Effects of Creatine Supplementation as Compared to Glucosamine/Chondroitin Sulfate Supplementation in Addition to Exercise and Physical Therapy in the Management of Knee Osteoarthritis.

Study Overview
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Brief Summary
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Osteoarthritis (OA) is one of the most common joint disorders, affecting not only the joints but also the surrounding muscles, which become weak. Resistance exercise reduces pain and improves function in patients with OA of the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used by patients with OA to reduce pain and thereby maintain the ability to perform daily activities. However, there is accumulating evidence for a negative effect of NSAIDs, thus many patients with OA are treated with dietary supplementations such as glucosamine and chondroitin sulfate, and some studies show a beneficial effects on cartilage and pain. However, their effect on OA symptoms and cartilage remains controversial. On the other hand creatine supplementation has also been observed to show promising effects when combined with resistance training exercise in the elderly, but the evidence is limited in terms of knee osteoarthritis. For this reason the purpose of this study is to determine the effects of creatine supplementation as compared to glucosamine/chondroitin sulfate in the management of knee osteoarthritis when combined with resistance training exercise.

Official Title
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Effects of Creatine Supplementation as Compared to Glucosamine/Chondroitin Sulfate Supplementation in Addition to Exercise and Physical Therapy in the Management of Knee Osteoarthritis.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: Creatine Supplementation
* Dietary Supplement: Glucosamine and Chondroitin sulfate supplementation
* Other: Supervised Exercise training
* Other: Home Exercise Program
* Procedure: Electrotherapy + Heating
* Procedure: Joint Mobilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-70 years Knee OA with history not less than three months. Radiological evidences of grade III or less on Kellgren classification. Knee pain on VNRS no more than 8/10 Exclusion Criteria: Neuromuscular conditions that may lead to fatigue such as multiple Sclerosis Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection). History of trauma or fractures in lower extremity. Signs of lumbar radiculopathy or myelopathy. History of knee surgery or replacement. Patients on intra-articular steroid therapy within two months before the commencement of the study. Impaired skin sensation. Impaired renal function

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group A (Creatine Supplementation)<br> | Dietary Supplement: Creatine Supplementation<br>* Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks<br>Other: Supervised Exercise training<br>* Lower Extremity Resistance Exercise Training Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM) 3 times supervised exercise for 4 weeks leg press, leg extension, Sit to stand squat (mini squats) Stationary Cycling (Maximum Resistance as per patient tolerance till failure) 3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval<br>Other: Home Exercise Program<br>* 2 sets of 10 repetitions/day of AROM isolated knee extension and knee flexion Isometric isolated knee extension and knee flexion Isometric terminal knee extension Sit to stand squat Isometric knee terminal extension<br>Procedure: Electrotherapy + Heating<br>* Interferential Current therapy (2P), in combination with heating pad for 20 minutes<br>Procedure: Joint Mobilization<br>* Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization<br>|
| Experimental: Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation)<br> | Dietary Supplement: Glucosamine and Chondroitin sulfate supplementation<br>* Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day<br>Other: Supervised Exercise training<br>* Lower Extremity Resistance Exercise Training Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM) 3 times supervised exercise for 4 weeks leg press, leg extension, Sit to stand squat (mini squats) Stationary Cycling (Maximum Resistance as per patient tolerance till failure) 3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval<br>Other: Home Exercise Program<br>* 2 sets of 10 repetitions/day of AROM isolated knee extension and knee flexion Isometric isolated knee extension and knee flexion Isometric terminal knee extension Sit to stand squat Isometric knee terminal extension<br>Procedure: Electrotherapy + Heating<br>* Interferential Current therapy (2P), in combination with heating pad for 20 minutes<br>Procedure: Joint Mobilization<br>* Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | Visual Analogue Scale was used to measure pain scoring from 0-10 cm on a horizontal 10cm line. A greater score reflects higher pain intensity. | 2 weeks | 
| Visual Analogue Scale | Visual Analogue Scale was used to measure pain scoring from 0-10 cm on a horizontal 10cm line. A greater score reflects higher pain intensity. | 4 weeks | 
| Knee Injury and Osteoarthritis Outcome Score | Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure physical function and quality of life. A greater score on Knee Injury and Osteoarthritis Outcome Score reflects good prognosis and outcome and a lower score shows poor prognosis and outcome. the score for Knee Injury and Osteoarthritis Outcome Score is reported in the form of percentage i.e. 0-100%. | 2 weeks | 
| Knee Injury and Osteoarthritis Outcome Score | Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure physical function and quality of life. A greater score on Knee Injury and Osteoarthritis Outcome Score reflects good prognosis and outcome and a lower score shows poor prognosis and outcome. the score for Knee Injury and Osteoarthritis Outcome Score is reported in the form of percentage i.e. 0-100%. | 4 weeks | 
| Knee Joint Range of Motion | Knee Joint Range of Motion will be measured via goniometry. It is a continuous scale and a greater score reflects greater angular movement possible at the knee joint, which is measured in degrees. | 2 weeks | 
| Knee Joint Range of Motion | Knee Joint Range of Motion will be measured via goniometry. It is a continuous scale and a greater score reflects greater angular movement possible at the knee joint, which is measured in degrees. | 4 weeks | 
| Body Composition | Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity. | 2 weeks | 
| Body Composition | Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity. | 4 weeks | 
| Fall risk | Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome. | 2 weeks | 
| Fall risk | Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome. | 4 weeks | 
| 5 repetition sit to stand test | Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score. | 2 weeks | 
| 5 repetition sit to stand test | Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score. | 4 weeks | 
| Modified sphygmomanometer dynamometry | Modified sphygmomanometer dynamometry was used to measure muscle strength. Greater score will reflect greater muscle strength. The unit of Modified sphygmomanometer dynamometry used will be mmHg (millimeter of mercury). | 2 weeks | 
| Modified sphygmomanometer dynamometry | Modified sphygmomanometer dynamometry was used to measure muscle strength. Greater score will reflect greater muscle strength. The unit of Modified sphygmomanometer dynamometry used will be mmHg (millimeter of mercury). | 4 weeks |