By Potentially Adding a Century Old Therapeutic Measure to Pain Treatment Regimens Called Osteopathic Manipulative Treatment, Can Help Decrease Muscle and Bone Pain and the Usage of Opioid Pain Medication.

NCT06930196 | Completed DMC FDA Device

• 1 other identifier: SkagitRegional
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

Osteopathic Manipulative Treatment (OMT) has been used to successfully treat patients for over a hundred years. Even though there have been many subjective clinical results, there is still little research measuring the actual mechanical change to a spinal segment produced by OMT or the actual palpatory changes that one is able to detect or elicit. The Ultralign SA201System (also called a Spineliner internationally) is an advanced technical instrument commercially used for spinal analysis and treatment. It was originally designed to assist chiropractors in locating and correcting "subluxations" or "fixations", which may share many characteristics in common with "somatic dysfunction" or perhaps be identical in all but name. This system can analyze selected regions of the spine for comparison to adjacent tissues as well as pre and post treatment changes using computer graphics and actual digital numbers to describe the changes around a spinal segment. In this study, only the analysis part of the SA201 will be used. The analytical function of the SA201 allows the user to place a force transducer (small, smooth, rubber-like rod) against the skin overlaying a subject's spine and release an impulse (gentle tap) into the somatic tissues of the underlying spinal segment. The force impulse is transmitted through the sensor to the underlying area, soft tissues and articular elements of the subject which results in the formation of a waveform that is characteristic of the ratio of tissue resistance and force dissipation. Interpretation of the waveform measured by the SA201's force sensor provides an indication of the "stiffness" or "compliance" of each spinal segment as well as its "hysteresis" (the lagging of an effect behind its cause or how quickly the tissues tested return towards their original condition). The shape of the wave may be analyzed and further interpreted to reflect muscle spasm or other underlying tissue conditions. In this research study the investigators will obtain hysteresis measurements before and after treatment of spinal areas diagnosed by palpation to contain somatic dysfunction (SD). Hysteresis is the time it takes for the tissues to recoil after a deforming force has been introduced. Measurements of hysteresis will be taken using the SA201 before and after use of two OMT techniques used to relieve SD, High Velocity Low Amplitude (HVLA), Muscle Energy (ME) and Counterstrain (CS). Selection of these three techniques shall be randomized. The investigators will note if the SA201 is able to detect a difference in the hysteresis characteristics of a given SD and document whether OMT is capable of changing this objective parameter related to tissue texture; furthermore, a difference (if there is one) may be detected and quantified to determine if there is a different outcome between the different treatment modalities. The investigators also used a pressure sensor system called the IsoTOUCH during the diagnosis/treatment in the study to gain a better understanding of the amount of pressure that the SA201uses to diagnose a SD compared to the diagnostic pressure the Palpator uses. The IsoTouch were a pair of gloves worn by the physician administering OMT. No sensation other than palpation with gloved fingers were felt by the patient. At preset pressures, the SA201will document hysteresis characteristics of segments considered to have somatic dysfunction or not. This permits comparison of the dysfunctional, normal and corrected sites diagnosed by hand and the sites independently determined by the technology. It should also be able to graphically illustrate the change in the dysfunctional segment's response to the SA201 stimulus pre and post treatment, as well as to document if there is a difference between the various OMT treatment modalities. This machine also allows for the testing of more than one element simultaneously without compromising other aspects of the study. While the SA201 and the IsoTouch palpation monitors are able to diagnosis all segments of the spine this study will limit diagnosis and treatment to the cervical spine only at this time. Later studies can potentially expand to the other areas of the spine and body.

Conditions

Osteopathic Manipulative Treatment

Keywords

OMT; Osteopathic Manipulative Treatment; Non opioid pain management; Alternative pain management; Musculoskeletal medicine

Outcome Measures

Primary Outcomes (1)

• Can tissue texture changes be objectively documented post OMT

  Each subject will have paraspinal cerivcal musculoskeletal hysteresis measurements taken of the cervical spine (OA-C7) using the Ultralign SA201. The Ultralign SA201 measures tissue texture changes in durometers. The durometer readings will be compared pre and post osteopathic manipulative to see if the overall change in the somatic dysfunction. Changes in the durometer shows changes in the tissue. After the final collection of data an ANOVA data analysis of the durometer readings will be performed to see if there is an objective change in tissue hysteresis after osteopathic manipulative treatment has been administered.

  2 weeks

Secondary Outcomes (1)

• How much pressure is actually used during diagnosis and treatment

  2 weeks

Other Outcomes (1)

• Pain rating

  Immediately before and after treatment

Study Arms (3)

Muscle Energy Treatment

ACTIVE COMPARATOR

Subjects received Muscle Energy osteopathic manipulative treatment after analysis with the SA201 for somatic dysfunction and then again after treatment.

Other: Muscle Energy; Device: The Ultralign SA201 used for measuring tissue texture changes; Device: IsoTouch

High Velocity Low Amplitude

ACTIVE COMPARATOR

Subjects received High Velocity High Amplitude osteopathic manipulative treatment after analysis with the SA201 for somatic dysfunction and then again after treatment.

Other: High Velocity Low Amplitude; Device: The Ultralign SA201 used for measuring tissue texture changes; Device: IsoTouch

Counterstrain

ACTIVE COMPARATOR

Subjects received Counterstrain osteopathic manipulative treatment after analysis with the SA201 for somatic dysfunction and then again after treatment.

Other: Counterstrain; Device: The Ultralign SA201 used for measuring tissue texture changes; Device: IsoTouch

Interventions

Counterstrain OTHER

Subjects were first analyzed for tissue texture changes with the SA201 then given an osteopathic treatment and analyzed post treatment with the SA201 to analyze for tissue texture changes.

Also known as: Intervention number 3

Counterstrain

Muscle Energy OTHER

Subjects were first analyzed with the Ultralign SA201/Spineliner, then treated with an osteopathic technique, and then reassessed with the SA201 for tissue texture changes.

Also known as: Intervention number 2

Muscle Energy Treatment

High Velocity Low Amplitude OTHER

Subjects were first analyzed for tissue texture changes with the SA201 then given an osteopathic treatment and analyzed post treatment with the SA201 to analyze for tissue texture changes.

Also known as: Intervention number 1

High Velocity Low Amplitude

The Ultralign SA201 used for measuring tissue texture changes DEVICE

The Ultralign SA201 was used for diagnostic purposes to measure the tissue texture changes of the paraspinal cervical muscles pre and post treatment

Also known as: Ultraslign SA201, Spineliner, SA201

Counterstrain; High Velocity Low Amplitude; Muscle Energy Treatment

IsoTouch DEVICE

The IsoTouch is a palpation monitoring system that uses capacitance pressure sensors in the pads of gloves to measure the palpation pressures used for both diagnosis and treatment using OMT. No sensation is felt by either the subject or operator other than a feeling of a glove being used during treatment. No electrical impulses are sent or should be experienced by either party as the sensors are merely pads that sense pressure.

Also known as: Palpation monitors

Counterstrain; High Velocity Low Amplitude; Muscle Energy Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects that will be sought for this study will be male or female subjects from the ages of 18-65 years. Because this is a one session study, where a person lives does not preclude them from participating in this study.
• Healthy Volunteers are the volunteers that may present with or without a cervical somatic dysfunction, having a cervical somatic dysfunction is a common biomechanical occurrence and does not constitute a person as being unhealthy.

You may not qualify if:

• Subjects younger than age 18 or over the age of 65 years.
• History of abnormal findings on brain or cervical CT/MRI
• History of diagnosis of symptomatic osteoarthritis of the cervical spine (as documented in previous imaging studies) or as evidenced by palpation and provocative tests during structural exam
• Significant scoliosis that contributes to back or neck pain diagnosed by structural exam
• Current diagnosis or history of depression, except for mild situational depression specifically diagnosed as associated with chronic headaches
• Significant psychiatric disorders present or past including, but not limited to: borderline personality, bipolar disorder or schizophrenia
• History of systemic disease which includes, but is not limited to: rheumatoid arthritis, Marfan's syndrome, fibromyalgia, Ehler-Danlos Syndrome or other connective tissue disease, lupus or ankylosing spondylitis
• History of neoplastic disease
• Involvement in current litigation involving the neuromusculoskeletal syndrome

Sponsors & Collaborators

• Skagit Regional Health: lead
• Philadelphia College of Osteopathic Medicine: collaborator
• University of Eastern Finland: collaborator

Study Sites (1)

Philadelphia College of Osteopathic Medicine

Philadelphia, Pennsylvania, 19131, United States

Location

Related Publications (6)

• Rehman Y, Ferguson H, Bozek A, Blair J, Allison A, Johnston R. Osteopathic Manual Treatment for Pain Severity, Functional Improvement, and Return to Work in Patients With Chronic Pain. J Am Osteopath Assoc. 2020 Dec 1;120(12):888-906. doi: 10.7556/jaoa.2020.128.

  PMID: 32946545 BACKGROUND

• Jerome JA. An Osteopathic Approach to Chronic Pain Management. J Am Osteopath Assoc. 2017 May 1;117(5):306-314. doi: 10.7556/jaoa.2017.056.

  PMID: 28459476 BACKGROUND

• Seffinger M. Foundations of Osteopathic Medicine. Fourth Edition. Wolters Kluwer; 2018.

  BACKGROUND

• Licciardone JC, Schultz MJ, Amen B. Osteopathic Manipulation in the Management of Chronic Pain: Current Perspectives. J Pain Res. 2020 Jul 20;13:1839-1847. doi: 10.2147/JPR.S183170. eCollection 2020.

  PMID: 32765058 BACKGROUND

• Barnes PL, Laboy F 3rd, Noto-Bell L, Ferencz V, Nelson J, Kuchera ML. A comparative study of cervical hysteresis characteristics after various osteopathic manipulative treatment (OMT) modalities. J Bodyw Mov Ther. 2013 Jan;17(1):89-94. doi: 10.1016/j.jbmt.2012.10.004. Epub 2012 Dec 5.

  PMID: 23294689 BACKGROUND

• Kim G, St. Laurent E, Keane J, Goldstein L. Muscle dysfunction in head and neck: Pain causes, osteopathic options. Practical Pain Management. 2020;20(2):54-56.

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Tocopherols

Intervention Hierarchy (Ancestors)

Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The person who provided treatment and the person who operated the machine were blinded to each other. Participants did not know which treatment they were going to receive until it was actually performed. The Statistician used only deidentified data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospitalist Physician, Principal Investigator Board certified in Family medicine and Neuromusculoskeletal Medicine

Model Details: 3 arm model but the goal was 5

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 16, 2025
• Study Start: June 1, 2011
• Primary Completion: June 30, 2012
• Study Completion: June 30, 2012
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Starting 6 months after publication information will be shared
• Access Criteria: Data information will be available to specified statisticians for ANOVA data analysis along with the investigators.

Locations

US (1)