Ankle OsteoarthritisNCT01760577
Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis
A study testing Botulinum Toxin A (Allergan, Inc, Irvine CA) and Hyalgan (Hyalgan, Fidia , Italy) in people with Ankle Osteoarthritis, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Ankle Osteoarthritis
- What is being tested?
- Botulinum Toxin A (Allergan, Inc, Irvine CA) and Hyalgan (Hyalgan, Fidia , Italy)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road
Kaohsiung City, 813
About this study
Official title: Comparing Effects of Intraarticular Botulinum Toxin A Versus Hyaluronate Plus Rehabilitation Exercise in Patients With Unilateral Ankle Osteoarthritis
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.
Read the 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.
- Conditions
- Ankle Osteoarthritis
- Being tested
- Botulinum Toxin A (Allergan, Inc, Irvine CA), Hyalgan (Hyalgan, Fidia , Italy)
- Keywords
- osteoarthritis, botulinum toxin, hyaluronate
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin A (Allergan, Inc, Irvine CA)Drug
Also called 100 units of Botulinum Toxin A in 2 cc NS
patients received intraarticular injections by the same experienced physician using aseptic procedures.
Hyalgan (Hyalgan, Fidia , Italy)Drug
Also called 2 ml Hyalgan, molecular weight 500-730kDa, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Drug: Hyalgan (Hyalgan, Fidia , Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 6 months after the injection
Secondary outcomes (6)
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.
Measured: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection.
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)
Measured: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
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
Measured: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
Timed " Up-and-Go" test (TUG)
A Timed " Up-and-Go" test (TUG) measures functional mobility and the dynamic balance of an individual.
Measured: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
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.
Measured: at 2 weeks, 1 month, 3 months, and 6 months post injection.
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.
Measured: at 2 weeks, 1 month, 3 months, and 6 months post injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startMay 2010
- Primary completionMay 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ankle OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Fen Sun, Kaohsiung Veterans General Hospital.
- Investigators
- Shu-Fen Sun, MD, Principal investigator, Kaohsiung Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760577
- Sponsor's protocol ID
- VGHKS100-061
- Status last verified
- Jan 2013
- First submitted
- 30 Dec 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16635582Sun 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.
PubMed 21938376Mahowald 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.
PubMed 16785116Singh 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.
PubMed 19131763Singh 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.
PubMed 19375681Mahowald 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.
PubMed 19351542Aoki 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.
PubMed 12887389Sun 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.
PubMed 19468874Konttinen 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.
PubMed 8024624Sun 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.
PubMed 24502534
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effects of Intraarticular Botulinum Toxin A Versus Hyaluronate Plus Rehabilitation Exercise in Patients With Unilateral Ankle Osteoarthritis
- ClinicalTrials.gov ID
- NCT01760577
- Acronym / sponsor ID
- VGHKS100-061
- Conditions
- Ankle Osteoarthritis
- Keywords
- osteoarthritis, botulinum toxin, hyaluronate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Botulinum Toxin A group | Experimental | Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA)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. |
| The hyaluronate group (Hyalgan, Italy) | Active comparator | Drug: Hyalgan (Hyalgan, Fidia , 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 . |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin A (Allergan, Inc, Irvine CA)Also: 100 units of Botulinum Toxin A in 2 cc NSpatients received intraarticular injections by the same experienced physician using aseptic procedures. | Drug | The Botulinum Toxin A group |
| Hyalgan (Hyalgan, Fidia , Italy)Also: 2 ml Hyalgan, molecular weight 500-730kDa, Fidia , ItalyThe 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. | Drug | The hyaluronate group (Hyalgan, Italy) |
Primary outcome
Ankle Osteoarthritis Scale (AOS) score
Time frame: at 6 months after the injection
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
6 secondary outcomes
AOFAS ankle/hindfoot score
Time frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection.
Visual analog scale (VAS)
Time frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
Single-leg stance test (SLS)
Time frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
Timed " Up-and-Go" test (TUG)
Time frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
global Patients satisfaction
Time frame: at 2 weeks, 1 month, 3 months, and 6 months post injection.
adverse effects
Time frame: at 2 weeks, 1 month, 3 months, and 6 months post injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
- Background: PubMed 16635582Sun 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.
- Background: PubMed 21938376Sun 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.
- Background: PubMed 16785116Mahowald 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.
- Background: PubMed 19131763Singh 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.
- Background: PubMed 19375681Singh 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.
- Background: PubMed 19351542Mahowald 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.
- Background: PubMed 12887389Aoki 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.
- Background: PubMed 19468874Sun 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.
- Background: PubMed 8024624Konttinen 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.
- Derived from this study: PubMed 24502534Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Fen Sun, MD principal investigator
Kaohsiung Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin A (Allergan, Inc, Irvine CA) and Hyalgan (Hyalgan, Fidia , Italy) in people with Ankle Osteoarthritis, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Osteoarthritis Scale (AOS) score (time frame: at 6 months after the injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01760577, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013; AzTrials last refreshed its copy on 7 Nov 2026.