Effects of Glucosamine and Chondroitin Sulfate Supplementation in Addition to Resistance Exercise Training and Manual Therapy in Patients With Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Effects of Glucosamine and Chondroitin Sulfate Supplementation in Addition to Resistance Exercise Training and Manual Therapy in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04654871
• Other study ID #: FUI/CTR/2020/11
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: December 2020
• Source: Foundation University Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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. Thus, it is important to investigate whether a potentially beneficial effect of glucosamine and chondroitin sulfate with resistance exercise and manual therapy in patients with knee OA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• knee osteoarthritis for at least 3 months

• knee pain no more than 8/10

• Grade III or less on radiograph (Kellgren classification)

Exclusion Criteria:

• Malignancy

• Any additional Inflammatory disorders

• Infection

• Knee trauma

• lower limb fracture

• Lumbar radiculopathy or myelopathy

• knee surgery or replacement

• Intra-articular steroid therapy in the last 2 months

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Chondroitin Sulfate
Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day

Procedure:
• Resistance exercise training
Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM) Supervised exercise thrice a week and Home Exercise 4 times a week Leg press knee extension Knee flexion Terminal knee extension Mini squats 3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval
• Manual therapy / Joint Mobilization
Ant. tib-fem glide Post tib-fem glide thrice a week Pattelo-femoral joint mobilization
• THE therapy
Interferential and Heating for 20 min

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Primary	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.	4 weeks
Primary	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%.	2 weeks
Primary	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%.	4 weeks
Primary	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.	2 weeks
Primary	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.	4 weeks
Primary	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.	2 weeks
Primary	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.	4 weeks
Primary	Fall risk	Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.	2 weeks
Primary	Fall risk	Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.	4 weeks
Primary	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.	2 weeks
Primary	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.	4 weeks
Primary	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).	2 weeks
Primary	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).	4 weeks