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

NCT ID: NCT04665804

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-10

Study Completion Date

2020-12-06

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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental Group A (Creatine Supplementation)

Group Type EXPERIMENTAL

Creatine Supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Supervised Exercise training

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

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

Joint Mobilization

Intervention Type PROCEDURE

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

Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation)

Group Type EXPERIMENTAL

Glucosamine and Chondroitin sulfate supplementation

Intervention Type DIETARY_SUPPLEMENT

Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day

Supervised Exercise training

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

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

Joint Mobilization

Intervention Type PROCEDURE

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

Interventions

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Creatine Supplementation

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

Intervention Type DIETARY_SUPPLEMENT

Glucosamine and Chondroitin sulfate supplementation

Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type 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

Intervention Type OTHER

Electrotherapy + Heating

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

Intervention Type PROCEDURE

Joint Mobilization

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation University Islamabad

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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FUI/CTR/2020/12

Identifier Type: -

Identifier Source: org_study_id