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Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis. (RHIZ'ART)

Primary Purpose

Rhizarthrosis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
infiltration of corticosteroids
infiltration of corticosteroids and hyaluronic acid
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhizarthrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults, ≥ 40 years
  • Pain located at the root of the thumb (near the wrist) and awakened by direct pressure and movement
  • Pain resistant to well-conducted medical treatment, with analgesics, NSAIDs, icing with pain (analog visual scale) ≥ 4 for more than 3 months

  • Radiological findings (kapandji face + profile incidence) typical of rhizarthrosis, stage II or III of Eaton and Litter, with at least 2 of the following 5 radiological elements observed on the trapeziometacarpal joint:

    • marginal osteophyte
    • pinching of the joint space
    • sclerosis of the subchondral space
    • subchondral kyst
    • absence of osteopenia
  • Patient with the ability to understand the protocol and signed informed consent
  • Patient receiving social security

Exclusion Criteria:

  • Known allergy to any of the products (corticosteroids or hyaluronic acid) including its excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol)
  • Change of analgesic treatment within 4 weeks before inclusion.
  • Patients with symptomatic bilateral rhizarthrosis
  • Scaphoid-trapezial arthrosis
  • Local or general infection
  • Severe coagulation disorders, ongoing anticoagulant therapy
  • severe and / or uncontrolled hypertension
  • Earlier local surgery
  • Associated inflammatory rheumatism
  • Tendinopathy of De Quervain, thumb to jump associated
  • Infiltrations earlier than 6 months
  • Diabetes imbalanced
  • Live vaccines
  • Severe water and / or sodium retention (hypernatremia), particularly in cases of heart failure, decompensated liver failure (edema and ascites failure)
  • Pregnant or lactating women
  • Immunocompromised or hemodialysis patients
  • Patients under guardianship, trusteeship, or deprived of liberty
  • Patients participating in another clinical research protocol involving a drug or medical device
  • Patients unable to follow the protocol, according to the judgment of the investigator

Sites / Locations

  • CH Cholet
  • CHD Vendée
  • CH Le Mans
  • CHU Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Infiltration of corticosteroids

Infiltration of corticosteroids and hyaluronic acid

Arm Description

Outcomes

Primary Outcome Measures

Analogical visual scale of pain (VAS)
Analogical visual scale of pain (VAS) To 0mm (no pain) form 100mm (maximum pain imaginable)

Secondary Outcome Measures

Progression of pain to activity at protocol follow-up visits
Analogical visual scale of pain (VAS)
Progression of pain at rest at protocol follow-up visits
Analogical visual scale of pain (VAS)
Comparison of pain between M0 and M3, by weekly collection on a patient book
Analogical visual scale of pain (VAS)
Evolution of the fhand unction with Cochin Hand Function Scale
Cochin Hand Function Scale
Evolution of the grip and opposition force
dynamometer mesures
Ultrasound appearance of lesions
ultrasound b-mode and Doppler - gradation of OMERACT
Comparison of infiltration pain
Analogical visual scale of pain (VAS)
Patient's feelings about the evolution of his pain
Verbal Scale of global evolution
Need for new infiltrations
Number of corticosteroid infiltrations
Use of analgesics and NSAIDs
Use of analgesics and NSAIDs
Need for surgical procedure
Number of patient requiring a surgical procedure
Number of days off work
Number of days off work

