NCT07260019

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. 1.Is there a significant difference in the effect on pain level (measured by VAS) between the groups?
  2. 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. 3.Group A (Control):\] Will receive a conventional physical therapy program (hot packs, TENS, and exercises).
  4. 4.Group B (Experimental):\] Will receive conventional therapy plus IASTM.
  5. 5.Group C (Experimental):\] Will receive conventional therapy plus Dry Cupping.
  6. 6.Undergo baseline assessments (measuring pain, ROM, PPT, and disability) before treatment and final assessments after 4 weeks.
  7. 7.Attend \[3 treatment sessions per week for four weeks\].
  8. 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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Dec 2025

Status
not yet recruiting

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

Study Progress43%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

November 21, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

November 21, 2025

Last Update Submit

November 21, 2025

Conditions

Keywords

IASTMDRY CUPPINGUPPER TRAPEZIUS TRIGGER POINTS

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 COMPARATOR

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 PacksDevice: Transcutaneous Electrical Nerve StimulationBehavioral: Exercise Program

Group B (IASTM Group)

EXPERIMENTAL

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 MobilizationOther: Hot PacksDevice: Transcutaneous Electrical Nerve StimulationBehavioral: Exercise Program

Group C (Dry Cupping Group)

EXPERIMENTAL

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 CuppingOther: Hot PacksDevice: Transcutaneous Electrical Nerve StimulationBehavioral: Exercise Program

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.

Also known as: IASTM , M2T Blade
Group B (IASTM Group)

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.

Group C (Dry Cupping Group)

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.

Group A (Control Group)Group B (IASTM Group)Group C (Dry Cupping Group)

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
Group A (Control Group)Group B (IASTM Group)Group C (Dry Cupping Group)

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

Group A (Control Group)Group B (IASTM Group)Group C (Dry Cupping Group)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

MeSH Terms

Interventions

Transcutaneous Electric Nerve StimulationResistance Training

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaExercise TherapyAftercareContinuity of Patient CarePatient CarePhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • IBRAHIM H MADY, Bsc

    Cairo University

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY DIRECTOR

Central Study Contacts

IBRAHIM H MADY, BSc

CONTACT

Fatma Seddik, Prof. Dr.

CONTACT

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