Patellofemoral Pain SyndromeNCT06696872
Enhancing Stability and Function in Adolescent
A study testing core exercises and Proprioceptive Neuromuscular Facilitation in people with Patellofemoral Pain Syndrome and Adolescents, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
This study investigated the comparative effects of proprioceptive neuromuscular facilitation (PNF) stretching and core strength exercises on static balance in adolescents with patellofemoral pain syndrome (PFPS). Read more about this study
- Who is it for?
- Ages 16 to 18 years
- Conditions the study is for
- Patellofemoral Pain Syndrome, Adolescents
- What is being tested?
- core exercises and Proprioceptive Neuromuscular Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2024to 12 Jul 2024
- 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 16 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants were between 16 and 18 years old.
- Patients had to have experienced anterior knee pain for at least 4 weeks, with the pain being exacerbated by at least two of the following activities: jumping, running, prolonged sitting, stair climbing, kneeling, and squatting (Chevidikunnan et al., 2016).
- Participants could not have undergone any surgical procedures on their lower limbs.
- Pain during the previous week needed to be greater than 30 mm on a 100 mm visual analogue scale (VAS) (Appendix I) (Rathleff et al., 2015).
- A spectrum of BMI was sought, with participants recruited to represent normal BMI percentile categories for both boys and girls. The normal BMI percentile categories for both boys and girls were defined as the 5th percentile to less than the 85th percentile (Appendix II) (King et al., 2012).
Who cannot join
- Adolescents with cruciate ligament injuries, meniscal injuries, collateral ligament injuries, and tenderness associated with any of these structures, any intra-articular injury, and tenderness over the iliotibial band, patellar tendon, pes anserine tendons, or evidence of joint effusion.
- Adolescents with referred pain from the hip or lumbar region, or a known case of articular cartilage damage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proprioceptive Neuromuscular Facilitation Versus Core Training for Enhancing Stability and Function in Adolescent With Patellofemoral Pain Syndrome
This study investigated the comparative effects of proprioceptive neuromuscular facilitation (PNF) stretching and core strength exercises on static balance in adolescents with patellofemoral pain syndrome (PFPS).
- Conditions
- Patellofemoral Pain Syndrome, Adolescents
- Being tested
- core exercises, Proprioceptive Neuromuscular Facilitation
- 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.
core exercisesOther
The core muscle strength training program were lasted for 8 weeks and comprised of 3 training sessions per week, with a total of 24 sessions. Each session were lasted for 30 to 45 minutes, starting with a brief warm-up exercise program consisting of low-intensity core strength exercises to prepare the neuromuscular system for the training loads and ending with a cool-down program
Proprioceptive Neuromuscular FacilitationOther
The hold-relax proprioceptive neuromuscular facilitation stretching protocol consisted of passively moving the dominant leg into a position where the subjects felt mild discomfort and holding that position for 30 seconds. Subjects were then asked to isometrically contract the stretched muscle for 10 seconds; this were followed by muscle relaxation in the same posi¬tion for 30 seconds, before being stretched to a new point of mild discomfort. The leg were then released
| Study group | Role | What they receive |
|---|---|---|
| Core exercises | Experimental | The participants were taught how to contract their deep abdominal muscles to obtain core muscle activation. The patient should be contracting the abdominal muscles, lifting her lower belly up away from pubic bone, while breathing slowly and normally. The patient should not hold her breath Receives: Other: core exercises |
| Proprioceptive Neuromuscular Facilitation | Experimental | The hold-relax proprioceptive neuromuscular facilitation stretching protocol consisted of passively moving the dominant leg into a position where the subjects felt mild discomfort and holding that position for 30 seconds. Subjects were then asked to isometrically contract the stretched muscle for 10 seconds; this were followed by muscle relaxation in the same position for 30 seconds, before being stretched to a new point of mild discomfort. The leg were then released Receives: Other: Proprioceptive Neuromuscular Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS-100 mm) for pain
Measured: All adolescents were assessed before and after the 8-week intervention period
Dynamic postural stability test and single leg test using the Biodex Balance System SD
Measured: All adolescents were assessed before and after the 8-week intervention period
Secondary outcomes (1)
Self-administered Anterior Knee Pain Scale (AKPS) or Kujala Patellofemoral Score
Measured: All adolescents were assessed before and after the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start20 Apr 2024
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
- Investigators
- Amira H Mohammed, PHD, Principal investigator, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696872
- Sponsor's protocol ID
- Patellofemoral Pain Syndrome
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data availability by requesting from the corresponding author and after publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioceptive Neuromuscular Facilitation Versus Core Training for Enhancing Stability and Function in Adolescent With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT06696872
- Acronym / sponsor ID
- Patellofemoral Pain Syndrome
- Conditions
- Patellofemoral Pain Syndrome, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 20 Nov 2024 (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.
