Effects of Glucosamine and Chondroitin Sulfate Supplementation in Addition to Resistance Exercise Training and Manual Therapy in Patients With Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
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. Thus, it is important to investigate whether a potentially beneficial effect of glucosamine and chondroitin sulfate with resistance exercise and manual therapy in patients with knee OA.

Official Title
-----------------
Effects of Glucosamine and Chondroitin Sulfate Supplementation in Addition to Resistance Exercise Training and Manual Therapy in Patients With Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis, Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Dietary Supplement: Chondroitin Sulfate
* Procedure: Resistance exercise training
* Procedure: Manual therapy / Joint Mobilization
* Procedure: THE therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: knee osteoarthritis for at least 3 months knee pain no more than 8/10 Grade III or less on radiograph (Kellgren classification) Exclusion Criteria: Malignancy Any additional Inflammatory disorders Infection Knee trauma lower limb fracture Lumbar radiculopathy or myelopathy knee surgery or replacement Intra-articular steroid therapy in the last 2 months

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br> | Dietary Supplement: Chondroitin Sulfate<br>* Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day<br>Procedure: Resistance exercise training<br>* Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM) Supervised exercise thrice a week and Home Exercise 4 times a week Leg press knee extension Knee flexion Terminal knee extension Mini squats 3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval<br>Procedure: Manual therapy / Joint Mobilization<br>* Ant. tib-fem glide Post tib-fem glide thrice a week Pattelo-femoral joint mobilization<br>Procedure: THE therapy<br>* Interferential and Heating for 20 min<br>|
| Experimental: Active Comparator Group<br> | Procedure: Resistance exercise training<br>* Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM) Supervised exercise thrice a week and Home Exercise 4 times a week Leg press knee extension Knee flexion Terminal knee extension Mini squats 3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval<br>Procedure: Manual therapy / Joint Mobilization<br>* Ant. tib-fem glide Post tib-fem glide thrice a week Pattelo-femoral joint mobilization<br>Procedure: THE therapy<br>* Interferential and Heating for 20 min<br>|

What is the study measuring?
-----------------
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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chondroitin sulfate, resistance exercise, strength training, manual therapy, glucosamine, joint mobilization