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

• ClinicalTrials.gov Identifier: NCT04654871
• Recruitment Status: Completed
• First Posted: December 4, 2020
• Last Update Posted: December 4, 2020
• Sponsor: Foundation University Islamabad
• Information provided by (Responsible Party): Foundation University Islamabad

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. 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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis; Osteoarthritis, Knee	Dietary Supplement: Chondroitin Sulfate; Procedure: Resistance exercise training; Procedure: Manual therapy / Joint Mobilization; Procedure: THE therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Glucosamine and Chondroitin Sulfate Supplementation in Addition to Resistance Exercise Training and Manual Therapy in Patients With Knee Osteoarthritis
• Actual Study Start Date: January 1, 2020
• Actual Primary Completion Date: September 1, 2020
• Actual Study Completion Date: November 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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%.
4. 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%.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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).
14. 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).

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Pakistan

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, Pakistan, 46000

Sponsors and Collaborators

Foundation University Islamabad

More Information

• Responsible Party: Foundation University Islamabad
• ClinicalTrials.gov Identifier: NCT04654871
• Other Study ID Numbers: FUI/CTR/2020/11
• First Posted: December 4, 2020
• Last Update Posted: December 4, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Foundation University Islamabad:

chondroitin sulfate; resistance exercise; strength training; manual therapy; glucosamine; joint mobilization

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases