NCT07609498

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

23 days

First QC Date

May 15, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

Myofascial ReleaseIASTMDOMSNeck DisabilityCervical ROM

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (2)

  • Cervical Range of Motion (CROM)

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

  • Pressure Pain Threshold (PPT)

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

Study Arms (2)

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.

Procedure: IASTMProcedure: 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

Procedure: IASTMProcedure: MFR

Interventions

IASTMPROCEDURE

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

IASTMMyofascial Release
MFRPROCEDURE

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

IASTMMyofascial Release

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Green International University

Lahore, Sheikhupura, Pakistan

Location

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Iqra Majeed Principal Investigator

    Green International University, Lahore, Punjab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The study uses a single masking in which the outcome assessor is blinded to group allocation. Participants will be assigned to either the IASTM group or the Myofascial Release group by an independent researcher who is not involved in the assessment. The assessor responsible for recording baseline and post intervention outcomes ( VAS, NDI, Universal goniometer) will not be informed of the participants intervention group. To maintain blinding, participants will be instructed not to disclose their group assignment during assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 27, 2026

Study Start

April 6, 2026

Primary Completion

April 29, 2026

Study Completion

May 6, 2026

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Only IPD used in the results publication will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
It will be available after the completion of study.
Access Criteria
Through the corresponding author.

Locations