SOFT KNEE BRACE VERSUS LATERAL WEDGE FOOT INSOLE on PAIN and PROPRIOCEPTION in KNEE OSTEOARTHRITIS PATIENTS.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Cairo University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- pain intenisty
Study Overview
Brief Summary
the aim of study is to investigate the efficacy of soft knee brace versus lateral wedge foot insole on pain and proprioception in knee OA
Detailed Description
Osteoarthritis is the most common disease of joints in adults around the world. Felson et al. reported that about one-third of all adults have radiological signs of osteoarthritis.
. according to epidemiological study the prevalence of knee osteoarthritis in the The Middle East and North Africa ( MENA) region increased 2.88-fold, from 6.16 million cases to 17.75 million, between 1990 and 2019 in MENA.
Individuals with knee OA may have a variety of impairments and functional limitations that prevent them from participating in regular exercise and physical activity. Physical therapists can offer a variety of supplemental treatment approaches that may help patients overcome these barriers and enhance the overall effectiveness of exercise therapy programs.
Soft braces are elastic, non-adhesive orthoses recommended in the non-surgical management of patients with knee osteoarthritis (OA). Because of ease of use, lack of complications, and low cost, soft braces are commonly used with the aim of reducing pain and activity limitations.
.according to Cudejko ,study in 2019 This study shows that decreased pain and reduced dynamic knee instability are pathways by which wearing a soft knee brace decreases activity limitations in patients with knee OA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Their ages range from 40-60 years old.
- •The patients included to this study according to American College of Rheumatology (ACR) criteria, namely, knee pain; and/or morning stiffness longer than 30 minutes and/or joint crepitus.
- •The patients Kellgren Lawrence scores grade II-IV.
- •All the patients included had a minimum score of 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total scores.
- •Unilateral symptomatic knee.
Exclusion Criteria
- •high tibial osteotomy other realignment surgery
- •knee replacement
- •knee arthroscopy within the last 6 months.
- •an intraarticular injection within the past 3 months.
- •rheumatoid arthritis or patellofemoral syndrome
- •diabetic neuropathic pain or fibromyalgia.
- •foot or ankle problems that contraindicated the use of load-modifying interventions in footwear
- •body mass index (BMI) ≥35 kg/m2.
Arms & Interventions
conventional physical therapy
the patient will receive treatment For 8weeks three times a week
Strengthening Exercises:
- Quadriceps Strengthening: Exercises like straight leg raises, quadriceps sets, and seated knee extensions help strengthen the quadriceps muscle, which supports the knee joint.
- Hamstring Strengthening: Hamstring curls and bridges target the hamstrings to enhance stability and support for the knee.
- Hip Strengthening: Exercises such as hip abductions, adductions, and clamshells strengthen the hip muscles (each 3 sets, 10 reps).
Flexibility Exercises:
- Hamstring Stretch: Gentle stretching of the hamstrings can alleviate tension around the knee.
- Quadriceps Stretch: Stretches like the standing quadriceps stretch help maintain flexibility in the front of the thigh.
- Calf Stretch: Stretching the calf muscles can prevent tightness TENS (Transcutaneous Electrical Nerve Stimulation): Helps manage pain by sending electrical impulses to the affected area.
Intervention: convential physical therapy program (Procedure)
soft knee brace
the patient will Wear soft knee brace for 8 weeks plus traditional physical therapy A commercially available soft brace (orthopedics ser. number 86) plus traditional physiotherapy The patient will wear the brace brace except for sleeping
A tight brace was defined as one that was fitted based on shank and thigh circumferences measured according to instructions provided by the distributor (standard fit). A non-tight brace was defined as being 1 size larger than a tight brace. plus conventional therapy Strengthening Exercises:
- Quadriceps Strengthening: Exercises like straight leg raises, quadriceps sets, and seated knee extensions help strengthen the quadriceps muscle, which supports the knee joint.
- Hamstring Strengthening: Hamstring curls and bridges target the hamstrings to enhance stability and support for the knee.
- Hip Strengthening: Exercises such as hip abductions, adductions, and clamshells strengthen the hip muscles (each 3 sets, 10 reps). (Deyle et al ., 2005) Flexibil
Intervention: soft knee brace (Device)
soft knee brace
the patient will Wear soft knee brace for 8 weeks plus traditional physical therapy A commercially available soft brace (orthopedics ser. number 86) plus traditional physiotherapy The patient will wear the brace brace except for sleeping
A tight brace was defined as one that was fitted based on shank and thigh circumferences measured according to instructions provided by the distributor (standard fit). A non-tight brace was defined as being 1 size larger than a tight brace. plus conventional therapy Strengthening Exercises:
- Quadriceps Strengthening: Exercises like straight leg raises, quadriceps sets, and seated knee extensions help strengthen the quadriceps muscle, which supports the knee joint.
- Hamstring Strengthening: Hamstring curls and bridges target the hamstrings to enhance stability and support for the knee.
- Hip Strengthening: Exercises such as hip abductions, adductions, and clamshells strengthen the hip muscles (each 3 sets, 10 reps). (Deyle et al ., 2005) Flexibil
Intervention: convential physical therapy program (Procedure)
lateral wedge foot insole
the patient will wear Lateral wedge insole 5mm for 8 weeks plus traditional physical therapy
Standardized non-customized laterally wedged insoles were evaluated. Insoles were made of high-density ethyl vinyl acetate, were wedged approximately 5° (as greater wedging is associated with foot discomfort and were worn inside the participant's own shoes. In loaded positions ,The insoles were wedged along the lateral edge of the entire length of the foot. Strengthening Exercises:
- Quadriceps Strengthening: Exercises like straight leg raises, quadriceps sets, and seated knee extensions help strengthen the quadriceps muscle, which supports the knee joint.
- Hamstring Strengthening: Hamstring curls and bridges target the hamstrings to enhance stability and support for the knee.
- Hip Strengthening: Exercises such as hip abductions, adductions, and clamshells strengthen the hip muscles (each 3 sets, 10 reps). (Deyle et al ., 2005)
Flexibility Exercises:
• Hamstring Stretch: Gentle stretc
Intervention: lateral wedge foot insole (Device)
lateral wedge foot insole
the patient will wear Lateral wedge insole 5mm for 8 weeks plus traditional physical therapy
Standardized non-customized laterally wedged insoles were evaluated. Insoles were made of high-density ethyl vinyl acetate, were wedged approximately 5° (as greater wedging is associated with foot discomfort and were worn inside the participant's own shoes. In loaded positions ,The insoles were wedged along the lateral edge of the entire length of the foot. Strengthening Exercises:
- Quadriceps Strengthening: Exercises like straight leg raises, quadriceps sets, and seated knee extensions help strengthen the quadriceps muscle, which supports the knee joint.
- Hamstring Strengthening: Hamstring curls and bridges target the hamstrings to enhance stability and support for the knee.
- Hip Strengthening: Exercises such as hip abductions, adductions, and clamshells strengthen the hip muscles (each 3 sets, 10 reps). (Deyle et al ., 2005)
Flexibility Exercises:
• Hamstring Stretch: Gentle stretc
Intervention: convential physical therapy program (Procedure)
Outcomes
Primary Outcomes
pain intenisty
Time Frame: 2 months
The visual analog scale (VAS) is the VAS, which consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) to the worst pain that could possibly feel (10)
Secondary Outcomes
- proprioception(2 months)
- physical function(2 months)
- range of motion(2 months)
Investigators
omar hashem abd el moamen elsayed
principle investigator
Cairo University