Osgood-Schlatter DiseaseNCT07590128
Combined Physical Therapy and Hold-Relax Technique for Adolescent Osgood-Schlatter Knee Pain
A study testing Hold-Relax Proprioceptive Neuromuscular Facilitation (PNF) and Progressive Rehabilitation Program in people with Osgood-Schlatter Disease, run by Benha University at 1 site in Algeria.
Trial summary
This pilot study evaluates the preliminary effectiveness of a combined rehabilitation program incorporating hold-relax (H-R) stretching techniques and progressive therapeutic exercises on knee pain and range of motion (ROM) in adolescent athletes diagnosed with Osgood-Schlatter disease. Read more about this study
- Who is it for?
- Ages 14 to 18 years, men only
- Conditions the study is for
- Osgood-Schlatter Disease
- What is being tested?
- Hold-Relax Proprioceptive Neuromuscular Facilitation (PNF) and Progressive Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteAlgeria
- Study dates
- 2 Jan 2026to 15 Apr 2026
- 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 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of Osgood-Schlatter disease
- Presence of anterior knee pain localized at the tibial tuberosity
- Regular participation in sports involving running and jumping
- No participation in structured rehabilitation programs within the previous 3 months
Who cannot join
- History of knee surgery or major trauma
- Presence of other knee pathologies (e.g., ligament or meniscal injuries)
- Neurological or systemic disorders affecting movement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Effects of a Combined Hold-Relax Technique and Progressive Rehabilitation Program on Knee Pain in Adolescent Athletes With Osgood-Schlatter Disease: A Pilot Study
This pilot study evaluates the preliminary effectiveness of a combined rehabilitation program incorporating hold-relax (H-R) stretching techniques and progressive therapeutic exercises on knee pain and range of motion (ROM) in adolescent athletes diagnosed with Osgood-Schlatter disease. Utilizing a retrospective, single-group pre-post design on a cohort of six athletic participants, this study aims to generate preliminary clinical evidence and assess feasibility to inform future larger-scale randomized controlled trials. Participants underwent a structured, multi-week rehabilitation protocol, with primary clinical outcomes assessed before and after the intervention period using validated measures of pain intensity and knee joint mobility.
- Conditions
- Osgood-Schlatter Disease
- Being tested
- Hold-Relax Proprioceptive Neuromuscular Facilitation (PNF), Progressive Rehabilitation Program
- Medical subject headings
- Osteochondrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hold-Relax Proprioceptive Neuromuscular Facilitation (PNF)Behavioural
A target-specific, manual stretching technique administered by a physical therapist to address muscular tightness in the lower extremity. The protocol focuses on the bilateral quadriceps and hamstring muscle groups to reduce the cumulative tensile traction forces exerted on the tibial tuberosity.
For each target muscle group, the procedure is performed as follows:
Passive Stretch: The physical therapist moves the joint to the limit of comfortable range of motion (ROM) where mild muscle tightness is felt.
Isometric Contraction: The participant performs an active, sub-maximal isometric contraction (approximately 50% of maximum voluntary contraction) against the therapist's manual resistance for 6 to 10 seconds, ensuring no actual joint movement occurs.
Relaxation and Deeper Passive Stretch: The participant is instructed to relax completely, and the therapist immediately moves the limb passively into a newly gained, deeper range of motion, holding the stati
Progressive Rehabilitation ProgramBehavioural
A structured, step-by-step active exercise program designed to build lower-limb load tolerance, correct biomechanical compensations, and stabilize the knee joint complex. The rehabilitation progresses systematically through targeted phases based on individual pain levels and movement quality:Phase 1 (Pain Mitigation and Muscle Activation): Focuses on isometric quadriceps setting, straight leg raises (SLR), gluteal bridging, and ankle/hip mobility exercises to avoid direct loading of the patellar tendon while minimizing disuse atrophy.Phase 2 (Strength and Load Tolerance): Introduces closed-kinetic chain exercises with controlled ranges of motion, including shallow wall sits, leg presses, bilateral squats, and progressive calf raises.Phase 3 (Eccentric and Functional Progression): Focuses on eccentric quadriceps strengthening (e.g., controlled step-downs) and sport-specific functional retraining to prepare the adolescent athlete's patellar tendon and tibial tubercle to absorb high groun
| Study group | Role | What they receive |
|---|---|---|
| Combined Rehabilitation and Hold-Relax Cohort | Active comparator | A single experimental group of adolescent athletes diagnosed with Osgood-Schlatter Disease (OSD). All participants in this cohort receive a structured, multi-week progressive rehabilitation program combined with Hold-Relax (H-R) proprioceptive neuromuscular facilitation (PNF) stretching techniques.
