Osteomyelitis ChronicNCT07283302
Pre-Surgery Rehab for a Child With Humeral Head and Shaft Deformity: A Case Report
A study testing Transcutaneous Electrical Nerve Stimulation, Low-Level Laser Therapy and Manual Therapy in people with Osteomyelitis Chronic and Bone Defects, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this observational study (single-patient case report) is to learn whether a structured pre-operative physical therapy rehabilitation program can improve shoulder function, reduce pain, and improve quality of life in an 11-year-old girl with humeral head and shaft deformity (post-inflammatory changes). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteomyelitis Chronic, Bone Defects
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation, Low-Level Laser Therapy and Manual Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Nov 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Not applicable (case report; single patient case).
Who cannot join
- Not applicable (case report; single patient case).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Out patinets clinics, Faculty of Physical Therapy Cairo University
Giza, 11432
About this study
Official title: Pre-operative Rehabilitation Protocol for a Pediatric Patient With Humeral Head and Shaft Deformity: A Case Report
The goal of this observational study (single-patient case report) is to learn whether a structured pre-operative physical therapy rehabilitation program can improve shoulder function, reduce pain, and improve quality of life in an 11-year-old girl with humeral head and shaft deformity (post-inflammatory changes).
The main questions it aims to answer are:
Read more
Does shoulder range of motion and muscle strength improve after the program? Does pain and functional ability (including posture) improve after the program?
Participants will:
Attend 12 sessions over October-November 2025 (2 sessions/week) at the Faculty of Physical Therapy, Cairo University
Receive a standardized session program that may include:
TENS, low-level laser therapy, manual therapy (Spencer technique), phonophoresis PNF stretching and progressive exercises, plus scapular taping Complete evaluations at baseline, mid-program, and after the program, including goniometry (ROM), manual muscle testing, pain scale (VAS), postural assessment, and a functional ability checklist
Read the detailed description
This study is a single-patient case report describing the design, delivery, and observed response to a pre-operative rehabilitation program for a pediatric patient with deformity involving the humeral head and shaft. The report will document the patient's baseline presentation, the clinical reasoning used to select pre-operative rehabilitation goals, and the step-by-step rehabilitation approach used to optimize the shoulder and upper-limb condition before planned surgical management.
The rehabilitation program is intended to maximize safe functional capacity pre-operatively by addressing modifiable impairments commonly associated with this condition, such as pain, limited range of motion, weakness, altered scapulohumeral mechanics, and compensatory movement patterns. The case report will describe treatment components (e.g., education, therapeutic exercise, flexibility and strengthening strategies, neuromuscular re-education, and other noninvasive physical therapy modalities as clinically indicated), how the program is progressed over time, and any precautions used to ensure age-appropriate and condition-appropriate care.
To evaluate response to the program, the study will collect structured pre- and post-program measurements relevant to shoulder/upper-limb status, such as:
- Pain and symptom severity
- Shoulder range of motion
- Muscle strength and/or functional performance
- Activity limitations and functional use of the affected arm
- Observed posture and movement quality (as clinically applicable) The report will also capture treatment adherence, any adverse events, and notable barriers/facilitators to participation (e.g., tolerance, fatigue, caregiver involvement). Findings will be presented descriptively to help clinicians and families understand what a pre-operative rehabilitation plan may include for a child with humeral deformity, and what types of short-term changes may be observed during the pre-surgical period.
- Conditions
- Osteomyelitis Chronic, Bone Defects
- Being tested
- Transcutaneous Electrical Nerve Stimulation, Low-Level Laser Therapy, Manual Therapy, Phonophoresis, PNF stretching
- Keywords
- Pre-operative rehabilitation, Humeral head deformity, Upper limb deformity, Pre-operative rehabilitation (prehabilitation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
a method of pain relief that uses a device to send low-voltage electrical impulses through electrodes placed on the skin
Low-Level Laser TherapyDevice
a non-invasive medical treatment that uses low-level lasers or light-emitting diodes (LEDs) to stimulate cell function and accelerate the body's natural healing process
Manual TherapyOther
a hands-on treatment approach
PhonophoresisOther
Also called Ultrasound
a medical procedure that uses therapeutic ultrasound to deliver topical medications through the skin and into deeper tissues
PNF stretchingOther
is an advanced technique that combines muscle contraction and relaxation to increase flexibility and range of motion
kinesio tapingOther
Kinesio tape will be applied to the shoulder and scapular region to support improved alignment and scapular control during movement.
