Prescriptive Mobilization Versus a Pragmatic Mobilization

NCT01940744 | Unknown

• 1 other identifier: Walsh992013
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

This study is designed to compare the outcomes of two types of manual therapy techniques on patients with low back pain. Both immediate- and long-term outcomes will be examined. The investigators hypothesize there will be no differences between the two applied treatment techniques in immediate and longer-term assessments.

Conditions

Mechanical Low Back Pain

Keywords

Low back pain; Non-specific Low back pain

Outcome Measures

Primary Outcomes (1)

• Modified Oswestry Disability Index

  The Modified Oswestry Disability Index (ODI) will be used to measure disability, will serve as the primary outcome measure for the study, and consists of 10 questions each scored from 0 to 5, with higher scores indicating greater disability. A 50% reduction in the ODI or greater from baseline has been considered a clinically important outcome

  Multiple points, up to 6 months

Secondary Outcomes (3)

• The Patient Acceptable Symptom State (PASS)

  Multiple points up to 6 months

• Numeric Pain Rating Scale

  Multiple points up to 6 months

• Global Rating of Change (GRoC)

  Multiple points up to 6 months

Study Arms (2)

Prescriptive Mobilization

EXPERIMENTAL

The prescriptively applied non-thrust manipulation will be involve a central lumbar posterior-anterior directed at L4 and L5. "The therapist will place the hypothenar eminence of 1 hand over the spinous process of L4. With the elbows remaining extended, the therapist will deliver a low-velocity, high amplitude oscillatory force (at approximately 2 Hz) directed at L4 for a total 60 seconds (Figure 1)". Following a 30-second rest the therapist will perform a similar set of oscillations directed at L5. A second set of oscillations will then be performed in a similar manner at L4 and L5. Patients will be seen for 4 visits.

Procedure: Prescriptive Mobilization

Pragmatic Mobilization

ACTIVE COMPARATOR

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). Patients will be seen for 4 visits.

Procedure: Pragmatic Mobilization

Interventions

Prescriptive Mobilization PROCEDURE

The therapist will place the hypothenar eminence of 1 hand over the spinous process of L4. With the elbows remaining extended, the therapist will deliver a low-velocity, high amplitude oscillatory force (at approximately 2 Hz) directed at L4 for a total 60 seconds (Figure 1)". Following a 30-second rest the therapist will perform a similar set of oscillations directed at L5. A second set of oscillations will then be performed in a similar manner at L4 and L5. Although not described in the original article, we'll target Grade III mobilizations. The procedure will be completed during a session after 2 sets of 60 seconds of non-thrust oscillatory manipulations will be performed over L4 and L5." Patients will be seen for 4 visits.

Also known as: Non-thrust manipulation

Prescriptive Mobilization

Pragmatic Mobilization PROCEDURE

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.

Also known as: Non-thrust manipulation (pragmatically applied)

Pragmatic Mobilization

Eligibility Criteria

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

You may qualify if:

• Patients will need to be 18 years of age or older with mechanically producible LBP. They will require a minimum Modified Oswestry Disability Index score of 20% and a baseline pain score of \>2.0/10 on the numeric analog scale for pain, and a within session change (improvement during the visit) in pain and/or range of motion during the assessment phase of the clinical examination.

Sponsors & Collaborators

• Walsh University: lead
• Des Moines University: collaborator
• Youngstown State University: collaborator

Study Sites (3)

Des Moines University

Des Moines, Iowa, 50312, United States

NOT YET RECRUITING

Walsh University

North Canton, Ohio, 44720, United States

RECRUITING

Youngstown State University

Youngstown, Ohio, 44555, United States

NOT YET RECRUITING

Related Publications (1)

• Donaldson M, Petersen S, Cook C, Learman K. A Prescriptively Selected Nonthrust Manipulation Versus a Therapist-Selected Nonthrust Manipulation for Treatment of Individuals With Low Back Pain: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Apr;46(4):243-50. doi: 10.2519/jospt.2016.6318. Epub 2016 Mar 8.

  PMID: 26954273 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Chad Cook, PhD, PT

  Walsh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

US (3)