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

NCT03848130 | Completed DMC

• 1 other identifier: IIRS-1509/PDPT/010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Medial Compartment Knee Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Rapid Assessment Physical Activity scale

  Upto 4 weeks

Study Arms (3)

Knee Taping with Home Exercises (Group 1)

ACTIVE COMPARATOR

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.

Other: Mulligan Knee Taping with Home Exercises

Lateral wedge insoles with Home Exercises (Group 2)

ACTIVE COMPARATOR

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.

Other: Lateral wedge insoles with Home Exercises

Traditional Physiotherapy with Home Exercises (Group 3)

ACTIVE COMPARATOR

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.

Other: Traditional Physiotherapy with Home Exercises

Interventions

Mulligan Knee Taping with Home Exercises 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).

Knee Taping with Home Exercises (Group 1)

Lateral wedge insoles with Home Exercises 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)

Lateral wedge insoles with Home Exercises (Group 2)

Traditional Physiotherapy with Home Exercises 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)

Traditional Physiotherapy with Home Exercises (Group 3)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knee OA in the age group of 40-70 year.
• Knee OA due to aging.
• Knee OA due to family history

You may not qualify if:

• Knee OA due to Trauma.
• Knee OA due to any knee pathology.

Sponsors & Collaborators

• Isra University: lead

Study Sites (1)

Rabbiya Riaz

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Knee Injuries

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 20, 2019
• Study Start: February 21, 2019
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

PA (1)