Neck PainMNPNCT05782621
Acupoint Focused Ultrasound Versus Laserpuncture In Mechanical Neck Pain
A study testing Acupoint focused ultrasound, Laserpuncture and conventional treatment in people with Neck Pain, run by Cairo University.
Trial summary
this study will be conducted to compare the effect of Acupoint focused ultrasound and Laser puncture on pain intensity level, neck range of motion, and neck function in patient with chronic mechanical neck pain Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Acupoint focused ultrasound, Laserpuncture and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2023to 30 May 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All subjects will be referred by the orthopedist. Cervical pain is episodic chronic, having occurred and recurred over regular or irregular intervals of time over at least the last 3 months.
- The subject is willing and able to refrain from non-study procedure therapies for the management of neck pain throughout study participation.
- Age ranged from 30-60 years BMI ranged from (25-30kg/m2)
Who cannot join
- Cervical pain is undiagnosed or has been diagnosed as being other than of benign musculoskeletal origin.
- Tension myositis syndrome. Osteoporosis with compression fractures. Congenital deformity of spine. Current active chronic pain disease. Cancer or cancer treatment in the past 6 months. Use of the following analgesics within 7 days of study onset - paracetamol, acetominophen, non-steroidal anti-inflammatory drugs (NSAIDs), compound analgesics, topical analgesics.
- Use of the following muscle relaxants within the prior 30 days of study onset - cyclobenzaprine, diazepam, meprobamate.
About this study
Official title: Acupoint Focused Ultrasound Versus Laserpuncture In Chronic Mechanical Neck Pain
this study will be conducted to compare the effect of Acupoint focused ultrasound and Laser puncture on pain intensity level, neck range of motion, and neck function in patient with chronic mechanical neck pain
Read the detailed description
Neck pain is a musculoskeletal condition with a high prevalence that may affect the physical, social, and psychological aspects of the individual, contributing to the increase in costs in society and business. Neck pain was significantly associated with repetitive movement, activities that require lifting and moving loads, and being in sitting and leaning positions.Non specific neck pain is a multifactorial and very common condition in adult individuals, traditional acupuncture (TA) and laser puncture (LP) may be treatment options for certain individuals in such a condition. The laser will be placed at the specific acupuncture points: Tianzhu, Fengchi, Jianjing, and Jianzhongshu . Because ultrasound can deliver vibration energy to soft tissues noninvasively, ultrasound has been applied to diagnostic imaging and therapeutic applications. To use ultrasound for acupoint stimulation, a stimulation device was developed using focused ultrasound. The application of an ultrasound stimulus to the acupuncture meridian system has been found safe and effective in many common clinical entities. The Sonicator head is applied to the chosen location as in standard ultrasound therapy, with a gentle circular motion. forty five patients will be assigned randomly to three groups; experimental group 1 will receive acupoint focused ultrasound, experimental group 2 will receive laserpuncture and the control group will receive conventional treatment three times a week for four weeks.
- Conditions
- Neck Pain
- Being tested
- Acupoint focused ultrasound, Laserpuncture, conventional treatment
- Keywords
- Acupoint Focused Ultrasound, Laserpuncture, Chronic Mechanical Neck Pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupoint focused ultrasoundOther
An ultrasound beam is normally pulsed in the ratio of 1:5. For perfect transmission of power from the treatment head to the body, the head will be applied perpendicularly to the skin surface. A stationary technique pulsed ultrasound (1 w/cm2) will be used. The application will be two minutes for each acupuncture point and the head will be glided to the next point in the same side; then to the other side for no more than 10 points, then the device will be turned off
LaserpunctureOther
The laser tip (0.03 cm2 of beam area) will be positioned with the "probe" head directly on the acupuncture point, in a perpendicular position and in direct contact with the skin, and every point will be treated for 2 min, totaling 16 min of treatment, plus 4 min of rest, to standardize with the traditional acupuncture time, which is 20 min
conventional treatmentOther
the patients will receive selective neck strengthening ex for (extension, flexion, sidebending, lateral rotation) and selective neck stretching ex for (extension, flexion, sidebending, lateral rotation)
| Study group | Role | What they receive |
|---|---|---|
| Acupoint focused ultrasound | Experimental | the patients will receive Acupoint focused ultrasound therapy three times a week for four weeks Receives: Other: Acupoint focused ultrasound; Other: conventional treatment |
| Laserpuncture | Experimental | the patients will receive Laserpuncture therapy three times a week for four weeks Receives: Other: Laserpuncture; Other: conventional treatment |
| conventional treatment | Active comparator | the patients will receive conventional treatment three times a week for four weeks Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
pain will be measured by visual analogue scale. It is a vertical or horizontal 100 mm line graduated by different levels of pain, starting from 0 (no pain) till 100 (worst pain)
Measured: up to four weeks
Disability
The Copenhagen Neck Functional Disability Scale will be used to evaluate the disability experienced by patients with neck pain. it consists of 15 items. These items are individually answered by either 'yes', 'occasionally' or 'no'. For questions one till five, a 'yes' indicates a good function. For questions six till fifteen, a 'no' indicates a good function. A good function receives a score of zero, a poor function receives a score of two and the answer 'occasionally' always receives a score of one. Afterwards, we add up all the scores of the questions to form the total score. This total score ranges from 0 to 30.The total score determines the level of functional disability, in which higher numbers represent a higher level of disability. A score of 0 indicates that there are no neck complaints present whereas 30 indicates that the patient is extremely disabled as a result of the neck complaints
Measured: up to four weeks
Secondary outcomes (1)
cervical range of motion
The digital goniometer will be used for measuring cervical range of motion
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start30 Mar 2023 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (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
- Acupoint Focused Ultrasound and Laserpuncture
