Delayed Onset Muscle Soreness (DOMS)COMPARE-DOMSNCT07609498
Effectiveness of Instrument-Assisted Soft Tissue Mobilization (IASTM) and Myofascial Release in Reducing Delayed Onset Muscle Soreness (DOMS) in the Cervicothoracic Region
A study testing IASTM and MFR in people with Delayed Onset Muscle Soreness (DOMS) and Muscle Soreness, run by Green International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Delayed Onset Muscle Soreness (DOMS), Muscle Soreness, Myalgia
- What is being tested?
- IASTM and MFR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Apr 2026to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Being tested
- IASTM, MFR
- Keywords
- Myofascial Release, IASTM, DOMS, Neck Disability, Cervical ROM
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASTMProcedure or surgery
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
MFRProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| IASTM | Experimental | 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. Receives: Procedure: IASTM; Procedure: MFR |
| Myofascial Release | Active comparator | 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 Receives: Procedure: IASTM; Procedure: MFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for pain
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.
Measured: Baseline (pre-induction), Post-DOMS induction (24 hours), 48 hours, and 72 hours.
Secondary outcomes (2)
Cervical Range of Motion (CROM)
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.
Measured: Baseline (pre-induction), Post-DOMS induction (24 hours), 48 hours, and 72 hours.
Pressure Pain Threshold (PPT)
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.
Measured: Baseline (pre-induction), Post-DOMS induction (24 hours), 48 hours, and 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start6 Apr 2026
- Primary completion29 Apr 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset Muscle Soreness (DOMS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a randomized, parallel-group design in which participants diagnosed with DOMS at cervicothoracic region are assigned into one of two intervention arms. Participants randomly allocated to either ( 1) IASTM or Myofascial Release alone. Before the baseline assessment was conducted on them, no form of treatment has been done on the participants. Participants were asked not to engage in any form of therapy or take medication throughout the study period. The interventions will be delivered over a 4 week period, and the outcomes will be compared between groups to evaluate the effects IASTM and MFR.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iqra Majeed, Green International University
- Investigators
- Iqra Majeed Principal Investigator, Principal investigator, Green International University, Lahore, Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609498
- Sponsor's protocol ID
- GIU/REC/26-25
- Acronym
- COMPARE-DOMS
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication will be shared
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07609498
- Acronym / sponsor ID
- COMPARE-DOMS / GIU/REC/26-25
- Keywords
- Myofascial Release, IASTM, DOMS, Neck Disability, Cervical ROM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Green International UniversityUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a randomized, parallel-group design in which participants diagnosed with DOMS at cervicothoracic region are assigned into one of two intervention arms. Participants randomly allocated to either ( 1) IASTM or Myofascial Release alone. Before the baseline assessment was conducted on them, no form of treatment has been done on the participants. Participants were asked not to engage in any form of therapy or take medication throughout the study period. The interventions will be delivered over a 4 week period, and the outcomes will be compared between groups to evaluate the effects IASTM and MFR.
| Arm | Type | Receives |
|---|---|---|
| IASTM | Experimental | Procedure: IASTM, Procedure: MFRInstrument-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. |
| Myofascial Release | Active comparator | Procedure: IASTM, Procedure: MFRMyofascial 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 |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IASTMThe 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 | Procedure or surgery | IASTM, Myofascial Release |
| MFRGroup 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 | Procedure or surgery | IASTM, Myofascial Release |
Primary outcome
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.
2 secondary outcomes
Cervical Range of Motion (CROM)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iqra Majeed Principal Investigator principal investigator
Green International University, Lahore, Punjab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IASTM and MFR in people with Delayed Onset Muscle Soreness (DOMS) and Muscle Soreness, run by Green International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) for pain (time frame: Baseline (pre-induction), Post-DOMS induction (24 hours), 48 hours, and 72 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.