Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

Ankle Osteoarthritis Clinical Trial

Official title:

Comparing Effects of Intraarticular Botulinum Toxin A Versus Hyaluronate Plus Rehabilitation Exercise in Patients With Unilateral Ankle Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760577
• Other study ID #: VGHKS100-061
• Status: Completed
• Phase: N/A
• First received: December 30, 2012
• Last updated: January 3, 2013
• Start date: May 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Osteoarthritis
• Osteoarthritis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (9)

Aoki KR. Evidence for antinociceptive activity of botulinum toxin type A in pain management. Headache. 2003 Jul-Aug;43 Suppl 1:S9-15. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2006 Apr 24. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle Osteoarthritis Scale (AOS) score	The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale.Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable	at 6 months after the injection	No
Secondary	AOFAS ankle/hindfoot score	AOFAS ankle/hindfoot score is a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment.	pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection.	No
Secondary	Visual analog scale (VAS)	The patient rate the intensity of average ankle movement pain in the previous week using a 10-cm horizontal Visual analog scale (VAS)	pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection	No
Secondary	Single-leg stance test (SLS)	Single-leg stance test (SLS) is done by raising one foot up without touching it to the supported lower extremity with ankle OA and maintain balance for as long as possible	pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection	No
Secondary	Timed " Up-and-Go" test (TUG)	A Timed " Up-and-Go" test (TUG) measures functional mobility and the dynamic balance of an individual.	pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection	No
Secondary	global Patients satisfaction	This rating is based on a 7-point categorical scale ranging from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied.	at 2 weeks, 1 month, 3 months, and 6 months post injection.	No
Secondary	adverse effects	patients recorded any systemic and local adverse effects (defined as any unwanted effect whether it was thought to be related to the study or not) on a diary card.	at 2 weeks, 1 month, 3 months, and 6 months post injection.	Yes