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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Dietary supplement: Creatine Supplementation; Other: Supervised Exercise training; Other: Home Exercise Program; Procedure: Electrotherapy + Heating; Procedure: Joint Mobilization; Dietary supplement: Glucosamine and Chondroitin sulfate supplementation

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 46000
      • Foundation University Institute of Rehabilitation Sciences.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group A (Creatine Supplementation)	Dietary supplement: Creatine Supplementation; Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks; 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; Other: 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; Procedure: Joint Mobilization; Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization
Experimental: Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation)	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; Other: 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; Procedure: Joint Mobilization; Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization; Dietary supplement: Glucosamine and Chondroitin sulfate supplementation; Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day

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

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): December 6, 2020
• Study Completion (Actual): December 6, 2020

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: FUI/CTR/2020/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No