NCT Number: NCT07260019
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 :
1. Is there a significant difference in the effect on pain level (measured by VAS) between the groups? 2. 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:
1. Group A (Control):] Will receive a conventional physical therapy program (hot packs, TENS, and exercises). 2. Group B (Experimental):] Will receive conventional therapy plus IASTM. 3. Group C (Experimental):] Will receive conventional therapy plus Dry Cupping.
Participants will be asked to do the following:
1. Undergo baseline assessments (measuring pain, ROM, PPT, and disability) before treatment and final assessments after 4 weeks. 2. Attend [3 treatment sessions per week for four weeks]. 3. 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).
Trial opening soon.
Get Notified20 year–50 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: IASTM , M2T Blade
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.
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.
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.
Other names: TENS
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
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".
Time frame: Baseline (before intervention) and after 4 weeks of treatment.
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.
Time frame: Baseline (before intervention) and after 4 weeks of treatment.
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.
Time frame: Baseline (before intervention) and after the 4-week intervention period.
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.
Contact information is provided by the study sponsor or research team.
Fatma Seddik, Prof. Dr.
CONTACT
IBRAHIM H MADY, BSc
CONTACT
Cairo University
Other
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