Prescriptive Mobilization Versus a Pragmatic Mobilization

Walsh University

Status: Unknown

Conditions: Mechanical Low Back Pain

Treatments: Procedure: Pragmatic Mobilization; Procedure: Prescriptive Mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT01940744

Walsh992013

Details and patient eligibility

About

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.

Full description

This randomized clinical trial is designed to compare the outcomes of a prescriptively applied non-thrust manipulation to a pragmatically applied non-thrust manipulation on subjects with mechanical low back pain. The study has two primary aims. Specific Aim 1 examines immediate effect differences between a pragmatically applied localized non-thrust manipulation versus a prescriptively applied, non-localized non-thrust manipulation in subjects with mechanical low back pain. