15 Participants
n=5 Participants
8 Participants
n=7 Participants
23 Participants
n=5 Participants
Reason for appointment
Pain
6 Participants
n=5 Participants
14 Participants
n=7 Participants
20 Participants
n=5 Participants
Reason for appointment
Both
1 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
Weight
70.5 kg
STANDARD_DEVIATION 17.8 • n=5 Participants
76.1 kg
STANDARD_DEVIATION 24.6 • n=7 Participants
73.6 kg
STANDARD_DEVIATION 21.7 • n=5 Participants
Height
168.4 cm
STANDARD_DEVIATION 8.1 • n=5 Participants
161.3 cm
STANDARD_DEVIATION 20.3 • n=7 Participants
164.6 cm
STANDARD_DEVIATION 16.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

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 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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard

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

Larry Bergstrom, MD

Mayo Clinic in Arizona

Phone: 480-301-7108

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place