Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423432
• Other study ID #: FUI/CTR/2020/4
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: Foundation University Islamabad
• Contact: Muhammad Osama, PhD*
• Phone: +923325540436
• Email: osamadpt[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteoarthritis is the 11th highest contributor to disability world wide. In terms of conservative management of patients with knee osteoarthritis, Resistance exercise has been shown to be an effective intervention for reducing pain and cartilage degeneration and improving muscle strength, joint biomechanics and physical functioning. But, research shows that co supplementation can further augment the effects of resistance exercise. However, it is imperative to point out that the existing evidence is majorly focused on the individual effects of resistance exercise training and non-pharmacological supplementation, and is still deficient in the effects of co-supplementation in addition to resistance exercise training in patients with knee osteoarthritis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Lower Extremity Resistance Exercise Training
3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press (8-12 RM) leg extension (8-12 RM) Sit to stand squat (with weight) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)
• Home Exercise Plan
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 terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)

Device:
• Electrotherapy + Heating
Iinterferential 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:
• Creatine Supplementation
Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
• Glucoseamine/ Chondritin Sulfate Supplementation
Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)

Locations

Country	Name	City	State
Pakistan	Foundation University Institute of Rehabilitation Sciences	Islamabad	Federal

Sponsors (2)

Lead Sponsor	Collaborator
Foundation University Islamabad	Isra University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Pain: Numeric Pain Rating Scale	Knee Pain will be quantified by using Numeric Pain Rating Scale	4 weeks
Primary	Knee Range of Motion	Knee Range of Motion will be quantified by using Gonimeter	4 weeks
Primary	Knee Isometric Muscle Strength	Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer	4 weeks
Primary	Six Minute Walk Test	Six Minute Walk Test will be used to quantify walking related performance fatigability, walkind distance and walking speed.	4 weeks
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.	4 weeks
Secondary	Body Composition	Body Composition will be quantified by using Bioelectrical Impedance	4 weeks
Secondary	Fall Risk	Fall risk will be quantified by using Biodex balance System	4 weeks
Secondary	Postural Stability	Postural Stability will be quantified by using Biodex balance System	4 weeks