Patellofemoral Pain SyndromePilatesNCT05120583
Pilates-based Core Strengthening on Patellofemoral Pain Syndrome
A study testing Pilates exercises and Traditional physical therapy program in people with Patellofemoral Pain Syndrome, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
Patellofemoral pain syndrome (PFPS) is one of the most common musculoskeletal pain conditions that tend to become a chronic problem. PFPS is common among young adolescents, particularly in physically active individuals aged 12 to 17 years old with more prevalence among females, as it affects females 1.5 - 3 times when… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Pilates exercises and Traditional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Nov 2020to 30 Oct 2021
- 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pain felt anterior to knee joint.
- Pain felt retro-patellar.
- Pain felt during rest and increased with activities like prolonged sitting, squatting, running, and stair climbing.
- Insidious onset lasting for more than 6 weeks.
- Without any traumatic incidence.
- Not participating in a physical therapy program for the past three months.
Who cannot join
- If they had a meniscal tear.
- Cruciate/collateral ligaments involvement.
- Knee osteoarthritis.
- Rheumatoid arthritis.
- A history of knee or hip surgery.
- Patellar dislocation/subluxation.
Show all 9Show fewer
- Traction apophysitis encompassing the patellofemoral complex.
- Any pathology in the patellar tendon.
- Spinal referred pain.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
Al Kharj, Riyadh Region
About this study
Official title: Incorporation of Pilates-based Core Strengthening Exercises Into the Rehabilitation Protocol for Adolescents With Patellofemoral Pain Syndrome: a Randomized Clinical Trial
Patellofemoral pain syndrome (PFPS) is one of the most common musculoskeletal pain conditions that tend to become a chronic problem. PFPS is common among young adolescents, particularly in physically active individuals aged 12 to 17 years old with more prevalence among females, as it affects females 1.5 - 3 times when compared to males.
Read the detailed description
Adolescents with PFPS usually complain of retro-patellar pain (behind the kneecap) or peripatellar pain (around the kneecap) and crepitation in the knee joint, and also there is discomfort while sitting with a flexed knee for a long time. Symptoms are usually exacerbated by activities that increase the load on patellofemoral joints such as weight-bearing activities, squatting, walking up or downstairs, and running.
PFPS takes place whenever the muscles around the knee fail to keep the kneecap properly aligned, leading to abnormal lateral tracking of the patella.Overuse such as running and jumping sports, the trauma of kneecaps such as fracture, dislocation, or knee surgery may also predispose to PFPS.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Pilates exercises, Traditional physical therapy program
- Keywords
- patellofemoral pain syndrome, Pilates exercises, functional status
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
Also called Pilates band
Side kick internal/ external rotation with Pilate's band
Traditional physical therapy programOther
Also called strengthening exercises
strength, flexibility
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Patients in the study group received Pilates exercises (25 minutes/ session). There are different types of equipment to be used in Pilates exercises to achieve different purposes; mat, Pilates band or elastic bands, and Pilate's ball were used. Receives: Other: Pilates exercises |
| control group | Experimental | Participants in control group received the traditional physical therapy program program (60 minutes/session, three sessions /week for three months). Receives: Other: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
assessed by using a visual analog scale, 10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation
Measured: at baseline
Pain assessment
assessed by using a visual analog scale,10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation
Measured: after 12 weeks
Muscle strength assessment
assessed using a calibrated handheld dynamometer
Measured: at baseline
Muscle strength assessment
assessed using a calibrated handheld dynamometer
Measured: after 12 weeks
Secondary outcomes (4)
Functional status
evaluated using the Arabic version of the Anterior Knee pain Questionnaire, The score ranges from 0 to 100, with 0 indicating complete functional limitation and 100 indicating no pain and no functional limitation.
Measured: at baseline
Functional status
evaluated using the Arabic version of the Anterior Knee pain Questionnaire, The score ranges from 0 to 100, with 0 indicating complete functional limitation and 100 indicating no pain and no functional limitation.
Measured: after 12 weeks
health-related quality of life
assessed by using the self-report Pediatric Quality of Life Inventory, it includes 23 items distributed among 4 domains [physical (8 items), emotional (5 items), social (5 items), and school functions (3 items)]. Each item is rated on a 5- points scale (0 means never, and 4 means almost always). Items are transformed linearly to 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0).
Measured: at baseline
health-related quality of life
assessed by using the self-report Pediatric Quality of Life Inventory, it includes 23 items distributed among 4 domains [physical (8 items), emotional (5 items), social (5 items), and school functions (3 items)]. Each item is rated on a 5- points scale (0 means never, and 4 means almost always). Items are transformed linearly to 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0).
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Nov 2020
- Primary completion20 Aug 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- Alshimaa Azab, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120583
- Sponsor's protocol ID
- RHPT/20/0049
- Acronym
- Pilates
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Park SK, Stefanyshyn DJ. Greater Q angle may not be a risk factor of patellofemoral pain syndrome. Clin Biomech (Bristol). 2011 May;26(4):392-6. doi: 10.1016/j.clinbiomech.2010.11.015. Epub 2010 Dec 21.
