NCT06376981

Brief Summary

Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
10mo left

Started Sep 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Sep 2024Mar 2027

First Submitted

Initial submission to the registry

April 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

September 19, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2027

Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

2.2 years

First QC Date

April 11, 2024

Last Update Submit

October 2, 2024

Conditions

Shoulder Tendinitis

Keywords

Shoulder tendinitisHyaluronic acidCorticosteroid injection

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale pain on activity ranging from 0 to 100 mm at month 3.

    Visual analog scale pain on activity ranging from 0 to 100 mm at month 3. Pain is defined by the worst pain felt during active examination: anterior elevation, abduction, internal and external rotation, etc.

    Month 3

Study Arms (2)

Combination of corticosteroid and hyaluronic acid injection

EXPERIMENTAL

An injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid

Drug: Hyaluronic acid injectionDrug: Corticosteroid injection

Corticosteroid injection alone

PLACEBO COMPARATOR

An injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum).

Drug: Corticosteroid injectionDrug: Placebo injection

Interventions

Hyaluronic acid injectionDRUG

An injection of 2 ml of Acid hyaluronic

Combination of corticosteroid and hyaluronic acid injection
Corticosteroid injectionDRUG

An injection of 1 ml of corticosteroids

Combination of corticosteroid and hyaluronic acid injectionCorticosteroid injection alone
Placebo injectionDRUG

An injection of 2 ml of placebo (physiological serum)

Corticosteroid injection alone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active patient aged between 18 and 65;
  • Patient suffering from pain compatible with supraspinatus tendinopathy for at least 2 months;
  • Patient with simple tendinopathy or partial tendon rupture;
  • Patient with tendinopathy confirmed by ultrasound or MRI;
  • Patient with an active pain visual analog scale ≥ 4 for more than 6 weeks;
  • Patient failing medical treatment (rest, analgesics, NSAIDs, physiotherapy);
  • Patient able to follow the protocol and having given oral informed consent to take part in the research;
  • Patient affiliated to the social security system or entitled person;

You may not qualify if:

  • Patient suffering from a transfixing tendon rupture;
  • Patients suffering from post-traumatic tendon rupture;
  • Patients suffering from calcific tendinopathy (calcification \> 5 mm);
  • Patients with associated glenohumeral osteoarthritis;
  • Patients with associated symptomatic acromioclavicular osteoarthritis;
  • Patients with shoulder pain for reasons other than tendinopathy (capsulitis, chronic inflammatory rheumatism, fibromyalgia, amyloidosis);
  • Patients who have had a subacromial infiltration in the previous 6 months;
  • Patients with a known allergy to one of the products including their excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol);
  • Patients with a known allergy to lidocaine;
  • Patients with a local or generalised infection, or suspected infection;
  • Patients with severe coagulation disorders or taking anticoagulants;
  • Patients with severe and/or uncontrolled hypertension \> 160/100 mmHg;
  • Patients with unbalanced diabetes (last HbA1c \> 8.5%);
  • Patients with a history of addiction to psychoactive substances;
  • Patient participating in another clinical research protocol with an impact on the research objectives;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHD Vendée

La Roche-sur-Yon, France

RECRUITING

CHU Nantes

Nantes, France

NOT YET RECRUITING

MeSH Terms

Interventions

Hyaluronic AcidAdrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Céline COZIC, Dr

    Centre Hospitalier Départemental Vendée

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura SOULARD

CONTACT

0251080582laura.soulard@ght85.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 22, 2024

Study Start

September 19, 2024

Primary Completion (Estimated)

December 19, 2026

Study Completion (Estimated)

March 19, 2027

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)