Full Information

First Posted
February 6, 2018
Last Updated
May 31, 2022
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT03431584
Brief Title
Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.
Acronym
RHIZ'ART
Official Title
Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 11, 2018 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
December 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The rhizarthrosis, or the degenerative osteoarthritis of the trapezo-metacarpal joint, is a frequent degenerative osteoarthritis. The treatment associates not pharmacological measures, such as resting relative of the joint, the orthosis of rest, glazing and pharmacological measures such analgesic, anti-inflammatory not steroidal per bones or premises, even infiltrations cortisone or by hyaluronic acid. No study has, for the moment, tested the interest of the combination of cortisone and hyaluronic acid in rhizarthrosis. In view of the current publications, we propose to carry out a study on two arms, with corticosteroids in reference arm; the experimental arm is the combination of hyaluronic acid and cortisone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhizarthrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infiltration of corticosteroids
Arm Type
Active Comparator
Arm Title
Infiltration of corticosteroids and hyaluronic acid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
infiltration of corticosteroids
Intervention Description
infiltration of corticosteroids
Intervention Type
Drug
Intervention Name(s)
infiltration of corticosteroids and hyaluronic acid
Intervention Description
infiltration of corticosteroids and hyaluronic acid
Primary Outcome Measure Information:
Title
Analogical visual scale of pain (VAS)
Description
Analogical visual scale of pain (VAS) To 0mm (no pain) form 100mm (maximum pain imaginable)
Time Frame
3 month post infiltration
Secondary Outcome Measure Information:
Title
Progression of pain to activity at protocol follow-up visits
Description
Analogical visual scale of pain (VAS)
Time Frame
1 month, 6 month, and 12 month post infiltration
Title
Progression of pain at rest at protocol follow-up visits
Description
Analogical visual scale of pain (VAS)
Time Frame
Base-line,1 month, 3month, 6 month, and 12 month post infiltration
Title
Comparison of pain between M0 and M3, by weekly collection on a patient book
Description
Analogical visual scale of pain (VAS)
Time Frame
3 month post infiltration
Title
Evolution of the fhand unction with Cochin Hand Function Scale
Description
Cochin Hand Function Scale
Time Frame
1 month, 6 month, and 12 month post infiltration
Title
Evolution of the grip and opposition force
Description
dynamometer mesures
Time Frame
1 month, 3 month, 6 month, and 12 month post infiltration
Title
Ultrasound appearance of lesions
Description
ultrasound b-mode and Doppler - gradation of OMERACT
Time Frame
Baseline and 3 month post infiltration
Title
Comparison of infiltration pain
Description
Analogical visual scale of pain (VAS)
Time Frame
the day of infiltration
Title
Patient's feelings about the evolution of his pain
Description
Verbal Scale of global evolution
Time Frame
3 month post infiltration
Title
Need for new infiltrations
Description
Number of corticosteroid infiltrations
Time Frame
over the 12 months of follow-up
Title
Use of analgesics and NSAIDs
Description
Use of analgesics and NSAIDs
Time Frame
over the 12 months of follow-up
Title
Need for surgical procedure
Description
Number of patient requiring a surgical procedure
Time Frame
over the 12 months of follow-up
Title
Number of days off work
Description
Number of days off work
Time Frame
over the 12 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults, ≥ 40 years Pain located at the root of the thumb (near the wrist) and awakened by direct pressure and movement Pain resistant to well-conducted medical treatment, with analgesics, NSAIDs, icing with pain (analog visual scale) ≥ 4 for more than 3 months Radiological findings (kapandji face + profile incidence) typical of rhizarthrosis, stage II or III of Eaton and Litter, with at least 2 of the following 5 radiological elements observed on the trapeziometacarpal joint: marginal osteophyte pinching of the joint space sclerosis of the subchondral space subchondral kyst absence of osteopenia Patient with the ability to understand the protocol and signed informed consent Patient receiving social security Exclusion Criteria: Known allergy to any of the products (corticosteroids or hyaluronic acid) including its excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol) Change of analgesic treatment within 4 weeks before inclusion. Patients with symptomatic bilateral rhizarthrosis Scaphoid-trapezial arthrosis Local or general infection Severe coagulation disorders, ongoing anticoagulant therapy severe and / or uncontrolled hypertension Earlier local surgery Associated inflammatory rheumatism Tendinopathy of De Quervain, thumb to jump associated Infiltrations earlier than 6 months Diabetes imbalanced Live vaccines Severe water and / or sodium retention (hypernatremia), particularly in cases of heart failure, decompensated liver failure (edema and ascites failure) Pregnant or lactating women Immunocompromised or hemodialysis patients Patients under guardianship, trusteeship, or deprived of liberty Patients participating in another clinical research protocol involving a drug or medical device Patients unable to follow the protocol, according to the judgment of the investigator
Facility Information:
Facility Name
CH Cholet
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
CHD Vendée
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CH Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30782680
Citation
Cormier G, Le Goff B, Denis A, Varin S, Auzanneau L, Dimet J, Le Thuaut A. Corticosteroids injections versus corticosteroids with hyaluronic acid injections in rhizarthrosis: the randomised multicentre RHIZ'ART trial study protocol. BMJ Open. 2019 Jan 9;9(1):e022553. doi: 10.1136/bmjopen-2018-022553.
Results Reference
derived

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Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.

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