Recruiting

Manual Therapy

Sponsor:

Youngstown State University

Code:

NCT05209659

Conditions

Musculoskeletal Manipulations

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pragmatic Mobilization

Study Details

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

Study ID

NCT05209659

Start date

Feb 15, 2022

Status verified date

Sep, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 17, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

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.

Study Design

Enrollment

32 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Interventions

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)

Primary outcome measure

  • 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 ]
  • Global Rating of Change [ Time Frame: collected at 2-week follow up via phone call, text message, email, or virtual meeting ]

Central Contacts and Locations

Central contacts

Damian L Keter, DPT, PhD(c)

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

Kenneth Learman, PhD

330-941-7125klearman@ysu.edu

Locations

The Therapy Institute

Recruiting

Haslett, Michigan, United States, 48840

Contacts

Old Bridge Spine and Wellness

Recruiting

Old Bridge, New Jersey, United States, 08857

Contacts

Tri County Physical Therapy Institute

Recruiting

Canfield, Ohio, United States, 44406

Contacts

More Information

Sponsor

Youngstown State University

Last update posted

Sep 29, 2022

Last verified

Sep, 2022

Keywords

  • Pan Adaptability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Youngstown State University on 2022-09-29.