Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis
NCT ID: NCT01760577
Last Updated: 2013-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2010-05-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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The Botulinum Toxin A group
The Botulinum Toxin A group received intraarticular injections of 100 units of Botulinum Toxin A (Allergan, Inc, Irvine CA) reconstituted in 2 cc normal saline.
Botulinum Toxin A (Allergan, Inc, Irvine CA)
patients received intraarticular injections by the same experienced physician using aseptic procedures.
The hyaluronate group (Hyalgan, Italy)
The hyaluronate group received intraarticular injections of 2 ml sodium hyaluronate (Hyalgan, molecular weight 500-730kDa, Fidia Pharmaceutical Corporation, Abano Terme, Italy) and subsequent 6 sessions of rehabilitation exercise for 50 miniutes/day, 3 days per week for 2 weeks and home exercise for 2 weeks .
Hyalgan (Hyalgan, Fidia , Italy)
The rehabilitation program consists of 6 sessions of rehabilitation exercise for 50 miniutes/day, 3 days per week for 2 weeks and home exercise program for another 2 weeks.
Interventions
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Botulinum Toxin A (Allergan, Inc, Irvine CA)
patients received intraarticular injections by the same experienced physician using aseptic procedures.
Hyalgan (Hyalgan, Fidia , Italy)
The rehabilitation program consists of 6 sessions of rehabilitation exercise for 50 miniutes/day, 3 days per week for 2 weeks and home exercise program for another 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* unilateral ankle pain that had lasted for at least 6 months, with no significant benefit from conservative treatment or with an inability to tolerate the side effects of medications
* ankle radiographs taken within 6 months equivalent to grade 2 on the Kellgren-Lawrence grading system
* a current total Ankle Osteoarthritis Scale (AOS) score of \>3 and \< 9 (possible range, 0-10)
* a normal activity level-i.e., not bedridden or confined to a wheelchair, and are able to walk 30 meters without the aid of a walker, crutches or cane
* no changes in shoes or orthotic devices during the study period.
Exclusion Criteria
* lower leg trauma other than ankle trauma
* previous surgery involving the spine, hip or knee
* the presence of an active joint infections of foot or ankle
* previous surgery or arthroscopy on the ankle within 12 months
* history of chicken or egg allergy
* intraarticular steroid or hyaluronate injection in the treated ankle within the previous 6 months
* treatment with anticoagulants or immunosuppressives
* a history of rheumatoid arthritis, gout, or any other inflammatory arthropathy
* the presence of other comorbidity (such as neoplasms, diabetes mellitus, paresis or recent trauma) or poor health status that would interfere with the clinical assessments during the study.
20 Years
85 Years
ALL
No
Sponsors
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Kaohsiung Veterans General Hospital.
OTHER
Responsible Party
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Shu-Fen Sun
MD
Principal Investigators
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Shu-Fen Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Veterans General Hospital, Taiwan
Locations
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Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road
Kaohsiung City, , Taiwan
Countries
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References
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Sun SF, Chou YJ, Hsu CW, Hwang CW, Hsu PT, Wang JL, Hsu YW, Chou MC. Efficacy of intra-articular hyaluronic acid in patients with osteoarthritis of the ankle: a prospective study. Osteoarthritis Cartilage. 2006 Sep;14(9):867-74. doi: 10.1016/j.joca.2006.03.003. Epub 2006 Apr 24.
Sun SF, Hsu CW, Sun HP, Chou YJ, Li HJ, Wang JL. The effect of three weekly intra-articular injections of hyaluronate on pain, function, and balance in patients with unilateral ankle arthritis. J Bone Joint Surg Am. 2011 Sep 21;93(18):1720-6. doi: 10.2106/JBJS.J.00315.
Mahowald ML, Singh JA, Dykstra D. Long term effects of intra-articular botulinum toxin A for refractory joint pain. Neurotox Res. 2006 Apr;9(2-3):179-88. doi: 10.1007/BF03033937.
Singh JA, Mahowald ML, Kushnaryov A, Goelz E, Dykstra D. Repeat injections of intra-articular botulinum toxin a for the treatment of chronic arthritis joint pain. J Clin Rheumatol. 2009 Feb;15(1):35-8. doi: 10.1097/RHU.0b013e3181953b14. No abstract available.
Singh JA, Mahowald ML, Noorbaloochi S. Intra-articular botulinum toxin A for refractory shoulder pain: a randomized, double-blinded, placebo-controlled trial. Transl Res. 2009 May;153(5):205-16. doi: 10.1016/j.trsl.2009.02.004. Epub 2009 Mar 13.
Mahowald ML, Krug HE, Singh JA, Dykstra D. Intra-articular Botulinum Toxin Type A: a new approach to treat arthritis joint pain. Toxicon. 2009 Oct;54(5):658-67. doi: 10.1016/j.toxicon.2009.03.028. Epub 2009 Apr 5.
Aoki KR. Evidence for antinociceptive activity of botulinum toxin type A in pain management. Headache. 2003 Jul-Aug;43 Suppl 1:S9-15. doi: 10.1046/j.1526-4610.43.7s.3.x.
Sun SF, Chou YJ, Hsu CW, Chen WL. Hyaluronic acid as a treatment for ankle osteoarthritis. Curr Rev Musculoskelet Med. 2009 Jun;2(2):78-82. doi: 10.1007/s12178-009-9048-5. Epub 2009 Mar 13.
Konttinen YT, Kemppinen P, Segerberg M, Hukkanen M, Rees R, Santavirta S, Sorsa T, Pertovaara A, Polak JM. Peripheral and spinal neural mechanisms in arthritis, with particular reference to treatment of inflammation and pain. Arthritis Rheum. 1994 Jul;37(7):965-82. doi: 10.1002/art.1780370701. No abstract available.
Sun SF, Hsu CW, Lin HS, Chou YJ, Chen JY, Wang JL. Efficacy of intraarticular botulinum toxin A and intraarticular hyaluronate plus rehabilitation exercise in patients with unilateral ankle osteoarthritis: a randomized controlled trial. J Foot Ankle Res. 2014 Feb 6;7(1):9. doi: 10.1186/1757-1146-7-9.
Other Identifiers
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VGHKS100-061
Identifier Type: -
Identifier Source: org_study_id
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