High Intensity Laser TherapyNCT06665282
Efficacy of Pulsed High Intensity Laser Therapy in Psoriatic Hand Arthritis
A study testing Pulsed high intensity laser therapy and Routine physical therapy program in people with High Intensity Laser Therapy and Psoriasis, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study was to evaluate the therapeutic efficacy of pulsed high intensity level laser therapy in improving symptoms of psoriatic hand arthritis. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- High Intensity Laser Therapy, Psoriasis, Hand
- What is being tested?
- Pulsed high intensity laser therapy and Routine physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both sexes of patients their age range between 30-50 years.
- Bilateral PsA following psoriasis
- All participants who are diagnosed with PsA, and experience clinical symptoms such as pain, swelling, tenderness and stiffness less than 1 year from the beginning of disease.
- All patients enrolled to the study will have their informed consent.
Who cannot join
- Positive rheumatic factor
- Circulatory disorders
- Diabetes
- Pregnant woman
- Skin diseases like urticaria.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
out-patient clinic, faculty of physical therapy, Cairo university
Giza
About this study
Official title: Efficacy of Pulsed High Intensity Laser Therapy in Treatment of Psoriatic Hand Arthritis
The purpose of the study was to evaluate the therapeutic efficacy of pulsed high intensity level laser therapy in improving symptoms of psoriatic hand arthritis.
Read the detailed description
Psoriatic arthritis is a chronic, inflammatory joint disease affecting 20%-30% of patients with psoriasis. It affects peripheral joints and axial skeleton, causing pain, stiffness, swelling, and joint destruction. High-intensity laser therapy can control inflammation and improve pain relief, range of motion, and functional improvement. This study aims to examine High-intensity laser therapy efficacy in managing Psoriatic arthritis, aiming to provide a safe, effective, and noninvasive treatment method.
- Conditions
- High Intensity Laser Therapy, Psoriasis, Hand
- Being tested
- Pulsed high intensity laser therapy, sham pulsed high intensity laser therapy, Routine physical therapy program
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed high intensity laser therapyDevice
The study employs a BTL-6000 high-intensity laser therapy (12 W) to apply high intensity laser therapy to deep tissues. high intensity laser therapy therapy uses powerful beams (>500 mw) to penetrate deeper, delivering high multi-directional energy in a short time. Pulsed laser therapy, a form of high intensity laser therapy therapy, enhances cell metabolism without disrupting it.
High-intensity laser therapy is a safe treatment method consisting of three phases. The first phase involves fast scanning around the wrist, hand, and fingers, with fluencies set at 510, 610, and 710mJ/cm2. The second phase involves holding the handpiece vertically to 90° on 10 fixed points around the metacarpophalangeal and interphalangeal joints, each radiated for 15 seconds, and a total dose of 1500 J. The third phase is the same but at a slower rate, with a total energy of 300 J.
sham pulsed high intensity laser therapyDevice
Patients in the control group will receive sham high-intensity laser therapy, where all parameters will be set up without switching on the start button and high intensity laser therapy machine is switched on with a visible light beam only
Routine physical therapy programOther
All patients of the study and control groups will receive the same routine physical therapy program for 30minutes and three times per week for successive eight weeks in the form of hot therapy, stretching and strengthening exercises. Hot therapy, in the form of warm baths for 10minutes, is applied before stretching exercises on the wrist joint and fingers to relieve joint pain and increase the range of motion. Strengthening exercises are in the form of isometric exercise for hand muscles and fingers to maintain muscles strength and joints flexibility
| Study group | Role | What they receive |
|---|---|---|
| Pulsed high intensity level laser therapy group | Experimental | This group includes 38 patients who will receive pulsed high intensity level laser therapy 3 sessions per week over 8 successive weeks in addition to routine physical therapy in the form of hot therapy, stretching and strengthening exercises Receives: Device: Pulsed high intensity laser therapy; Other: Routine physical therapy program |
| Shame pulsed high intensity laser level therapy | Active comparator | This group includes 38 patients who will receive shame pulsed high intensity laser level therapy 3 sessions per week over 8 successive weeks in addition to routine physical therapy in the form of hot therapy, stretching and strengthening exercises Receives: Device: sham pulsed high intensity laser therapy; Other: Routine physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of Hand Grip Strength using manual dynamometer
The Handheld Jamar dynamometer device 12-0600 will be used to measure hand grip strength, with a readout in pounds and kilograms. The strength will be measured with the elbow at 90° according to the American Society of Hand Therapists' recommendations. Patients will be instructed to sit while the affected limb is placed in shoulder adduction, internal rotation, elbow flexion, forearm mid position, and wrist neutral position. Three consecutive measurements will be performed with a 2-minute interval, and the mean strength value of the three trials will be considered as the hand grip measure.
Measured: at baseline and after 2 months
Secondary outcomes (3)
assessment of Joint counts for tenderness
Joint counts for tenderness was the sum of the number of the affected joints
Measured: at baseline and after 2 months
assessment of Joint swelling count
Joint swelling count is the sum of the swollen joints at the dominant hand before and after the treatment
Measured: at baseline and after 2 months
assessment of pain intensity using visual analogue scale
The Visual Analog Scale was used to measure pain intensity, with a 100mm horizontal line starting with no pain and ending with worse pain. Patients marked their pain intensity points on the scale, and the researcher measured the distance between the "no pain" mark and the patient's mark, providing a range of scores from 0 to 100mm.
