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Completed

NCT Number: NCT04665804

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, 46000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

creatine supplementation

Dietary Supplement

Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks

Glucosamine and Chondroitin sulfate supplementation

Dietary Supplement

Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day

Supervised Exercise training

Other

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

Other

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

Electrotherapy + Heating

Procedure

Interferential Current therapy (2P), in combination with heating pad for 20 minutes

Joint Mobilization

Procedure

Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 2 weeks

    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. Visual Analogue Scale

    Time frame: 4 weeks

    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.

  3. Knee Injury and Osteoarthritis Outcome Score

    Time frame: 2 weeks

    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. Knee Injury and Osteoarthritis Outcome Score

    Time frame: 4 weeks

    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%.

  5. Knee Joint Range of Motion

    Time frame: 2 weeks

    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.

  6. Knee Joint Range of Motion

    Time frame: 4 weeks

    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.

  7. Body Composition

    Time frame: 2 weeks

    Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.

  8. Body Composition

    Time frame: 4 weeks

    Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.

  9. Fall risk

    Time frame: 2 weeks

    Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.

  10. Fall risk

    Time frame: 4 weeks

    Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.

  11. 5 repetition sit to stand test

    Time frame: 2 weeks

    Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.

  12. 5 repetition sit to stand test

    Time frame: 4 weeks

    Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.

  13. Modified sphygmomanometer dynamometry

    Time frame: 2 weeks

    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).

  14. Modified sphygmomanometer dynamometry

    Time frame: 4 weeks

    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).

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2020
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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