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

NCT ID: NCT07260019

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-12-31

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?

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).

Conditions

Upper Trapezius Trigger Points; Non Specific Chronic Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Hot Packs

Intervention Type: OTHER

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.

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

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.

Exercise Program

Intervention Type: BEHAVIORAL

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 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.

Group Type: EXPERIMENTAL

Instrument Assisted Soft Tissue Mobilization

Intervention Type: DEVICE

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.

Hot Packs

Intervention Type: OTHER

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.

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

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.

Exercise Program

Intervention Type: BEHAVIORAL

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 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.

Group Type: EXPERIMENTAL

Dry Cupping

Intervention Type: DEVICE

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.

Hot Packs

Intervention Type: OTHER

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.

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

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.

Exercise Program

Intervention Type: BEHAVIORAL

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

Interventions

Instrument 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.

Intervention Type: DEVICE

Dry 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.

Intervention Type: DEVICE

Hot 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.

Intervention Type: OTHER

Transcutaneous 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.

Intervention Type: DEVICE

Exercise 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

Intervention Type: BEHAVIORAL

Other Intervention Names

IASTM , M2T Blade; TENS

Eligibility Criteria

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

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Hassan Elsayed Mohamed Mady

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

IBRAHIM H MADY, Bsc

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Fatma Seddik, Prof.Dr

Role: STUDY_DIRECTOR

Basic Science Department, Faculty Of Physical Therapy, Cairo University

Ahmed Said, Dr

Role: STUDY_DIRECTOR

Basic Science Department, Faculty Of Physical Therapy, Cairo University

Central Contacts

IBRAHIM H MADY, BSc

Role: CONTACT

ibrahimmady47@gmail.com

+201556822721

Fatma Seddik, Prof. Dr.

Role: CONTACT

+201223417697

Other Identifiers

P.T.REC/012/006052

Identifier Type: -

Identifier Source: org_study_id