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Universiteit van CaïroINSTRUMENT ASSISSTED SOFT TISSUE MOBILIZATION VERSUS DRY CUPPING ON UPPER TRAPEZIUS TRIGGER POINTS: A RANDOMIZED CONTROLLED TRIAL
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De klinische studie NCT07260019 is een interventioneel studie bij Upper Trapezius Trigger Points, Non Specific Chronic Neck Pain met de status nog niet rekruterend. De inclusie van 75 deelnemers start op 1 december 2025. De studie wordt geleid door de Universiteit van Caïro en de voltooiing is gepland op 1 december 2026. Laatste update op ClinicalTrials.gov: 2 december 2025.
Beknopte samenvatting
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).
Officiële titel
INSTRUMENT ASSISSTED SOFT TISSUE MOBILIZATION VERSUS DRY CUPPING ON UPPER TRAPEZIUS TRIGGER POINTS: A RANDOMIZED CONTROLLED TRIAL
Aandoeningen
Upper Trapezius Trigger PointsNon Specific Chronic Neck PainAndere studie-ID's
- P.T.REC/012/006052
NCT-ID
Startdatum (Werkelijk)
2025-12-01
Laatste update geplaatst
2025-12-02
Verwachte einddatum
2026-12
Inschrijving (Geschat)
75
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Trefwoorden
IASTM
DRY CUPPING
UPPER TRAPEZIUS TRIGGER POINTS
DRY CUPPING
UPPER TRAPEZIUS TRIGGER POINTS
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Enkelblind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Actieve comparatorGroup A (Control Group) 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. | Hot Packs 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. Transcutane elektrische zenuwstimulatie 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. Oefenprogramma 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 |
ExperimenteelGroup B (IASTM Group) 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. | Instrument Geassisteerde Zachte Weefsel Mobilisatie 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. Hot Packs 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. Transcutane elektrische zenuwstimulatie 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. Oefenprogramma 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 |
ExperimenteelGroup C (Dry Cupping Group) 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. | DRY Cupping 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 Packs 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. Transcutane elektrische zenuwstimulatie 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. Oefenprogramma 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 |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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". | Baseline (before intervention) and after 4 weeks of treatment. |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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. | 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. | 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. | Baseline (before intervention) and after the 4-week intervention period. |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene
Minimumleeftijd
20 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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
- 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.
Universiteit van Caïro1100 actieve klinische studies om te verkennenVerantwoordelijke instantie
Ibrahim Hassan Elsayed Mohamed Mady, Hoofdonderzoeker, Principal Investigator, Cairo University
Centraal Contactpersoon
Contact: IBRAHIM H MADY, BSc, +201556822721, [email protected]
Contact: Fatma Seddik, Prof. Dr., +201223417697
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