- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06529991
Self-Myofascial Release of the Upper Cervical Muscles
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Auburn, Alabama, United States, 36832
- Edward Via College of Osteopathic Medicine-Auburn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Myofascial Release Treatment
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Pre-Baseline measurement and immediately after 5-minute self-myofascial release intervention
|
|
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
|
Pre-Baseline measurement and immediately after 5-minute self-myofascial release intervention
|
|
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.
|
Pre-Baseline measurement and immediately after 5-minute self-myofascial release intervention
|
|
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.
|
Pre-Baseline measurement and immediately after 5-minute self-myofascial release intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Prior to 5-minute self-myofascial release intervention
|
|
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.
|
Prior to 5-minute self-myofascial release intervention
|
|
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.
|
Prior to 5-minute self-myofascial release intervention
|
|
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.
|
Prior to 5-minute self-myofascial release intervention
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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