Soft Knee Brace Versus Lateral Wedge in Knee Osteoarthritis

NCT ID: NCT06836934

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-02-26

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.

Conditions

Knee Osteoarthristis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

convential physical therapy program

Intervention Type: PROCEDURE

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 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 (J. D. Deyle et al 2005) TENS (Transcutaneous Electrical Nerve Stimulation): Helps manage pain by sending electrical impulses to the affected area.

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

Group Type: EXPERIMENTAL

soft knee brace

Intervention Type: DEVICE

A commercially available soft brace (orthomedics ser. number 86) plus traditional physiotherapy

convential physical therapy program

Intervention Type: PROCEDURE

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 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 (J. D. Deyle et al 2005) TENS (Transcutaneous Electrical Nerve Stimulation): Helps manage pain by sending electrical impulses to the affected area.

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

Group Type: EXPERIMENTAL

lateral wedge foot insole

Intervention Type: DEVICE

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°

convential physical therapy program

Intervention Type: PROCEDURE

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 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 (J. D. Deyle et al 2005) TENS (Transcutaneous Electrical Nerve Stimulation): Helps manage pain by sending electrical impulses to the affected area.

Interventions

soft knee brace

A commercially available soft brace (orthomedics ser. number 86) plus traditional physiotherapy

Intervention Type: 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°

Intervention Type: DEVICE

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 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 (J. D. Deyle et al 2005) TENS (Transcutaneous Electrical Nerve Stimulation): Helps manage pain by sending electrical impulses to the affected area.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

omar hashem abd el moamen elsayed

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

omar ha abdelmoamen el sayed

Role: PRINCIPAL_INVESTIGATOR

cairo universty

Locations

Cairo Universty

Giza, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/005582

Identifier Type: -

Identifier Source: org_study_id