Effect of High Intensity Laser Plus Exercises on Wrist PainNCT04984187
Effect of High Intensity Laser Versus Plus Exercises
A study testing high intensity laser plus exercise, high intensity laser only and exercise in people with Effect of High Intensity Laser Plus Exercises on Wrist Pain, run by Badr University at 1 site in Egypt.
Trial summary
High-intensity laser therapy (HILT) has been used more recently in the therapeutic protocols of musculoskeletal pain management. This study is conducted to find out the effect of high intensity laser therapy only versus high intensity laser pulse exercises on level of wrist pain, function and Joint position sense in… Read more about this study
- Who is it for?
- Ages 10 to 16 years, women only
- Conditions the study is for
- Effect of High Intensity Laser Plus Exercises on Wrist Pain
- What is being tested?
- high intensity laser plus exercise, high intensity laser only and exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2021to 30 Aug 2021
- 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 10 to 16 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- All girls diagnosed with generalized chronic wrist pain and referred by orthopaedic physician.
- Their age between 10-16 years old
- They will be able to follow instructions.
- All are medically stable
Who cannot join
- • Bone fractures and tumors.
- Cases after plastic surgery.
- Hypertension (due to secondary vasoconstriction)
- Diabetes mellitus
- Pacemakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of High Intensity Laser Therapy Plus Therapeutic Interventions in Treatment of Girls Gymnasts With Non-specific Wrist Pain
High-intensity laser therapy (HILT) has been used more recently in the therapeutic protocols of musculoskeletal pain management. This study is conducted to find out the effect of high intensity laser therapy only versus high intensity laser pulse exercises on level of wrist pain, function and Joint position sense in girls Gymnasts
Read the detailed description
Effect of high intensity laser plus exercises on wrist pain ..three groups of gymnastics girls suffer from non specific wrist is allocating ..the first group will receive exercises only , the second will receive laser only while the third will receive exercises plus laser
- Being tested
- high intensity laser plus exercise, high intensity laser only, exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity laser plus exerciseOther
high intensity laser plus exercise
high intensity laser onlyDevice
high intensity laser only
exerciseOther
Also called exercise only
exercise only
| Study group | Role | What they receive |
|---|---|---|
| Laser group | Other | High Intensity Laser Therapy only , this group will receive laser for 4 weeks three times /week Receives: Device: high intensity laser only |
| Exercise group | Other | Exercise , selected physiotherapy exercises will receive for 4 weeks ,3times/week Receives: Other: exercise |
| High intensity laser grouo | Experimental | High intensity laser plus exercise will receive the selected exercises and laser 4 weeks, 3 times/week Receives: Other: high intensity laser plus exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRWE
The PRWE is a 15-item questionnaire that is used to rate wrist outcomes based on patient pain and function and is based on an 11-point (0-10) scale.
Measured: pre and post 4 weeks of intervention, decrease score indicate improvement
Secondary outcomes (1)
JBS
JPS assesses precision or accuracy in repositioning a joint at a predetermined target angle
Measured: pre and post 4 weeks of intervention, decrease score indicate improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start25 Jul 2021
- Primary completion25 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of High Intensity Laser Plus Exercises on Wrist PainStudies 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
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanaa mohsen, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984187
- Sponsor's protocol ID
- Hanaa 6
- Status last verified
- Sep 2021
- First submitted
- 7 Jul 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- 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 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Intensity Laser Therapy Plus Therapeutic Interventions in Treatment of Girls Gymnasts With Non-specific Wrist Pain
- ClinicalTrials.gov ID
- NCT04984187
- Acronym / sponsor ID
- Hanaa 6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 30 Jul 2021 (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.
High-intensity laser therapy (HILT) has been used more recently in the therapeutic protocols of musculoskeletal pain management. This study is conducted to find out the effect of high intensity laser therapy only versus high intensity laser pulse exercises on level of wrist pain, function and Joint position sense in girls Gymnasts
Detailed description
Effect of high intensity laser plus exercises on wrist pain ..three groups of gymnastics girls suffer from non specific wrist is allocating ..the first group will receive exercises only , the second will receive laser only while the third will receive exercises plus laser
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser group | Other | Device: high intensity laser onlyHigh Intensity Laser Therapy only , this group will receive laser for 4 weeks three times /week |
| Exercise group | Other | Other: exerciseExercise , selected physiotherapy exercises will receive for 4 weeks ,3times/week |
| High intensity laser grouo | Experimental | Other: high intensity laser plus exerciseHigh intensity laser plus exercise will receive the selected exercises and laser 4 weeks, 3 times/week |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- All girls diagnosed with generalized chronic wrist pain and referred by orthopaedic physician.
- Their age between 10-16 years old
- They will be able to follow instructions.
- All are medically stable
Key exclusion criteria (5 listed)
- • Bone fractures and tumors.
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 plus exercisehigh intensity laser plus exercise | Other | High intensity laser grouo |
| high intensity laser onlyhigh intensity laser only | Device | Laser group |
| exerciseAlso: exercise onlyexercise only | Other | Exercise group |
Primary outcome
PRWE
Time frame: pre and post 4 weeks of intervention, decrease score indicate improvement
The PRWE is a 15-item questionnaire that is used to rate wrist outcomes based on patient pain and function and is based on an 11-point (0-10) scale.
1 secondary outcome
JBS
Time frame: pre and post 4 weeks of intervention, decrease score indicate improvement
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 14 Sep 2021.
- Individual participant dataSharing planned: No
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 high intensity laser plus exercise, high intensity laser only and exercise in people with Effect of High Intensity Laser Plus Exercises on Wrist Pain, run by Badr 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 14 Sep 2021. 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?
PRWE (time frame: pre and post 4 weeks of intervention, decrease score indicate improvement). 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 14 Sep 2021.