Osteopathic Manipulative TreatmentNCT06930196
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.
A study testing Counterstrain, Muscle Energy and High Velocity Low Amplitude in people with Osteopathic Manipulative Treatment, run by Skagit Regional Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteopathic Manipulative Treatment
- What is being tested?
- Counterstrain, Muscle Energy and High Velocity Low Amplitude
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2011to 30 Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia College of Osteopathic Medicine
Philadelphia, Pennsylvania, 19131
About this study
Official title: Pain: A Century's Old Approach to Treatment With Objective Documentation
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.
Read more
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.
Read the 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.
- Conditions
- Osteopathic Manipulative Treatment
- Being tested
- Counterstrain, Muscle Energy, High Velocity Low Amplitude, The Ultralign SA201 used for measuring tissue texture changes, IsoTouch
- Keywords
- OMT, Osteopathic Manipulative Treatment, Non opioid pain management, Alternative pain management, Musculoskeletal medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounterstrainOther
Also called Intervention number 3
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.
Muscle EnergyOther
Also called Intervention number 2
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.
High Velocity Low AmplitudeOther
Also called Intervention number 1
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.
The Ultralign SA201 used for measuring tissue texture changesDevice
Also called Ultraslign SA201, Spineliner, SA201
The Ultralign SA201 was used for diagnostic purposes to measure the tissue texture changes of the paraspinal cervical muscles pre and post treatment
IsoTouchDevice
Also called Palpation monitors
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Counterstrain; Device: The Ultralign SA201 used for measuring tissue texture changes; Device: IsoTouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (1)
How much pressure is actually used during diagnosis and treatment
Palpation monitors will be used during diagnosis and treatment to observe the level of pressure used in pounds to assess reproducibility and consistency of each treatment and diagnosis. The palpation monitors will only be used during the diagnosis and treatment phase of OMT. The monitoring of this will allow for reproducibility and consistency to be shown with osteopathic manipulative treatment.
The amount of pressure in pounds will be measured during both diagnosis and treatment to see the amount of diagnostic pressure used to diagnosis and treat a segment. By understanding this, it allows for better information for others who would like to reproduce this study but also for those in clinical practice to know how much or how little pressure is used during diagnosis and treatment. If activating forces show a very low pressure being used, then some treatments with low activating pressures may be able to be used in more delicate populations such as those with rheumatoid arthritis.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Jun 2011
- Primary completion30 Jun 2012
- Study completion30 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteopathic Manipulative TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arm model but the goal was 5
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skagit Regional Health
- Sponsor type
- University, hospital or other
- Collaborators
- Philadelphia College of Osteopathic Medicine, University of Eastern Finland
- Responsible party
- Principal investigator, Precious L Barnes DO, MS, MS, Skagit Regional Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930196
- Sponsor's protocol ID
- SkagitRegional
- Status last verified
- Apr 2025
- First submitted
- 18 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared
Publications
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.
PubMed 32946545Jerome 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.
PubMed 28459476Seffinger M. Foundations of Osteopathic Medicine. Fourth Edition. Wolters Kluwer; 2018.
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.
PubMed 32765058Barnes 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.
PubMed 23294689Kim 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain: A Century's Old Approach to Treatment With Objective Documentation
- ClinicalTrials.gov ID
- NCT06930196
- Acronym / sponsor ID
- SkagitRegional
- Conditions
- Osteopathic Manipulative Treatment
- Keywords
- OMT, Osteopathic Manipulative Treatment, Non opioid pain management, Alternative pain management, Musculoskeletal medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Skagit Regional HealthUniversity, hospital or other
- Collaborators
- Philadelphia College of Osteopathic Medicine, University of Eastern Finland
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 30 Jun 2012 (actual)
- Study completion
- 30 Jun 2012 (actual)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 arm model but the goal was 5
| Arm | Type | Receives |
|---|---|---|
| Muscle Energy Treatment | Active comparator | Other: Muscle Energy, Device: The Ultralign SA201 used for measuring tissue texture changes, Device: IsoTouchSubjects received Muscle Energy osteopathic manipulative treatment after analysis with the SA201 for somatic dysfunction and then again after treatment. |
| High Velocity Low Amplitude | Active comparator | Other: High Velocity Low Amplitude, Device: The Ultralign SA201 used for measuring tissue texture changes, Device: IsoTouchSubjects received High Velocity High Amplitude osteopathic manipulative treatment after analysis with the SA201 for somatic dysfunction and then again after treatment. |
| Counterstrain | Active comparator | Other: Counterstrain, Device: The Ultralign SA201 used for measuring tissue texture changes, Device: IsoTouchSubjects received Counterstrain osteopathic manipulative treatment after analysis with the SA201 for somatic dysfunction and then again after treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounterstrainAlso: Intervention number 3Subjects 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. | Other | Counterstrain |
| Muscle EnergyAlso: Intervention number 2Subjects were first analyzed with the Ultralign SA201/Spineliner, then treated with an osteopathic technique, and then reassessed with the SA201 for tissue texture changes. | Other | Muscle Energy Treatment |
| High Velocity Low AmplitudeAlso: Intervention number 1Subjects 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. | Other | High Velocity Low Amplitude |
| The Ultralign SA201 used for measuring tissue texture changesAlso: Ultraslign SA201, Spineliner, SA201The Ultralign SA201 was used for diagnostic purposes to measure the tissue texture changes of the paraspinal cervical muscles pre and post treatment | Device | Counterstrain, High Velocity Low Amplitude, Muscle Energy Treatment |
| IsoTouchAlso: Palpation monitorsThe 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. | Device | Counterstrain, High Velocity Low Amplitude, Muscle Energy Treatment |
Primary outcome
Can tissue texture changes be objectively documented post OMT
Time frame: 2 weeks
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.
1 secondary outcome
How much pressure is actually used during diagnosis and treatment
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 32946545Rehman 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.
- Background: PubMed 28459476Jerome 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.
- BackgroundSeffinger M. Foundations of Osteopathic Medicine. Fourth Edition. Wolters Kluwer; 2018.
- Background: PubMed 32765058Licciardone 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.
- Background: PubMed 23294689Barnes 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.
- BackgroundKim 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counterstrain, Muscle Energy and High Velocity Low Amplitude in people with Osteopathic Manipulative Treatment, run by Skagit Regional Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can tissue texture changes be objectively documented post OMT (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06930196, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.