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.

Completed NA Last updated 16 April 2025

What this trial tests

NA trial testing Counterstrain in Osteopathic Manipulative Treatment in 213 participants. Completed in 30 June 2012.

Timeline

1 June 2011

Primary endpoint
30 June 2012

30 June 2012

Quick facts

Lead sponsor	Skagit Regional Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	213
Start date	1 June 2011
Primary completion	30 June 2012
Estimated completion	30 June 2012
Sites	1 location across United States

Drugs / interventions tested

• Counterstrain
• Muscle Energy
• High Velocity Low Amplitude
• The Ultralign SA201 used for measuring tissue texture changes
• IsoTouch

Conditions studied

• Osteopathic Manipulative Treatment — all drugs for Osteopathic Manipulative Treatment →

Sponsor

Skagit Regional Health

Who can join

Adults 18 to 65, any sex, with Osteopathic Manipulative Treatment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.