Trial Outcomes & Findings for Intra-articular Glucocorticoid Treatment of the Elbow (NCT NCT00972530)

Last Updated: 2019-03-14

Results Overview

The patients were followed for six months and if signs and symptoms recurred in between the patients were told to contact the rheumatology department. In such cases the elbow was re-examined and if a relapse could be confirmed the duration of effect was recorded and if needed the patient was offered another injection.

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

Regular visits at one week, 3 months and 6 months.

Results posted on

2019-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Activity Normal activity without restrictions	Immobilisation 48 hours postinjection rest
Overall Study STARTED	44	46
Overall Study COMPLETED	44	46
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intra-articular Glucocorticoid Treatment of the Elbow

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Activity n=44 Participants Normal activity without restrictions	Immobilisation n=46 Participants 48 hours postinjection rest	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	28 Participants n=7 Participants	59 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Age, Continuous	59.7 years STANDARD_DEVIATION 15.2 • n=5 Participants	59.0 years STANDARD_DEVIATION 14.6 • n=7 Participants	59.3 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Sweden	44 participants n=5 Participants	46 participants n=7 Participants	90 participants n=5 Participants

PRIMARY outcome

Timeframe: Regular visits at one week, 3 months and 6 months.

Outcome measures

Outcome measures
Measure	Activity n=44 Participants Normal activity without restrictions	Immobilisation n=46 Participants 48 hours postinjection rest
Relapse of Arthritis Pain 6 months	42 participants	41 participants
Relapse of Arthritis Function one week	44 participants	46 participants
Relapse of Arthritis Function 3 months	43 participants	43 participants
Relapse of Arthritis Function 6 months	42 participants	41 participants
Relapse of Arthritis Pain one week	44 participants	45 participants
Relapse of Arthritis Pain 3 months	43 participants	43 participants
Relapse of Arthritis Relapse	8 participants	13 participants
Relapse of Arthritis Mobility one week	44 participants	46 participants
Relapse of Arthritis Mobility 3 months	43 participants	43 participants
Relapse of Arthritis Mobility 6 months	42 participants	41 participants

Adverse Events

Activity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Immobilisation

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 Tomas Weitoft

Department of Research and Development County Council of Gavleborg/Uppsala University

Phone: +46 26 154388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place