HUPS: Hyalgan Use in Painful Shoulder
CompletedPhase 3NCT00377624
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Three-arm, parallel, double-blind, masked observer, randomized, PB-Saline controlled clinical trial. In order to avoid problems in the interpretation of the final results due to disparate enrollment from various centers, the number of patients enrolled per site will be the same per site. Study patients will be randomized to receive either 20 mg sodium hyaluronate, 3 i.a. sodium hyaluronate injections, followed by 2 PBSaline mock i.a. injections or 5 i.a. PB-Saline control injections. One investigator will administer the injection and the joint assessor will be blinded to the study. The anterior or posterior approach for the shoulder injection will be used.
Study details
- Official title
- Sodium Hyaluronate for Treatment of Chronic Painful Shoulder With Limitation of Motion Due to Glenohumeral Joint Osteoarthritis, Rotator Cuff Tear and/or Primary or Secondary Adhesive Capsulitis
- Conditions
- Osteoarthritis of Shoulder
- Interventions
- Drug: sodium hyaluronate
- Sponsor
- Sanofi
- Start date
- 2002-01
- Sex
- All
- Age range
- from 35 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. INCLUSION CRITERIA: 1. Patients with chronic shoulder pain with all of the following: of at least 6 months, but not greater than 5 years duration without clinically significant improvement in shoulder pain over the past one month, and present at least 50% of the days during the previous month. 2. Patients who have failed conventional therapy including but not limited to the following: NSAIDs; one or more i.a. or local peri-articular steroid injections and physiotherapy (a minimum of one month of previous physiotherapy treatment is required. 3. At screening, patients on chronic analgesic/anti-inflammatory medication should have a VAS pain score of \>/= 30 mm and \</= 90 mm indicating a lack of adequate and sustained response to previous and current therapies. At screening, patients not on chronic analgesic/anti-inflammatory medication should have a VAS pain score of \>/= 40 mm and \</= 90 mm. If bilateral shoulder pain is present, the investigator will use the more painful shoulder. 4. At baseline, after all analgesic/anti-inflammatory medications have been discontinued for 2 weeks, patients should have a VAS pain score of \>/= 40 mm and \</= 90 mm. 5. Patients with a limitation of shoulder motion in at least 1 direction at screening and baseline for the following active range of motions: Abduction with scapula fixed must be \</= 80°; internal rotation in abduction must be ,/= 55°, and/or external rotation in abduction must be 180°. These limitations of shoulder motion are in comparison to normal expected ranges. 6. Patients with a retained active Range Of Motion ("ROM") \>/= 30 percent in all directions at screening and baseline to rule out frozen shoulder. The ROM should be: \>/= 30° for abduction with scapula fixed, \>/= 30° external rotation, and \>/= 20° for internal rotation. 7. Patients with at least one of the following conditions as examined and determined by Investigator: Osteoarthritis of the Glenohumeral Joint (OA), Rotator cuff tear (complete or partial), Adhesive capsulitis of the shoulder. 8. Patients who are able to complete efficacy measur…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00377624