Back to results

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

Primary Purpose

Medial Compartment Knee Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Mulligan Knee Taping with Home Exercises

Lateral wedge insoles with Home Exercises

Traditional Physiotherapy with Home Exercises

About this trial

This is an interventional treatment trial for Medial Compartment Knee Osteoarthritis focused on measuring Knee osteoarthritis, Knee injury and Osteoarthritis Outcome Score, Rapid assessment of physical activity, Quality of life, Traditional physiotherapy

Eligibility Criteria

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

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.

Sites / Locations

Rabbiya Riaz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Knee Taping with Home Exercises (Group 1)

Lateral wedge insoles with Home Exercises (Group 2)

Traditional Physiotherapy with Home Exercises (Group 3)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03848130

First Posted

January 25, 2019

Last Updated

July 26, 2019

Sponsor

Isra University

1. Study Identification

Unique Protocol Identification Number

NCT03848130

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

February 21, 2019 (Actual)

Primary Completion Date

July 25, 2019 (Actual)

Study Completion Date

July 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Isra University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Medial Compartment Knee Osteoarthritis

Keywords

Knee osteoarthritis, Knee injury and Osteoarthritis Outcome Score, Rapid assessment of physical activity, Quality of life, Traditional physiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Knee Taping with Home Exercises (Group 1)

Arm Type

Active Comparator

Arm Description

Arm Title

Lateral wedge insoles with Home Exercises (Group 2)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Traditional Physiotherapy with Home Exercises (Group 3)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Mulligan Knee Taping with Home Exercises

Intervention Description

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

Intervention Name(s)

Lateral wedge insoles with Home Exercises

Intervention Description

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

Intervention Name(s)

Traditional Physiotherapy with Home Exercises

Intervention Description

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)

Primary Outcome Measure Information:

Title

Knee injury and osteoarthritis outcome pain score

Description

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.

Time Frame

Upto 4 weeks

Title

Knee injury and osteoarthritis outcome stiffness score

Description

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.

Time Frame

Upto 4 weeks

Title

Knee injury and osteoarthritis outcome functional status score

Description

Time Frame

Upto 4 weeks

Title

Knee injury and osteoarthritis outcome quality of life score

Description

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.

Time Frame

Upto 4 weeks

Secondary Outcome Measure Information:

Title

Rapid Assessment Physical Activity scale

Description

Time Frame

Upto 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Rabbiya Riaz

City

Rawalpindi

State/Province

Punjab

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs