NCT06529991

Brief Summary

The primary objective is to examine the influence of the suboccipital muscles on the superficial back line. The investigators will measure the following as part of this objective:

  • Changes in biomechanical and viscoelastic properties of points within the superficial back fascial train measured by a handheld myotonometer.
  • Pain pressure threshold measured by algometry.
  • Ankle range of motion.
  • Foot plantar pressure changes. All participants will have a 5-minute self-myofascial release intervention.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 26, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2026

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

July 12, 2024

Last Update Submit

August 4, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Muscle Stiffness

    Using myotonometry to assess muscle stiffness (N/m) in the plantar fascia, gastrocnemius, biceps femoris, semitendinosus, thoracolumbar fascia, and semispinalis.

    Pre-Baseline measurement and immediately after 5-minute self-myofascial release intervention

  • Plantar foot pressure

    Using Novel EMED plantar pressure platform to assess the distribution of plantar foot pressure (kPa) in different regions of the foot

    Pre-Baseline measurement and immediately after 5-minute self-myofascial release intervention

  • Ankle dorsiflexion

    Using the weight-bearing lunge test to measure ankle dorsiflexion (degrees). This is a functional test of ankle dorsiflexion range of motion in a loaded position.

    Pre-Baseline measurement and immediately after 5-minute self-myofascial release intervention

  • Pain pressure threshold

    Using algometry to measure pain pressure threshold (kPa) at the erector spinae, sacrum, posterior leg, plantar fascia, and thenar eminence.

    Pre-Baseline measurement and immediately after 5-minute self-myofascial release intervention

Secondary Outcomes (4)

  • Subjective intensity, frequency, and duration of non-debilitating lower extremity pain and back pain

    Prior to 5-minute self-myofascial release intervention

  • Perceived Stress Scale-10 (PSS-10)

    Prior to 5-minute self-myofascial release intervention

  • Pittsburgh Sleep Quality Index (PSQI)

    Prior to 5-minute self-myofascial release intervention

  • General Anxiety Disorder-7 (GAD-7)

    Prior to 5-minute self-myofascial release intervention

Study Arms (1)

Self-Myofascial Release Treatment

EXPERIMENTAL
Device: Occipivot suboccipital pillow self-myofascial release

Interventions

Subjects will be instructed in the use of the Occipivot suboccipital pillow and how "it should feel." They will be supervised as it is placed. Once verbal verification is obtained regarding the feel and placement of the wedge, the treatment time will begin and continue for 5 minutes.

Self-Myofascial Release Treatment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 19 years of age and older from VCOM-Auburn and the Auburn area.

You may not qualify if:

  • pain that alters gait and/or limits/alters normal daily function
  • currently undergoing treatment by a healthcare provider
  • loss of function
  • use of prescription drugs for muscle or muscle relaxants
  • Pregnancy (hormonal changes affecting tissues could be a confounding variable)
  • inflammatory arthritis and fibromyalgia
  • diabetes or prediabetes
  • lumbar radiculopathy or disc pathology
  • previous surgery of the spine or lower extremity
  • injury to the lower extremity within the past 6 months
  • neurological or musculoskeletal diseases
  • cancer or blood disorder
  • current tobacco use
  • other conditions that alter gait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Via College of Osteopathic Medicine-Auburn

Auburn, Alabama, 36832, United States

RECRUITING

Related Publications (14)

  • Cho SH, Kim SH, Park DJ. The comparison of the immediate effects of application of the suboccipital muscle inhibition and self-myofascial release techniques in the suboccipital region on short hamstring. J Phys Ther Sci. 2015 Jan;27(1):195-7. doi: 10.1589/jpts.27.195. Epub 2015 Jan 9.

    PMID: 25642072BACKGROUND
  • Donald R. Murphy, Brett M. Carr, Ronald J. Tyszkowski,A possible cervical cause of low back pain: pelvic distortion,Journal of Bodywork and Movement Therapies,Volume 4, Issue 2,2000,Pages 83-89

    BACKGROUND
  • Ajimsha MS, Shenoy PD, Gampawar N. Role of fascial connectivity in musculoskeletal dysfunctions: A narrative review. J Bodyw Mov Ther. 2020 Oct;24(4):423-431. doi: 10.1016/j.jbmt.2020.07.020. Epub 2020 Jul 30.

