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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Osteoarthritis, Knee
• Intervention / Treatment: Dietary supplement: Chondroitin Sulfate; Procedure: Resistance exercise training; Procedure: Manual therapy / Joint Mobilization; Procedure: THE therapy

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 46000
      • Foundation University Institute of Rehabilitation Sciences.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	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; Procedure: Manual therapy / Joint Mobilization; Ant. tib-fem glide Post tib-fem glide thrice a week Pattelo-femoral joint mobilization; Procedure: THE therapy; Interferential and Heating for 20 min
Experimental: Active Comparator Group	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; Procedure: Manual therapy / Joint Mobilization; Ant. tib-fem glide Post tib-fem glide thrice a week Pattelo-femoral joint mobilization; Procedure: THE therapy; Interferential and Heating for 20 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Fall risk	Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.	2 weeks
Fall risk	Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.	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.	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.	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).	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).	4 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Publications and helpful links

General Publications

• Babur MN, Siddiqi FA, Tassadaq N, Arshad Tareen MA, Osama M. Effects of glucosamine and chondroitin sulfate supplementation in addition to resistance exercise training and manual therapy in patients with knee osteoarthritis: A randomized controlled trial. J Pak Med Assoc. 2022 Jul;72(7):1272-1277. doi: 10.47391/JPMA.2444.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: strength training; chondroitin sulfate; resistance exercise; manual therapy; glucosamine; joint mobilization
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: FUI/CTR/2020/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No