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | This single-arm case report includes a structured pre-operative physical therapy rehabilitation program for a pediatric patient with humeral head and shaft deformity. The intervention consists of supervised sessions incorporating pain-modulation modalities (as clinically indicated), manual therapy to improve shoulder mobility, therapeutic exercises for flexibility, strengthening, and neuromuscular control, and scapular stabilization/positioning strategies (including taping as needed). Treatment is progressed based on tolerance and clinical response, with the goal of improving pre-operative shoulder pain, range of motion, strength, posture, and functional use of the upper limb. Receives: Device: Transcutaneous Electrical Nerve Stimulation; Device: Low-Level Laser Therapy; Other: Manual Therapy; Other: Phonophoresis; Other: PNF stretching; Other: kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Shoulder range of motion will be assessed using a standard universal goniometer to quantify the motion of the affected upper limb.
Measured: 4 weeks
Manual Muscle Testing
Upper-limb and shoulder muscle strength will be assessed using standardized Manual Muscle Testing procedures. Key muscle groups around the shoulder and scapula (e.g., shoulder flexors, abductors, internal/external rotators, and scapular stabilizers)
Measured: 4 weeks
Functional Ability
Functional status of the affected upper limb will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. The patient (with caregiver assistance as needed) will rate the difficulty of performing common daily activities and the impact of symptoms such as pain on function. Responses are summed and converted to a 0-100 score, where higher scores indicate greater disability.
Measured: 4 weeks
Secondary outcomes (1)
Pain intensity
Pain intensity will be measured using a Visual Analog Scale (VAS). The patient will be asked to rate her pain by marking on a 10-cm line anchored by "no pain" (0) and "worst pain imaginable" (10).
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 posted15 Dec 2025
- Study start1 Oct 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis ChronicStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Eldaly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283302
- Sponsor's protocol ID
- P.T.REC/012/006101
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Rehabilitation Protocol for a Pediatric Patient With Humeral Head and Shaft Deformity: A Case Report
- ClinicalTrials.gov ID
- NCT07283302
- Acronym / sponsor ID
- P.T.REC/012/006101
- Conditions
- Osteomyelitis Chronic, Bone Defects
- Keywords
- Pre-operative rehabilitation, Humeral head deformity, Upper limb deformity, Pre-operative rehabilitation (prehabilitation)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 15 Dec 2025 (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.
The goal of this observational study (single-patient case report) is to learn whether a structured pre-operative physical therapy rehabilitation program can improve shoulder function, reduce pain, and improve quality of life in an 11-year-old girl with humeral head and shaft deformity (post-inflammatory changes).
The main questions it aims to answer are:
Does shoulder range of motion and muscle strength improve after the program? Does pain and functional ability (including posture) improve after the program?
Participants will:
Attend 12 sessions over October-November 2025 (2 sessions/week) at the Faculty of Physical Therapy, Cairo University
Receive a standardized session program that may include:
TENS, low-level laser therapy, manual therapy (Spencer technique), phonophoresis PNF stretching and progressive exercises, plus scapular taping Complete evaluations at baseline, mid-program, and after the program, including goniometry (ROM), manual muscle testing, pain scale (VAS), postural assessment, and a functional ability checklist
Detailed description
This study is a single-patient case report describing the design, delivery, and observed response to a pre-operative rehabilitation program for a pediatric patient with deformity involving the humeral head and shaft. The report will document the patient's baseline presentation, the clinical reasoning used to select pre-operative rehabilitation goals, and the step-by-step rehabilitation approach used to optimize the shoulder and upper-limb condition before planned surgical management.