PubMed 21177007Rabelo ND, Lima B, Reis AC, Bley AS, Yi LC, Fukuda TY, Costa LO, Lucareli PR. Neuromuscular training and muscle strengthening in patients with patellofemoral pain syndrome: a protocol of randomized controlled trial. BMC Musculoskelet Disord. 2014 May 16;15:157. doi: 10.1186/1471-2474-15-157.
PubMed 24884455Van Der Heijden RA, Lankhorst NE, Van Linschoten R, Bierma-Zeinstra SM, Van Middelkoop M. Exercise for treating patellofemoral pain syndrome: an abridged version of Cochrane systematic review. Eur J Phys Rehabil Med. 2016 Feb;52(1):110-33. Epub 2015 Jul 9.
PubMed 26158920
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporation of Pilates-based Core Strengthening Exercises Into the Rehabilitation Protocol for Adolescents With Patellofemoral Pain Syndrome: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05120583
- Acronym / sponsor ID
- Pilates / RHPT/20/0049
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- patellofemoral pain syndrome, Pilates exercises, functional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 15 Nov 2021 (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.
Patellofemoral pain syndrome (PFPS) is one of the most common musculoskeletal pain conditions that tend to become a chronic problem. PFPS is common among young adolescents, particularly in physically active individuals aged 12 to 17 years old with more prevalence among females, as it affects females 1.5 - 3 times when compared to males.
Detailed description
Adolescents with PFPS usually complain of retro-patellar pain (behind the kneecap) or peripatellar pain (around the kneecap) and crepitation in the knee joint, and also there is discomfort while sitting with a flexed knee for a long time. Symptoms are usually exacerbated by activities that increase the load on patellofemoral joints such as weight-bearing activities, squatting, walking up or downstairs, and running.
PFPS takes place whenever the muscles around the knee fail to keep the kneecap properly aligned, leading to abnormal lateral tracking of the patella.Overuse such as running and jumping sports, the trauma of kneecaps such as fracture, dislocation, or knee surgery may also predispose to PFPS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Pilates exercisesPatients in the study group received Pilates exercises (25 minutes/ session). There are different types of equipment to be used in Pilates exercises to achieve different purposes; mat, Pilates band or elastic bands, and Pilate's ball were used. |
| control group | Experimental | Other: Traditional physical therapy programParticipants in control group received the traditional physical therapy program program (60 minutes/session, three sessions /week for three months). |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Pain felt anterior to knee joint.
- Pain felt retro-patellar.
- Pain felt during rest and increased with activities like prolonged sitting, squatting, running, and stair climbing.
- Insidious onset lasting for more than 6 weeks.
- Without any traumatic incidence.
Key exclusion criteria (9 listed)
- If they had a meniscal tear.
- Cruciate/collateral ligaments involvement.
- Knee osteoarthritis.
- Rheumatoid arthritis.
- A history of knee or hip surgery.
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 |
|---|---|---|
| Pilates exercisesAlso: Pilates bandSide kick internal/ external rotation with Pilate's band | Other | study group |
| Traditional physical therapy programAlso: strengthening exercisesstrength, flexibility | Other | control group |
Primary outcome
Pain assessment
Time frame: at baseline
assessed by using a visual analog scale, 10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation
Pain assessment
Time frame: after 12 weeks
assessed by using a visual analog scale,10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation
Muscle strength assessment
Time frame: at baseline
assessed using a calibrated handheld dynamometer
Muscle strength assessment
Time frame: after 12 weeks
assessed using a calibrated handheld dynamometer
4 secondary outcomes
Functional status
Time frame: at baseline
Functional status
Time frame: after 12 weeks
health-related quality of life
Time frame: at baseline
health-related quality of life
Time frame: after 12 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 22 Nov 2021.
- Background: PubMed 21177007Park SK, Stefanyshyn DJ. Greater Q angle may not be a risk factor of patellofemoral pain syndrome. Clin Biomech (Bristol). 2011 May;26(4):392-6. doi: 10.1016/j.clinbiomech.2010.11.015. Epub 2010 Dec 21.
- Background: PubMed 24884455Rabelo ND, Lima B, Reis AC, Bley AS, Yi LC, Fukuda TY, Costa LO, Lucareli PR. Neuromuscular training and muscle strengthening in patients with patellofemoral pain syndrome: a protocol of randomized controlled trial. BMC Musculoskelet Disord. 2014 May 16;15:157. doi: 10.1186/1471-2474-15-157.
- Results publication: PubMed 26158920Van Der Heijden RA, Lankhorst NE, Van Linschoten R, Bierma-Zeinstra SM, Van Middelkoop M. Exercise for treating patellofemoral pain syndrome: an abridged version of Cochrane systematic review. Eur J Phys Rehabil Med. 2016 Feb;52(1):110-33. Epub 2015 Jul 9.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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.
Alshimaa Azab, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises and Traditional physical therapy program in people with Patellofemoral Pain Syndrome, run by Qassim 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 9 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 22 Nov 2021. 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 assessment (time frame: at baseline). 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?
On the ClinicalTrials.gov record for NCT05120583, which also lists 3 linked publications.
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 22 Nov 2021.