search
Back to results

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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Creatine Supplementation
Glucosamine and Chondroitin sulfate supplementation
Supervised Exercise training
Home Exercise Program
Electrotherapy + Heating
Joint Mobilization
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foundation University Institute of Rehabilitation Sciences.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental Group A (Creatine Supplementation)

Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 7, 2020
Last Updated
December 7, 2020
Sponsor
Foundation University Islamabad
search

1. Study Identification

Unique Protocol Identification Number
NCT04665804
Brief 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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
December 6, 2020 (Actual)
Study Completion Date
December 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group A (Creatine Supplementation)
Arm Type
Experimental
Arm Title
Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation)
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine Supplementation
Intervention Description
Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucosamine and Chondroitin sulfate supplementation
Intervention Description
Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day
Intervention Type
Other
Intervention Name(s)
Supervised Exercise training
Intervention Description
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
Intervention Name(s)
Home Exercise Program
Intervention Description
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
Procedure
Intervention Name(s)
Electrotherapy + Heating
Intervention Description
Interferential Current therapy (2P), in combination with heating pad for 20 minutes
Intervention Type
Procedure
Intervention Name(s)
Joint Mobilization
Intervention Description
Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
2 weeks
Title
Visual Analogue Scale
Description
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.
Time Frame
4 weeks
Title
Knee Injury and Osteoarthritis Outcome Score
Description
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%.
Time Frame
2 weeks
Title
Knee Injury and Osteoarthritis Outcome Score
Description
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%.
Time Frame
4 weeks
Title
Knee Joint Range of Motion
Description
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.
Time Frame
2 weeks
Title
Knee Joint Range of Motion
Description
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.
Time Frame
4 weeks
Title
Body Composition
Description
Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
Time Frame
2 weeks
Title
Body Composition
Description
Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
Time Frame
4 weeks
Title
Fall risk
Description
Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.
Time Frame
2 weeks
Title
Fall risk
Description
Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.
Time Frame
4 weeks
Title
5 repetition sit to stand test
Description
Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
Time Frame
2 weeks
Title
5 repetition sit to stand test
Description
Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
Time Frame
4 weeks
Title
Modified sphygmomanometer dynamometry
Description
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).
Time Frame
2 weeks
Title
Modified sphygmomanometer dynamometry
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Foundation University Institute of Rehabilitation Sciences.
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs