Knee OsteoarthritisNCT04665804
Effects of Creatine Supplementation as Compared to Glucosamine/Chondroitin Sulfate Supplementation in Addition to Exercise and Physical Therapy in the Management of Knee Osteoarthritis.
A study testing Creatine Supplementation, Glucosamine and Chondroitin sulfate supplementation and Supervised Exercise training in people with Knee Osteoarthritis, run by Foundation University Islamabad at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Creatine Supplementation, Glucosamine and Chondroitin sulfate supplementation and Supervised Exercise training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2020to 6 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University Institute of Rehabilitation Sciences.
Islamabad, Federal, 46000
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Creatine Supplementation, Glucosamine and Chondroitin sulfate supplementation, Supervised Exercise training, Home Exercise Program, Electrotherapy + Heating
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine SupplementationDietary supplement
Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
Glucosamine and Chondroitin sulfate supplementationDietary supplement
Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day
Supervised Exercise trainingOther
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 ProgramOther
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 + HeatingProcedure or surgery
Interferential Current therapy (2P), in combination with heating pad for 20 minutes
Joint MobilizationProcedure or surgery
Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A (Creatine Supplementation) | Experimental | Not described Receives: Dietary Supplement: Creatine Supplementation; Other: Supervised Exercise training; Other: Home Exercise Program; Procedure: Electrotherapy + Heating; Procedure: Joint Mobilization |
| Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation) | Experimental | Not described Receives: Dietary Supplement: Glucosamine and Chondroitin sulfate supplementation; Other: Supervised Exercise training; Other: Home Exercise Program; Procedure: Electrotherapy + Heating; Procedure: Joint Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Fall risk
Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.
Measured: 2 weeks
Fall risk
Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start10 Jun 2020
- Primary completion6 Dec 2020
- Study completion6 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665804
- Sponsor's protocol ID
- FUI/CTR/2020/12
- Status last verified
- Dec 2020
- First submitted
- 7 Dec 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04665804
- Acronym / sponsor ID
- FUI/CTR/2020/12
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 6 Dec 2020 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A (Creatine Supplementation) | Experimental | Dietary Supplement: Creatine Supplementation, Other: Supervised Exercise training, Other: Home Exercise Program, Procedure: Electrotherapy + Heating, Procedure: Joint Mobilization |
| Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation) | Experimental | Dietary Supplement: Glucosamine and Chondroitin sulfate supplementation, Other: Supervised Exercise training, Other: Home Exercise Program, Procedure: Electrotherapy + Heating, Procedure: Joint Mobilization |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine SupplementationCreatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks | Dietary supplement | Experimental Group A (Creatine Supplementation) |
| Glucosamine and Chondroitin sulfate supplementationGlucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day | Dietary supplement | Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation) |
| Supervised Exercise trainingLower 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 | Experimental Group A (Creatine Supplementation), Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation) |
| Home Exercise Program2 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 | Other | Experimental Group A (Creatine Supplementation), Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation) |
| Electrotherapy + HeatingInterferential Current therapy (2P), in combination with heating pad for 20 minutes | Procedure or surgery | Experimental Group A (Creatine Supplementation), Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation) |
| Joint MobilizationTibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization | Procedure or surgery | Experimental Group A (Creatine Supplementation), Experimental Group B (Glucosamine and Chondroitin sulfate Supplementation) |
Primary outcome
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.
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.
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%.
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%.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Supplementation, Glucosamine and Chondroitin sulfate supplementation and Supervised Exercise training in people with Knee Osteoarthritis, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 2 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.