Health TrialsbyHealthPanel

Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.

ConditionsBase-of-thumb OsteoarthritisOsteoarthritis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The main objective of this study will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Individuals aged at least 18 years;

Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain);

Pain involving the base of the thumb;

X-ray evidence of trapezometacarpial osteoarthritis with at least two of the following items involving the trapezometacarpial joint: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts;

Disqualifiers

• Secondary osteoarthritis;

History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;

Uncontrolled dysphagia, pneumonia, cardiovascular diseases, or clinical or subclinical signs of neuromuscular transmission disorders;

Contra-indication to onabotulinumtoxinA;

Trial design

Design model

Parallel

Treatments tested in this trial

  • OnabotulinumtoxinA

    Drug

    intra-articular injection

  • Normal saline (placebo)

    Drug

    intra-articular injection

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: 2 intra-articular injections of onabotulinumtoxinAExperimental treatment 1 intervention
Group B: 1 intra-articular injection of onabotulinumtoxinA and 1 of normal salineExperimental treatment 2 interventions
Group C: 2 intra-articular injections of normal salinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Base-of-thumb pain on a self-administered 11-point numeric rating scale

French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain)

Time frame
6 months

Secondary outcomes

1

Base-of-thumb pain on a self-administered 11-point numeric rating scale

French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain)

Time frame
1 and 12 months
2

Hand-specific activity limitations on the self-administered Cochin Hand Function Scale

mean change from baseline in hand-specific activity limitations in the previous 2 weeks on the self-administered Cochin Hand Function Scale (0: no limitations to 90: maximal limitations) at 6 and 12 months

Time frame
6 and 12 months
3

patient global assessment on a self-administered 11-point numeric rating scale

mean change from baseline in patient global assessment on a self-administered 11-point numeric rating scale (0: worst possible condition to 100: best possible condition) at 6 and 12 months

Time frame
6 and 12 months
4

health-related quality of life on the self-administered EQ-5D-5L questionnaire

mean change from baseline in health-related quality of life on the self-administered EQ-5D-5L questionnaire (0: death, 1: best quality of life) at 6 and 12 months

Time frame
6 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
Apply now