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Enrolling by invitation NCT06836934

Soft Knee Brace Versus Lateral Wedge in Knee Osteoarthritis

No phase Interventional Knee Osteoarthristis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: soft knee brace, lateral wedge foot insole, convential physical therapy program.
Who it may be relevant to
Registry conditions: Knee Osteoarthristis. Basic parameters: 40 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

SOFT KNEE BRACE VERSUS LATERAL WEDGE FOOT INSOLE on PAIN and PROPRIOCEPTION in KNEE OSTEOARTHRITIS PATIENTS.

Overview

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.

Interventions

  • Device soft knee brace
    A commercially available soft brace (orthomedics ser. number 86) plus traditional physiotherapy
  • Device lateral wedge foot insole
    Wearing Lateral wedge insole 5mm for 8 weeks Standardized non-customized laterally wedged insoles were evaluated. Insoles were made of high-density ethyl vinyl acetate, were wedged approximately 5°
  • Procedure convential physical therapy program
    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 Exer

Primary outcome measures

  • pain intenisty [Time frame: 2 months]
Secondary outcome measures (3)
  • proprioception [Time frame: 2 months]
  • physical function [Time frame: 2 months]
  • range of motion [Time frame: 2 months]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo Universty — Giza

Identifiers

NCT: NCT06836934 · P.T.REC/012/005582

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