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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665804
• Other study ID #: FUI/CTR/2020/12
• Status: Completed
• Phase: N/A
• Start date: June 10, 2020
• Est. completion date: December 6, 2020

Study information

• Verified date: December 2020
• Source: Foundation University Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 6, 2020
• Est. primary completion date: December 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Creatine Supplementation
Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
• Glucosamine and Chondroitin sulfate supplementation
Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day

Other:
• Supervised Exercise training
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
• Home Exercise Program
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

Procedure:
• Electrotherapy + Heating
Interferential Current therapy (2P), in combination with heating pad for 20 minutes
• Joint Mobilization
Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization

Locations

Country	Name	City	State
Pakistan	Foundation University Institute of Rehabilitation Sciences.	Islamabad	Federal

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Fall risk	Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.	2 weeks
Primary	Fall risk	Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.	4 weeks
Primary	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
Primary	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
Primary	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
Primary	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