Patellofemoral OsteoarthritisNCT04589871
Taping Technique With Supervised Exercises Protocol on Pain and Functional Status in Individuals With Arthritis
A study testing Taping technique and A supervised exercise protocol in people with Patellofemoral Osteoarthritis, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Osteoarthritis (OA) is claimed to be a global burden and a key health issue that affects the large weight-bearing joints of the lower extremity such as the knee and hip joints. The study was aimed to find out the efficacy of the tapping technique in addition to the supervised exercise protocol on pain intensity and… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Patellofemoral Osteoarthritis
- What is being tested?
- Taping technique and A supervised exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 5 Jun 2019to 19 Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The individuals with unilateral patella-femoral osteoarthritis
- Aged between 40-60years;
- Pain more than 3cm on VAS;
- Crepitus on movement,
- Showing osteophytes on standing skyline view of radiograph (Kallgren/Lawrence grade ≥2),
- found positive for the special tests (coordination test for the muscle vastus medialis, apprehension test for patellar, Clarke's test, and Waldron's test with phase I and II)
Who cannot join
- The individuals with involvement of tibio-femoral joint;
- Presence of patella alta/baja;
- History of rheumatoid arthritis/traumatic knee, knee surgeries within six months
- On steroid injection, neurological deficit, fragile skin around the knee, allergic to tape;
- Poor cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Taping Technique in Addition to the Supervised Exercises Protocol on Pain and Functional Status in Individuals With Patello-femoral Arthritis
Osteoarthritis (OA) is claimed to be a global burden and a key health issue that affects the large weight-bearing joints of the lower extremity such as the knee and hip joints. The study was aimed to find out the efficacy of the tapping technique in addition to the supervised exercise protocol on pain intensity and functional status of an individual with patella-femoral arthritis.
Read the detailed description
The study was based on a controlled pretest-posttest experimental group design. After initial screening, forty individuals (mean age 55years, ranged 40-60years) with patello-femoral arthritis randomly (n=20each) assigned into two group A and B. Group A received taping technique in addition to the supervised exercises protocol while group B received supervised exercises protocol only. Both the groups received their specified treatment 5 consecutive days in a week for 4weeks. Data collected for the variables (VAS and WOMAC) at day1 pre-intervention (baseline) and at day 28th post-intervention. The t-test used for within and between group analysis with keeping the p<0.05.
- Conditions
- Patellofemoral Osteoarthritis
- Being tested
- Taping technique, A supervised exercise protocol
- Keywords
- Patellofemoral osteoarthritis, Therapeutic exercises, VAS, WOMAC, Taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taping techniqueOther
Fixmull stretch and Leukotape (rigid tape) were used in taping to guide the patellar trajectory orientation while performing the movement. Individuals were asked to lay down in supine position with knee in a slightly bent position. Fixomull stretch was used as an adhesive pre-wrap to protect the skin and provide some of the checking force. The main check strap was provided by stripes of rigid tape (Leukotape). The knee cap was taped, started on the outer aspect of the knee cap and pulled inwards. Finished at the back of the inside of the knee. Two further pieces of tape (Fixomull Stretch and Leukotape) applied distal to the patella unloaded the infrapatellar fat pad.
A supervised exercise protocolOther
Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A received a taping technique in addition to the supervised exercises protocol Receives: Other: Taping technique; Other: A supervised exercise protocol |
| Group B | Active comparator | Group B received supervised exercises protocol only Receives: Other: A supervised exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Knee pain assessed by Visual Analog Scale (VAS). It is a 10-cm horizontal line marked with 0 (no pain) and 10 (worst pain) on its either end.
Measured: 4-weeks
Functional status
Functional status of knee assessed by functional subscale of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It has eight test-questions. The test questions are scored on a scale of 0 - 4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-32 for Physical Function.
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start5 Jun 2019
- Primary completion13 Oct 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral 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
- Model description
- Two-arm parallel groups randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- AMIR IQBAL, MPT-Ortho, Principal investigator, Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589871
- Sponsor's protocol ID
- RRC-2019-16
- Status last verified
- Oct 2020
- First submitted
- 11 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Taping Technique in Addition to the Supervised Exercises Protocol on Pain and Functional Status in Individuals With Patello-femoral Arthritis
- ClinicalTrials.gov ID
- NCT04589871
- Acronym / sponsor ID
- RRC-2019-16
- Conditions
- Patellofemoral Osteoarthritis
- Keywords
- Patellofemoral osteoarthritis, Therapeutic exercises, VAS, WOMAC, Taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 13 Oct 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 19 Oct 2020 (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.
