NCT07096076

Brief Summary

This randomized controlled trial aimed to compare the immediate effects of two self-myofascial release techniques-suboccipital muscle inhibition and thoracolumbal fascia inhibition-on hamstring flexibility, spinal range of motion, and balance in healthy adults. A total of 75 participants with hamstring tightness were randomly assigned to one of three groups: suboccipital inhibition, thoracolumbal inhibition, or control. All participants performed hamstring stretching, and the intervention groups received one of the inhibition techniques immediately after. Outcomes were measured at baseline and within 30 minutes post-intervention. The study found that both techniques led to significant improvements in hamstring flexibility and spinal mobility, with region-specific benefits. The thoracolumbal technique was more effective for trunk and hamstring flexibility, while the suboccipital technique provided greater cervical mobility gains. Balance improvements were limited. These findings support the use of targeted myofascial interventions in clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

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

First Submitted

Initial submission to the registry

March 25, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 28, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

March 25, 2025

Last Update Submit

July 31, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Change in Cervical Range of Motion (degrees) from Baseline to Post-Intervention

    Cervical range of motion (flexion, extension, lateral flexion, rotation) in healthy individuals with hamstring tightness.

    Baseline and immediately (within 30 minutes) post-intervention

  • Change in Finger-to-Floor Distance from Baseline to Post-Intervention

    Finger-to-Floor Distance was used to assess hamstring flexibility. Measurements were taken pre-intervention and within 30 minutes following the intervention.

    Baseline and immediately (within 30 minutes) post-intervention

  • Change in Y Balance Test from Baseline to Post-Intervention

    The Y Balance Test was used to assess dynamic balance, with participants reaching in the anterior, posteromedial, and posterolateral directions while standing on one leg. The average reach distance in centimeters (cm) was recorded for each direction. The test was administered at baseline and within 30 minutes post-intervention to assess immediate changes in balance performance.

    Baseline and immediately (within 30 minutes) post-intervention

  • Change in Active Knee Extension Angle (degrees) from Baseline to Post-Intervention

    Active Knee Extension Test (AKET): Degree of knee extension measured using a goniometer. Higher values indicate greater flexibility.

    Baseline and immediately (within 30 minutes) post-intervention

  • Change in The Stork Balance Test from Baseline to Post-Intervention

    The Stork Balance Test was used to evaluate static balance by measuring how long (in seconds) a participant could maintain a balanced stance on one leg.

    Baseline and immediately (within 30 minutes) post-intervention

  • Change in Lumbal Range of Motion (degrees) from Baseline to Post-Intervention

    Lumbal range of motion (flexion, extension) in healthy individuals with hamstring tightness.

    Baseline and immediately (within 30 minutes) post-intervention

Study Arms (3)

Control Group

ACTIVE COMPARATOR
Other: hamstring stretching

Thoracolumbar fascia inhibition group

EXPERIMENTAL
Other: Thoracolumbar fascia inhibitionOther: hamstring stretching

Suboccipital inhibition group

EXPERIMENTAL
Other: Suboccipital inhibition groupOther: hamstring stretching

Interventions

Soft tissue mobilization: Participants will be asked to lie on their backs without a pillow in a hook-lying position, placing a foam roller under the inferior part of the scapula and clasping their hands behind the cervical region. Then, they will be instructed to lift their hips off the ground and roll the foam roller in a cranial and caudal direction from the inferior scapular region to the sacral area for 30 seconds, performing flexion and extension movements with their knees. This application will be performed in a total of 4 sets.

Thoracolumbar fascia inhibition group

Soft tissue mobilization: Participants will be asked to lie in a supine position on an appropriate surface and keep their knees in extension. Then, they will be instructed to hold both ends of a sheet and place the middle part of the sheet on the plantar surface of one foot. Using the sheet and by dorsiflexing the ankle, they will pull the extended leg toward themselves. This position should be maintained for 30 seconds (8). It is important that the opposite knee does not flex during the exercise. The application will be performed bilaterally.

Suboccipital inhibition group

Participants performed passive hamstring stretching using a sheet for self-assistance. Participants will be asked to lie supine on an appropriate surface and keep their knees in extension. Then, they will be instructed to hold both ends of a sheet and place the middle part of the sheet on the plantar surface of one foot. Using the sheet and performing ankle dorsiflexion, they will pull the leg-kept in knee extension-toward themselves. This position should be held for 30 seconds (8). It is important that the opposite knee does not move into flexion during the exercise. The application will be performed bilaterally.

Control GroupSuboccipital inhibition groupThoracolumbar fascia inhibition group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers between the ages of 18 and 25
  • Hamstring muscle tightness as defined by Active Knee Extension Test (AKET) ≥ 20°
  • Ability to follow study instructions and provide informed consent
  • No participation in other clinical studies within the last 3 months

You may not qualify if:

  • AKET \< 20° (i.e., no hamstring tightness)
  • History of musculoskeletal, neurological, or systemic diseases affecting balance or flexibility
  • Recent injury or surgery involving the spine, pelvis, or lower extremities
  • Use of medications affecting muscle tone or balance
  • Inability to perform the required movements or assessments
  • Pregnancy or suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit Üniversity

Kozlu, Zonguldak Province, 67600, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 25, 2025

First Posted

July 31, 2025

Study Start

March 28, 2025

Primary Completion

June 2, 2025

Study Completion

June 26, 2025

Last Updated

August 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

All procedures involving human participants were conducted in accordance with ethical standards. Written informed consent was obtained from all participants prior to the study. Data other than the participants' personal information (e.g., pre- and post-intervention muscle flexibility measurements) were used solely for research purposes. Participant privacy and confidentiality were strictly protected throughout the study.

Shared Documents
STUDY PROTOCOL, SAP

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