Supraspinatus TendinitisNCT07615920
HILT vs ESWT in Supraspinatus Tendinitis
A study testing High-Intensity Laser Therapy, Extracorporeal Shock Wave Therapy and Conventional Physical Therapy in people with Supraspinatus Tendinitis, run by Kafrelsheikh University at 1 site in Saudi Arabia.
Trial summary
This randomized controlled trial aims to compare the effectiveness of High-Intensity Laser Therapy (HILT) and Extracorporeal Shock Wave Therapy (ESWT) in patients with supraspinatus tendinitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Supraspinatus Tendinitis
- What is being tested?
- High-Intensity Laser Therapy, Extracorporeal Shock Wave Therapy and Conventional Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jul 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female participants aged between 18 and 60 years.
- Clinically diagnosed supraspinatus tendinitis confirmed by ultrasound imaging.
- Shoulder pain duration greater than 3 months.
- Ability to understand and follow study instructions.
- Willingness to participate and provide informed consent.
Who cannot join
- Full-thickness rotator cuff tear.
- Previous shoulder surgery.
- Pregnancy.
- Neurological disorders affecting the upper limb.
- Corticosteroid injection within the previous 3 months.
- Shoulder fracture or dislocation.
- Systemic inflammatory diseases.
- Participation in other physical therapy programs during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Faisal Medical Complex
Ta'if, Mecca Region, 26561
Adel M Al-qarni, Bsc in Physical Therapy, +966566505440, Taif-kfh-Pt@moh.gov.sa
About this study
Official title: Comparative Effectiveness of High-Intensity Laser Therapy Versus Extracorporeal Shock Wave Therapy in Patients With Supraspinatus Tendinitis
This randomized controlled trial aims to compare the effectiveness of High-Intensity Laser Therapy (HILT) and Extracorporeal Shock Wave Therapy (ESWT) in patients with supraspinatus tendinitis.
- Conditions
- Supraspinatus Tendinitis
- Being tested
- High-Intensity Laser Therapy, Extracorporeal Shock Wave Therapy, Conventional Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser TherapyDevice
High-Intensity Laser Therapy (HILT) is an advanced electrotherapy modality that uses high-power laser energy to penetrate deep musculoskeletal tissues and stimulate biological healing processes. The device emits laser wavelengths ranging between 808-1064 nm with high peak power output, allowing deeper tissue penetration compared to conventional low-level laser therapy. HILT provides analgesic, anti-inflammatory, and biostimulatory effects through increasing local blood circulation, enhancing cellular metabolism, stimulating collagen synthesis, and promoting tissue regeneration. The treatment is non-invasive, safe, and commonly used in musculoskeletal rehabilitation, particularly for tendinopathies and chronic pain conditions.
Extracorporeal Shock Wave TherapyDevice
Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive therapeutic modality that delivers high-energy acoustic waves to injured musculoskeletal tissues. The device generates focused or radial shock waves that stimulate tissue healing, neovascularization, pain reduction, and cellular repair mechanisms. ESWT is widely used in the management of tendinopathies, calcific disorders, and chronic musculoskeletal pain. Treatment parameters typically include energy flux density, frequency, number of impulses, and treatment sessions. The therapy is considered safe and effective, with minimal side effects
Conventional Physical TherapyOther
The conventional physical therapy program consisted of a combination of therapeutic exercises and physical therapy modalities aimed at reducing pain, improving shoulder range of motion, enhancing muscle strength, and restoring functional performance. The program included hot pack application, Transcutaneous Electrical Nerve Stimulation (TENS), stretching exercises, range of motion exercises, strengthening exercises for the rotator cuff and scapular stabilizers, as well as a home exercise program. Treatment sessions were conducted three times per week according to the patient's tolerance and clinical condition
| Study group | Role | What they receive |
|---|---|---|
| Group A: HILT + Conventional PT | Active comparator | Not described Receives: Device: High-Intensity Laser Therapy; Other: Conventional Physical Therapy |
| Group B: ESWT + Conventional PT | Active comparator | Not described Receives: Device: Extracorporeal Shock Wave Therapy; Other: Conventional Physical Therapy |
| Group C: Conventional Physical Therapy Only | Active comparator | Not described Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured using Visual Analogue Scale (VAS).
Pain intensity will be assessed using the Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: At baseline and immediately after 4 weeks of intervention
Secondary outcomes (4)
Shoulder Pain and Disability Measured by the Shoulder Pain and Disability Index (SPADI)
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index (SPADI). The SPADI score ranges from 0 to 100, with higher scores indicating greater pain and disability.
Measured: At baseline and immediately after 4 weeks of intervention
Upper Extremity Function Measured by the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Upper extremity function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. DASH scores range from 0 to 100, with higher scores indicating greater disability.
Measured: Time Frame: Baseline and immediately after 4 weeks of intervention.
Shoulder Range of Motion Measured Using a Digital Goniometer
Shoulder range of motion (flexion, abduction, and external rotation) will be measured in degrees using a digital goniometer. Higher values indicate greater shoulder mobility.
Measured: Baseline and immediately after 4 weeks of intervention.
