Neck PainNCT06552780
High Intensity Laser Versus Ischemic Compression on Myofascial Trigger Points in the Upper Trapezius
A study testing TENs , ultrasound therapy in people with Neck Pain, run by Cairo University at 1 site in Egypt.
Trial summary
TO Investigate the effect of high intensity laser versus ischemic compression on myofascial trigger points on neck pain, cervical range of motion,pressure pain thershold and cervical disability and to show that the more effectivness therapy will provide significant clinical value Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- TENs , ultrasound therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 19 May 2024to 1 Feb 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The age of patients range from 20 to 50 years .
- patient Body mass index starting from 19 to 25 kg\m.
- presence of myofascial trigger points in the shortened upper trapezius muscle evaluated .
Who cannot join
- patients with fibromyalgia syndrome.
- cancer or tumor or any type diagnosed .
- patients with disc herniation or spinal canal stenosis.
- pregnancy -
- patients diagnosed with epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
TO Investigate the effect of high intensity laser versus ischemic compression on myofascial trigger points on neck pain, cervical range of motion,pressure pain thershold and cervical disability and to show that the more effectivness therapy will provide significant clinical value
Read the detailed description
Randomized controlled Trial , participants will be assigned into three groups (study group A ,study group B and study group c ) Subject selection will be 63 subjects , 21 subjects in each group with trigger points in the upper trapezius.
Groups
- Conditions
- Neck Pain
- Being tested
- TENs , ultrasound therapy
- Keywords
- "myofascial pain syndrome" "trigger points" "high intensity laser " "ischemic compression"
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENs , ultrasound therapyDevice
Also called high intensity (power) laser, ischemic compression, TENs , ultrasound therapy , isometric exercise and stretching exercise.
effect of high intensity laser versus ischemic compression on myofascial trigger points in the upper trapezius
| Study group | Role | What they receive |
|---|---|---|
| high intensity laser , TENs and ultrasound and isometric exercise | Experimental | Group A ( study group )will receive high intensity laser ,TENs , ultrasound therapy , and isometric exercise. Receives: Device: TENs , ultrasound therapy |
| ischemic compression ,TENs , ultrasound and isometric exercise | Experimental | Group B ( study group) will receive ischemic compression ,TENs and ultrasound therapy and isometric exercise. Receives: Device: TENs , ultrasound therapy |
| TENs , ultrasound and isometric exercise | Experimental | Group C (control group ) will receive TENs and ultrasound therapy and isometric exercise only. Receives: Device: TENs , ultrasound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical range of motion (CROM)
All the cervical active movements will be measured by cervical range of motion device (CROM) especially in cervical flexion ,extension and medial and lateral rotation.one tester will document the results.
cervical range of motion (cROM) will be measured by using Electronic CROM Goniometer in all ranges.
Measured: 30 seconds
Secondary outcomes (1)
cervical pain
Cervical pain will be measured by Cervical range of motion device (CROM) .The patient will actively perform cervical movements in flexion ,extension and medial and lateral rotation then one tester will document the results as VAS will be used to measure pain levels .The VAS is a 10_cm line divided into 10 equal sections , with 10 expressing "unbearable pain " and 0 indicating no pain .each patient will be asked to point on this line to their level of neck pain .as pain level decreases ,the patient state improves. Pain will be assessed before and after treatment.
Measured: one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start19 May 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Model description
- Treatment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa mohamed abdelfatah elrefaey, Cairo University
- Investigators
- RAGIAA KAMEL, PROFFESOR DR, Principal investigator, RAGIAA M KAMEL , PROF DR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552780
- Sponsor's protocol ID
- 012\005287
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Laser Versus Ischemic Compression on Myofascial Trigger Points in the Upper Trapezius
- ClinicalTrials.gov ID
- NCT06552780
- Acronym / sponsor ID
- 012\005287
- Conditions
- Neck Pain
- Keywords
- "myofascial pain syndrome" "trigger points" "high intensity laser " "ischemic compression"
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 May 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 14 Aug 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.
TO Investigate the effect of high intensity laser versus ischemic compression on myofascial trigger points on neck pain, cervical range of motion,pressure pain thershold and cervical disability and to show that the more effectivness therapy will provide significant clinical value
Detailed description
Randomized controlled Trial , participants will be assigned into three groups (study group A ,study group B and study group c ) Subject selection will be 63 subjects , 21 subjects in each group with trigger points in the upper trapezius.
Groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Treatment
| Arm | Type | Receives |
|---|---|---|
| high intensity laser , TENs and ultrasound and isometric exercise | Experimental | Device: TENs , ultrasound therapyGroup A ( study group )will receive high intensity laser ,TENs , ultrasound therapy , and isometric exercise. |
| ischemic compression ,TENs , ultrasound and isometric exercise | Experimental | Device: TENs , ultrasound therapyGroup B ( study group) will receive ischemic compression ,TENs and ultrasound therapy and isometric exercise. |
| TENs , ultrasound and isometric exercise | Experimental | Device: TENs , ultrasound therapyGroup C (control group ) will receive TENs and ultrasound therapy and isometric exercise only. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The age of patients range from 20 to 50 years .
- patient Body mass index starting from 19 to 25 kg\m.
- presence of myofascial trigger points in the shortened upper trapezius muscle evaluated .
Key exclusion criteria (5 listed)
- patients with fibromyalgia syndrome.
- cancer or tumor or any type diagnosed .
- patients with disc herniation or spinal canal stenosis.
- pregnancy -
- patients diagnosed with epilepsy.
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 |
|---|---|---|
| TENs , ultrasound therapyAlso: high intensity (power) laser, ischemic compression, TENs , ultrasound therapy , isometric exercise and stretching exercise.effect of high intensity laser versus ischemic compression on myofascial trigger points in the upper trapezius | Device | TENs , ultrasound and isometric exercise, high intensity laser , TENs and ultrasound and isometric exercise, ischemic compression ,TENs , ultrasound and isometric exercise |
Primary outcome
cervical range of motion (CROM)
Time frame: 30 seconds
All the cervical active movements will be measured by cervical range of motion device (CROM) especially in cervical flexion ,extension and medial and lateral rotation.one tester will document the results. cervical range of motion (cROM) will be measured by using Electronic CROM Goniometer in all ranges.
1 secondary outcome
cervical pain
Time frame: one minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- 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.
RAGIAA KAMEL, PROFFESOR DR principal investigator
RAGIAA M KAMEL , PROF DR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENs , ultrasound therapy in people with Neck Pain, 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 3 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: status not confirmed, as of the sponsor's last update on 19 Aug 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?
Results are not available in the source record.
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?
cervical range of motion (CROM) (time frame: 30 seconds). 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 19 Aug 2024.