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

Primary Purpose

Osteoarthritis, Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Chondroitin Sulfate
Resistance exercise training
Manual therapy / Joint Mobilization
THE therapy
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring chondroitin sulfate, resistance exercise, strength training, manual therapy, glucosamine, joint mobilization

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foundation University Institute of Rehabilitation Sciences.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental Group

Active Comparator Group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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%.
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%.
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.
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.
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.
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.
Fall risk
Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.
Fall risk
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 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 will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
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).
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).

Secondary Outcome Measures

Full Information

First Posted
November 26, 2020
Last Updated
December 3, 2020
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT04654871
Brief Title
Effects of Glucosamine and Chondroitin Sulfate Supplementation in Addition to Resistance Exercise Training and Manual Therapy in Patients With Knee Osteoarthritis
Official Title
Effects of Glucosamine and Chondroitin Sulfate Supplementation in Addition to Resistance Exercise Training and Manual Therapy in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Osteoarthritis, Knee
Keywords
chondroitin sulfate, resistance exercise, strength training, manual therapy, glucosamine, joint mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Title
Active Comparator Group
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Chondroitin Sulfate
Intervention Description
Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day
Intervention Type
Procedure
Intervention Name(s)
Resistance exercise training
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Manual therapy / Joint Mobilization
Intervention Description
Ant. tib-fem glide Post tib-fem glide thrice a week Pattelo-femoral joint mobilization
Intervention Type
Procedure
Intervention Name(s)
THE therapy
Intervention Description
Interferential and Heating for 20 min
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
2 weeks
Title
Visual Analogue Scale
Description
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.
Time Frame
4 weeks
Title
Knee Injury and Osteoarthritis Outcome Score
Description
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%.
Time Frame
2 weeks
Title
Knee Injury and Osteoarthritis Outcome Score
Description
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%.
Time Frame
4 weeks
Title
Knee Joint Range of Motion
Description
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.
Time Frame
2 weeks
Title
Knee Joint Range of Motion
Description
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.
Time Frame
4 weeks
Title
Body Composition
Description
Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
Time Frame
2 weeks
Title
Body Composition
Description
Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
Time Frame
4 weeks
Title
Fall risk
Description
Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.
Time Frame
2 weeks
Title
Fall risk
Description
Fall risk will be measured via Biodex balance system, and greater score reflects greater fall risk and poorer outcome.
Time Frame
4 weeks
Title
5 repetition sit to stand test
Description
Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
Time Frame
2 weeks
Title
5 repetition sit to stand test
Description
Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
Time Frame
4 weeks
Title
Modified sphygmomanometer dynamometry
Description
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).
Time Frame
2 weeks
Title
Modified sphygmomanometer dynamometry
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Foundation University Institute of Rehabilitation Sciences.
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36156542
Citation
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.
Results Reference
derived

Learn more about this trial

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

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