Clinical trial NCT06836934: Soft Knee Brace Versus Lateral Wedge in Knee Osteoarthritis
Official title: SOFT KNEE BRACE VERSUS LATERAL WEDGE FOOT INSOLE on PAIN and PROPRIOCEPTION in KNEE OSTEOARTHRITIS PATIENTS.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Knee Osteoarthristis
Keywords: knee osteoarthritis soft knee brace lateral wedge foot insole
proprioception pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: soft knee brace and lateral wedge foot insole
Primary purpose: TREATMENT

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.

Osteoarthritis wedged insoles for patients with medial compartment knee osteoarthritis is certainly a very interesting treatment option because of its low cost, low complexity and virtually absence of side effects.

To reduce pain, improve physical function, and, possibly, slow disease progression in KOA, the use of knee braces has often been suggested. These are generally the main purposes of knee braces, but the optimal choice for an orthosis remains unclear, and long-term implications are lacking. A variety of different bracing types, manufacturers, and products are currently available on the market. Short-lever elastic knee braces have been used to improve pain, specifically during squats or walking, and daily use or the use of soft knee braces while resting is suggested to provide moderate pain relief and small-to-moderate effects on performance-based physical function in patients. Several authors, with respect to these findings, highlight the importance of soft braces to improve pain reduction and physical function in both the short and long term in KOA treatment, but additional high-quality studies are warranted to improve confidence in the findings

that lateral wedge insoles may be modestly effective in reducing pain in patients with medial knee OA. However, the treatment effect was small and most treated patients did not achieve conventional levels of min imally important response. Future modifications of the screening strategy or treatment might offer greater levels of efficacy.

Eligibility criteria: Inclusion Criteria:

1. Their ages range from 40-60 years old.
2. 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.
3. The patients Kellgren Lawrence scores grade II-IV.
4. All the patients included had a minimum score of 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total scores.
5. Unilateral symptomatic knee.

Exclusion Criteria:

* 1. high tibial osteotomy other realignment surgery 2. knee replacement 3. knee arthroscopy within the last 6 months. 4. an intraarticular injection within the past 3 months. 5. rheumatoid arthritis or patellofemoral syndrome 6. diabetic neuropathic pain or fibromyalgia. 7. foot or ankle problems that contraindicated the use of load-modifying interventions in footwear 8. body mass index (BMI) ≥35 kg/m2.

Primary outcomes:
measure: pain intenisty
timeFrame: 2 months
Secondary outcomes:
measure: proprioception
timeFrame: 2 months
measure: physical function
timeFrame: 2 months
measure: range of motion
timeFrame: 2 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Universty
Study officials:
affiliation: cairo universty
name: omar ha abdelmoamen el sayed
role: PRINCIPAL_INVESTIGATOR
References: