Osteo Arthritis KneeNCT04536519
Foot Wear Modification Along With Physical Therapy in Knee Osteoarthritis
A study testing osteoarthritis management in people with Osteo Arthritis Knee, run by Isra University at 1 site in Pakistan.
Trial summary
Orthotics and Prosthetics are important areas where physiotherapists order a variety of assistive aids to restore, compensate, or prevent physical ailments and disorders, such as here, Knee Osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- osteoarthritis management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Oct 2019to 29 Mar 2022
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both gender
- diagnosed patient with knee osteoarthritis on clinical and radiographic basis,
- aged 50 years or above,
- knee pain from at least one month with an intensity equal or more than 4 on 11 points Numeric rating pain scale,
- falling between grade 2-3 on Kellgren-Lawrence Classification System for knee osteoarthritis,
- having BMI range between 22-25 kg/m2 and participating in study with their own will with a signed consent form.
Who cannot join
- trauma in knee region,
- having knee or lower limb surgery for fracture or arthroplasty,
- getting steroid based intra-articular injection or physiotherapy treatment in last 6 months,
- getting lidocaine intra-articular injection in last one month, with condition of systemic arthritic condition, severe co-morbidities or
- serious medical conditions or systemic disease causing dependent edema making difficult to wear foot wear in open or close shoes.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Janjua Rehab Center, Gujranwala
Chak One Hundred Seventy-five Nine Left, Punjab Province
About this study
Official title: Effects Of Foot Wear Modification Along With Physical Therapy On Functional Status In Knee Osteoarthritis
Orthotics and Prosthetics are important areas where physiotherapists order a variety of assistive aids to restore, compensate, or prevent physical ailments and disorders, such as here, Knee Osteoarthritis.
This study will be helpful not only in establishing the role of footwear modification as an adjunct treatment protocol for knee osteoarthritis but also elicit a multidisciplinary team approach which is a much-needed area, especially in the emergency rehabilitation area.
Read the detailed description
2.1 MULTIDISCIPLINARY TEAM APPROACH As defined by World Health Organization, Curriculum Contents and International Practice Patterns, physical therapy is an autonomous profession where clinical make clinical decisions based on clinical reasoning, differentially diagnose, determine prognosis, and make plan of care including discharge planning and outcome assessment.
Orthotics and Prosthetics are important areas where physiotherapist order variety of assistive aids to restore, compensate or prevent physical ailments and disorders, such as here, Knee Osteoarthritis.
This study will be helpful not only establishing role of foot wear modification as adjunct treatment protocol for knee osteoarthritis but also elicit a multidisciplinary team approach which is a much needed area especially in emergency rehabilitation area.
2.2 LITERATURE GAP Although, there is work on performance of modified foot wears, which have been studied mostly alone or as adjunct with pharmacology. There is less literature on conservative treatment of osteoarthritis with foot wear modification coupled with physiotherapy treatment. This study will create a unique impact paying ways for type of preferable footwear that should be used, based on results, and combining treatment with physiotherapy care.
2.3 UNSETTLED DEBATE OVER TYPE OF FOOTWEAR The debate is still underway, worldwide, regarding which shoe type or foot wear should be preferred over other. The study results will come up with a contribution towards determining right foot wear for osteoarthritis.
2.4 COST EFFECTIVENESS The knee osteoarthritis is a problem that degenerative in nature and is triggered due to posture and abnormal force distribution. Right shoes are proven to alter walk posture, step length and degree of ease in walk. This simple remedy can be integral for reduction in care cost by minimizing disability and pain.
2.5 NOVEL SHOE MAKING APPROACH Although, advising foot wears and its modification is technical phenomenon, yet, this study can impact formulation of a shoe pattern that can help the arthritis patients. This can open new shoe making approach on public shoe outlets, from where old age individuals can directly buy the shoes that be the potential healer and disease modifier.
- Conditions
- Osteo Arthritis Knee
- Being tested
- osteoarthritis management
- Keywords
- osteoarthritis, knee joint
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteoarthritis managementOther
Also called physical therapy
The conventional physical therapy will be consisted of an array of protocols being deployed in parallel. This will consist of
- Patient education regarding deforming forces, strategies of prevention and home exercise program
- Decreasing stiffness by controlled active range of motion and mobilization techniques involving join play.
- Mechanical stresses will be controlled in form of support provided by foot wear modification
- Range of motion will be increased muscle stretches and manual mobilization techniques
- Muscle performance and neuromuscular control will be addressed by gentle exercises of low intensity and repetitive exercises.
