Trigger Point Pain, MyofascialNCT05474898
IONTOPHORESIS Versus Ultrasound in Mechanical Neck Pain
A study testing Magnesium Sulphate Iontophoresis +conventional therapy, High- Power Pain Threshold Ultrasound +conventional therapy and conventional theapy in people with Trigger Point Pain, Myofascial, run by Cairo University at 1 site in Egypt.
Trial summary
to investigate the effects of Magnesium Sulphate Iontophoresis versus High Power Pain Threshold Ultrasound on pain, function and range of motion on active MTrPs found in the upper trapezius. Read more about this study
- Who is it for?
- Ages 19 to 23 years
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- Magnesium Sulphate Iontophoresis +conventional therapy, High- Power Pain Threshold Ultrasound +conventional therapy and conventional theapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Aug 2022to 15 Nov 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 19 to 23 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects, with age ranged from 19-23 years (Forman et al, 2014) from both genders. The subjects had active MTrPs in the upper fibers of trapezius muscle.
Who cannot join
- • History of whiplash injury.
- History of cervical spine surgery.
- Cervical radiculopathy or myelopathy.
- Having undergone physical therapy within the past three months before the study.
- Non- rheumatologic diseases as multiple sclerosis, thyroid dysfunction and chronic infection.
- Rheumatologic condition as poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Cairo
Hend Hamdy, PHD, 01024420121, hendhamdy110@yahoo.com
About this study
Official title: Magnesium Sulphate Iontophoresis Versus High- Power Pain Threshold Ultrasound in Mechanical Neck Pain
to investigate the effects of Magnesium Sulphate Iontophoresis versus High Power Pain Threshold Ultrasound on pain, function and range of motion on active MTrPs found in the upper trapezius.
Read the detailed description
Myofascial pain syndrome (MPS) is a musculoskeletal chronic pain disorder that affects the majority of pain population and characterized by the presence of trigger points. MPS is usually associated with tenderness, spasm, movement limitation and referred pain .
Myofascial trigger points (MTrPs) are hyperirritable taut fibers of skeletal muscle. The taut fibers within the muscle create palpable nodules that may cause local pain, and refer pain elsewhere with soft tissue examination .
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- Magnesium Sulphate Iontophoresis +conventional therapy, High- Power Pain Threshold Ultrasound +conventional therapy, conventional theapy
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulphate Iontophoresis +conventional therapyOther
will receive Mgso4 Iontophoresis in addition to conventional therapy twice a week/4 weeks
High- Power Pain Threshold Ultrasound +conventional therapyOther
will receive HPPT-US on the upper trapezius in addition to conventional therapy twice a week/4 weeks
conventional theapyOther
will receive postural correction exercise-stretching and strengthening twice a week/4weeks
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | Not described Receives: Other: Magnesium Sulphate Iontophoresis +conventional therapy; Other: conventional theapy |
| Group (B) | Experimental | Not described Receives: Other: High- Power Pain Threshold Ultrasound +conventional therapy; Other: conventional theapy |
| Group (c) | Other | Not described Receives: Other: conventional theapy |
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 the VAS ;each subject will instructed to put point on line from no pain to tolerable pain
Measured: up to four weeks
Secondary outcomes (3)
Pain pressure threshold (PPT)
Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity by Algometer.
Measured: up to four weeks
neck disability
will be measured by Arabic neck disability index
Measured: up to four weeks
range of motion
will be measured by myrin gravity reference goniometer
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 posted26 Jul 2022
- Study start8 Aug 2022
- Primary completion1 Oct 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
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 Trigger Point Pain, MyofascialStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Hamdy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474898
- Sponsor's protocol ID
- p.T.RCE/012/003552
- Status last verified
- Sep 2022
- First submitted
- 23 Jul 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ibrahim NA, Hamdy HA, Elbanna RHM, Mohamed DMA, Ali EA. Transdermal iontophoresis versus high power pain threshold ultrasound in Mechanical Neck Pain: a randomized controlled trial. J Orthop Surg Res. 2024 Oct 15;19(1):658. doi: 10.1186/s13018-024-05078-z.
PubMed 39407315
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulphate Iontophoresis Versus High- Power Pain Threshold Ultrasound in Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05474898
- Acronym / sponsor ID
- p.T.RCE/012/003552
- Conditions
- Trigger Point Pain, Myofascial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 26 Jul 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.
to investigate the effects of Magnesium Sulphate Iontophoresis versus High Power Pain Threshold Ultrasound on pain, function and range of motion on active MTrPs found in the upper trapezius.
Detailed description
Myofascial pain syndrome (MPS) is a musculoskeletal chronic pain disorder that affects the majority of pain population and characterized by the presence of trigger points. MPS is usually associated with tenderness, spasm, movement limitation and referred pain .
Myofascial trigger points (MTrPs) are hyperirritable taut fibers of skeletal muscle. The taut fibers within the muscle create palpable nodules that may cause local pain, and refer pain elsewhere with soft tissue examination .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Other: Magnesium Sulphate Iontophoresis +conventional therapy, Other: conventional theapy |
| Group (B) | Experimental | Other: High- Power Pain Threshold Ultrasound +conventional therapy, Other: conventional theapy |
| Group (c) | Other | Other: conventional theapy |
Who may qualify
- Ages
- 19 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects, with age ranged from 19-23 years (Forman et al, 2014) from both genders. The subjects had active MTrPs in the upper fibers of trapezius muscle.
Key exclusion criteria (6 listed)
- • History of whiplash injury.
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 |
|---|---|---|
| Magnesium Sulphate Iontophoresis +conventional therapywill receive Mgso4 Iontophoresis in addition to conventional therapy twice a week/4 weeks | Other | Group (A) |
| High- Power Pain Threshold Ultrasound +conventional therapywill receive HPPT-US on the upper trapezius in addition to conventional therapy twice a week/4 weeks | Other | Group (B) |
| conventional theapywill receive postural correction exercise-stretching and strengthening twice a week/4weeks | Other | Group (A), Group (B), Group (c) |
Primary outcome
pain intensity
Time frame: up to four weeks
The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain
3 secondary outcomes
Pain pressure threshold (PPT)
Time frame: up to four weeks
neck disability
Time frame: up to four weeks
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 27 Sep 2022.
- Derived from this study: PubMed 39407315Ibrahim NA, Hamdy HA, Elbanna RHM, Mohamed DMA, Ali EA. Transdermal iontophoresis versus high power pain threshold ultrasound in Mechanical Neck Pain: a randomized controlled trial. J Orthop Surg Res. 2024 Oct 15;19(1):658. doi: 10.1186/s13018-024-05078-z.
- Individual participant dataSharing planned: Undecided
Related trials for Trigger Point Pain, Myofascial
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Not yet recruiting
Focused Versus Multi-Target Trigger Point Injection for Chronic Myofascial Neck Pain
Myofacial Pain Syndrome, Chronic Neck Pain
Not yet recruiting
Comparison of Suboccipital Release and Muscle Energy Technique in Subjects With Mechanical Neck Pain and Forward Head Posture
Myofascial Trigger Points, Neck Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulphate Iontophoresis +conventional therapy, High- Power Pain Threshold Ultrasound +conventional therapy and conventional theapy in people with Trigger Point Pain, Myofascial, 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 1 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: status not confirmed, as of the sponsor's last update on 27 Sep 2022. 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?
Contact Hend Hamdy, PHD (01024420121, hendhamdy110@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?
On the ClinicalTrials.gov record for NCT05474898, 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 27 Sep 2022.