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

NCT ID: NCT03848130

Last Updated: 2019-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-21
• Study Completion Date: 2019-07-25

Brief 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.

Detailed 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.

Conditions

Medial Compartment Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Knee Taping with Home Exercises (Group 1)

Knee osteoarthritis patients were assessed by 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 and were assigned into knee taping group.Each subject in first group completed 4 weeks of physical therapy sessions which were aimed to decrease pain and stiffness, increase functional activity level, and improve quality of life. Each subject was evaluated for changes in symptoms on, 1st week, 2nd week, 3rd week and 4th week.

Group Type: ACTIVE_COMPARATOR

Mulligan Knee Taping with Home Exercises

Intervention Type: OTHER

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 (Group 2)

Knee osteoarthritis patients were assessed by 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 and were assigned into lateral wedge insole group.Each subject in second group completed 4 weeks of physical therapy sessions which were aimed to decrease pain and stiffness, increase functional activity level, and improve quality of life. Each subject was evaluated for changes in symptoms on, 1st week, 2nd week, 3rd week and 4th week.

Group Type: ACTIVE_COMPARATOR

Lateral wedge insoles with Home Exercises

Intervention Type: OTHER

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 (Group 3)

Knee osteoarthritis patients were assessed by 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 and were assigned into traditional physiotherapy group.Each subject in third group completed 4 weeks of physical therapy sessions which were aimed to decrease pain and stiffness, increase functional activity level, and improve quality of life. Each subject was evaluated for changes in symptoms on, 1st week, 2nd week, 3rd week and 4th week.

Group Type: ACTIVE_COMPARATOR

Traditional Physiotherapy with Home Exercises

Intervention Type: OTHER

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)

Interventions

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).

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isra University

OTHER

Sponsor Role: lead

Responsible Party

Rabbiya Riaz

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rabbiya Riaz

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IIRS-1509/PDPT/010

Identifier Type: -

Identifier Source: org_study_id