Effects of Lateral Wedge Insoles, Knee Taping on the Management of Knee Osteoarthritis

Medial Compartment Knee Osteoarthritis Clinical Trial

Official title:

Effects of Lateral Wedge Insoles, Knee Taping on the Management of Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848130
• Other study ID #: IIRS-1509/PDPT/010
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: July 25, 2019

Study information

• Verified date: July 2019
• Source: Isra University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Knee osteoarthritis (OA) is a degenerative, progressive and wide spread disease, which may lead the patient to severe outcomes e.g. pain, loss of joint motion, inflexibility, disability and decreases the quality of life (QOL). As it affects the adults of older age, therefore should be emphasized.Effectiveness of Mulligan knee taping, lateral wedge insoles and traditional physical therapy(Ultrasound therapy with stretching and strengthening exercises) with home exercises as baseline treatment were assessed through RAPA and complete KOOS questionnaire.

Description:

A total of 60 patients with medial compartment 3rd grade knee osteoarthritis were recruited and randomly divided into three groups, 20 in each group.The data was collected through general demographic questionnaire, rapid assessment of physical activity (RAPA) to determine physical activity level and Knee injury and Osteoarthritis Outcome Score (KOOS) to determine the level of pain severity, stiffness, functional activities, recreational activities and Quality of life for enhancing functional independence while having osteoarthritis. For between-group analysis, one way ANOVA was used and for within-group analysis longitudinal repeated measures analysis of variance (RM-ANOVA) with Tukey's multiple comparisons test was used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 25, 2019
• Est. primary completion date: July 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Knee OA in the age group of 40-70 year.

• Knee OA due to aging.

• Knee OA due to family history

Exclusion Criteria:

• Knee OA due to Trauma.

• Knee OA due to any knee pathology.

Related Conditions & MeSH terms

• Medial Compartment Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Mulligan Knee Taping with Home Exercises
Each patient in group I i.e. taping group with home exercises was given 40 minutes session. Each session started in sitting or lying position with leg extended and mulligan tape was used. Taping was started in the middle of patella, at the level of superior aspect of patella and pulled the tape medially and fixed the tape at medial border. This tilts the lateral border of patella away from femur and produced skin wrinkling. Besides this, home exercises such as quads isometrics and self stretchings & ROMs were also guided. This session was repeated three times a week for one month (Total 12 sessions/ one month).
• Lateral wedge insoles with Home Exercises
Each patient in group II i.e. lateral wedge insole with home exercises group was given 20-minute session. In each session, Lateral wedge insoles of 7mm made of silicon or ledos material were advised and home exercises in the same way. This session was repeated once a month but evaluations were obtained after a complete week for one month. (Total 4 sessions/one month)
• Traditional Physiotherapy with Home Exercises
Each patient in group III i.e. traditional physiotherapy with home exercises group was given 40 to 45-minute session. Each session started in lying position. In each session, therapeutic ultrasound with 1.5MHz frequency and continuous mode for 7 minute was given. Then passive stretchings of the following muscle groups was done; calf, hamstring, quadriceps, hip flexors and hip adductors & abductors and followed by strengthening exercises manually and with quadriceps bench. Home exercises were guided in the same way. This session was repeated 3 to 4 times a month. (Total 12 to 16 sessions/ one month)

Locations

Country	Name	City	State
Pakistan	Rabbiya Riaz	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Isra University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee injury and osteoarthritis outcome pain score	Pain associated with daily tasks is measured through Knee injury and osteoarthritis outcome pain score scale with categories as "None" for no pain and "Extreme" for maximum pain value.	Upto 4 weeks
Primary	Knee injury and osteoarthritis outcome stiffness score	It is also measured through Knee injury and osteoarthritis outcome stiffness score scale with categories as "None" for no pain and "Extreme" for maximum pain value.	Upto 4 weeks
Primary	Knee injury and osteoarthritis outcome functional status score	Degree of difficulty in performing daily tasks associated with knee joint is measured through Knee injury and osteoarthritis outcome functional status score in categories as "None" for no difficulty in task and "Extreme" for maximum difficulty in performing task.	Upto 4 weeks
Primary	Knee injury and osteoarthritis outcome quality of life score	Quality of life regarding knee joint disease is measured through Knee injury and osteoarthritis outcome quality of life score in categories as according to patient's satisfaction.	Upto 4 weeks
Secondary	Rapid Assessment Physical Activity scale	Physical activity level of the patients was also observed through rapid assessment of physical activity with categories as "0" for No involvement and "1" for yes and the results showed that those who are involved in any type of physical activity have a better functional outcome.	Upto 4 weeks