Clinical trial NCT06930196: 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.
Official title: Pain: A Century's Old Approach to Treatment With Objective Documentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopathic Manipulative Treatment
Keywords: OMT
Osteopathic Manipulative Treatment
Non opioid pain management
Alternative pain management
Musculoskeletal medicine
Lead sponsor: Skagit Regional Health
Sponsor class: OTHER
Collaborators: name: Philadelphia College of Osteopathic Medicine
name: University of Eastern Finland
First posted: 2025-04-16
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 arm model but the goal was 5
Primary purpose: TREATMENT

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.

Detailed description: Subjects will randomly choose a number 1-3. The number correlates to one of three treatment techniques ME, CS, or HVLA. Prior to treatment subjects will be analyzed with the Ultralign SA201 to the cervical region only to assess the hysteresis of the segment. The subject will then go to another room and be treated with the OMT technique chosen prior to the start of the study. Post treatment the subject will then return to be reassessed by the Ultralign SA201 for post treatment analysis.

The Ultralign SA201 is able to measure tissue texture hysteresis using durometers. A durometer is a standardized way of measuring the hardness of materials like rubber or plastic. It is a measure of how resistant a plastic is to deformation caused by mechanical indentation or abrasion. Durometer measurement scales range from 0 to 100. This scale is commonly used to measure the plasticity of airplane wings to ensure that a plane is still in acceptable flight conditions. In this study we are looking at the changes in hysteresis of the cervical region (measured in durometers) to see if objective changes in the cervical region post OMT can be observed.

The physician treating the subjects and the physician operating the SA201 will remained blind to the others findings until the completion of the study. There by making this a partially blinded study. The Ultralign SA201 operator will also remain blind to the OMT technique used until completion of the study. By using the Ultralign SA201 it was projected that it would be able to detect tissue texture (hysteresis) changes objectively supporting the usage of OMT as an adjunctive treatment for treating pain.

Subjects will also do a pre and post treatment questionnaire using the Numeric Pain Rating scale to describe their pain (if any) along with noting their experience while being analyzed by the SA201. A 0 is no pain and a 10 is the worst pain.

Ultimately the pre and post treatment pain scales will be compared to see if there is a decrease in overall pain as well as to see if there is an overall change in hysteresis measurements (in durometers) in conjunction with the decrease in pain.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

1. Subjects younger than age 18 or over the age of 65 years.
2. History of abnormal findings on brain or cervical CT/MRI
3. 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
4. Significant scoliosis that contributes to back or neck pain diagnosed by structural exam
5. Current diagnosis or history of depression, except for mild situational depression specifically diagnosed as associated with chronic headaches
6. Significant psychiatric disorders present or past including, but not limited to: borderline personality, bipolar disorder or schizophrenia
7. 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
8. History of neoplastic disease
9. Involvement in current litigation involving the neuromusculoskeletal syndrome

Primary outcomes:
measure: Can tissue texture changes be objectively documented post OMT
timeFrame: 2 weeks
Secondary outcomes:
measure: How much pressure is actually used during diagnosis and treatment
timeFrame: 2 weeks
Other outcomes:
measure: Pain rating
timeFrame: Immediately before and after treatment
Locations:
city: Philadelphia
country: United States
facility: Philadelphia College of Osteopathic Medicine
state: Pennsylvania
Study officials:
References:
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citation: 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.
citation: 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.