The intervention protocol consists of:
* Hold-Relax stretching targeting the quadriceps and hamstring muscle groups to reduce tensile stress on the tibial tuberosity.
* Progressive therapeutic exercises focusing on lower extremity strengthening, load tolerance, and functional biomechanics. Receives: Behavioral: Hold-Relax Proprioceptive Neuromuscular Facilitation (PNF); Behavioral: Progressive Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Knee Pain Intensity on the Visual Analog Scale (VAS)
Knee pain during athletic activity is assessed using a 10-centimeter Visual Analog Scale (VAS). The scale is a horizontal line where 0 centimeters indicates "no pain" and 10 centimeters indicates "the worst possible pain."
The outcome is calculated as the change in the pain score (post-intervention score minus baseline score). A negative change indicates an improvement (reduction) in knee pain.
Measured: Baseline (Day 1, pre-intervention) and post-intervention (Week 10, immediately following completion of the last rehabilitation session).
Secondary outcomes (1)
Change from Baseline in Active Knee Flexion Range of Motion
Active knee joint flexion range of motion measured in degrees of joint angle using a standard universal goniometer. The participant lies in a supine position and actively bends the knee as far as possible.
The outcome is calculated as the change in degrees from baseline to post-intervention. An increase in degrees indicates an improved range of motion.
Measured: Baseline (Day 1, pre-intervention) and post-intervention (Week 10, immediately following completion of the last rehabilitation session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start2 Jan 2026
- Primary completion30 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osgood-Schlatter DiseaseStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Farag Al Kholy, Benha University
- Investigators
- Mahmoud El sayed, Bachelor of Physical Therapy, Principal investigator, Benha UniversityAhmed Said, Bachelor of Physical Therapy, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590128
- Sponsor's protocol ID
- SKE 05/2026
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Effects of a Combined Hold-Relax Technique and Progressive Rehabilitation Program on Knee Pain in Adolescent Athletes With Osgood-Schlatter Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT07590128
- Acronym / sponsor ID
- SKE 05/2026
- Conditions
- Osgood-Schlatter Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 15 May 2026 (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 pilot study evaluates the preliminary effectiveness of a combined rehabilitation program incorporating hold-relax (H-R) stretching techniques and progressive therapeutic exercises on knee pain and range of motion (ROM) in adolescent athletes diagnosed with Osgood-Schlatter disease. Utilizing a retrospective, single-group pre-post design on a cohort of six athletic participants, this study aims to generate preliminary clinical evidence and assess feasibility to inform future larger-scale randomized controlled trials. Participants underwent a structured, multi-week rehabilitation protocol, with primary clinical outcomes assessed before and after the intervention period using validated measures of pain intensity and knee joint mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Rehabilitation and Hold-Relax Cohort | Active comparator | Behavioral: Hold-Relax Proprioceptive Neuromuscular Facilitation (PNF), Behavioral: Progressive Rehabilitation ProgramA single experimental group of adolescent athletes diagnosed with Osgood-Schlatter Disease (OSD). All participants in this cohort receive a structured, multi-week progressive rehabilitation program combined with Hold-Relax (H-R) proprioceptive neuromuscular facilitation (PNF) stretching techniques. The intervention protocol consists of: * Hold-Relax stretching targeting the quadriceps and hamstring muscle groups to reduce tensile stress on the tibial tuberosity. * Progressive therapeutic exercises focusing on lower extremity strengthening, load tolerance, and functional biomechanics. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Osgood-Schlatter disease
- Presence of anterior knee pain localized at the tibial tuberosity
- Regular participation in sports involving running and jumping
- No participation in structured rehabilitation programs within the previous 3 months
Key exclusion criteria (3 listed)
