Neck PainNPNCT05434039
Diclofenac Phonophoresis Versus High Power Pain Threshold Ultrasound on Patients With Neck Pain
A study testing diclofenac phonophoresis, high power pain threshold ultrasound and conventional therapy in people with Neck Pain, run by Cairo University.
Trial summary
the aim of this study is to investigate the effect of diclofenac phonophoresis versus high power pain threshold ultrasound in patients with mechanical non-specific neck pain Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- diclofenac phonophoresis, high power pain threshold ultrasound and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2022to 1 Sep 2022
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed as non-specific neck pain with upper trapezius and suboccipital muscles active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern
- body mass index from 18 to 25 kg/m2
- their ages from 18-30
Who cannot join
- if they had trigger point injections within the past 6 months
- history of neck or upper back surgery, trauma or fracture
- history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities
- cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diclofenac Phonophoresis Versus High Power Pain Threshold Ultrasound in Patients With Mechanical Non-specific Neck Pain
the aim of this study is to investigate the effect of diclofenac phonophoresis versus high power pain threshold ultrasound in patients with mechanical non-specific neck pain
Read the detailed description
Neck pain can be a long-lasting condition, Between half and three quarters of patients with neck pain will experience recurrence within 1-5 years. Costs for the society due to neck pain are consequently high. Neck pain (NP) is one of the common musculoskeletal problems. NP can be caused by the stress over the musculoskeletal system due to postural disorders and may also be associated with other causes such as intervertebral disc herniation, nerve compression, or fracture. Musculoskeletal pain due to trigger points is one of the most prevalent reasons for patients to seek treatment. The aim of physical therapy treatment in patient with myofascial pain syndrome is to reduce the pain and restore normal function. Most physical therapy treatments for MPS are targeted to the deactivation of MTrPs. Physical therapy techniques include manual therapies; such as ischemic compression, spray and stretch, strain and counter strain, muscle energy techniques, trigger point pressure release, transverse friction massage; needling therapies, and other techniques such as thermotherapy, ultrasound therapy , phonophoresis and laser therapy.Due to the semi-solid properties, a special method is needed for transdermal permeation of lidocaine. Therefore, many studies have focused on enhancing the level of transdermal permeation by either changing the physiochemical properties of lidocaine or using physical modalities In particular, there has been considerable interest in transdermal permeation using various methods based on the idea that the amount and depth of transdermal permeation can be increased using various physical modalities. patients with mechanical neck pain will be allocated randomly into three equal groups; group A will receive phonophoresis and traditional therapy, group B will receive high power pain thresholdand traditional therapy and group C will receive traditional therapy
- Conditions
- Neck Pain
- Being tested
- diclofenac phonophoresis, high power pain threshold ultrasound, conventional therapy
- Keywords
- phonophoresis, high power pain threshold ultrasound, 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.
diclofenac phonophoresisOther
the patients will be in comfortable position and apply diclofenac phonophoresis on upper trapezius and suboccipital muscle by ultrasound device. diclofenac gel was applied circularly with a thickness of 2-3 mm. Then ultrasound with was applied with 1 MHz frequency and 1.5 Wt/cm2 power over the trigger points on the trapezius and suboccipital muscle, for 10 min.
high power pain threshold ultrasoundOther
the patients will be in comfortable position and The frequency was set to 1 MHz, and the intensity will be increased from 0.5 to 2 until the patient reported an unpleasant sensation. The probe was held there for 4 s; then, the intensity was reduced by 50%, and the probe will be moved over and around the trigger point. This process is done several times for three minutes
conventional therapyOther
the patient will receive an active range of motion exercise, stretching and strengthening of all cervical muscles
| Study group | Role | What they receive |
|---|---|---|
| diclofenac phonophoresis | Experimental | the patients will receive diclofenac phonophoresis and traditional therapy three times a week for four weeks Receives: Other: diclofenac phonophoresis; Other: conventional therapy |
| high power pain threshold ultrasound | Experimental | the patients will receive high power pain threshold ultrasound and traditional therapy three times a week for four weeks Receives: Other: high power pain threshold ultrasound; Other: conventional therapy |
| conventional therapy | Active comparator | the patients will receive traditional therapy three times a week for four weeks Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
The scale that will be used is visual analogue scale ;each subject will be instructed to put point on line from no pain to tolerable pain
Measured: up to four weeks
Secondary outcomes (3)
cervical range of motion
range of cervical will be measured by CROM device
Measured: up to four weeks
pressure pain threshold
pressure pain threshold will be measured by commander algometer
Measured: up to four weeks
neck disability
neck disability will be measured by Arabic neck disability index
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 posted27 Jun 2022
- Study start30 Jul 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (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
- diclofenac phonophoresis and high power pain threshold
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434039
- Sponsor's protocol ID
- p.t.REC/012/003672
- Acronym
- NP
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 27 Jul 2022
- 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 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diclofenac Phonophoresis Versus High Power Pain Threshold Ultrasound in Patients With Mechanical Non-specific Neck Pain
- ClinicalTrials.gov ID
- NCT05434039
- Acronym / sponsor ID
- NP / p.t.REC/012/003672
- Conditions
- Neck Pain
- Keywords
- phonophoresis, high power pain threshold ultrasound, neck pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jul 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 27 Jun 2022 (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 aim of this study is to investigate the effect of diclofenac phonophoresis versus high power pain threshold ultrasound in patients with mechanical non-specific neck pain
Detailed description
Neck pain can be a long-lasting condition, Between half and three quarters of patients with neck pain will experience recurrence within 1-5 years. Costs for the society due to neck pain are consequently high. Neck pain (NP) is one of the common musculoskeletal problems. NP can be caused by the stress over the musculoskeletal system due to postural disorders and may also be associated with other causes such as intervertebral disc herniation, nerve compression, or fracture. Musculoskeletal pain due to trigger points is one of the most prevalent reasons for patients to seek treatment. The aim of physical therapy treatment in patient with myofascial pain syndrome is to reduce the pain and restore normal function. Most physical therapy treatments for MPS are targeted to the deactivation of MTrPs. Physical therapy techniques include manual therapies; such as ischemic compression, spray and stretch, strain and counter strain, muscle energy techniques, trigger point pressure release, transverse friction massage; needling therapies, and other techniques such as thermotherapy, ultrasound therapy , phonophoresis and laser therapy.Due to the semi-solid properties, a special method is needed for transdermal permeation of lidocaine. Therefore, many studies have focused on enhancing the level of transdermal permeation by either changing the physiochemical properties of lidocaine or using physical modalities In particular, there has been considerable interest in transdermal permeation using various methods based on the idea that the amount and depth of transdermal permeation can be increased using various physical modalities. patients with mechanical neck pain will be allocated randomly into three equal groups; group A will receive phonophoresis and traditional therapy, group B will receive high power pain thresholdand traditional therapy and group C will receive traditional therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- diclofenac phonophoresis and high power pain threshold
| Arm | Type | Receives |
|---|---|---|
| diclofenac phonophoresis | Experimental | Other: diclofenac phonophoresis, Other: conventional therapythe patients will receive diclofenac phonophoresis and traditional therapy three times a week for four weeks |
| high power pain threshold ultrasound | Experimental | Other: high power pain threshold ultrasound, Other: conventional therapythe patients will receive high power pain threshold ultrasound and traditional therapy three times a week for four weeks |
| conventional therapy | Active comparator | Other: conventional therapythe patients will receive traditional therapy three times a week for four weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- diagnosed as non-specific neck pain with upper trapezius and suboccipital muscles active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern
- body mass index from 18 to 25 kg/m2
- their ages from 18-30
Key exclusion criteria (4 listed)
- if they had trigger point injections within the past 6 months
- history of neck or upper back surgery, trauma or fracture
- history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities
- cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases
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 |
|---|---|---|
| diclofenac phonophoresisthe patients will be in comfortable position and apply diclofenac phonophoresis on upper trapezius and suboccipital muscle by ultrasound device. diclofenac gel was applied circularly with a thickness of 2-3 mm. Then ultrasound with was applied with 1 MHz frequency and 1.5 Wt/cm2 power over the trigger points on the trapezius and suboccipital muscle, for 10 min. | Other | diclofenac phonophoresis |
| high power pain threshold ultrasoundthe patients will be in comfortable position and The frequency was set to 1 MHz, and the intensity will be increased from 0.5 to 2 until the patient reported an unpleasant sensation. The probe was held there for 4 s; then, the intensity was reduced by 50%, and the probe will be moved over and around the trigger point. This process is done several times for three minutes | Other | high power pain threshold ultrasound |
| conventional therapythe patient will receive an active range of motion exercise, stretching and strengthening of all cervical muscles | Other | conventional therapy, diclofenac phonophoresis, high power pain threshold ultrasound |
Primary outcome
pain intensity
Time frame: up to four weeks
The scale that will be used is visual analogue scale ;each subject will be instructed to put point on line from no pain to tolerable pain
3 secondary outcomes
cervical range of motion
Time frame: up to four weeks
pressure pain threshold
Time frame: up to four weeks
neck disability
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 27 Jul 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing diclofenac phonophoresis, high power pain threshold ultrasound and conventional therapy 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 4 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 27 Jul 2022. 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?
Contact al shaymaa sh abd el azeim, lecturer (01033771553, shimaashaaban30@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: up to four weeks). 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 27 Jul 2022.