Upper Trapezius Trigger PointsNCT07260019
INSTRUMENT ASSISSTED SOFT TISSUE MOBILIZATION VERSUS DRY CUPPING ON UPPER TRAPEZIUS TRIGGER POINTS: A RANDOMIZED CONTROLLED TRIAL
A study testing Instrument Assisted Soft Tissue Mobilization, Dry Cupping and Hot Packs in people with Upper Trapezius Trigger Points and Non Specific Chronic Neck Pain, run by Cairo University.
Trial summary
The goal of this randomized controlled trial is to compare the effects of Instrument Assisted Soft Tissue Mobilization (IASTM) and dry cupping in patients (both genders), aged 20-50 years, diagnosed with chronic non-specific neck pain who have active upper trapezius trigger points. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Upper Trapezius Trigger Points, Non Specific Chronic Neck Pain
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization, Dry Cupping and Hot Packs
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants aged 20 to 50.
- Diagnosis of chronic non-specific neck pain (> 4 weeks duration).
- Had an active upper trapezius TrP (defined as a tender nodule in a taut band that referred pain in a pattern specific for upper trapezius TrP1 or TrP2).
- Pain of at least 40 mm on a visual analogue scale (VAS).
- Body mass index from 18 - 30 kg/m2
Who cannot join
- Participants who will exhibit signs of fibromyalgia syndrome.
- Participants with a specific neck pain such as cervical radiculopathy with neurological deficits (e.g., motor weakness, significant sensory loss), cervical instability, fracture, tumor, infection, or inflammatory arthropathies.
- Sensory problems in the upper or midback regions, heart/circulation problems.
- Participants who will have vascular syndromes such as vertebrobasilar insufficiency.
- Participants with skin lesions, fragile skin, or a history of bleeding disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Fatma Seddik, Prof. Dr. contact
About this study
The goal of this randomized controlled trial is to compare the effects of Instrument Assisted Soft Tissue Mobilization (IASTM) and dry cupping in patients (both genders), aged 20-50 years, diagnosed with chronic non-specific neck pain who have active upper trapezius trigger points. The main questions it aims to answer are :
- Is there a significant difference in the effect on pain level (measured by VAS) between the groups?
- Is there a significant difference in the effect on cervical range of motion (CROM), pressure pain threshold (PPT), and functional disability (NDI) between the groups?
Read more
Researchers will compare three groups:
- Group A (Control):] Will receive a conventional physical therapy program (hot packs, TENS, and exercises).
- Group B (Experimental):] Will receive conventional therapy plus IASTM.
- Group C (Experimental):] Will receive conventional therapy plus Dry Cupping.
Participants will be asked to do the following:
- Undergo baseline assessments (measuring pain, ROM, PPT, and disability) before treatment and final assessments after 4 weeks.
- Attend [3 treatment sessions per week for four weeks].
- At each session, all participants will receive the conventional physical therapy program , while Groups B and C will receive their additional intervention (IASTM or dry cupping).
- Being tested
- Instrument Assisted Soft Tissue Mobilization, Dry Cupping, Hot Packs, Transcutaneous Electrical Nerve Stimulation, Exercise Program
- Keywords
- IASTM, DRY CUPPING, UPPER TRAPEZIUS TRIGGER POINTS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue MobilizationDevice
Also called IASTM , M2T Blade
While the participant is seated, a lubricant (Vaseline) is applied to the skin. The M2T blade is used at a 45° angle to apply slow sweeping strokes along the muscle from origin to insertion (sweeping technique) over the upper trapezius for approximately three minutes.
Dry CuppingDevice
While the participant is in a prone position , a single 5cm inner diameter plastic cup is applied to the skin directly over the pre-determined treatment location. The cup is secured by pumping a manual hand-pump three times. The cup is left in place for 5 minutes.
Hot PacksOther
Commercially accessible hot packs (made of bentonite) are placed over the neck and the upper part of the shoulder musculature while the patient is in a prone position. The application lasts for 15-20 minutes.
Transcutaneous Electrical Nerve StimulationDevice
Also called TENS
Applied while the patient is sitting. Electrodes are placed directly over or surrounding the trigger point and along the muscle belly. Parameters: Pulse rate 60-100Hz , Pulse width 40-250 μs. Intensity is set to a tolerable tingling sensation. Treatment duration is 20-30 minutes.
Exercise ProgramBehavioural
A supervised home exercise program consisting of:
Range of Motion Exercises: Cervical flexion, extension, lateral flexion, rotation, and shoulder shrugs.
Strengthening Exercises: Isometric cervical flexion, extension, lateral flexion, and rotation; scapular retractions; and chin tucks.
