Trial Outcomes & Findings for Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis. (NCT NCT03431584)
NCT ID: NCT03431584
Last Updated: 2025-12-02
Results Overview
Analogical visual scale of pain (VAS) To 0 cm (no pain) form 10 cm (worst pain imaginable)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
150 participants
Primary outcome timeframe
3 month post infiltration
Results posted on
2025-12-02
Participant Flow
150 patients were randomised, 1 patient was excluded from follow-up after infiltration before the first visit at M1 and was not analysed.
Participant milestones
| Measure |
Infiltration of corticosteroids and hyaluronic acid
infiltration of corticosteroids and hyaluronic acid: infiltration of corticosteroids and hyaluronic acid
|
Infiltration of corticosteroids
infiltration of corticosteroids: infiltration of corticosteroids
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
76
|
|
Overall Study
COMPLETED
|
65
|
69
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Infiltration of Corticosteroids
n=76 Participants
infiltration of corticosteroids: infiltration of corticosteroids
|
Infiltration of Corticosteroids and Hyaluronic Acid
n=73 Participants
infiltration of corticosteroids and hyaluronic acid: infiltration of corticosteroids and hyaluronic acid
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 Years
STANDARD_DEVIATION 9 • n=76 Participants
|
62 Years
STANDARD_DEVIATION 9 • n=73 Participants
|
62 Years
STANDARD_DEVIATION 9 • n=149 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=76 Participants
|
61 Participants
n=73 Participants
|
123 Participants
n=149 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=76 Participants
|
12 Participants
n=73 Participants
|
26 Participants
n=149 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 3 month post infiltrationAnalogical visual scale of pain (VAS) To 0 cm (no pain) form 10 cm (worst pain imaginable)
Outcome measures
| Measure |
Infiltration of corticosteroids
n=73 Participants
infiltration of corticosteroids: infiltration of corticosteroids
|
Infiltration of corticosteroids and hyaluronic acid
n=73 Participants
infiltration of corticosteroids and hyaluronic acid: infiltration of corticosteroids and hyaluronic acid
|
|---|---|---|
|
Analogical Visual Scale of Pain (VAS)
|
-1.66 centimeter
Interval -2.29 to -1.03
|
-2.65 centimeter
Interval -3.29 to -2.01
|
Adverse Events
Infiltration of corticosteroids
Serious events: 16 serious events
Other events: 13 other events
Deaths: 1 deaths
Infiltration of corticosteroids and hyaluronic acid
Serious events: 11 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infiltration of corticosteroids
n=76 participants at risk
infiltration of corticosteroids: infiltration of corticosteroids
|
Infiltration of corticosteroids and hyaluronic acid
n=73 participants at risk
infiltration of corticosteroids and hyaluronic acid: infiltration of corticosteroids and hyaluronic acid
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
7.9%
6/76 • Number of events 6 • Through study completion, , an average of 1 year
|
2.7%
2/73 • Number of events 2 • Through study completion, , an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/76 • Through study completion, , an average of 1 year
|
1.4%
1/73 • Number of events 1 • Through study completion, , an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/76 • Through study completion, , an average of 1 year
|
1.4%
1/73 • Number of events 1 • Through study completion, , an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS STENOSANS
|
1.3%
1/76 • Number of events 1 • Through study completion, , an average of 1 year
|
0.00%
0/73 • Through study completion, , an average of 1 year
|
|
Gastrointestinal disorders
PANCREATITIS
|
1.3%
1/76 • Number of events 1 • Through study completion, , an average of 1 year
|
0.00%
0/73 • Through study completion, , an average of 1 year
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.00%
0/76 • Through study completion, , an average of 1 year
|
1.4%
1/73 • Number of events 1 • Through study completion, , an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
1.3%
1/76 • Number of events 1 • Through study completion, , an average of 1 year
|
0.00%
0/73 • Through study completion, , an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
1.3%
1/76 • Number of events 1 • Through study completion, , an average of 1 year
|
0.00%
0/73 • Through study completion, , an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKAEMIA
|
1.3%
1/76 • Number of events 1 • Through study completion, , an average of 1 year
|
0.00%
0/73 • Through study completion, , an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CANCER
|
0.00%
0/76 • Through study completion, , an average of 1 year
|
1.4%
1/73 • Number of events 1 • Through study completion, , an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PYOGENIC GRANULOMA
|
0.00%
0/76 • Through study completion, , an average of 1 year
|
1.4%
1/73 • Number of events 1 • Through study completion, , an average of 1 year
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.00%
0/76 • Through study completion, , an average of 1 year
|
1.4%
1/73 • Number of events 1 • Through study completion, , an average of 1 year
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/76 • Through study completion, , an average of 1 year
|
1.4%
1/73 • Number of events 1 • Through study completion, , an average of 1 year
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/76 • Through study completion, , an average of 1 year
|
1.4%
1/73 • Number of events 1 • Through study completion, , an average of 1 year
|
|
Surgical and medical procedures
JOINT ARTHROPLASTY
|
1.3%
1/76 • Number of events 1 • Through study completion, , an average of 1 year
|
0.00%
0/73 • Through study completion, , an average of 1 year
|
|
Surgical and medical procedures
TRAPEZIECTOMY
|
2.6%
2/76 • Number of events 2 • Through study completion, , an average of 1 year
|
0.00%
0/73 • Through study completion, , an average of 1 year
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
1.3%
1/76 • Number of events 1 • Through study completion, , an average of 1 year
|
2.7%
2/73 • Number of events 2 • Through study completion, , an average of 1 year
|
|
General disorders
PYREXIA
|
1.3%
1/76 • Number of events 1 • Through study completion, , an average of 1 year
|
0.00%
0/73 • Through study completion, , an average of 1 year
|
|
Eye disorders
CATARACT
|
0.00%
0/76 • Through study completion, , an average of 1 year
|
1.4%
1/73 • Number of events 1 • Through study completion, , an average of 1 year
|
Other adverse events
| Measure |
Infiltration of corticosteroids
n=76 participants at risk
infiltration of corticosteroids: infiltration of corticosteroids
|
Infiltration of corticosteroids and hyaluronic acid
n=73 participants at risk
infiltration of corticosteroids and hyaluronic acid: infiltration of corticosteroids and hyaluronic acid
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.1%
13/76 • Number of events 13 • Through study completion, , an average of 1 year
|
13.7%
10/73 • Number of events 10 • Through study completion, , an average of 1 year
|
Additional Information
Dr. Grégoire CORMIER
Centre Hospitalier Departemental Vendée
Phone: 251446197
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place