Knee OsteoarthristisNCT06836934
Soft Knee Brace Versus Lateral Wedge in Knee Osteoarthritis
A study testing soft knee brace, lateral wedge foot insole and convential physical therapy program in people with Knee Osteoarthristis, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- soft knee brace, lateral wedge foot insole and convential physical therapy program
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2024to 26 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SOFT KNEE BRACE VERSUS LATERAL WEDGE FOOT INSOLE on PAIN and PROPRIOCEPTION in KNEE OSTEOARTHRITIS PATIENTS.
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
Read the 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
- Being tested
- soft knee brace, lateral wedge foot insole, convential physical therapy program
- Keywords
- knee osteoarthritis soft knee brace lateral wedge foot insole, proprioception pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft knee braceDevice
A commercially available soft brace (orthomedics ser. number 86) plus traditional physiotherapy
lateral wedge foot insoleDevice
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 programProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| conventional physical therapy | Active comparator | 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. Receives: Procedure: convential physical therapy program |
| soft knee brace | Experimental | 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 Receives: Device: soft knee brace; Procedure: convential physical therapy program |
| lateral wedge foot insole | Experimental | 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 Receives: Device: lateral wedge foot insole; Procedure: convential physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intenisty
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)
Measured: 2 months
Secondary outcomes (3)
proprioception
Digital inclinometer is a valid tool alternative for isokinetic dynamometer in measuring active knee JPS in OA individuals at target angle 30˚ of knee flexion. However, there were high intra-class reliability and low inter-class reliability at target angle 30˚ of knee flexion. Also, the study revealed that another type of digital inclinometer (SPI Tronic, Penn tool co, Maplewood, NJ) is reliable and valid
Measured: 2 months
physical function
The WOMAC Osteoarthritis Index(English version) has been assessed for validity and reliability and it was reports that it is valid and reliable .The original English language version of the WOMAC Osteoarthritis Index has been translated and validated into more than fifty languages as German(7), French(8), Spanish(9), Italian (10), Turkish(11), Moroccan (12) and classic Arabic(13).The classic Arabic version of the WOMAC(ArWOMAC) was in literal Arabic language to match the largest Arab population use.
Measured: 2 months
range of motion
Knee flexion ROM measurement The individual was placed at dorsal decubitus, with 90 degrees of hip flexion. Hip positioning was guaranteed using a thigh device which aided in the maintenance of the pre-set position.
The digital inclinometer was placed proximally and anteriorly on the leg, resting on the tibial crest.
Knee extension ROM measurement The individual was at dorsal decubitus, with extended legs. The evaluated limb was raised by the heel, with knee stabilization in contact with the stretcher. The instruments positioning in relation to the segment was the same as the measurements performed for knee flexion.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Oct 2024
- Primary completion20 Feb 2025 (estimated)
- Study completion26 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- soft knee brace and lateral wedge foot insole
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, omar hashem abd el moamen elsayed, Cairo University
- Investigators
- omar ha abdelmoamen el sayed, Principal investigator, cairo universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836934
- Sponsor's protocol ID
- P.T.REC/012/005582
- Status last verified
- Nov 2024
- First submitted
- 16 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOFT KNEE BRACE VERSUS LATERAL WEDGE FOOT INSOLE on PAIN and PROPRIOCEPTION in KNEE OSTEOARTHRITIS PATIENTS.
- ClinicalTrials.gov ID
- NCT06836934
- Acronym / sponsor ID
- P.T.REC/012/005582
- Conditions
- Knee Osteoarthristis
- Keywords
- knee osteoarthritis soft knee brace lateral wedge foot insole, proprioception pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 26 Feb 2025 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- soft knee brace and lateral wedge foot insole
| Arm | Type | Receives |
|---|---|---|
| conventional physical therapy | Active comparator | Procedure: convential physical therapy programthe 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. |
| soft knee brace | Experimental | Device: soft knee brace, Procedure: convential physical therapy programthe 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 |
| lateral wedge foot insole | Experimental | Device: lateral wedge foot insole, Procedure: convential physical therapy programthe 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| soft knee braceA commercially available soft brace (orthomedics ser. number 86) plus traditional physiotherapy | Device | soft knee brace |
| lateral wedge foot insoleWearing 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° | Device | lateral wedge foot insole |
| convential physical therapy programStrengthening 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. | Procedure or surgery | conventional physical therapy, lateral wedge foot insole, soft knee brace |
Primary outcome
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)
3 secondary outcomes
proprioception
Time frame: 2 months
physical function
Time frame: 2 months
range of motion
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
omar ha abdelmoamen el sayed principal investigator
cairo universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft knee brace, lateral wedge foot insole and convential physical therapy program in people with Knee Osteoarthristis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intenisty (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.