OsteoarthritisNCT01739296
Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis
A study testing Lateral wedge insole with subtalar strapping in people with Osteoarthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Lateral wedge insole with subtalar strapping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Meet the American College of Rheumatology criteria for knee Osteoarthritis
- Varus malalignment of the knee
- Absence of previous fracture on the index knee
- Absence of previous surgery on the index knee
- Absence of Rheumatoid Arthritis
- No Intra-articular injection on the index knee in the past 6 months
- Receiving usual care for Osteoarthritis for at least 6 months
- Be able to understand and agree with the informed consent
Who cannot join
- Undergo surgery during the study
- Undergo Intra-articular injection during the study
- Develop articular infection of the index joint during the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Ortopedia e Traumatologia HC-FMUSP
São Paulo, São Paulo, 05410-000
About this study
Official title: Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis: a Randomized Clinical Trial
This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment.
Read the detailed description
The objective of this study is to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment. Fifty-eight patients with knee osteoarthritis were randomized to use either a lateral wedge or a neutral insole. VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne questionnaires were applied at baseline, and weeks two, eight, and 24.
- Conditions
- Osteoarthritis
- Being tested
- Neutral insole with subtalar strapping (sham), Lateral wedge insole with subtalar strapping
- Keywords
- osteoarthritis, osteoarthritis, knee, foot orthoses, orthotic insoles
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral insole with subtalar strapping (sham)Other
Also called Neutral
Neutral insole with subtalar strapping (sham)
Lateral wedge insole with subtalar strappingOther
Also called Wedge
Lateral wedge insole with subtalar strapping
| Study group | Role | What they receive |
|---|---|---|
| Wedge | Experimental | Lateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily Receives: Other: Lateral wedge insole with subtalar strapping |
| Neutral | Sham comparator | Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily Receives: Other: Neutral insole with subtalar strapping (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms
Evaluation of patient's symptoms using WOMAC (western ontario and mcmaster universities osteoarthritis index), VAS (visual analogic scale of pain) and Lequesne questionaires
Measured: 24 weeks
Secondary outcomes (1)
Ankle pain
Number of patients that reported ankle pain related to the use of the insole as a measure of tolerability
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gustavo C Campos, MD, Principal investigator, FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739296
- Sponsor's protocol ID
- 839/2011
- Status last verified
- Sep 2013
- First submitted
- 22 Nov 2012
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01739296
- Acronym / sponsor ID
- 839/2011
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, osteoarthritis, knee, foot orthoses, orthotic insoles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 Dec 2012 (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.
This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment.
Detailed description
The objective of this study is to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment. Fifty-eight patients with knee osteoarthritis were randomized to use either a lateral wedge or a neutral insole. VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne questionnaires were applied at baseline, and weeks two, eight, and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wedge | Experimental | Other: Lateral wedge insole with subtalar strappingLateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily |
| Neutral | Sham comparator | Other: Neutral insole with subtalar strapping (sham)Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Meet the American College of Rheumatology criteria for knee Osteoarthritis
- Varus malalignment of the knee
- Absence of previous fracture on the index knee
- Absence of previous surgery on the index knee
- Absence of Rheumatoid Arthritis
Key exclusion criteria (3 listed)
- Undergo surgery during the study
- Undergo Intra-articular injection during the study
- Develop articular infection of the index joint during the study
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 |
|---|---|---|
| Neutral insole with subtalar strapping (sham)Also: NeutralNeutral insole with subtalar strapping (sham) | Other | Neutral |
| Lateral wedge insole with subtalar strappingAlso: WedgeLateral wedge insole with subtalar strapping | Other | Wedge |
Primary outcome
Symptoms
Time frame: 24 weeks
Evaluation of patient's symptoms using WOMAC (western ontario and mcmaster universities osteoarthritis index), VAS (visual analogic scale of pain) and Lequesne questionaires
1 secondary outcome
Ankle pain
Time frame: 24 weeks
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 11 Sep 2013.
- Brazilian Orthopaedics AssociationLink provided by the sponsor.
- Orthopaedics and Traumatology Institute websiteLink provided by the sponsor.
- University of São Paulo websiteLink provided by the sponsor.
- Brazilian Knee Surgery Association websiteLink provided by the sponsor.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Gustavo C Campos, MD principal investigator
FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral wedge insole with subtalar strapping in people with Osteoarthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 8 inclusion and 3 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 11 Sep 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Symptoms (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2013.