Dosage: Performed daily for 10-15 repetitions and 2-3 sets
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control Group) | Active comparator | Participants will receive a conventional physical therapy program. This includes hot packs applied over the neck and upper shoulders for 15-20 minutes , Transcutaneous Electrical Nerve Stimulation (TENS) applied for 20-30 minutes , and a supervised exercise program (including range of motion, isometric strengthening, chin tucks, and scapular retractions). The treatment will be administered for 3 sessions per week for four weeks. Receives: Other: Hot Packs; Device: Transcutaneous Electrical Nerve Stimulation; Behavioral: Exercise Program |
| Group B (IASTM Group) | Experimental | Participants will receive the same conventional physical therapy program as Group A (hot packs, TENS, and exercises) . In addition, they will receive Instrument Assisted Soft Tissue Mobilization (IASTM). This combined treatment will be administered for 3 sessions per week for four weeks. Receives: Device: Instrument Assisted Soft Tissue Mobilization; Other: Hot Packs; Device: Transcutaneous Electrical Nerve Stimulation; Behavioral: Exercise Program |
| Group C (Dry Cupping Group) | Experimental | Participants will receive the same conventional physical therapy program as Group A (hot packs, TENS, and exercises) . In addition, they will receive Dry Cupping. This combined treatment will be administered for 3 sessions per week for four weeks. Receives: Device: Dry Cupping; Other: Hot Packs; Device: Transcutaneous Electrical Nerve Stimulation; Behavioral: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Level
Pain intensity will be assessed using the Visual Analogue Scale (VAS). The VAS is a self-reported 10 cm line where 0 cm represents "no pain" and 10 cm represents "worst imaginable pain".
Measured: Baseline (before intervention) and after 4 weeks of treatment.
Secondary outcomes (3)
Cervical Range of Motion (CROM)
Active cervical range of motion will be measured in degrees using a Cervical Range of Motion (CROM) device. Measurements will be taken for flexion, extension, lateral flexion (right and left), and rotation (right and left) . Three trials will be averaged for each movement.
Measured: Baseline (before intervention) and after 4 weeks of treatment.
Pressure Pain Threshold (PPT)
PPT will be assessed using a manual pressure algometer applied to the identified myofascial trigger point. Pressure will be increased at a rate of 1 kg/cm² per second until the patient first reports the sensation of pressure changing to pain. The average of three measurements, taken 30 seconds apart, will be recorded.
Measured: Baseline (before intervention) and after 4 weeks of treatment.
Functional Disability
Functional disability will be assessed using the validated Arabic version of the Neck Disability Index (NDI-AR). This is a 10-item self-reported questionnaire that evaluates limitations in daily activities and functional impairment due to neck pain.
Measured: Baseline (before intervention) and after the 4-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Trapezius Trigger PointsStudies 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
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Hassan Elsayed Mohamed Mady, Cairo University
- Investigators
- IBRAHIM H MADY, Bsc, Principal investigator, Cairo UniversityFatma Seddik, Prof.Dr, Study director, Basic Science Department, Faculty Of Physical Therapy, Cairo UniversityAhmed Said, Dr, Study director, Basic Science Department, Faculty Of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260019
- Sponsor's protocol ID
- P.T.REC/012/006052
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 2 Dec 2025
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSTRUMENT ASSISSTED SOFT TISSUE MOBILIZATION VERSUS DRY CUPPING ON UPPER TRAPEZIUS TRIGGER POINTS: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07260019
- Acronym / sponsor ID
- P.T.REC/012/006052
- Keywords
- IASTM, DRY CUPPING, UPPER TRAPEZIUS TRIGGER POINTS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Dec 2025 (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 goal of this randomized controlled trial is to compare the effects of Instrument Assisted Soft Tissue Mobilization (IASTM) and dry cupping in patients (both genders), aged 20-50 years, diagnosed with chronic non-specific neck pain who have active upper trapezius trigger points. The main questions it aims to answer are :
- Is there a significant difference in the effect on pain level (measured by VAS) between the groups?
- Is there a significant difference in the effect on cervical range of motion (CROM), pressure pain threshold (PPT), and functional disability (NDI) between the groups?
Researchers will compare three groups:
- Group A (Control):] Will receive a conventional physical therapy program (hot packs, TENS, and exercises).
- Group B (Experimental):] Will receive conventional therapy plus IASTM.
- Group C (Experimental):] Will receive conventional therapy plus Dry Cupping.
Participants will be asked to do the following:
- Undergo baseline assessments (measuring pain, ROM, PPT, and disability) before treatment and final assessments after 4 weeks.
- Attend [3 treatment sessions per week for four weeks].