- History of knee surgery or major trauma
- Presence of other knee pathologies (e.g., ligament or meniscal injuries)
- Neurological or systemic disorders affecting movement
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 |
|---|---|---|
| Hold-Relax Proprioceptive Neuromuscular Facilitation (PNF)A target-specific, manual stretching technique administered by a physical therapist to address muscular tightness in the lower extremity. The protocol focuses on the bilateral quadriceps and hamstring muscle groups to reduce the cumulative tensile traction forces exerted on the tibial tuberosity. For each target muscle group, the procedure is performed as follows: Passive Stretch: The physical therapist moves the joint to the limit of comfortable range of motion (ROM) where mild muscle tightness is felt. Isometric Contraction: The participant performs an active, sub-maximal isometric contraction (approximately 50% of maximum voluntary contraction) against the therapist's manual resistance for 6 to 10 seconds, ensuring no actual joint movement occurs. Relaxation and Deeper Passive Stretch: The participant is instructed to relax completely, and the therapist immediately moves the limb passively into a newly gained, deeper range of motion, holding the stati | Behavioural | Combined Rehabilitation and Hold-Relax Cohort |
| Progressive Rehabilitation ProgramA structured, step-by-step active exercise program designed to build lower-limb load tolerance, correct biomechanical compensations, and stabilize the knee joint complex. The rehabilitation progresses systematically through targeted phases based on individual pain levels and movement quality:Phase 1 (Pain Mitigation and Muscle Activation): Focuses on isometric quadriceps setting, straight leg raises (SLR), gluteal bridging, and ankle/hip mobility exercises to avoid direct loading of the patellar tendon while minimizing disuse atrophy.Phase 2 (Strength and Load Tolerance): Introduces closed-kinetic chain exercises with controlled ranges of motion, including shallow wall sits, leg presses, bilateral squats, and progressive calf raises.Phase 3 (Eccentric and Functional Progression): Focuses on eccentric quadriceps strengthening (e.g., controlled step-downs) and sport-specific functional retraining to prepare the adolescent athlete's patellar tendon and tibial tubercle to absorb high groun | Behavioural | Combined Rehabilitation and Hold-Relax Cohort |
Primary outcome
Change from Baseline in Knee Pain Intensity on the Visual Analog Scale (VAS)
Time frame: Baseline (Day 1, pre-intervention) and post-intervention (Week 10, immediately following completion of the last rehabilitation session).
Knee pain during athletic activity is assessed using a 10-centimeter Visual Analog Scale (VAS). The scale is a horizontal line where 0 centimeters indicates "no pain" and 10 centimeters indicates "the worst possible pain." The outcome is calculated as the change in the pain score (post-intervention score minus baseline score). A negative change indicates an improvement (reduction) in knee pain.
1 secondary outcome
Change from Baseline in Active Knee Flexion Range of Motion
Time frame: Baseline (Day 1, pre-intervention) and post-intervention (Week 10, immediately following completion of the last rehabilitation session).
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 15 May 2026.
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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.
Mahmoud El sayed, Bachelor of Physical Therapy principal investigator
Benha University
Ahmed Said, Bachelor of Physical Therapy principal investigator
Benha 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 Hold-Relax Proprioceptive Neuromuscular Facilitation (PNF) and Progressive Rehabilitation Program in people with Osgood-Schlatter Disease, run by Benha University at 1 site in Algeria.
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 4 inclusion and 3 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 15 May 2026. 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 Algeria. 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?
Change from Baseline in Knee Pain Intensity on the Visual Analog Scale (VAS) (time frame: Baseline (Day 1, pre-intervention) and post-intervention (Week 10, immediately following completion of the last rehabilitation session).). 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 15 May 2026.