Trial Outcomes & Findings for The Possible Correlations Between the Genes Related to Pain Sensation and the Pain Sensitivity in the General Population (NCT NCT01950078)

Results Overview

The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "pain" when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold.

Recruitment status

COMPLETED

Target enrollment

1533 participants

Primary outcome timeframe

30 minutes before the operation

Results posted on

2015-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Surgical Patients grouped by receiving surgery	Healthy Volunteers Group grouped by healthy college students
Overall Study STARTED	1025	508
Overall Study COMPLETED	1005	496
Overall Study NOT COMPLETED	20	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Possible Correlations Between the Genes Related to Pain Sensation and the Pain Sensitivity in the General Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgical Patients n=1005 Participants grouped by receiving surgery	Healthy Volunteers Group n=496 Participants grouped by healthy college students	Total n=1501 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=93 Participants	7 Participants n=4 Participants	18 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	990 Participants n=93 Participants	489 Participants n=4 Participants	1479 Participants n=27 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Female	1005 Participants n=93 Participants	309 Participants n=4 Participants	1314 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	187 Participants n=4 Participants	187 Participants n=27 Participants
Region of Enrollment China	1005 participants n=93 Participants	496 participants n=4 Participants	1501 participants n=27 Participants

PRIMARY outcome

Timeframe: 30 minutes before the operation

The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "pain" when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold.

Outcome measures

Outcome measures
Measure	Surgical Patients n=1005 Participants grouped by receiving surgery	Healthy Volunteers Group n=496 Participants grouped by healthy college students
Preoperative Pressure Pain Threshold (PPT)	2.33 kg/cm2 Standard Deviation 0.97	3.24 kg/cm2 Standard Deviation 1.25

SECONDARY outcome

Timeframe: 30 minutes before the operation

The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "ok" when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance.

Outcome measures

Outcome measures
Measure	Surgical Patients n=1005 Participants grouped by receiving surgery	Healthy Volunteers Group n=496 Participants grouped by healthy college students
Preoperative Pressure Pain Tolerance (PTO)	4.65 kg/cm2 Standard Deviation 1.66	6.38 kg/cm2 Standard Deviation 2.56

Adverse Events

Surgical Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Volunteers Group

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

Dr. Xianwei Zhang

Huazhong University of Science and Technology

Phone: 027 83663173

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place