- At each session, all participants will receive the conventional physical therapy program , while Groups B and C will receive their additional intervention (IASTM or dry cupping).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Control Group) | Active comparator | Other: Hot Packs, Device: Transcutaneous Electrical Nerve Stimulation, Behavioral: Exercise ProgramParticipants will receive a conventional physical therapy program. This includes hot packs applied over the neck and upper shoulders for 15-20 minutes , Transcutaneous Electrical Nerve Stimulation (TENS) applied for 20-30 minutes , and a supervised exercise program (including range of motion, isometric strengthening, chin tucks, and scapular retractions). The treatment will be administered for 3 sessions per week for four weeks. |
| Group B (IASTM Group) | Experimental | Device: Instrument Assisted Soft Tissue Mobilization, Other: Hot Packs, Device: Transcutaneous Electrical Nerve Stimulation, Behavioral: Exercise ProgramParticipants will receive the same conventional physical therapy program as Group A (hot packs, TENS, and exercises) . In addition, they will receive Instrument Assisted Soft Tissue Mobilization (IASTM). This combined treatment will be administered for 3 sessions per week for four weeks. |
| Group C (Dry Cupping Group) | Experimental | Device: Dry Cupping, Other: Hot Packs, Device: Transcutaneous Electrical Nerve Stimulation, Behavioral: Exercise ProgramParticipants will receive the same conventional physical therapy program as Group A (hot packs, TENS, and exercises) . In addition, they will receive Dry Cupping. This combined treatment will be administered for 3 sessions per week for four weeks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants aged 20 to 50.
- Diagnosis of chronic non-specific neck pain (> 4 weeks duration).
- Had an active upper trapezius TrP (defined as a tender nodule in a taut band that referred pain in a pattern specific for upper trapezius TrP1 or TrP2).
- Pain of at least 40 mm on a visual analogue scale (VAS).
- Body mass index from 18 - 30 kg/m2
Key exclusion criteria (5 listed)
- Participants who will exhibit signs of fibromyalgia syndrome.
- Participants with a specific neck pain such as cervical radiculopathy with neurological deficits (e.g., motor weakness, significant sensory loss), cervical instability, fracture, tumor, infection, or inflammatory arthropathies.
- Sensory problems in the upper or midback regions, heart/circulation problems.
- Participants who will have vascular syndromes such as vertebrobasilar insufficiency.
- Participants with skin lesions, fragile skin, or a history of bleeding disorders.
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 |
|---|---|---|
| Instrument Assisted Soft Tissue MobilizationAlso: IASTM , M2T BladeWhile the participant is seated, a lubricant (Vaseline) is applied to the skin. The M2T blade is used at a 45° angle to apply slow sweeping strokes along the muscle from origin to insertion (sweeping technique) over the upper trapezius for approximately three minutes. | Device | Group B (IASTM Group) |
| Dry CuppingWhile the participant is in a prone position , a single 5cm inner diameter plastic cup is applied to the skin directly over the pre-determined treatment location. The cup is secured by pumping a manual hand-pump three times. The cup is left in place for 5 minutes. | Device | Group C (Dry Cupping Group) |
| Hot PacksCommercially accessible hot packs (made of bentonite) are placed over the neck and the upper part of the shoulder musculature while the patient is in a prone position. The application lasts for 15-20 minutes. | Other | Group A (Control Group), Group B (IASTM Group), Group C (Dry Cupping Group) |
| Transcutaneous Electrical Nerve StimulationAlso: TENSApplied while the patient is sitting. Electrodes are placed directly over or surrounding the trigger point and along the muscle belly. Parameters: Pulse rate 60-100Hz , Pulse width 40-250 μs. Intensity is set to a tolerable tingling sensation. Treatment duration is 20-30 minutes. | Device | Group A (Control Group), Group B (IASTM Group), Group C (Dry Cupping Group) |
| Exercise ProgramA supervised home exercise program consisting of: Range of Motion Exercises: Cervical flexion, extension, lateral flexion, rotation, and shoulder shrugs. Strengthening Exercises: Isometric cervical flexion, extension, lateral flexion, and rotation; scapular retractions; and chin tucks. Dosage: Performed daily for 10-15 repetitions and 2-3 sets | Behavioural | Group A (Control Group), Group B (IASTM Group), Group C (Dry Cupping Group) |
Primary outcome
Pain Intensity Level
Time frame: Baseline (before intervention) and after 4 weeks of treatment.
Pain intensity will be assessed using the Visual Analogue Scale (VAS). The VAS is a self-reported 10 cm line where 0 cm represents "no pain" and 10 cm represents "worst imaginable pain".
3 secondary outcomes
Cervical Range of Motion (CROM)
Time frame: Baseline (before intervention) and after 4 weeks of treatment.
Pressure Pain Threshold (PPT)
Time frame: Baseline (before intervention) and after 4 weeks of treatment.
Functional Disability
Time frame: Baseline (before intervention) and after the 4-week intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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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.
Fatma Seddik, Prof. Dr. contact
IBRAHIM H MADY, Bsc principal investigator
Cairo University
Fatma Seddik, Prof.Dr study director
Basic Science Department, Faculty Of Physical Therapy, Cairo University
Ahmed Said, Dr study director
Basic Science Department, Faculty Of Physical Therapy, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Instrument Assisted Soft Tissue Mobilization, Dry Cupping and Hot Packs in people with Upper Trapezius Trigger Points and Non Specific Chronic 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 5 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: opening soon, as of the sponsor's last update on 2 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IBRAHIM H MADY, BSc (+201556822721, ibrahimmady47@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Level (time frame: Baseline (before intervention) and after 4 weeks of treatment.). 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 2 Dec 2025.