Trial Outcomes & Findings for Genetics of Diabetes Audit and Research in Tayside Scotland (DOLORisk Dundee) (NCT NCT02783469)
NCT ID: NCT02783469
Last Updated: 2021-07-16
Results Overview
Neuropathic pain will be identified according to the validated Douleur Neuropathique en Quatre Questions (DN4) questionnaire (English language)
COMPLETED
1915 participants
April 2016 - December 2016
2021-07-16
Participant Flow
At baseline recruitment, participants of GoDARTS who had provided consent to be contacted about related studies, were sent and invited to complete and return a DOLORisk Dundee questionnaire on neuropathic pain and pain-related traits, between December 2016. Approximately 18 months later, participants of the baseline survey who provided further consent to be recontacted, were sent a similar follow-up questionnaire.
Participant milestones
| Measure |
GoDARTS
Participants of the baseline DOLORisk Dundee survey
|
|---|---|
|
Overall Study
STARTED
|
1915
|
|
Overall Study
COMPLETED
|
1915
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data is missing for 3 participants
Baseline characteristics by cohort
| Measure |
GoDARTS
n=1915 Participants
Participants of the DOLORisk Dundee baseline survey
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1912 Participants • Age data is missing for 3 participants
|
|
Age, Categorical
Between 18 and 65 years
|
491 Participants
n=1912 Participants • Age data is missing for 3 participants
|
|
Age, Categorical
>=65 years
|
1421 Participants
n=1912 Participants • Age data is missing for 3 participants
|
|
Age, Continuous
|
71 years
n=1912 Participants • Age data is missing for 3 participants
|
|
Sex: Female, Male
Female
|
754 Participants
n=1912 Participants • Gender data is missing for 3 participants
|
|
Sex: Female, Male
Male
|
1158 Participants
n=1912 Participants • Gender data is missing for 3 participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1915 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1915 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1915 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1915 Participants
|
|
Race (NIH/OMB)
White
|
1904 Participants
n=1915 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1915 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=1915 Participants
|
|
Douleur Neuropathique en Quatre Questions (DN4)
DN4 ≥ 3
|
348 Participants
n=875 Participants • Only people who reported current pain or currently taking pain medication were asked to complete the DN4 (n=1276). Participants are only included in the DN4 count if all items in the DN4 are non-missing (n=875).
|
|
Douleur Neuropathique en Quatre Questions (DN4)
DN4 < 3
|
527 Participants
n=875 Participants • Only people who reported current pain or currently taking pain medication were asked to complete the DN4 (n=1276). Participants are only included in the DN4 count if all items in the DN4 are non-missing (n=875).
|
|
Pain Duration
Duration ≥ 3 months
|
1144 Participants
n=1238 Participants • Only participants who reported current pain or currently taking pain medication were asked to complete the pain duration question (n=1276). Pain duration is missing for 38 of these participants (n=1238).
|
|
Pain Duration
Duration < 3 months
|
94 Participants
n=1238 Participants • Only participants who reported current pain or currently taking pain medication were asked to complete the pain duration question (n=1276). Pain duration is missing for 38 of these participants (n=1238).
|
PRIMARY outcome
Timeframe: April 2016 - December 2016Population: Chronic neuropathic pain = DN4 ≥ 3 \& pain duration ≥ 3 months Chronic nociceptive pain = DN4 \< 3 \& pain duration ≥ 3 months No pain = no current pain or currently taking pain medication Note: Participants were included in the chronic neuropathic pain group if they satisfied the above criteria, regardless of the number of missing DN4 items, and excluded from the chronic nociceptive pain group if the number of missing DN4 items plus the their DN4 score totalled 3 or more.
Neuropathic pain will be identified according to the validated Douleur Neuropathique en Quatre Questions (DN4) questionnaire (English language)
Outcome measures
| Measure |
GoDARTS
n=1503 Participants
Participants of the DOLORisk Dundee baseline survey
|
|---|---|
|
Neuropathic Pain
Chronic Neuropathic Pain
|
482 Participants
|
|
Neuropathic Pain
Chronic Nociceptive Pain
|
461 Participants
|
|
Neuropathic Pain
No Pain
|
560 Participants
|
Adverse Events
GoDARTS
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