Knee OsteoarthritisPhase 3NCT01765101
Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis
A Phase 3 study testing customized insoles and ready made insoles in people with Knee Osteoarthritis, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis, under the basis of International… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- customized insoles and ready made insoles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Dec 2013
- Phase
- Phase 3
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fulfill the combined clinical and radiographic criteria for knee osteoarthritis, as established by the American College of Rheumatology
- with Kellgren-Lawrence scores of 2 or higher in the isolated medial compartment
Who cannot join
- with a history of previous knee surgery with an implant
- reduced lateral compartment and/or combined medial and lateral compartments in knee joints were excluded
- pregnant or planning to become pregnant
- self-reported history of vertigo, malignancy, stroke, or other conditions that may impair vestibular function
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111-01
Ru-Lan Hsieh, MD, 886-2-28332211 ext. 2531, M001052@ms.skh.org.tw
Ru-Lan Hsieh, MD
About this study
Official title: Therapeutic Effects of Ready-made Full-length Lateral Wedged Insoles and Customized Full-length Lateral Wedged Insoles on Patients With Knee Osteoarthritis : a Double Blind, Randomized Controlled Study
Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis, under the basis of International Classification Functioning, Disability and Health.
Read the detailed description
A total of 90 patients will be collected. The participants will be randomized into two groups, including ready-made full-length lateral wedged shoe insoles group and customized full-length lateral wedged shoe insoles group. The psychological function (Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire), physical activity (CHAMPS physical activity questionnaire), functional performance (Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score) and quality of life (World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life) will be evaluated. Physical functional ability (10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time), pain (Visual analog scale, pain pressure threshold ) and balance performance (static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk) will be evaluated before and immediately after the ready-made full-length shoe insoles and customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, pain, balance, psychological, physical activity, functional performance, and quality of life, will be re-evaluated at one month after and three months after modified shoe insoles wearing. Subjects and evaluator were both blinded to the group's classification during the whole course of study.
- Conditions
- Knee Osteoarthritis
- Being tested
- customized insoles, ready made insoles
- Keywords
- knee osteoarthritis, therapeutic effect, insole
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customized insolesOther
Also called customized full-length lateral wedged insoles: ICB
To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance
ready made insolesOther
Also called ready made full-length lateral wedged insoles: La New
To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance
| Study group | Role | What they receive |
|---|---|---|
| customized insoles | Experimental | customized full-length lateral wedged shoe insoles
1 month and 3 months study the immediate, short-term and intermediate-term therapeutic effects Receives: Other: customized insoles |
| ready made insoles | Placebo comparator | ready-made full-length lateral wedged shoe insoles at 1 and 3 months
study the immediate, short-term and intermediate-term therapeutic effects Receives: Other: ready made insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Visual analog scale, pain pressure threshold
Measured: change from baseline at one month and three months after modified shoe insoles wearing
Secondary outcomes (6)
Physical functional ability
10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time
Measured: change from baseline at one month and three months after modified shoe insoles wearing
psychological function
Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire
Measured: change from baseline at one month and three months after modified shoe insoles wearing
functional performance
Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score
Measured: change from baseline at one month and three months after modified shoe insoles wearing
quality of life
World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life
Measured: change from baseline at one month and three months after modified shoe insoles wearing
balance performance
static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk
Measured: change from baseline at one month and three months after modified shoe insoles wearing
physical activity
CHAMPS physical activity questionnaire
Measured: change from baseline at one month and three months after modified shoe insoles wearing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765101
- Sponsor's protocol ID
- SKH-8302-102-DR-32
- Status last verified
- Jan 2013
- First submitted
- 4 Jan 2013
- Last updated
- 11 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Ready-made Full-length Lateral Wedged Insoles and Customized Full-length Lateral Wedged Insoles on Patients With Knee Osteoarthritis : a Double Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01765101
- Acronym / sponsor ID
- SKH-8302-102-DR-32
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, therapeutic effect, insole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 10 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.
Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis, under the basis of International Classification Functioning, Disability and Health.
Detailed description
A total of 90 patients will be collected. The participants will be randomized into two groups, including ready-made full-length lateral wedged shoe insoles group and customized full-length lateral wedged shoe insoles group. The psychological function (Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire), physical activity (CHAMPS physical activity questionnaire), functional performance (Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score) and quality of life (World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life) will be evaluated. Physical functional ability (10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time), pain (Visual analog scale, pain pressure threshold ) and balance performance (static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk) will be evaluated before and immediately after the ready-made full-length shoe insoles and customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, pain, balance, psychological, physical activity, functional performance, and quality of life, will be re-evaluated at one month after and three months after modified shoe insoles wearing. Subjects and evaluator were both blinded to the group's classification during the whole course of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| customized insoles | Experimental | Other: customized insolescustomized full-length lateral wedged shoe insoles 1 month and 3 months study the immediate, short-term and intermediate-term therapeutic effects |
| ready made insoles | Placebo comparator | Other: ready made insolesready-made full-length lateral wedged shoe insoles at 1 and 3 months study the immediate, short-term and intermediate-term therapeutic effects |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- fulfill the combined clinical and radiographic criteria for knee osteoarthritis, as established by the American College of Rheumatology
- with Kellgren-Lawrence scores of 2 or higher in the isolated medial compartment
Key exclusion criteria (4 listed)
- with a history of previous knee surgery with an implant
- reduced lateral compartment and/or combined medial and lateral compartments in knee joints were excluded
- pregnant or planning to become pregnant
- self-reported history of vertigo, malignancy, stroke, or other conditions that may impair vestibular function
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 |
|---|---|---|
| customized insolesAlso: customized full-length lateral wedged insoles: ICBTo study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance | Other | customized insoles |
| ready made insolesAlso: ready made full-length lateral wedged insoles: La NewTo study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance | Other | ready made insoles |
Primary outcome
pain
Time frame: change from baseline at one month and three months after modified shoe insoles wearing
Visual analog scale, pain pressure threshold
6 secondary outcomes
Physical functional ability
Time frame: change from baseline at one month and three months after modified shoe insoles wearing
psychological function
Time frame: change from baseline at one month and three months after modified shoe insoles wearing
functional performance
Time frame: change from baseline at one month and three months after modified shoe insoles wearing
quality of life
Time frame: change from baseline at one month and three months after modified shoe insoles wearing
balance performance
Time frame: change from baseline at one month and three months after modified shoe insoles wearing
physical activity
Time frame: change from baseline at one month and three months after modified shoe insoles wearing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2013.
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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.
Ru-Lan Hsieh, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing customized insoles and ready made insoles in people with Knee Osteoarthritis, run by Taipei Medical University 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru-Lan Hsieh, MD (886-2-28332211 ext. 2531, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: change from baseline at one month and three months after modified shoe insoles wearing). 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 Jan 2013.