    PMID: 33218543BACKGROUND
  • Gacto-Sanchez M, Medina-Mirapeix F, Benitez-Martinez JC, Montilla-Herrador J, Palanca A, Agustin RM. Estimating Quadriceps and Hamstrings Strength Through Myoton Among Recreational Athletes. J Sport Rehabil. 2023 Jun 14;32(7):827-833. doi: 10.1123/jsr.2022-0437. Print 2023 Sep 1.

    PMID: 37611914BACKGROUND
  • Konor MM, Morton S, Eckerson JM, Grindstaff TL. Reliability of three measures of ankle dorsiflexion range of motion. Int J Sports Phys Ther. 2012 Jun;7(3):279-87.

    PMID: 22666642BACKGROUND
  • Lee JH. Effects of forward head posture on static and dynamic balance control. J Phys Ther Sci. 2016 Jan;28(1):274-7. doi: 10.1589/jpts.28.274. Epub 2016 Jan 30.

    PMID: 26957773BACKGROUND
  • Munoz-Munoz S, Munoz-Garcia MT, Alburquerque-Sendin F, Arroyo-Morales M, Fernandez-de-las-Penas C. Myofascial trigger points, pain, disability, and sleep quality in individuals with mechanical neck pain. J Manipulative Physiol Ther. 2012 Oct;35(8):608-13. doi: 10.1016/j.jmpt.2012.09.003.

    PMID: 23158466BACKGROUND
  • Orner S, Kratzer W, Schmidberger J, Gruner B. Quantitative tissue parameters of Achilles tendon and plantar fascia in healthy subjects using a handheld myotonometer. J Bodyw Mov Ther. 2018 Jan;22(1):105-111. doi: 10.1016/j.jbmt.2017.06.015. Epub 2017 Jun 21.

    PMID: 29332731BACKGROUND
  • Overmann L, Schleip R, Michalak J. Exploring fascial properties in patients with depression and chronic neck pain: An observational study. Acta Psychol (Amst). 2024 Apr;244:104214. doi: 10.1016/j.actpsy.2024.104214. Epub 2024 Mar 10.

    PMID: 38461580BACKGROUND
  • Skinner B, Dunn L, Moss R. The Acute Effects of Theragun Percussive Therapy on Viscoelastic Tissue Dynamics and Hamstring Group Range of Motion. J Sports Sci Med. 2023 Sep 1;22(3):496-501. doi: 10.52082/jssm.2023.496. eCollection 2023 Sep.

    PMID: 37711710BACKGROUND
  • Staffe AT, Bech MW, Clemmensen SLK, Nielsen HT, Larsen DB, Petersen KK. Total sleep deprivation increases pain sensitivity, impairs conditioned pain modulation and facilitates temporal summation of pain in healthy participants. PLoS One. 2019 Dec 4;14(12):e0225849. doi: 10.1371/journal.pone.0225849. eCollection 2019.

    PMID: 31800612BACKGROUND
  • Trybulski R, Stanula A, Zebrowska A, Podlesny M, Hall B. Acute Effects of the Dry Needling Session on Gastrocnemius Muscle Biomechanical Properties, and Perfusion with Latent Trigger Points - A Single-Blind Randomized Controlled Trial in Mixed Martial Arts Athletes. J Sports Sci Med. 2024 Mar 1;23(1):136-146. doi: 10.52082/jssm.2024.136. eCollection 2024 Mar.

    PMID: 38455447BACKGROUND
  • van Leeuwen RJ, Szadek K, de Vet H, Zuurmond W, Perez R. Pain Pressure Threshold in the Region of the Sacroiliac Joint in Patients Diagnosed with Sacroiliac Joint Pain. Pain Physician. 2016 Mar;19(3):147-54.

    PMID: 27008288BACKGROUND
  • Gulrandhe P, Yadav V, Naqvi WM. Correlation Between Foot Posture and Hamstring Muscle Tightness. Cureus. 2023 Jul 17;15(7):e42046. doi: 10.7759/cureus.42046. eCollection 2023 Jul.

    PMID: 37602068BACKGROUND

Central Study Contacts

Daniel Cawley, DC, MSHS, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study will utilize a pretest-posttest design which will measure changes in the following in response to a 5-minute self-myofascial release intervention: muscle biomechanical properties, plantar pressure distribution, pain pressure threshold, ankle range of motion. Investigators will correlate subjective measures of stress, anxiety, sleep, and pain experience with treatment response and evaluate changes in these subjective measures after 1 treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 31, 2024

Study Start

June 26, 2024

Primary Completion

October 1, 2025

Study Completion

April 26, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations