- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07609498
Effectiveness of Instrument-Assisted Soft Tissue Mobilization (IASTM) and Myofascial Release in Reducing Delayed Onset Muscle Soreness (DOMS) in the Cervicothoracic Region (COMPARE-DOMS)
To Compare the Effectiveness of Instrument Assisted Soft Tissue Mobilisation ( IASTM ) and Myofascial Release to Reducing Delayed Onset Muscle Soreness ( DOMS ) on Cervicothoracic Region
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sheikhupura
-
Lahore, Sheikhupura, Pakistan
- Green International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IASTM
Instrument-Assisted Soft Tissue Mobilization (IASTM) is a type of therapy where the practitioner utilizes unique instruments that are made of either metals or hard plastics that have smooth curved surfaces to glide on the skin surface to work on soft tissues.
IASTM helps in identifying and breaking down areas of muscle tightness and adhesion.
Blood flow is stimulated, pain, stiffness, and soreness are minimized, and mobility of the tissues is enhanced, thereby increasing joint range of motion.
|
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
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
|
|
Active Comparator: Myofascial Release
Myofascial Release (MFR) is an effective therapeutic massage technique that can be utilized to relieve muscle and fascia pain and tightness.
The practitioner uses a series of gentle stretching or applying sustained pressure on areas where tension is felt until the fascia releases.
Such release eases pain, improves circulation, joint mobility and muscle motion, enhances flexibility and posture
|
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (pre-induction), Post-DOMS induction (24 hours), 48 hours, and 72 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (pre-induction), Post-DOMS induction (24 hours), 48 hours, and 72 hours.
|
|
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.
|
Baseline (pre-induction), Post-DOMS induction (24 hours), 48 hours, and 72 hours.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Iqra Majeed Principal Investigator, Green International University, Lahore, Punjab
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIU/REC/26-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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