About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Instrument Assisted Soft Tissue Mobilization
DeviceWhile 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 Cupping
DeviceWhile 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
Other interventionCommercially 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 Stimulation
DeviceApplied 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 Program
BehavioralA 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
Treatment groups
Trial outcomes
Primary outcomes
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".
Secondary outcomes
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.
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.
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.
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Sponsors and contacts
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