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Not yet recruitingNCT07260019Updated Dec 2, 2025

INSTRUMENT ASSISSTED SOFT TISSUE MOBILIZATION VERSUS DRY CUPPING ON UPPER TRAPEZIUS TRIGGER POINTS: A RANDOMIZED CONTROLLED TRIAL

An interventional study of Instrument Assisted Soft Tissue Mobilization and Dry Cupping in Upper Trapezius Trigger Points and Non Specific Chronic Neck Pain, sponsored by Cairo University. Not yet recruiting. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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?

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).
02

Conditions studied

  • Upper Trapezius Trigger Points
  • Non Specific Chronic Neck Pain

Keywords

  • IASTM
  • DRY CUPPING
  • UPPER TRAPEZIUS TRIGGER POINTS
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Participants aged 20 to 50.
  2. Diagnosis of chronic non-specific neck pain (> 4 weeks duration).
  3. 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).
  4. Pain of at least 40 mm on a visual analogue scale (VAS).
  5. Body mass index from 18 - 30 kg/m2

Exclusion criteria

Exclusion Criteria:

  1. Participants who will exhibit signs of fibromyalgia syndrome.
  2. 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.
  3. Sensory problems in the upper or midback regions, heart/circulation problems.
  4. Participants who will have vascular syndromes such as vertebrobasilar insufficiency.
  5. Participants with skin lesions, fragile skin, or a history of bleeding disorders.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Active comparator
    Group 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.

    Other: Hot Packs · Device: Transcutaneous Electrical Nerve Stimulation · Behavioral: Exercise Program

  • Experimental
    Group 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.

    Device: Instrument Assisted Soft Tissue Mobilization · Other: Hot Packs · Device: Transcutaneous Electrical Nerve Stimulation · Behavioral: Exercise Program

  • Experimental
    Group 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.

    Device: Dry Cupping · Other: Hot Packs · Device: Transcutaneous Electrical Nerve Stimulation · Behavioral: Exercise Program

Interventions

  • DeviceInstrument Assisted Soft Tissue Mobilization

    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.

    Also known as: IASTM , M2T Blade

  • DeviceDry 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.

  • OtherHot 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.

  • DeviceTranscutaneous Electrical Nerve Stimulation

    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.

    Also known as: TENS

  • BehavioralExercise Program

    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

06

What researchers measure

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".

    Time frame: Baseline (before intervention) and after 4 weeks of treatment.

Secondary outcomes

  1. 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.

    Time frame: Baseline (before intervention) and after 4 weeks of treatment.

  2. 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.

    Time frame: Baseline (before intervention) and after 4 weeks of treatment.

  3. 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.

    Time frame: Baseline (before intervention) and after the 4-week intervention period.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07260019
Lead sponsor
Cairo University
Responsible party
Ibrahim Hassan Elsayed Mohamed Mady (Principal Investigator, Cairo University) — Principal investigator
First posted
Dec 2, 2025
Start date
Dec 1, 2025 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 2, 2025

Study contacts

IBRAHIM H MADY, BSc
Contact
ibrahimmady47@gmail.com
+201556822721
Fatma Seddik, Prof. Dr.
Contact
+201223417697
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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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