INSTRUMENT ASSISSTED SOFT TISSUE MOBILIZATION VERSUS DRY CUPPING ON UPPER TRAPEZIUS TRIGGER POINTS: A RANDOMIZED CONTROLLED TRIAL
1 other identifier
interventional
75
0 countries
N/A
Brief 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. 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?
- 3.Group A (Control):\] Will receive a conventional physical therapy program (hot packs, TENS, and exercises).
- 4.Group B (Experimental):\] Will receive conventional therapy plus IASTM.
- 5.Group C (Experimental):\] Will receive conventional therapy plus Dry Cupping.
- 6.Undergo baseline assessments (measuring pain, ROM, PPT, and disability) before treatment and final assessments after 4 weeks.
- 7.Attend \[3 treatment sessions per week for four weeks\].
- 8.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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedFirst Posted
Study publicly available on registry
December 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
December 2, 2025
November 1, 2025
11 months
November 21, 2025
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (3)
Cervical Range of Motion (CROM)
Baseline (before intervention) and after 4 weeks of treatment.
Pressure Pain Threshold (PPT)
Baseline (before intervention) and after 4 weeks of treatment.
Functional Disability
Baseline (before intervention) and after the 4-week intervention period.
Study Arms (3)
Group A (Control Group)
ACTIVE COMPARATORParticipants 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)
EXPERIMENTALParticipants 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)
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
IBRAHIM H MADY, Bsc
Cairo University
- STUDY DIRECTOR
Fatma Seddik, Prof.Dr
Basic Science Department, Faculty Of Physical Therapy, Cairo University
- STUDY DIRECTOR
Ahmed Said, Dr
Basic Science Department, Faculty Of Physical Therapy, Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The study is described as a "single blinded randomized controlled trial". Given the distinct physical nature of the interventions (IASTM vs. Dry Cupping), it is not feasible to blind the participants or the care providers. Blinding will be applied to the Outcomes Assessor, who will perform the outcome measurements without knowledge of the participant's group assignment to prevent bias.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 21, 2025
First Posted
December 2, 2025
Study Start
December 1, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 2, 2025
Record last verified: 2025-11