Neck PainMTPNCT06267755
Efficacy of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain
A study testing Extracorporeal Shockwave therapy and Traditional physical therapy in people with Neck Pain, run by Cairo University.
Trial summary
this study will be conducted to investigate the effect of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Extracorporeal Shockwave therapy and Traditional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2024to 30 Aug 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sixty patients receiving a diagnosis of non-specific neck pain with upper trapezius myofascial trigger points by an orthopaedist physician.
- Body mass index of participants was normal less than (30 kg/m2)(Al-asadi, 2018).
- Age over 18 years.
- Presence of taught band.
- Presence of hyper irritable spot in a taught band, and reproduction of the typical referred pain pattern of the myofascial trigger point in response to compression
Who cannot join
- Having signs and symptoms of neurological disorders that cause nerve root compression.
- Headache as a consequence of specific headache diagnosis.
- Having a history of specific signs of malignancy, or infection.
- Having a history of trauma with or without proven structural disorders in the region of the neck, shoulder, and head (e.g. whiplash).
- Having signs and symptoms of cerebrovascular insufficiency.
- Having a severe chronic disease of the locomotor system (e.g. polyarthritis, muscular disease
- Any participant with contraindications to shock wave therapy
Trial locations and contacts
No sites are listed yet.
About this study
this study will be conducted to investigate the effect of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain
Read the detailed description
Neck pain is one of the most commonly reported musculoskeletal disorders. The prevalence for neck pain varies between 16.7% and 75.1% in the general population. Up to 67% of world's population may present chronic non-specific neck pain at least once in their lives. The upper trapezius is probably the muscle most often beset by trigger points, it is indicated that the upper trapezius is the most sensitive of 8 different muscles (upper trapezius, pectoralis major, levator scapulae, teres major, supraspinatus, gluteus medius, infraspinatus, paraspinal) to the pressure of an algometer.Recently, the extracorporeal shock wave has been widely known to be an effective therapeutic modality in myofascial pain syndrome treatment and a systematic review provided promising insight into the effectiveness of ESWT in Myofascial pain syndrome treatment. sixty patients with non specific neck pain will be assigned randomly to two groups; first one will receive shock wave therapy and traditional therapy and the second one will receive traditional therapy only for six weeks.
- Conditions
- Neck Pain
- Being tested
- Extracorporeal Shockwave therapy, Traditional physical therapy
- Keywords
- Extracorporeal Shockwave Therapy, Ultrasonography Changes, Non Specific 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.
Extracorporeal Shockwave therapyOther
the patients will receive Extracorporeal Shockwave therapy sessions by 600 impulses with 1.6 bar pressure at a frequency of 8 Hz on site of the upper trapezius
Traditional physical therapyOther
the patients will receive Traditional physical therapy in the form of Integrated neuro-muscular inhibition technique + posture correction and scapular stabilization exercises.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Shockwave therapy | Experimental | Thirty patients will receive Extracorporeal Shockwave therapy and Traditional physical therapy three times per week for six consecutive weeks. Receives: Other: Extracorporeal Shockwave therapy; Other: Traditional physical therapy |
| Traditional physical therapy | Active comparator | Thirty patients will receive Traditional physical therapy three times per week for six consecutive weeks. Receives: Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle thickness
Ultrasonography device will be used to assess muscle thickness
Measured: up to six weeks
hypoechoic area intensity
An ultrasonography device will be used to assess the hypoechoic area intensity
Measured: up to six weeks
Secondary outcomes (4)
neck disability
Arabic version of neck disability index will be used to measure neck disability. It consists of 10 questions: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. 5 Each item is scored from 0 (no disability) to 5 (total disability). The maximum possible score is 50.
Measured: up to six weeks
pressure pain threshold
Digital algometer will be used to measure pressure pain threshold
Measured: up to six weeks
cervical range of motion
The cervical range of motion (CROM) device will be used to measure cervical ROM
Measured: up to six weeks
pain intensity
The visual analog scale (VAS) will be used to measure pain intensity. it is a10 cm line, oriented vertically or horizontally, with one end representing "no pain" and the other end representing pain as bad as it can be
Measured: up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start20 Feb 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (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
- extracorporeal shockwave and traditional therapy
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mahmoud Ismail Abdel-Aal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267755
- Sponsor's protocol ID
- P.T.REC/012/004884
- Acronym
- MTP
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain
- ClinicalTrials.gov ID
- NCT06267755
- Acronym / sponsor ID
- MTP / P.T.REC/012/004884
- Conditions
- Neck Pain
- Keywords
- Extracorporeal Shockwave Therapy, Ultrasonography Changes, Non Specific Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 20 Feb 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.
this study will be conducted to investigate the effect of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain
Detailed description
Neck pain is one of the most commonly reported musculoskeletal disorders. The prevalence for neck pain varies between 16.7% and 75.1% in the general population. Up to 67% of world's population may present chronic non-specific neck pain at least once in their lives. The upper trapezius is probably the muscle most often beset by trigger points, it is indicated that the upper trapezius is the most sensitive of 8 different muscles (upper trapezius, pectoralis major, levator scapulae, teres major, supraspinatus, gluteus medius, infraspinatus, paraspinal) to the pressure of an algometer.Recently, the extracorporeal shock wave has been widely known to be an effective therapeutic modality in myofascial pain syndrome treatment and a systematic review provided promising insight into the effectiveness of ESWT in Myofascial pain syndrome treatment. sixty patients with non specific neck pain will be assigned randomly to two groups; first one will receive shock wave therapy and traditional therapy and the second one will receive traditional therapy only for six weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- extracorporeal shockwave and traditional therapy
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shockwave therapy | Experimental | Other: Extracorporeal Shockwave therapy, Other: Traditional physical therapyThirty patients will receive Extracorporeal Shockwave therapy and Traditional physical therapy three times per week for six consecutive weeks. |
| Traditional physical therapy | Active comparator | Other: Traditional physical therapyThirty patients will receive Traditional physical therapy three times per week for six consecutive weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sixty patients receiving a diagnosis of non-specific neck pain with upper trapezius myofascial trigger points by an orthopaedist physician.
- Body mass index of participants was normal less than (30 kg/m2)(Al-asadi, 2018).
- Age over 18 years.
- Presence of taught band.
- Presence of hyper irritable spot in a taught band, and reproduction of the typical referred pain pattern of the myofascial trigger point in response to compression
Key exclusion criteria (7 listed)
- Having signs and symptoms of neurological disorders that cause nerve root compression.
- Headache as a consequence of specific headache diagnosis.
- Having a history of specific signs of malignancy, or infection.
- Having a history of trauma with or without proven structural disorders in the region of the neck, shoulder, and head (e.g. whiplash).
- Having signs and symptoms of cerebrovascular insufficiency.
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 |
|---|---|---|
| Extracorporeal Shockwave therapythe patients will receive Extracorporeal Shockwave therapy sessions by 600 impulses with 1.6 bar pressure at a frequency of 8 Hz on site of the upper trapezius | Other | Extracorporeal Shockwave therapy |
| Traditional physical therapythe patients will receive Traditional physical therapy in the form of Integrated neuro-muscular inhibition technique + posture correction and scapular stabilization exercises. | Other | Extracorporeal Shockwave therapy, Traditional physical therapy |
Primary outcome
muscle thickness
Time frame: up to six weeks
Ultrasonography device will be used to assess muscle thickness
hypoechoic area intensity
Time frame: up to six weeks
An ultrasonography device will be used to assess the hypoechoic area intensity
4 secondary outcomes
neck disability
Time frame: up to six weeks
pressure pain threshold
Time frame: up to six weeks
cervical range of motion
Time frame: up to six weeks
pain intensity
Time frame: up to six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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 Extracorporeal Shockwave therapy and Traditional physical 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 5 inclusion and 7 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 20 Feb 2024. 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 Mahmoud Fouad, master (01227740639, mahmoud.adel27392@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle thickness (time frame: up to six 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 20 Feb 2024.