Clinical trial NCT01760577: Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis
Official title: Comparing Effects of Intraarticular Botulinum Toxin A Versus Hyaluronate Plus Rehabilitation Exercise in Patients With Unilateral Ankle Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Osteoarthritis
Keywords: osteoarthritis, botulinum toxin, hyaluronate
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A versus intraarticular hyaluronate plus rehabilitation exercise in patients with ankle osteoarthritis.

Detailed description: Recent pilot studies report that intraarticular injection of Botulinum Toxin A into painful joints of patients with various types of arthritis leads to significant and durable improvement in pain and function and is safe to use. To date, there is no published literature that evaluate the effects of intraarticular Botulinum Toxin A in the treatment of ankle OA. Sun el al reported that 3 or 5 weekly injection of hyaluronate may improve pain and physical function in patients with ankle OA and the treatment effects may last for 6 months. The effect of one injection of hyaluronate plus exercise had never been studied. The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A versus intraarticular hyaluronate plus rehabilitation exercise for patients with ankle OA.

Eligibility criteria: Inclusion Criteria:

* an age of 20-85 years with diagnosis of ankle osteoarthritis
* 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:

* pregnancy or lactation in women
* 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.

Primary outcomes:
measure: Ankle Osteoarthritis Scale (AOS) score
timeFrame: at 6 months after the injection
Secondary outcomes:
measure: AOFAS ankle/hindfoot score
timeFrame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection.
measure: Visual analog scale (VAS)
timeFrame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
measure: Single-leg stance test (SLS)
timeFrame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
measure: Timed " Up-and-Go" test (TUG)
timeFrame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
measure: global Patients satisfaction
timeFrame: at 2 weeks, 1 month, 3 months, and 6 months post injection.
measure: adverse effects
timeFrame: at 2 weeks, 1 month, 3 months, and 6 months post injection.
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road
Study officials:
affiliation: Kaohsiung Veterans General Hospital, Taiwan
name: Shu-Fen Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.