This study investigated the comparative effects of proprioceptive neuromuscular facilitation (PNF) stretching and core strength exercises on static balance in adolescents with patellofemoral pain syndrome (PFPS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core exercises | Experimental | Other: core exercisesThe participants were taught how to contract their deep abdominal muscles to obtain core muscle activation. The patient should be contracting the abdominal muscles, lifting her lower belly up away from pubic bone, while breathing slowly and normally. The patient should not hold her breath |
| Proprioceptive Neuromuscular Facilitation | Experimental | Other: Proprioceptive Neuromuscular FacilitationThe hold-relax proprioceptive neuromuscular facilitation stretching protocol consisted of passively moving the dominant leg into a position where the subjects felt mild discomfort and holding that position for 30 seconds. Subjects were then asked to isometrically contract the stretched muscle for 10 seconds; this were followed by muscle relaxation in the same position for 30 seconds, before being stretched to a new point of mild discomfort. The leg were then released |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Participants were between 16 and 18 years old.
- Patients had to have experienced anterior knee pain for at least 4 weeks, with the pain being exacerbated by at least two of the following activities: jumping, running, prolonged sitting, stair climbing, kneeling, and squatting (Chevidikunnan et al., 2016).
- Participants could not have undergone any surgical procedures on their lower limbs.
- Pain during the previous week needed to be greater than 30 mm on a 100 mm visual analogue scale (VAS) (Appendix I) (Rathleff et al., 2015).
- A spectrum of BMI was sought, with participants recruited to represent normal BMI percentile categories for both boys and girls. The normal BMI percentile categories for both boys and girls were defined as the 5th percentile to less than the 85th percentile (Appendix II) (King et al., 2012).
Key exclusion criteria (2 listed)
- Adolescents with cruciate ligament injuries, meniscal injuries, collateral ligament injuries, and tenderness associated with any of these structures, any intra-articular injury, and tenderness over the iliotibial band, patellar tendon, pes anserine tendons, or evidence of joint effusion.
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 |
|---|---|---|
| core exercisesThe core muscle strength training program were lasted for 8 weeks and comprised of 3 training sessions per week, with a total of 24 sessions. Each session were lasted for 30 to 45 minutes, starting with a brief warm-up exercise program consisting of low-intensity core strength exercises to prepare the neuromuscular system for the training loads and ending with a cool-down program | Other | Core exercises |
| Proprioceptive Neuromuscular FacilitationThe hold-relax proprioceptive neuromuscular facilitation stretching protocol consisted of passively moving the dominant leg into a position where the subjects felt mild discomfort and holding that position for 30 seconds. Subjects were then asked to isometrically contract the stretched muscle for 10 seconds; this were followed by muscle relaxation in the same posi¬tion for 30 seconds, before being stretched to a new point of mild discomfort. The leg were then released | Other | Proprioceptive Neuromuscular Facilitation |
Primary outcome
Visual analogue scale (VAS-100 mm) for pain
Time frame: All adolescents were assessed before and after the 8-week intervention period
Dynamic postural stability test and single leg test using the Biodex Balance System SD
Time frame: All adolescents were assessed before and after the 8-week intervention period
1 secondary outcome
Self-administered Anterior Knee Pain Scale (AKPS) or Kujala Patellofemoral Score
Time frame: All adolescents were assessed before and after the 8-week intervention period
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 Nov 2024.
- Individual participant dataSharing planned: Yes. data availability by requesting from the corresponding author and after publication
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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.
Amira H Mohammed, PHD principal investigator
Delta University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core exercises and Proprioceptive Neuromuscular Facilitation in people with Patellofemoral Pain Syndrome and Adolescents, run by Delta University for Science and Technology at 1 site in Egypt.
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 5 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 20 Nov 2024. 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 Egypt. 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?
Visual analogue scale (VAS-100 mm) for pain (time frame: All adolescents were assessed before and after the 8-week intervention period). 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 Nov 2024.