NCT04654871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

8 months

First QC Date

November 26, 2020

Last Update Submit

December 3, 2020

Conditions

Keywords

chondroitin sulfateresistance exercisestrength trainingmanual therapyglucosaminejoint mobilization

Outcome Measures

Primary Outcomes (14)

  • 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

Study Arms (2)

Experimental Group

EXPERIMENTAL
Dietary Supplement: Chondroitin SulfateProcedure: Resistance exercise trainingProcedure: Manual therapy / Joint MobilizationProcedure: THE therapy

Active Comparator Group

EXPERIMENTAL
Procedure: Resistance exercise trainingProcedure: Manual therapy / Joint MobilizationProcedure: THE therapy

Interventions

Chondroitin SulfateDIETARY_SUPPLEMENT

Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day

Experimental Group

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

Active Comparator GroupExperimental Group

Ant. tib-fem glide Post tib-fem glide thrice a week Pattelo-femoral joint mobilization

Active Comparator GroupExperimental Group
THE therapyPROCEDURE

Interferential and Heating for 20 min

Active Comparator GroupExperimental Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee osteoarthritis for at least 3 months
  • knee pain no more than 8/10
  • Grade III or less on radiograph (Kellgren classification)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, 46000, Pakistan

Location

Related Publications (1)

  • Osama M, Babur MN, Siddiqi FA, Tassadaq N, Arshad Tareen MA. 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.

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Interventions

Chondroitin SulfatesResistance TrainingMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ChondroitinGlycosaminoglycansPolysaccharidesCarbohydratesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaComplementary Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2020

First Posted

December 4, 2020

Study Start

January 1, 2020

Primary Completion

September 1, 2020

Study Completion

November 1, 2020

Last Updated

December 4, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations