Applying Pain Adaptability to Manual Therapy Practice
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|ClinicalTrials.gov Identifier: NCT05209659|
Recruitment Status : Not yet recruiting
First Posted : January 26, 2022
Last Update Posted : January 26, 2022
Mechanism research has identified pain adaptive and non-adaptive phenotypes by documenting the response to an ice immersion bath. Pain adaptive individuals exhibited a rapid response to cold and a rapid resolution of symptoms with continued exposure. Non-pain adaptive individuals had the opposite. Pain-adaptive individuals have the endogenous (internal) capacity to self-modulate pain therefore may pursue active self management techniques, whereas non-pain adaptive phenotypes may be more prone to use of external mechanisms (e.g., analgesic medications) for pain relief. A pain adaptive individual is likely to benefit from all forms of conservative active or passive pain modulatory treatments and is expected to have a favorable prognosis. Although this finding is useful, ice bath immersion is an impractical assessment for clinical practice, leaving clinicians with the inability to identify pain adaptive individuals.
Emerging evidence indicates that an associative clinical response associated with an early within session (during the first visit) and between session (from the first to the second visit) during a posterior to anterior mobilization, identifies individuals who have a favorable prognosis with spinal pain. While neurophysiological basis for the analgesic effect of manual therapy has been proposed to date no one has investigated if the associative clinical response is purely another way of identifying pain adaptive or non-pain adaptive individuals. If a within-session or between-session response is associated with the pain adaptive mechanism found during an ice-bath immersion, clinicians could adopt the clinical evaluation technique and improve their ability to identify proper patients for management. The investigators will evaluate the relationship between the pain adaptive mechanistic response from ice-bath immersion and the associative clinical response that occurs during a PA mobilization of the spine.
|Condition or disease||Intervention/treatment|
|Musculoskeletal Manipulations Low Back Pain||Other: Pragmatic Mobilization|
|Study Type :||Observational|
|Estimated Enrollment :||32 participants|
|Official Title:||Applying Pain Adaptability to Manual Therapy Practice|
|Estimated Study Start Date :||February 15, 2022|
|Estimated Primary Completion Date :||December 17, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Low Back Pain
Pragmatic Mobilization The pragmatically applied non-thrust manipulation will be based on the original concepts outlined by Maitland and will of consist of passive, low velocity, oscillatory movements within the physiological range of the joint, applied to the comparable spinal level of the patient (defined as the spinal level that reproduced the patient's familiar pain). The techniques will be modified based on clinician assessment and patient feedback and consist of Grade I through Grade IV movements. Since the pragmatic approach is clinician-driven, no time limit will be placed on the application and the number of mobilizations used will depend on the patient feedback (the exact definition of a pragmatic treatment)
Other: Pragmatic Mobilization
The techniques will of consist of passive, low velocity, oscillatory movements within the physiological range of the joint, applied to the comparable spinal level of the patient (defined as the spinal level that reproduced the patient's familiar pain). The techniques will be modified based on clinician assessment and patient feedback and consist of Grade I through Grade IV movements. Common techniques used may include unilateral posterior-anterior movements, central posterior-anterior movements, and sidelying rotations (without thrust). Since the pragmatic approach is clinician-driven, no time limit will be placed on the application and the number of mobilizations used will depend on the patient feedback (the exact definition of a pragmatic treatment). Patients will be seen for 4 visits.
Other Name: Non-thrust manipulation (pragmatically applied)
- Numeric Pain Rating Scale [ Time Frame: collected at baseline and continuously during 5 minute cold pressor test: 2-week follow up via phone call, text message, email, or virtual meeting ]Numeric Pain Rating Scale is a self-reported pain scale which has demonstrated validity and reliability in dealing with multiple pain complaints including chronic spine pain. The scale ranges from 0 to 10 with 0 indicating no perceived pain and 10 indicating maximum perceived pain possible. Aminimally clinically importance difference (MCID) of 1 to 1.7 points or 30% improvement has been suggested.
- Global Rating of Change [ Time Frame: collected at 2-week follow up via phone call, text message, email, or virtual meeting ]The Global Rating of Change scale is a self-reported scale ranging from -7 (a very great deal worse) to +7 (a very great deal better) with a score of 0 indicating no change from baseline. This scale has demonstrated reliability and validity in assessment of self-reported improvement in the physical therapy profession. Psychometric assessments of this tool have been somewhat limited as it is often utilized as the criterion measure in the assessment of other instruments. A MCID of 2-2.5 points has been suggested.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05209659
|Contact: Damian L Keter, DPT, PhD(c)||216-791-3800 ext email@example.com|
|Contact: Kenneth Learman, PhDfirstname.lastname@example.org|
|United States, Michigan|
|The Therapy Institute|
|Haslett, Michigan, United States, 48840|
|Contact: Stephen Houghton 517-339-4050 email@example.com|
|United States, New Jersey|
|Old Bridge Spine and Wellness|
|Old Bridge, New Jersey, United States, 08857|
|Contact: Michael Zolotnitsky, DPT 732-757-5430 Michael.Zolotnisky@spineandwellness.com|
|United States, Ohio|
|Tri County Physical Therapy Institute|
|Canfield, Ohio, United States, 44406|
|Contact: David Griswold, PhD 330-533-1080 DWGriswold@ysu.edu|
|Sub-Investigator: David Griswold, PhD|
|Study Chair:||Kenneth Learman, PhD||Professor, Department of Graduate Studies in Health and Rehabilitation Sciences, Youngstown State University, Youngstown, Ohio|
|Study Director:||Severine Van Slambrouck, PhD||IRB Director, Youngstown State University, Youngstown, Ohio|
|Principal Investigator:||Damian L Keter||Student, Youngstown State University|