Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Applying Pain Adaptability to Manual Therapy Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05209659
Recruitment Status : Not yet recruiting
First Posted : January 26, 2022
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Damian Keter, Youngstown State University

Brief Summary:

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

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort Intervention/treatment
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)

Other Names:
  • Mobilization
  • Mobilisation




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A convenience sample of individuals whom fit inclusion/exclusion criteria will be recruited from outpatient orthopedic clinics and university sites across a geographically diverse segment of the United States.
Criteria

Inclusion Criteria:

  • Presenting with lumbar spine pain
  • >/= 3/10 as reported on NPRS
  • Reported disability of >/= 10 points on the modified Oswestry Disability Index (ODI).

Exclusion Criteria:

  • Demonstration of any signs of upper motor neuron lesion including unexplained loss of function of bowel/bladder, unexplained gait changes, pathologic hyper-reflexia.
  • Diagnosis which contradicts the application of prolonged cold including but not limited to severe vascular disease, open wounds/sores on involved extremity.
  • Diagnosis which contradicts the application of joint mobilizations including but not limited to instability, inflammatory conditions, severe osteoporosis.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Damian L Keter, DPT, PhD(c) 216-791-3800 ext 61113 dlketer@student.ysu.edu
Contact: Kenneth Learman, PhD 330-941-7125 klearman@ysu.edu

Locations
Layout table for location information
United States, Michigan
The Therapy Institute
Haslett, Michigan, United States, 48840
Contact: Stephen Houghton    517-339-4050    houghton.sm@gmail.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         
Sponsors and Collaborators
Youngstown State University
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Damian Keter, Principial Investigator, PhD Candidate, Youngstown State University
ClinicalTrials.gov Identifier: NCT05209659    
Other Study ID Numbers: 290
First Posted: January 26, 2022    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Damian Keter, Youngstown State University:
Pan Adaptability
Additional relevant MeSH terms:
Layout table for MeSH terms
Low Back Pain
Back Pain
Pain
Neurologic Manifestations