Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

NCT01760577 | Completed DMC

• 1 other identifier: VGHKS100-061
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Osteoarthritis

Keywords

osteoarthritis, botulinum toxin, hyaluronate

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• AOFAS ankle/hindfoot score

  pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection.

• Visual analog scale (VAS)

  pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection

• Single-leg stance test (SLS)

  pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection

• Timed " Up-and-Go" test (TUG)

  pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection

• global Patients satisfaction

  at 2 weeks, 1 month, 3 months, and 6 months post injection.

Study Arms (2)

The Botulinum Toxin A group

EXPERIMENTAL

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.

Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA)

The hyaluronate group (Hyalgan, Italy)

ACTIVE COMPARATOR

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 .

Drug: Hyalgan (Hyalgan, Fidia , Italy)

Interventions

Botulinum Toxin A (Allergan, Inc, Irvine CA) DRUG

patients received intraarticular injections by the same experienced physician using aseptic procedures.

Also known as: 100 units of Botulinum Toxin A in 2 cc NS

The Botulinum Toxin A group

Hyalgan (Hyalgan, Fidia , Italy) DRUG

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.

Also known as: 2 ml Hyalgan, molecular weight 500-730kDa, Fidia , Italy

The hyaluronate group (Hyalgan, Italy)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road

Kaohsiung City, 813, Taiwan

Location

Related Publications (10)

• 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.

  PMID: 16635582 BACKGROUND

• 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.

  PMID: 21938376 BACKGROUND

• 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.

  PMID: 16785116 BACKGROUND

• 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.

  PMID: 19131763 BACKGROUND

• 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.

  PMID: 19375681 BACKGROUND

• 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.

  PMID: 19351542 BACKGROUND

• 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.

  PMID: 12887389 BACKGROUND

• 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.

  PMID: 19468874 BACKGROUND

• 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.

  PMID: 8024624 BACKGROUND

• 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.

  PMID: 24502534 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Botulinum Toxins, Type A; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Shu-Fen Sun, MD

  Kaohsiung Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 30, 2012
• First Posted: January 4, 2013
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 4, 2013

Record last verified: 2013-01

Locations

TW (1)