Quality of Life Measured by the Short Form-36 Health Survey (SF-36)
Quality of life will be assessed using the Short Form-36 Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Baseline and immediately after 4 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jul 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TendinitisStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sami abdu akkur, Kafrelsheikh University
- Investigators
- Yasmin Mohamed Mahmoud, Study director, Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical TherapyMahmoud Mohamed Ewida, PHD, Study chair, Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical TherapyShaimaa Ramadan Eldeab, PHD, Study director, Lecturer of orthopedic physical therapy Department of physical therapy for musculoskeletal disorders and it's surgerySami ABDU Akkur, MASTER DEGREE STUDENT, Principal investigator, Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615920
- Sponsor's protocol ID
- KFSIRB200-1036
- Status last verified
- Oct 2026
- First submitted
- 19 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of High-Intensity Laser Therapy Versus Extracorporeal Shock Wave Therapy in Patients With Supraspinatus Tendinitis
- ClinicalTrials.gov ID
- NCT07615920
- Acronym / sponsor ID
- KFSIRB200-1036
- Conditions
- Supraspinatus Tendinitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 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 randomized controlled trial aims to compare the effectiveness of High-Intensity Laser Therapy (HILT) and Extracorporeal Shock Wave Therapy (ESWT) in patients with supraspinatus tendinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: HILT + Conventional PT | Active comparator | Device: High-Intensity Laser Therapy, Other: Conventional Physical Therapy |
| Group B: ESWT + Conventional PT | Active comparator | Device: Extracorporeal Shock Wave Therapy, Other: Conventional Physical Therapy |
| Group C: Conventional Physical Therapy Only | Active comparator | Other: Conventional Physical Therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female participants aged between 18 and 60 years.
- Clinically diagnosed supraspinatus tendinitis confirmed by ultrasound imaging.
- Shoulder pain duration greater than 3 months.
- Ability to understand and follow study instructions.
- Willingness to participate and provide informed consent.
Key exclusion criteria (8 listed)
- Full-thickness rotator cuff tear.
- Previous shoulder surgery.
- Pregnancy.
- Neurological disorders affecting the upper limb.
- Corticosteroid injection within the previous 3 months.
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 |
|---|---|---|
| High-Intensity Laser TherapyHigh-Intensity Laser Therapy (HILT) is an advanced electrotherapy modality that uses high-power laser energy to penetrate deep musculoskeletal tissues and stimulate biological healing processes. The device emits laser wavelengths ranging between 808-1064 nm with high peak power output, allowing deeper tissue penetration compared to conventional low-level laser therapy. HILT provides analgesic, anti-inflammatory, and biostimulatory effects through increasing local blood circulation, enhancing cellular metabolism, stimulating collagen synthesis, and promoting tissue regeneration. The treatment is non-invasive, safe, and commonly used in musculoskeletal rehabilitation, particularly for tendinopathies and chronic pain conditions. | Device | Group A: HILT + Conventional PT |
| Extracorporeal Shock Wave TherapyExtracorporeal Shock Wave Therapy (ESWT) is a non-invasive therapeutic modality that delivers high-energy acoustic waves to injured musculoskeletal tissues. The device generates focused or radial shock waves that stimulate tissue healing, neovascularization, pain reduction, and cellular repair mechanisms. ESWT is widely used in the management of tendinopathies, calcific disorders, and chronic musculoskeletal pain. Treatment parameters typically include energy flux density, frequency, number of impulses, and treatment sessions. The therapy is considered safe and effective, with minimal side effects | Device | Group B: ESWT + Conventional PT |
| Conventional Physical TherapyThe conventional physical therapy program consisted of a combination of therapeutic exercises and physical therapy modalities aimed at reducing pain, improving shoulder range of motion, enhancing muscle strength, and restoring functional performance. The program included hot pack application, Transcutaneous Electrical Nerve Stimulation (TENS), stretching exercises, range of motion exercises, strengthening exercises for the rotator cuff and scapular stabilizers, as well as a home exercise program. Treatment sessions were conducted three times per week according to the patient's tolerance and clinical condition | Other | Group A: HILT + Conventional PT, Group B: ESWT + Conventional PT, Group C: Conventional Physical Therapy Only |
Primary outcome
Pain intensity measured using Visual Analogue Scale (VAS).
Time frame: At baseline and immediately after 4 weeks of intervention
Pain intensity will be assessed using the Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.
4 secondary outcomes
Shoulder Pain and Disability Measured by the Shoulder Pain and Disability Index (SPADI)
Time frame: At baseline and immediately after 4 weeks of intervention
Upper Extremity Function Measured by the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Time frame: Time Frame: Baseline and immediately after 4 weeks of intervention.
Shoulder Range of Motion Measured Using a Digital Goniometer
Time frame: Baseline and immediately after 4 weeks of intervention.
Quality of Life Measured by the Short Form-36 Health Survey (SF-36)
Time frame: Baseline and immediately after 4 weeks of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Yasmin Mohamed Mahmoud study director
Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy
Mahmoud Mohamed Ewida, PHD study chair
Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy
Shaimaa Ramadan Eldeab, PHD study director
Lecturer of orthopedic physical therapy Department of physical therapy for musculoskeletal disorders and it's surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Laser Therapy, Extracorporeal Shock Wave Therapy and Conventional Physical Therapy in people with Supraspinatus Tendinitis, run by Kafrelsheikh 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 20 Oct 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SAMI ABDU AKKUR, MASTER (+966500433558, pt.sami558@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured using Visual Analogue Scale (VAS). (time frame: At baseline and immediately after 4 weeks of intervention). 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 2026.