Rheumatoid Arthritis
Conditions
Keywords
rheumatoid arthritis, treatment
Brief summary
BACKGROUND: Intra-articular glucocorticoid injections are frequently used to relieve symptoms of arthritis. Postinjection rest has been shown to improve the outcome of knee joint injections, but not for wrist injections. Consequently, different joints respond differently on postinjection regimens. OBJECTIVES: To investigate whether better treatment results might be achieved of post-injection rest following intra-articular glucocorticoid treatment for elbow synovitis. METHODS: 90 patients with rheumatoid arthritis (RA) and elbow synovitis were treated with 20 mg intra-articular triamcinolone hexacetonide and randomised to either a 48 hour immobilisation in a triangular sling (n=46) or normal activity without restrictions (n=44). Primary endpoint was relapse of synovitis. In addition, pain, function according to a self assessment questionnaire (PREE) and range of movement were followed for six months.
Interventions
BEHAVIORALimmobilisation in a triangular sling
Intervention group: Immobilisation 48 hours in a triangular sling (mitella) Control group: normal activity without restrictions
Sponsors
Meda AB
Region Gävleborg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Rheumatoid arthritis, and * Clinical signs of elbow synovitis
Exclusion criteria
* Patients in function class 4 according to Steinbrocker as well as patients with oral glucocorticoid treatment corresponding to more than 7.5 mg prednisolone or intra-articular treatment in the joint the past three months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse of Arthritis | Regular visits at one week, 3 months and 6 months. | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Activity Normal activity without restrictions | 44 |
| Immobilisation 48 hours postinjection rest | 46 |
| Total | 90 |
Baseline characteristics
| Characteristic | Total | Activity | Immobilisation |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 12 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 31 Participants | 28 Participants |
| Age, Continuous | 59.3 years STANDARD_DEVIATION 14.8 | 59.7 years STANDARD_DEVIATION 15.2 | 59.0 years STANDARD_DEVIATION 14.6 |
| Region of Enrollment Sweden | 90 participants | 44 participants | 46 participants |
| Sex: Female, Male Female | 72 Participants | 38 Participants | 34 Participants |
| Sex: Female, Male Male | 18 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 46 |
| serious Total, serious adverse events | 0 / 44 | 0 / 46 |
Outcome results
Primary
Relapse of Arthritis
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.
Time frame: Regular visits at one week, 3 months and 6 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Activity | Relapse of Arthritis | Mobility one week | 44 participants |
| Activity | Relapse of Arthritis | Relapse | 8 participants |
| Activity | Relapse of Arthritis | Mobility 3 months | 43 participants |
| Activity | Relapse of Arthritis | Mobility 6 months | 42 participants |
| Activity | Relapse of Arthritis | Pain one week | 44 participants |
| Activity | Relapse of Arthritis | Pain 3 months | 43 participants |
| Activity | Relapse of Arthritis | Pain 6 months | 42 participants |
| Activity | Relapse of Arthritis | Function one week | 44 participants |
| Activity | Relapse of Arthritis | Function 3 months | 43 participants |
| Activity | Relapse of Arthritis | Function 6 months | 42 participants |
| Immobilisation | Relapse of Arthritis | Function one week | 46 participants |
| Immobilisation | Relapse of Arthritis | Pain 3 months | 43 participants |
| Immobilisation | Relapse of Arthritis | Relapse | 13 participants |
| Immobilisation | Relapse of Arthritis | Mobility one week | 46 participants |
| Immobilisation | Relapse of Arthritis | Function 6 months | 41 participants |
| Immobilisation | Relapse of Arthritis | Mobility 3 months | 43 participants |
| Immobilisation | Relapse of Arthritis | Pain 6 months | 41 participants |
| Immobilisation | Relapse of Arthritis | Mobility 6 months | 41 participants |
| Immobilisation | Relapse of Arthritis | Function 3 months | 43 participants |
| Immobilisation | Relapse of Arthritis | Pain one week | 45 participants |