Clinical trial NCT04536519: Foot Wear Modification Along With Physical Therapy in Knee Osteoarthritis
Official title: Effects Of Foot Wear Modification Along With Physical Therapy On Functional Status In Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: osteoarthritis
knee joint
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized controlled trial with 2 group
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: knee osteoarthritis outcome score
timeFrame: 24 week
measure: The Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 24 week
measure: Short Form 36 Health Survey Questionnaire
timeFrame: 24 week
Secondary outcomes:
measure: Manual Muscle Testing
timeFrame: 24 week
Other outcomes:
Locations:
city: Gujrānwāla
country: Pakistan
facility: Janjua Rehab Center, Gujranwala
state: Punjab
Study officials:
References: