The effectiveness of intra-articular hyaluronan (Synvisc®) for the treatment of osteoarthritis affecting the first metatarsophalangeal joint of the foot (hallux limitus)

Completed

• Conditions: Osteoarthritis of the first metatatarsophalangeal joint (hallux limitus); Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12607000654459
• Lead Sponsor: a Trobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

i) be aged at least 18 years;
ii) report having symptoms of pain during motion or rest, and stiffness in the first metatarsophalangeal joint for at least 3 months;
iii) report having pain rated at least 20mm on a 100mm visual analogue pain scale (VAPS);
iv) have pain upon palpation of the dorsal aspect of the first metatarsophalangeal joint;
v) Radiographic evidence of osteoarthritis (score 1 or 2 for either osteophytes or joint space narrowing using radiographic classification described by Menz et al.[2007]) at the first metatarsophalangeal joint;
vi) be normally active and able to walk household distances (>50 meters) without the aid of a walker, crutches or cane;
vii) be willing to attend the La Trobe University Medical Centre for treatment with either Synvisc® or placebo (single intra-articular injection) and attend the Health Sciences Clinic of La Trobe University for the initial assessment and the outcome measurements (at baseline and 1, 3 and 6 months post-treatment);
viii) not receive other intra-articular injections into the first metatarsophalangeal joint, apart from the study intervention, during the course of the study;
(ix) be willing to discontinue taking all pain-relieving medications (analgesics and non-steroidal anti-inflammatory medications, except paracetamol up to 4g/day, taken by mouth or applied topically):
- for at least 14 days prior to the initial assessment;
- during the study period (6 months after the final treatment with Synvisc®).
Participants who do take paracetamol need to discontinue its use at least 24 hours prior to the:
- initial assessment;
- follow-up assessments at 1, 3 and 6 months after the treatment with Synvisc®;
(x) be willing to not receive any physical therapy on the involved first metatarsophalangeal joint or trial of shoe modifications or orthotics during the study period.

Exclusion Criteria

i) No radiographic evidence of osteoarthritis (score 0 for osteophytes and joint space narrowing using radiographic classification described by Menz et al.[2007]), or severe radiographic evidence of osteoarthritis (score 3 for either osteophytes or joint space narrowing using radiographic classification described by Menz et al.[2007]) at the first metatarsophalangeal joint;
ii) previous surgery on the first metatarsophalangeal joint;
iii) intra-articular steroid, or any other intra-articular injection at the first metatarsophalangeal joint, in the previous 6 months;
iv) treatment with systemic steroid (excluding inhalation or topical steroids), immunosuppressives or anticoagulants (except for acetylsalicylic acid at dosages of up to 325 mg/day);
v) presence of joint infections of the foot;
vi) significant deformity of the first metatarsophalangeal joint including hallux abducto valgus;
vii) presence of peripheral vascular disease;
viii) presence of one or more conditions that can confound pain and functional assessments of the first metatarsophalangeal joint, such as significant hallux abducto valgus, metatarsalgia, plantar fasciitis, pre-dislocation syndrome, sprains of the foot, Achilles tendinopathy, degenerative joint disease of the foot (other than the first metatarsophalangeal joint) or painful corns and callus;
ix) planning to undergo any surgical procedure or receive any injections at the involved first metatarsophalangeal joint during the study period;
x) presence of systemic inflammatory condition or infection, such as inflammatory arthritis, diagnosed with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, septic arthritis, gout/acute pseudogout, or any other connective tissue disease;
xi) Evidence of gout or other musculoskeletal disease other than osteoarthritis within the feet. Gout will be screened for using clinical history and physical assessment (painful joint, abrupt onset, swelling), radiographic assessment (asymmetrical joint swelling, subcortical cysts without erosion and tophi) as well as serum uric acid levels;
xii) active skin disease or infection in the area of the injection site;
xiii) any medical condition that, in the opinion of the investigators, makes the participant unsuitable for inclusion (e.g., severe progressive chronic disease, malignancy, bleeding disorder, clinically important pain in a part of the musculoskeletal system other than the first metatarsophalangeal joint, or fibromyalgia);
xiv) pregnant or lactating women, or women who are of child bearing age or have not undergone menopause (Synvisc® has not been tested in pregnant women or women who are nursing);
xv) cognitive impairment (defined as a score of <7 on the Short Portable Mental Status Questionnaire);
xvi) known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations, or to avian proteins, feathers, and egg products;
xvii) Involvement in any clinical research study in the previous 3 months that could be considered to affect the results of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain sub-score of the Foot Health Status Questionnaire[Baseline, 1, 3 and 6 months after the intervention commencement];Function sub-score of the Foot Health Status Questionnaire[Baseline, 1, 3 and 6 months after the intervention commencement]