- Balance improvement by employing balance training activities as part of treatment
- Physical conditioning low impact or non-impact aerobics This conventional exercise will be given as baseline treatment to both of groups.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Heel Wedged Insole Alone with physical therapy | Active comparator | the lateral heel wedged insole (19) comprised non-custom, high density based on insoles of ethyl-vinyl acetate distributed bilaterally, preferably, covered in leather, were used in the study. The insole were equipped with a lateral wedge of 50 to 60.
In the case of unilateral knee osteoarthritis, the non-wedge insole were used to compensate for possible leg length discrepancy in the contra-lateral leg. Shoes used was based on gymnast type to keep wedge insole in place. This further finalized individual to individual with unanimous decisions of Cordwainers, orthotics, and principal researcher, physiotherapist. Receives: Other: osteoarthritis management |
| Lateral aand medial Heel Wedged Insole with physiotherapy | Active comparator | medial arch support part were combine with aforementioned lateral heel wedged support, full length support. There is a debate, however, 4 to 6 mm of full length support is considered to be effective for required alteration in mechanics Receives: Other: osteoarthritis management |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee osteoarthritis outcome score
questionaire used to evaluate charecteristics of knee joint
Measured: 24 week
The Western Ontario and McMaster Universities Osteoarthritis Index
questionaire used to evaluate charecteristics of knee joint
Measured: 24 week
Short Form 36 Health Survey Questionnaire
The Short Form 36 Health Survey Questionnaire (SF-36) is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions. Culture-specific data are required to calculate SF-36 norm-based scores.
Measured: 24 week
Secondary outcomes (1)
Manual Muscle Testing
muscle grading and power evaluation
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start5 Oct 2019
- Primary completion10 Dec 2021
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Model description
- a randomized controlled trial with 2 group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usman janjua, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536519
- Sponsor's protocol ID
- 1502-PHD-001
- Status last verified
- Mar 2022
- First submitted
- 20 Aug 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Transcript and interview recording will be kept in a password protected environment. Identifying details will be taken out during data collection and analysis, any final report and any publication so people reading these will not able to identify these details. The documents pertaining to the administration of the research, such as consent form will be kept in a folder called project folder. This is a locked away security. People who are allowed to see the documents cannot pass this information to anyone else. All the documents will be destroyed after 7 years while audio recording will be erased after 2 years. Only staff involved in the data collection and analysis and people in authority will know the identity of the patients. Patients who will meet the criteria, their recruitment process will be kept secret only staff physiotherapist will know about it.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Foot Wear Modification Along With Physical Therapy On Functional Status In Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04536519
- Acronym / sponsor ID
- 1502-PHD-001
- Conditions
- Osteo Arthritis Knee
- Keywords
- osteoarthritis, knee joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 2 Sep 2020 (actual)
- 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.
Orthotics and Prosthetics are important areas where physiotherapists order a variety of assistive aids to restore, compensate, or prevent physical ailments and disorders, such as here, Knee Osteoarthritis.
This study will be helpful not only in establishing the role of footwear modification as an adjunct treatment protocol for knee osteoarthritis but also elicit a multidisciplinary team approach which is a much-needed area, especially in the emergency rehabilitation area.
Detailed description
2.1 MULTIDISCIPLINARY TEAM APPROACH As defined by World Health Organization, Curriculum Contents and International Practice Patterns, physical therapy is an autonomous profession where clinical make clinical decisions based on clinical reasoning, differentially diagnose, determine prognosis, and make plan of care including discharge planning and outcome assessment.
Orthotics and Prosthetics are important areas where physiotherapist order variety of assistive aids to restore, compensate or prevent physical ailments and disorders, such as here, Knee Osteoarthritis.
This study will be helpful not only establishing role of foot wear modification as adjunct treatment protocol for knee osteoarthritis but also elicit a multidisciplinary team approach which is a much needed area especially in emergency rehabilitation area.
2.2 LITERATURE GAP Although, there is work on performance of modified foot wears, which have been studied mostly alone or as adjunct with pharmacology. There is less literature on conservative treatment of osteoarthritis with foot wear modification coupled with physiotherapy treatment. This study will create a unique impact paying ways for type of preferable footwear that should be used, based on results, and combining treatment with physiotherapy care.
2.3 UNSETTLED DEBATE OVER TYPE OF FOOTWEAR The debate is still underway, worldwide, regarding which shoe type or foot wear should be preferred over other. The study results will come up with a contribution towards determining right foot wear for osteoarthritis.
2.4 COST EFFECTIVENESS The knee osteoarthritis is a problem that degenerative in nature and is triggered due to posture and abnormal force distribution. Right shoes are proven to alter walk posture, step length and degree of ease in walk. This simple remedy can be integral for reduction in care cost by minimizing disability and pain.
2.5 NOVEL SHOE MAKING APPROACH Although, advising foot wears and its modification is technical phenomenon, yet, this study can impact formulation of a shoe pattern that can help the arthritis patients. This can open new shoe making approach on public shoe outlets, from where old age individuals can directly buy the shoes that be the potential healer and disease modifier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- a randomized controlled trial with 2 group
| Arm | Type | Receives |
|---|---|---|
| Lateral Heel Wedged Insole Alone with physical therapy | Active comparator | Other: osteoarthritis managementthe lateral heel wedged insole (19) comprised non-custom, high density based on insoles of ethyl-vinyl acetate distributed bilaterally, preferably, covered in leather, were used in the study. The insole were equipped with a lateral wedge of 50 to 60. In the case of unilateral knee osteoarthritis, the non-wedge insole were used to compensate for possible leg length discrepancy in the contra-lateral leg. Shoes used was based on gymnast type to keep wedge insole in place. This further finalized individual to individual with unanimous decisions of Cordwainers, orthotics, and principal researcher, physiotherapist. |
| Lateral aand medial Heel Wedged Insole with physiotherapy | Active comparator | Other: osteoarthritis managementmedial arch support part were combine with aforementioned lateral heel wedged support, full length support. There is a debate, however, 4 to 6 mm of full length support is considered to be effective for required alteration in mechanics |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- both gender
- diagnosed patient with knee osteoarthritis on clinical and radiographic basis,
- aged 50 years or above,
- knee pain from at least one month with an intensity equal or more than 4 on 11 points Numeric rating pain scale,
- falling between grade 2-3 on Kellgren-Lawrence Classification System for knee osteoarthritis,
Key exclusion criteria (5 listed)
- trauma in knee region,
- having knee or lower limb surgery for fracture or arthroplasty,
- getting steroid based intra-articular injection or physiotherapy treatment in last 6 months,
- getting lidocaine intra-articular injection in last one month, with condition of systemic arthritic condition, severe co-morbidities or
- serious medical conditions or systemic disease causing dependent edema making difficult to wear foot wear in open or close shoes.
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 |
|---|---|---|
| osteoarthritis managementAlso: physical therapyThe conventional physical therapy will be consisted of an array of protocols being deployed in parallel. This will consist of * Patient education regarding deforming forces, strategies of prevention and home exercise program * Decreasing stiffness by controlled active range of motion and mobilization techniques involving join play. * Mechanical stresses will be controlled in form of support provided by foot wear modification * Range of motion will be increased muscle stretches and manual mobilization techniques * Muscle performance and neuromuscular control will be addressed by gentle exercises of low intensity and repetitive exercises. * Balance improvement by employing balance training activities as part of treatment * Physical conditioning low impact or non-impact aerobics This conventional exercise will be given as baseline treatment to both of groups. | Other | Lateral Heel Wedged Insole Alone with physical therapy, Lateral aand medial Heel Wedged Insole with physiotherapy |
Primary outcome
knee osteoarthritis outcome score
Time frame: 24 week
questionaire used to evaluate charecteristics of knee joint
The Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 24 week
questionaire used to evaluate charecteristics of knee joint
Short Form 36 Health Survey Questionnaire
Time frame: 24 week
The Short Form 36 Health Survey Questionnaire (SF-36) is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions. Culture-specific data are required to calculate SF-36 norm-based scores.
1 secondary outcome
Manual Muscle Testing
Time frame: 24 week
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 31 Mar 2022.
- Individual participant dataSharing planned: No. Transcript and interview recording will be kept in a password protected environment. Identifying details will be taken out during data collection and analysis, any final report and any publication so people reading these will not able to identify these details. The documents pertaining to the administration of the research, such as consent form will be kept in a folder called project folder. This is a locked away security. People who are allowed to see the documents cannot pass this information to anyone else. All the documents will be destroyed after 7 years while audio recording will be erased after 2 years. Only staff involved in the data collection and analysis and people in authority will know the identity of the patients. Patients who will meet the criteria, their recruitment process will be kept secret only staff physiotherapist will know about it.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteoarthritis management in people with Osteo Arthritis Knee, run by Isra University at 1 site in Pakistan.
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 5 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 31 Mar 2022. 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 Pakistan. 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?
knee osteoarthritis outcome score (time frame: 24 week). The study lists 3 primary outcomes in all. 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 31 Mar 2022.