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Completed

NCT Number: NCT06529991

Self-Myofascial Release of the Upper Cervical Muscles

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Via College of Osteopathic Medicine-Auburn

Auburn, Alabama, 36832, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Occipivot suboccipital pillow self-myofascial release

Device

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.

Primary outcomes

  1. Muscle Stiffness

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

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

  2. Plantar foot pressure

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

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

  3. Ankle dorsiflexion

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

    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.

  4. Pain pressure threshold

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

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

Secondary outcomes

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

    Time frame: Prior to 5-minute self-myofascial release intervention

    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.

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

    Time frame: Prior to 5-minute self-myofascial release intervention

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

  3. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Prior to 5-minute self-myofascial release intervention

    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.

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

    Time frame: Prior to 5-minute self-myofascial release intervention

    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.

Sponsors and collaborators

Lead sponsor

Edward Via Virginia College of Osteopathic Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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