Medial Compartment Knee OsteoarthritisNCT03848130
Effects of Lateral Wedge Insoles, Knee Taping on the Management of Knee Osteoarthritis
A study testing Mulligan Knee Taping with Home Exercises, Lateral wedge insoles with Home Exercises and Traditional Physiotherapy with Home Exercises in people with Medial Compartment Knee Osteoarthritis, run by Isra University at 1 site in Pakistan.
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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Medial Compartment Knee Osteoarthritis
- What is being tested?
- Mulligan Knee Taping with Home Exercises, Lateral wedge insoles with Home Exercises and Traditional Physiotherapy with Home Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Feb 2019to 25 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee OA in the age group of 40-70 year.
- Knee OA due to aging.
- Knee OA due to family history
Who cannot join
- Knee OA due to Trauma.
- Knee OA due to any knee pathology.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Mulligan Knee Taping with Home Exercises, Lateral wedge insoles with Home Exercises, Traditional Physiotherapy with Home Exercises
- Keywords
- Knee osteoarthritis, Knee injury and Osteoarthritis Outcome Score, Rapid assessment of physical activity, Quality of life, Traditional physiotherapy
- Medical subject headings
- Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan Knee Taping with Home ExercisesOther
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 ExercisesOther
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 ExercisesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Traditional Physiotherapy with Home Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Upto 4 weeks
Secondary outcomes (1)
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.
Measured: Upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start21 Feb 2019
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Compartment Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabbiya Riaz, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848130
- Sponsor's protocol ID
- IIRS-1509/PDPT/010
- Status last verified
- Jul 2019
- First submitted
- 25 Jan 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lateral Wedge Insoles, Knee Taping on the Management of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03848130
- Acronym / sponsor ID
- IIRS-1509/PDPT/010
- Conditions
- Medial Compartment Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Knee injury and Osteoarthritis Outcome Score, Rapid assessment of physical activity, Quality of life, Traditional physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Knee Taping with Home Exercises (Group 1) | Active comparator | Other: Mulligan Knee Taping with Home ExercisesKnee 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. |
| Lateral wedge insoles with Home Exercises (Group 2) | Active comparator | Other: Lateral wedge insoles with Home ExercisesKnee 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. |
| Traditional Physiotherapy with Home Exercises (Group 3) | Active comparator | Other: Traditional Physiotherapy with Home ExercisesKnee 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Knee OA in the age group of 40-70 year.
- Knee OA due to aging.
- Knee OA due to family history
Key exclusion criteria (2 listed)
- Knee OA due to Trauma.
- Knee OA due to any knee pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulligan Knee Taping with Home ExercisesEach 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). | Other | Knee Taping with Home Exercises (Group 1) |
| Lateral wedge insoles with Home ExercisesEach 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) | Other | Lateral wedge insoles with Home Exercises (Group 2) |
| Traditional Physiotherapy with Home ExercisesEach 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) | Other | Traditional Physiotherapy with Home Exercises (Group 3) |
Primary outcome
Knee injury and osteoarthritis outcome pain score
Time frame: Upto 4 weeks
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
Time frame: Upto 4 weeks
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
Time frame: Upto 4 weeks
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
Time frame: Upto 4 weeks
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.
1 secondary outcome
Rapid Assessment Physical Activity scale
Time frame: Upto 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan Knee Taping with Home Exercises, Lateral wedge insoles with Home Exercises and Traditional Physiotherapy with Home Exercises in people with Medial Compartment Knee Osteoarthritis, run by Isra University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and osteoarthritis outcome pain score (time frame: Upto 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.