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Completed

NCT Number: NCT07609498

Effectiveness of Instrument-Assisted Soft Tissue Mobilization (IASTM) and Myofascial Release in Reducing Delayed Onset Muscle Soreness (DOMS) in the Cervicothoracic Region

The current study is a randomized controlled trail comparing the effectiveness of IASTM and Myofascial Release for individuals with DOMS at cervicothoracic region. The trail aims to evaluate improvements in pain, ROM, and neck disability. Interventions will be delivered twice weekly for a specific duration. The primary outcomes is pain reduction, while the secondary outcomes include improved disability level and ROM. To conclude, IASTM demonstrated a significantly higher improvement compared to MFR in acute cervicothoracic DOMS in terms of pain, disability level, and ROM in all directions tested in adults.

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Key information

Age range

30 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Green International University

Lahore, Sheikhupura, Pakistan

About this study

Delayed onset muscle soreness (DOMS) is a physiological condition that develops in the course of time after strenuous unaccustomed physical exertion. In particular, DOMS occurs mostly in response to eccentric muscle actions, i.e., when muscle fibers lengthen while still performing work. Examples of eccentric actions may be, among others, lowering the load (weight training), downhill running, decelerating movements, and controlled return phase of resistance exercise (1). Unlike most types of physiological phenomena, DOMS usually develops after some period of time. Typically, it appears 12-24 hours after the workout and reaches its peak in 24-72 hours; afterwards, it will subside gradually over several days. DOMS is considered a normal adaptation reaction of the muscle. However, despite being physiologically beneficial and helping to adapt skeletal muscles to subsequent exercises through repeated bout phenomenon, DOMS may lead to considerable discomfort and even affect a person's quality of life. As the result of damage of muscle fibers and adjacent connective tissue in response to unaccustomed mechanical load, inflammatory reaction, swelling, and stimulation of pain receptors occurs. These processes are responsible for characteristic soreness associated with DOMS, which may impair individual's ability to perform certain activities and exercise.

The randomization process took place after participants were screened and underwent baseline assessment. Then, those who met the criteria were randomly allocated to Group A and Group B. Those patients in Group A were assigned to receive Instrument Assisted Soft Tissue Mobilization, whereas those participants who belonged to Group B were subjected to Myofascial Release. Random allocation was performed by a computer and carried out through opaque sealed envelopes opened by an independent individual.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants aged between 30 and 40 years.
  • Individuals presenting with delayed onset muscle soreness (DOMS) in the cervicothoracic region.
  • Willingness to participate in either the IASTM or myofascial release intervention protocols.
  • Ability to understand and sign the informed consent form.

Exclusion criteria

  • History of recent cervical or thoracic spine surgery, fractures, or severe trauma in the region.
  • Presence of open wounds, active skin infections, or severe dermatological conditions in the cervicothoracic area where interventions will be applied.
  • Diagnosed neurological deficits, cervical radiculopathy, or myelopathy.
  • Known contraindications to soft tissue mobilization or manual therapy (e.g., severe osteoporosis, bleeding disorders, or anticoagulant use).
  • Current use of muscle relaxants, heavy analgesics, or NSAIDs that could mask DOMS symptoms during the study period.

Treatment and study plan

IASTM

Procedure

The participants in this group were given the Instrument Assisted Soft Tissue Mobilization (IASTM). They were rubbed with a very small amount of gel or lotion to allow easy mobilization of the tool over the skin. The instrument has been developed to treat conditions of the cervical-thoracic joint region. The instrument was applied over the upper trapezius muscle and the cervicothoracic joint region using controlled unidirectional strokes for 8-10 minutes each day with moderate pressure. The process was done once every day for 2-3 days after the occurrence of Delayed Onset Muscle Soreness

MFR

Procedure

Group B: Myofascial Release Those who fell under Group B were subjected to myofascial release. The physiotherapist used hands to apply slow and gentle pressure on the tissues that needed release. Fascia and muscles of the upper trapezius, levator scapulae, and cervicothoracic paraspinal muscles were applied pressure on until there was release of the

Primary outcomes

  1. Visual Analog Scale (VAS) for pain

    Time frame: Baseline (pre-induction), Post-DOMS induction (24 hours), 48 hours, and 72 hours.

    The Visual Analog Scale (VAS) is a 100 mm continuous line used to self-report cervicothoracic pain intensity. The scale ranges from 0 mm (indicating "no pain") to 100 mm (indicating "worst imaginable pain"). Participants mark a point on the line that represents their current pain perception at rest and during active movement.

Secondary outcomes

  1. Cervical Range of Motion (CROM)

    Time frame: Baseline (pre-induction), Post-DOMS induction (24 hours), 48 hours, and 72 hours.

    Active cervical range of motion will be measured in degrees using a digital inclinometer or a cervical range of motion instrument. Movement planes will include cervical flexion, extension, lateral flexion (left and right), and rotation (left and right). Decreased ranges indicate higher functional restriction due to muscle soreness.

  2. Pressure Pain Threshold (PPT)

    Time frame: Baseline (pre-induction), Post-DOMS induction (24 hours), 48 hours, and 72 hours.

    Pressure pain threshold will be measured in kilograms per square centimeter (kg/cm²) using a digital hand-held pressure algometer applied over standardized trigger points in the upper trapezius and levator scapulae muscles. PPT determines the minimum pressure at which a sensation of pressure changes to pain.

Sponsors and collaborators

Lead sponsor

Green International University

Other

Registry information

Official study title

To Compare the Effectiveness of Instrument Assisted Soft Tissue Mobilisation ( IASTM ) and Myofascial Release to Reducing Delayed Onset Muscle Soreness ( DOMS ) on Cervicothoracic Region

Acronym: COMPARE-DOMS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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