Measured: at baseline and after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Aug 2023
- Primary completion1 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intensity Laser TherapyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Shawky Helmy Abdelhamid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665282
- Sponsor's protocol ID
- Mahmoud-004436
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulsed High Intensity Laser Therapy in Treatment of Psoriatic Hand Arthritis
- ClinicalTrials.gov ID
- NCT06665282
- Acronym / sponsor ID
- Mahmoud-004436
- Conditions
- High Intensity Laser Therapy, Psoriasis, Hand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 30 Oct 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.
The purpose of the study was to evaluate the therapeutic efficacy of pulsed high intensity level laser therapy in improving symptoms of psoriatic hand arthritis.
Detailed description
Psoriatic arthritis is a chronic, inflammatory joint disease affecting 20%-30% of patients with psoriasis. It affects peripheral joints and axial skeleton, causing pain, stiffness, swelling, and joint destruction. High-intensity laser therapy can control inflammation and improve pain relief, range of motion, and functional improvement. This study aims to examine High-intensity laser therapy efficacy in managing Psoriatic arthritis, aiming to provide a safe, effective, and noninvasive treatment method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed high intensity level laser therapy group | Experimental | Device: Pulsed high intensity laser therapy, Other: Routine physical therapy programThis group includes 38 patients who will receive pulsed high intensity level laser therapy 3 sessions per week over 8 successive weeks in addition to routine physical therapy in the form of hot therapy, stretching and strengthening exercises |
| Shame pulsed high intensity laser level therapy | Active comparator | Device: sham pulsed high intensity laser therapy, Other: Routine physical therapy programThis group includes 38 patients who will receive shame pulsed high intensity laser level therapy 3 sessions per week over 8 successive weeks in addition to routine physical therapy in the form of hot therapy, stretching and strengthening exercises |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both sexes of patients their age range between 30-50 years.
- Bilateral PsA following psoriasis
- All participants who are diagnosed with PsA, and experience clinical symptoms such as pain, swelling, tenderness and stiffness less than 1 year from the beginning of disease.
- All patients enrolled to the study will have their informed consent.
Key exclusion criteria (5 listed)
- Positive rheumatic factor
- Circulatory disorders
- Diabetes
- Pregnant woman
- Skin diseases like urticaria.
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 |
|---|---|---|
| Pulsed high intensity laser therapyThe study employs a BTL-6000 high-intensity laser therapy (12 W) to apply high intensity laser therapy to deep tissues. high intensity laser therapy therapy uses powerful beams (>500 mw) to penetrate deeper, delivering high multi-directional energy in a short time. Pulsed laser therapy, a form of high intensity laser therapy therapy, enhances cell metabolism without disrupting it. High-intensity laser therapy is a safe treatment method consisting of three phases. The first phase involves fast scanning around the wrist, hand, and fingers, with fluencies set at 510, 610, and 710mJ/cm2. The second phase involves holding the handpiece vertically to 90° on 10 fixed points around the metacarpophalangeal and interphalangeal joints, each radiated for 15 seconds, and a total dose of 1500 J. The third phase is the same but at a slower rate, with a total energy of 300 J. | Device | Pulsed high intensity level laser therapy group |
| sham pulsed high intensity laser therapyPatients in the control group will receive sham high-intensity laser therapy, where all parameters will be set up without switching on the start button and high intensity laser therapy machine is switched on with a visible light beam only | Device | Shame pulsed high intensity laser level therapy |
| Routine physical therapy programAll patients of the study and control groups will receive the same routine physical therapy program for 30minutes and three times per week for successive eight weeks in the form of hot therapy, stretching and strengthening exercises. Hot therapy, in the form of warm baths for 10minutes, is applied before stretching exercises on the wrist joint and fingers to relieve joint pain and increase the range of motion. Strengthening exercises are in the form of isometric exercise for hand muscles and fingers to maintain muscles strength and joints flexibility | Other | Pulsed high intensity level laser therapy group, Shame pulsed high intensity laser level therapy |
Primary outcome
Assessment of change of Hand Grip Strength using manual dynamometer
Time frame: at baseline and after 2 months
The Handheld Jamar dynamometer device 12-0600 will be used to measure hand grip strength, with a readout in pounds and kilograms. The strength will be measured with the elbow at 90° according to the American Society of Hand Therapists' recommendations. Patients will be instructed to sit while the affected limb is placed in shoulder adduction, internal rotation, elbow flexion, forearm mid position, and wrist neutral position. Three consecutive measurements will be performed with a 2-minute interval, and the mean strength value of the three trials will be considered as the hand grip measure.
3 secondary outcomes
assessment of Joint counts for tenderness
Time frame: at baseline and after 2 months
assessment of Joint swelling count
Time frame: at baseline and after 2 months
assessment of pain intensity using visual analogue scale
Time frame: at baseline and after 2 months
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 30 Oct 2024.
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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 Pulsed high intensity laser therapy and Routine physical therapy program in people with High Intensity Laser Therapy and Psoriasis, 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 4 inclusion and 5 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 30 Oct 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?
Assessment of change of Hand Grip Strength using manual dynamometer (time frame: at baseline and after 2 months). 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 30 Oct 2024.