The rehabilitation program is intended to maximize safe functional capacity pre-operatively by addressing modifiable impairments commonly associated with this condition, such as pain, limited range of motion, weakness, altered scapulohumeral mechanics, and compensatory movement patterns. The case report will describe treatment components (e.g., education, therapeutic exercise, flexibility and strengthening strategies, neuromuscular re-education, and other noninvasive physical therapy modalities as clinically indicated), how the program is progressed over time, and any precautions used to ensure age-appropriate and condition-appropriate care.
To evaluate response to the program, the study will collect structured pre- and post-program measurements relevant to shoulder/upper-limb status, such as:
- Pain and symptom severity
- Shoulder range of motion
- Muscle strength and/or functional performance
- Activity limitations and functional use of the affected arm
- Observed posture and movement quality (as clinically applicable) The report will also capture treatment adherence, any adverse events, and notable barriers/facilitators to participation (e.g., tolerance, fatigue, caregiver involvement). Findings will be presented descriptively to help clinicians and families understand what a pre-operative rehabilitation plan may include for a child with humeral deformity, and what types of short-term changes may be observed during the pre-surgical period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Device: Transcutaneous Electrical Nerve Stimulation, Device: Low-Level Laser Therapy, Other: Manual Therapy, Other: Phonophoresis, Other: PNF stretching, Other: kinesio tapingThis single-arm case report includes a structured pre-operative physical therapy rehabilitation program for a pediatric patient with humeral head and shaft deformity. The intervention consists of supervised sessions incorporating pain-modulation modalities (as clinically indicated), manual therapy to improve shoulder mobility, therapeutic exercises for flexibility, strengthening, and neuromuscular control, and scapular stabilization/positioning strategies (including taping as needed). Treatment is progressed based on tolerance and clinical response, with the goal of improving pre-operative shoulder pain, range of motion, strength, posture, and functional use of the upper limb. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Not applicable (case report; single patient case).
Key exclusion criteria (1 listed)
- Not applicable (case report; single patient case).
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulationa method of pain relief that uses a device to send low-voltage electrical impulses through electrodes placed on the skin | Device | interventional |
| Low-Level Laser Therapya non-invasive medical treatment that uses low-level lasers or light-emitting diodes (LEDs) to stimulate cell function and accelerate the body's natural healing process | Device | interventional |
| Manual Therapya hands-on treatment approach | Other | interventional |
| PhonophoresisAlso: Ultrasounda medical procedure that uses therapeutic ultrasound to deliver topical medications through the skin and into deeper tissues | Other | interventional |
| PNF stretchingis an advanced technique that combines muscle contraction and relaxation to increase flexibility and range of motion | Other | interventional |
| kinesio tapingKinesio tape will be applied to the shoulder and scapular region to support improved alignment and scapular control during movement. | Other | interventional |
Primary outcome
Range of Motion
Time frame: 4 weeks
Shoulder range of motion will be assessed using a standard universal goniometer to quantify the motion of the affected upper limb.
Manual Muscle Testing
Time frame: 4 weeks
Upper-limb and shoulder muscle strength will be assessed using standardized Manual Muscle Testing procedures. Key muscle groups around the shoulder and scapula (e.g., shoulder flexors, abductors, internal/external rotators, and scapular stabilizers)
Functional Ability
Time frame: 4 weeks
Functional status of the affected upper limb will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. The patient (with caregiver assistance as needed) will rate the difficulty of performing common daily activities and the impact of symptoms such as pain on function. Responses are summed and converted to a 0-100 score, where higher scores indicate greater disability.
1 secondary outcome
Pain intensity
Time frame: 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 15 Dec 2025.
- Individual participant dataSharing planned: No
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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 Transcutaneous Electrical Nerve Stimulation, Low-Level Laser Therapy and Manual Therapy in people with Osteomyelitis Chronic and Bone Defects, run by Cairo University 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 1 inclusion and 1 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 Dec 2025. 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?
Range of Motion (time frame: 4 weeks). The study lists 3 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 15 Dec 2025.