Muscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

External Tibia Torsion and Passive Muscle Stiffness of Quadriceps as Two Important Contributors of Joint Loading During Walking in People With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628508
• Other study ID #: HSEARS20170406003
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2018
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Knee osteoarthritis (KOA) is a common chronic painful musculoskeletal condition among older adults. It poses great challenge to the health care system due to its inability to be cured. Understanding factors associated with disease progression in KOA should assist the development of novel prevention/rehabilitation strategies. This study investigate factors including muscle properties, lower limb alignment and joint loading in patients with knee osteoarthritis before and after a six-week exercise program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age between 50-80

2. having radiographic tibiofemoral joint OA in the medial compartment defined as Kellgren and Lawrence grade = 2 to 3

3. having medial knee pain on most days of the month

4. having a minimum average pain score of 2 on an 11-point numerical rating scale in the past week while walking

Exclusion Criteria:

1. having lateral tibiofemoral compartment osteophytes greater than the medial side.

2. having undergone intra-articular corticosteroid injection or knee surgery to either knee within the past 3 months

3. having a systemic arthritic condition (e.g., rheumatoid arthritis)

4. having a knee joint replacement or high tibial osteotomy in the past

5. having any other muscular, joint or neurological condition influencing lower limb function

6. unable to walk unaided

7. having low back, hip, ankle or foot pain > 3 on numerical rating scale

8. having a body mass index (BMI) >36 kg/ m2

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Exercise
Comprehensive exercise program including strengthening, stretching, gait modification etc.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System	External knee moment in the frontal plane during early stance phase of walking	At baseline and one week after intervention
Secondary	Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score	Pain intensity measured by the pain subscale of Knee injury and Osteoarthritis Outcome Score (KOOS). The minimum value is 0 and maximum value is 100. The higher scores mean a better outcome.	At baseline and one week after intervention
Secondary	Tibial Torsion as Assessed by X-ray Imaging	The angle between tibial and femur in the transverse plane	At baseline
Secondary	Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography	Young's modulus by ultrasound elastography	At baseline and one week after intervention