AzTrials
AzTrials

Suboccipital MusclesNCT06529991

Self-Myofascial Release of the Upper Cervical Muscles

A study testing Occipivot suboccipital pillow self-myofascial release in people with Suboccipital Muscles and Superficial Back Line, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
What is being tested?
Occipivot suboccipital pillow self-myofascial release
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
26 Jun 2024to 5 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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Edward Via College of Osteopathic Medicine-Auburn

    Auburn, Alabama, 36832

Other trials in United States

About this study

Official title: Exploring the Effect of Self-Myofascial Release of the Upper Cervical Muscles on the Superficial Back Fascial Train

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.

Read the detailed description

The superficial back line is a network myofascial segments that are connected and extend from the plantar foot up through the posterior lower extremity and back, up to the head. These connective tissue and muscular tracks play a role in supporting upright stance and motion. Dysfunction in one segment of the superficial back line can manifest as pain in a different segment of the fascial system. For example, hamstring and gastrocnemius muscle tightness have been associated with altered foot biomechanics and pain. The suboccipital muscles play an important role in head and body posture; therefore, they can influence eye positioning as it relates to head movements and perturbations. Because of this, the suboccipital muscles may have a hierarchical control over the SBFL. Dysfunction in the suboccipital muscles may exert more widespread effects on muscles and tissues at distant regions of the SBFL. Studies have shown that neck pain and forward head posture are associated with altered gait and ankle posture respectively. In addition, stress, anxiety, and poor sleep quality are associated with increased pain sensitivity and disability. How the interconnectedness of the SBFL responds to treatment is not fully understood. Proper treatment of musculoskeletal pain requires a better understanding of the function of myofascial connections and how dysfunction in one segment affects other regions. Also, enhanced understanding of the influence of stress, anxiety, and low sleep quality on response to treatment is needed. This understanding will better inform clinical practice and support the need for a more holistic approach to treating musculoskeletal pain.

The primary objective is to examine the influence of the suboccipital muscles on the superficial back line. Specifically, 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.

A secondary objective is to demonstrate a relationship between changes within the SBFL and stress, anxiety, sleep quality and non-debilitating pain. To achieve this secondary objective, the investigators will use the following:

  • Perceived Stress Scale-10 (PSS-10)
  • General Anxiety Disorder-7 (GAD-7)
  • Pittsburgh Sleep Quality Index (PSQI)
  • Numerical Rating Scale (NRS) will be utilized to record participants' intensity, frequency, and duration of non-debilitating lower extremity pain and back pain.
Being tested
Occipivot suboccipital pillow self-myofascial release

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Occipivot suboccipital pillow self-myofascial releaseDevice

    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.

Study groups in NCT06529991
Study groupRoleWhat they receive
Self-Myofascial Release TreatmentExperimentalNot described
Receives: Device: Occipivot suboccipital pillow self-myofascial release

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle Stiffness

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

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

  2. Plantar foot pressure

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

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

  3. 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.

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

  4. Pain pressure threshold

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

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

Secondary outcomes (4)
  1. Subjective intensity, frequency, and duration of non-debilitating lower extremity pain and back pain

    Using Numerical Rating Scale (NRS) to measure. Scales from 0-10 with 0 indicating no pain and 10 indicating severe pain. Scales from 1-5 with 1 indicating no pain ever and 5 indicating pain always.

    Measured: Prior to 5-minute self-myofascial release intervention

  2. Perceived Stress Scale-10 (PSS-10)

    Measuring the degree to which situations in one's life are considered stressful. Scales from 0-4 with 0=never and 4=very often.

    Measured: Prior to 5-minute self-myofascial release intervention

  3. Pittsburgh Sleep Quality Index (PSQI)

    Used to evaluate overall sleep quality. Each questionnaire's 19 self-reported items belong to one of seven subdomains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Response scores range from 0-3 with lower scores indicating less disturbances and higher scores indicating more disturbances.

    Measured: Prior to 5-minute self-myofascial release intervention

  4. General Anxiety Disorder-7 (GAD-7)

    Used to measure symptoms of anxiety. Scores range from 0-3 with lower scores indicating less anxiety symptoms and higher scores indicating more anxiety symptoms.

    Measured: Prior to 5-minute self-myofascial release intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study start26 Jun 2024
  3. Primary completion15 Mar 2026
  4. Study completion5 May 2026

Resources

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
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06529991
Sponsor's protocol ID
2024-048
Status last verified
May 2026
First submitted
12 Jul 2024
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25642072
  • 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

  • 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.

    PubMed 33218543
  • 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.

    PubMed 37611914
  • 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.

    PubMed 22666642
  • 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.

    PubMed 26957773
  • 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.

    PubMed 23158466
  • 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.

    PubMed 29332731
  • 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.

    PubMed 38461580
  • 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.

    PubMed 37711710
  • 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.

    PubMed 31800612
  • 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.

    PubMed 38455447
  • 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.

    PubMed 27008288
  • 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.

    PubMed 37602068

Questions about this trial

What is this clinical trial studying?

A study testing Occipivot suboccipital pillow self-myofascial release in people with Suboccipital Muscles and Superficial Back Line, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.

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 1 inclusion and 14 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 8 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 United States. 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?

Muscle Stiffness (time frame: Pre-Baseline measurement and immediately after 5-minute self-myofascial release intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06529991, which also lists 14 linked publications.

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 8 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in