Neck PainMNPNCT05540093
Influence of Adding High Power Pain Threshold Ultrasound to Traditional Therapy on Axioappendicular Muscles Amplitude and Fatigue in Mechanical Neck Pain Randomized Clinical Trials
A study testing high power pain threshold ultrasound and traditional therapy in people with Neck Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study will investigate the effect of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in neck pain Read more about this study
- Who is it for?
- Ages 19 to 38 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- high power pain threshold ultrasound and traditional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2022to 1 Jan 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 19 to 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with mechanical neck pain from both genders.
- age between 19 and 38 years
- patients will be required to have active TrPs in the upper trapezius and levator muscle and neck pain
Who cannot join
- Patients will be excluded if they have History of whiplash injury,
- History of cervical spine surgery,
- Cervical radiculopathy or myelopathy,
- Having undergone physical therapy within the past 3 months before the study
- Non- rheumatologic diseases as multiple sclerosis,
- thyroid dysfunction and chronic infection and Rheumatologic condition as mild systemic lupus erythematosus, poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study will investigate the effect of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in neck pain
Read the detailed description
Myofascial pain syndrome is a common musculoskeletal pain disorder affecting almost 95% of people with chronic pain disorders and is a common finding in especially pain management centres.It is characterized by trigger points, defined as hyperirritable spots within taut bands of skeletal muscle fibers. The syndrome is associated with tenderness in the muscle, referred pain, spasm and restriction of motion. Patients with MPS begin with one active MTrP (called the primary MTrP) in the affected muscles due to chronic repetitive minor muscle strain, poor posture, systemic diseases, or neuro-musculoskeletal lesions. When not treated correctly, expansion of the pain region and additional active MTrPs (called secondary or satellite MTrPs) will develop one of the most appropriate treatments for trigger points ultrasound therapy. The high-power pain threshold ultrasound (HPPTUS) technique is one of the ultrasound modifications used to treat trigger points In 2004, Majlesi et al. performed the first clinical study to compare this technique with the traditional ultrasound technique in patients with myofascial trigger points. The results showed that HPPTUS was much more effective than the traditional technique, and pain reduction and improved range of motion (ROM) were significant in a smaller number of sessions.sixty patients with mechanical neck pain will be assigned randomly to two equal group. one group will receive high power pain threshold ultrasound and traditional therapy and the other receive traditional therapy alone for four weeks.
.
- Conditions
- Neck Pain
- Being tested
- high power pain threshold ultrasound, traditional therapy
- Keywords
- high power pain threshold ultrasound, 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.
high power pain threshold ultrasoundOther
After explaining the procedure, and the trigger points will be marked by a physical therapist that . Then, the hand placed next to the prone position with the head in the neutral position, and the hands placed next to the body. The frequency was set to 1 MHz, and the intensity increased from 0.5 to 2 until the patient reported an unpleasant sensation. The probe will be held there for 4 s; then, the intensity was reduced by 50%, and the probe was moved over and around the trigger point. This process is done several times for three minutes.
traditional therapyOther
the patients will receive traditional therapy in the form of postural correction exercise, active range of motion and stretching exercise for cervical muscles
| Study group | Role | What they receive |
|---|---|---|
| high power pain threshold ultrasound | Experimental | the patients will receive high power pain threshold ultrasound and traditional therapy twice a week for four weeks Receives: Other: high power pain threshold ultrasound; Other: traditional therapy |
| traditional therapy | Active comparator | the patients will receive traditional therapy twice a week for four weeks Receives: Other: traditional therapy |
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
Measured: up to four weeks
pressure pain threshold
commander algometer device will be used to measure pressure pain threshold
Measured: up to four weeks
Secondary outcomes (2)
neck disability
neck disability index will be used to measure neck disability.
Measured: up to four weeks
muscle amplitude and fatigue
electromyography will be used to measure muscle amplitude and fatigue
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 posted14 Sep 2022
- Study start20 Sep 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- high power pain threshold ultrasound and traditional therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
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
- NCT05540093
- Sponsor's protocol ID
- p.t.REC/012/003619
- Acronym
- MNP
- Status last verified
- Jan 2023
- First submitted
- 12 Sep 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abd El Azeim AS, Mohamed FS, Felaya EE, Ragab MM, Elkhateeb YS. Influence of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in mechanical neck pain randomized controlled trials. J Bodyw Mov Ther. 2025 Jun;42:629-637. doi: 10.1016/j.jbmt.2025.01.045. Epub 2025 Jan 26.
PubMed 40325732
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Adding High Power Pain Threshold Ultrasound to Traditional Therapy on Axioappendicular Muscles Amplitude and Fatigue in Mechanical Neck Pain Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT05540093
- Acronym / sponsor ID
- MNP / p.t.REC/012/003619
- Conditions
- Neck Pain
- Keywords
- high power pain threshold ultrasound, mechanical neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 14 Sep 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 purpose of this study will investigate the effect of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in neck pain
Detailed description
Myofascial pain syndrome is a common musculoskeletal pain disorder affecting almost 95% of people with chronic pain disorders and is a common finding in especially pain management centres.It is characterized by trigger points, defined as hyperirritable spots within taut bands of skeletal muscle fibers. The syndrome is associated with tenderness in the muscle, referred pain, spasm and restriction of motion. Patients with MPS begin with one active MTrP (called the primary MTrP) in the affected muscles due to chronic repetitive minor muscle strain, poor posture, systemic diseases, or neuro-musculoskeletal lesions. When not treated correctly, expansion of the pain region and additional active MTrPs (called secondary or satellite MTrPs) will develop one of the most appropriate treatments for trigger points ultrasound therapy. The high-power pain threshold ultrasound (HPPTUS) technique is one of the ultrasound modifications used to treat trigger points In 2004, Majlesi et al. performed the first clinical study to compare this technique with the traditional ultrasound technique in patients with myofascial trigger points. The results showed that HPPTUS was much more effective than the traditional technique, and pain reduction and improved range of motion (ROM) were significant in a smaller number of sessions.sixty patients with mechanical neck pain will be assigned randomly to two equal group. one group will receive high power pain threshold ultrasound and traditional therapy and the other receive traditional therapy alone for four weeks.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- high power pain threshold ultrasound and traditional therapy
| Arm | Type | Receives |
|---|---|---|
| high power pain threshold ultrasound | Experimental | Other: high power pain threshold ultrasound, Other: traditional therapythe patients will receive high power pain threshold ultrasound and traditional therapy twice a week for four weeks |
| traditional therapy | Active comparator | Other: traditional therapythe patients will receive traditional therapy twice a week for four weeks |
Who may qualify
- Ages
- 19 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients with mechanical neck pain from both genders.
- age between 19 and 38 years
- patients will be required to have active TrPs in the upper trapezius and levator muscle and neck pain
Key exclusion criteria (6 listed)
- Patients will be excluded if they have History of whiplash injury,
- History of cervical spine surgery,
- Cervical radiculopathy or myelopathy,
- Having undergone physical therapy within the past 3 months before the study
- Non- rheumatologic diseases as multiple sclerosis,
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 power pain threshold ultrasoundAfter explaining the procedure, and the trigger points will be marked by a physical therapist that . Then, the hand placed next to the prone position with the head in the neutral position, and the hands placed next to the body. The frequency was set to 1 MHz, and the intensity increased from 0.5 to 2 until the patient reported an unpleasant sensation. The probe will be held there for 4 s; then, the intensity was reduced by 50%, and the probe was moved over and around the trigger point. This process is done several times for three minutes. | Other | high power pain threshold ultrasound |
| traditional therapythe patients will receive traditional therapy in the form of postural correction exercise, active range of motion and stretching exercise for cervical muscles | Other | high power pain threshold ultrasound, traditional therapy |
Primary outcome
pain intensity
Time frame: up to four weeks
pain will be measured by visual analogue scale
pressure pain threshold
Time frame: up to four weeks
commander algometer device will be used to measure pressure pain threshold
2 secondary outcomes
neck disability
Time frame: up to four weeks
muscle amplitude and fatigue
Time frame: up to four weeks
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 25 Jan 2023.
- Derived from this study: PubMed 40325732Abd El Azeim AS, Mohamed FS, Felaya EE, Ragab MM, Elkhateeb YS. Influence of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in mechanical neck pain randomized controlled trials. J Bodyw Mov Ther. 2025 Jun;42:629-637. doi: 10.1016/j.jbmt.2025.01.045. Epub 2025 Jan 26.
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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 high power pain threshold ultrasound and traditional 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 6 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 25 Jan 2023. 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?
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?
On the ClinicalTrials.gov record for NCT05540093, which also lists 1 linked publication.
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 25 Jan 2023.