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ahmed Ahmed Asr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782621
- Sponsor's protocol ID
- P.T.REC/012/004126
- Acronym
- MNP
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupoint Focused Ultrasound Versus Laserpuncture In Chronic Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05782621
- Acronym / sponsor ID
- MNP / P.T.REC/012/004126
- Conditions
- Neck Pain
- Keywords
- Acupoint Focused Ultrasound, Laserpuncture, Chronic Mechanical Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 23 Mar 2023 (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 study will be conducted to compare the effect of Acupoint focused ultrasound and Laser puncture on pain intensity level, neck range of motion, and neck function in patient with chronic mechanical neck pain
Detailed description
Neck pain is a musculoskeletal condition with a high prevalence that may affect the physical, social, and psychological aspects of the individual, contributing to the increase in costs in society and business. Neck pain was significantly associated with repetitive movement, activities that require lifting and moving loads, and being in sitting and leaning positions.Non specific neck pain is a multifactorial and very common condition in adult individuals, traditional acupuncture (TA) and laser puncture (LP) may be treatment options for certain individuals in such a condition. The laser will be placed at the specific acupuncture points: Tianzhu, Fengchi, Jianjing, and Jianzhongshu . Because ultrasound can deliver vibration energy to soft tissues noninvasively, ultrasound has been applied to diagnostic imaging and therapeutic applications. To use ultrasound for acupoint stimulation, a stimulation device was developed using focused ultrasound. The application of an ultrasound stimulus to the acupuncture meridian system has been found safe and effective in many common clinical entities. The Sonicator head is applied to the chosen location as in standard ultrasound therapy, with a gentle circular motion. forty five patients will be assigned randomly to three groups; experimental group 1 will receive acupoint focused ultrasound, experimental group 2 will receive laserpuncture and the control group will receive conventional treatment three times a week for four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Acupoint Focused Ultrasound and Laserpuncture
| Arm | Type | Receives |
|---|---|---|
| Acupoint focused ultrasound | Experimental | Other: Acupoint focused ultrasound, Other: conventional treatmentthe patients will receive Acupoint focused ultrasound therapy three times a week for four weeks |
| Laserpuncture | Experimental | Other: Laserpuncture, Other: conventional treatmentthe patients will receive Laserpuncture therapy three times a week for four weeks |
| conventional treatment | Active comparator | Other: conventional treatmentthe patients will receive conventional treatment three times a week for four weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All subjects will be referred by the orthopedist. Cervical pain is episodic chronic, having occurred and recurred over regular or irregular intervals of time over at least the last 3 months.
- The subject is willing and able to refrain from non-study procedure therapies for the management of neck pain throughout study participation.
- Age ranged from 30-60 years BMI ranged from (25-30kg/m2)
Key exclusion criteria (3 listed)
- Cervical pain is undiagnosed or has been diagnosed as being other than of benign musculoskeletal origin.
- Tension myositis syndrome. Osteoporosis with compression fractures. Congenital deformity of spine. Current active chronic pain disease. Cancer or cancer treatment in the past 6 months. Use of the following analgesics within 7 days of study onset - paracetamol, acetominophen, non-steroidal anti-inflammatory drugs (NSAIDs), compound analgesics, topical analgesics.
- Use of the following muscle relaxants within the prior 30 days of study onset - cyclobenzaprine, diazepam, meprobamate.
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 |
|---|---|---|
| Acupoint focused ultrasoundAn ultrasound beam is normally pulsed in the ratio of 1:5. For perfect transmission of power from the treatment head to the body, the head will be applied perpendicularly to the skin surface. A stationary technique pulsed ultrasound (1 w/cm2) will be used. The application will be two minutes for each acupuncture point and the head will be glided to the next point in the same side; then to the other side for no more than 10 points, then the device will be turned off | Other | Acupoint focused ultrasound |
| LaserpunctureThe laser tip (0.03 cm2 of beam area) will be positioned with the "probe" head directly on the acupuncture point, in a perpendicular position and in direct contact with the skin, and every point will be treated for 2 min, totaling 16 min of treatment, plus 4 min of rest, to standardize with the traditional acupuncture time, which is 20 min | Other | Laserpuncture |
| conventional treatmentthe patients will receive selective neck strengthening ex for (extension, flexion, sidebending, lateral rotation) and selective neck stretching ex for (extension, flexion, sidebending, lateral rotation) | Other | Acupoint focused ultrasound, Laserpuncture, conventional treatment |
Primary outcome
pain intensity
Time frame: up to four weeks
pain will be measured by visual analogue scale. It is a vertical or horizontal 100 mm line graduated by different levels of pain, starting from 0 (no pain) till 100 (worst pain)
Disability
Time frame: up to four weeks
The Copenhagen Neck Functional Disability Scale will be used to evaluate the disability experienced by patients with neck pain. it consists of 15 items. These items are individually answered by either 'yes', 'occasionally' or 'no'. For questions one till five, a 'yes' indicates a good function. For questions six till fifteen, a 'no' indicates a good function. A good function receives a score of zero, a poor function receives a score of two and the answer 'occasionally' always receives a score of one. Afterwards, we add up all the scores of the questions to form the total score. This total score ranges from 0 to 30.The total score determines the level of functional disability, in which higher numbers represent a higher level of disability. A score of 0 indicates that there are no neck complaints present whereas 30 indicates that the patient is extremely disabled as a result of the neck complaints
1 secondary outcome
cervical range of motion
Time frame: up to four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acupoint focused ultrasound, Laserpuncture and conventional treatment in people with Neck Pain, run by Cairo University.
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 3 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
pain intensity (time frame: up to four weeks). The study lists 2 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 23 Mar 2023.