Osteoarthritis (OA) is claimed to be a global burden and a key health issue that affects the large weight-bearing joints of the lower extremity such as the knee and hip joints. The study was aimed to find out the efficacy of the tapping technique in addition to the supervised exercise protocol on pain intensity and functional status of an individual with patella-femoral arthritis.
Detailed description
The study was based on a controlled pretest-posttest experimental group design. After initial screening, forty individuals (mean age 55years, ranged 40-60years) with patello-femoral arthritis randomly (n=20each) assigned into two group A and B. Group A received taping technique in addition to the supervised exercises protocol while group B received supervised exercises protocol only. Both the groups received their specified treatment 5 consecutive days in a week for 4weeks. Data collected for the variables (VAS and WOMAC) at day1 pre-intervention (baseline) and at day 28th post-intervention. The t-test used for within and between group analysis with keeping the p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel groups randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Taping technique, Other: A supervised exercise protocolGroup A received a taping technique in addition to the supervised exercises protocol |
| Group B | Active comparator | Other: A supervised exercise protocolGroup B received supervised exercises protocol only |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The individuals with unilateral patella-femoral osteoarthritis
- Aged between 40-60years;
- Pain more than 3cm on VAS;
- Crepitus on movement,
- Showing osteophytes on standing skyline view of radiograph (Kallgren/Lawrence grade ≥2),
Key exclusion criteria (5 listed)
- The individuals with involvement of tibio-femoral joint;
- Presence of patella alta/baja;
- History of rheumatoid arthritis/traumatic knee, knee surgeries within six months
- On steroid injection, neurological deficit, fragile skin around the knee, allergic to tape;
- Poor cooperation
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 |
|---|---|---|
| Taping techniqueFixmull stretch and Leukotape (rigid tape) were used in taping to guide the patellar trajectory orientation while performing the movement. Individuals were asked to lay down in supine position with knee in a slightly bent position. Fixomull stretch was used as an adhesive pre-wrap to protect the skin and provide some of the checking force. The main check strap was provided by stripes of rigid tape (Leukotape). The knee cap was taped, started on the outer aspect of the knee cap and pulled inwards. Finished at the back of the inside of the knee. Two further pieces of tape (Fixomull Stretch and Leukotape) applied distal to the patella unloaded the infrapatellar fat pad. | Other | Group A |
| A supervised exercise protocolQuadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis; | Other | Group A, Group B |
Primary outcome
Pain Intensity
Time frame: 4-weeks
Knee pain assessed by Visual Analog Scale (VAS). It is a 10-cm horizontal line marked with 0 (no pain) and 10 (worst pain) on its either end.
Functional status
Time frame: 4-weeks
Functional status of knee assessed by functional subscale of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It has eight test-questions. The test questions are scored on a scale of 0 - 4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-32 for Physical Function.
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 20 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Patellofemoral Osteoarthritis
RecruitingObservational study
Assessing the Association Between WBCT PFJ Morphological Metrics and Knee Symptoms
Knee Osteoarthritis, Patellofemoral Pain (PFPS)
Active, not recruiting
Persona Ti-Nidium Post-Market Clinical Follow-up
Knee Pain Chronic, Osteoarthritis
RecruitingPhase 2
Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.
Patellofemoral Osteoarthritis
RecruitingObservational study
FDG PET/MRI Imaging of Patellofemoral Joint Osteoarthritis
Patellofemoral Osteoarthritis, Knee Osteoarthritis
RecruitingPhase 2
Implantation of Engineered Cartilage Grafts for Treatment of Patellofemoral Osteoarthritis Versus Surgical Comparators.
Patellofemoral Osteoarthritis
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.
AMIR IQBAL, MPT-Ortho principal investigator
Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taping technique and A supervised exercise protocol in people with Patellofemoral Osteoarthritis, run by King Saud University at 1 site in Saudi Arabia.
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 6 inclusion and 5 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 20 Oct 2020. 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 Saudi Arabia. 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?
Pain Intensity (time frame: 4-weeks). The study lists 2 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 20 Oct 2020; AzTrials last refreshed its copy on 27 Oct 2026.