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Not yet recruiting NCT07260019

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

No phase Interventional Upper Trapezius Trigger Points Non Specific Chronic Neck Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Instrument Assisted Soft Tissue Mobilization, Dry Cupping, Hot Packs, Transcutaneous Electrical Nerve Stimulation.
Who it may be relevant to
Registry conditions: Upper Trapezius Trigger Points, Non Specific Chronic Neck Pain. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • Device 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.
  • 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.
  • Other 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.
  • Device 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.
  • Behavioral 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

Primary outcome measures

  • Pain Intensity Level [Time frame: Baseline (before intervention) and after 4 weeks of treatment.]
Secondary outcome measures (3)
  • Cervical Range of Motion (CROM) [Time frame: Baseline (before intervention) and after 4 weeks of treatment.]
  • Pressure Pain Threshold (PPT) [Time frame: Baseline (before intervention) and after 4 weeks of treatment.]
  • Functional Disability [Time frame: Baseline (before intervention) and after the 4-week intervention period.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07260019 · P.T.REC/012/006052

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