Applying Pain Adaptability to Manual Therapy Practice

NCT05209659 | Unknown

• 1 other identifier: 290
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Musculoskeletal Manipulations; Low Back Pain

Keywords

Pan Adaptability

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Rating Scale

  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.

  collected at baseline and continuously during 5 minute cold pressor test: 2-week follow up via phone call, text message, email, or virtual meeting

• Global Rating of Change

  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.

  collected at 2-week follow up via phone call, text message, email, or virtual meeting

Study Arms (1)

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

Interventions

Pragmatic Mobilization OTHER

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)

Also known as: Mobilization, Mobilisation

Low Back Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals whom fit inclusion/exclusion criteria will be recruited from outpatient orthopedic clinics via convenience sample as well as recruited from university and community sites across a geographically diverse segment of the United States.

You may qualify if:

• History of lumbar spine pain in the past 12 months
• Ability to reproduce low back discomfort with PA mobilization

You may not qualify if:

• 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.

Sponsors & Collaborators

• Youngstown State University: lead

Study Sites (3)

The Therapy Institute

Haslett, Michigan, 48840, United States

RECRUITING

Old Bridge Spine and Wellness

Old Bridge, New Jersey, 08857, United States

RECRUITING

Tri County Physical Therapy Institute

Canfield, Ohio, 44406, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Learman, PhD

  Professor, Department of Graduate Studies in Health and Rehabilitation Sciences, Youngstown State University, Youngstown, Ohio

  STUDY CHAIR

• Severine Van Slambrouck, PhD

  IRB Director, Youngstown State University, Youngstown, Ohio

  STUDY DIRECTOR

• Damian L Keter

  Student, Youngstown State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damian L Keter, DPT, PhD(c)

CONTACT

216-791-3800; dlketer@student.ysu.edu

Kenneth Learman, PhD

CONTACT

330-941-7125; klearman@ysu.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principial Investigator, PhD Candidate

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 26, 2022
• Study Start: February 15, 2022
• Primary Completion: December 17, 2022
• Study Completion: December 31, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

US (3)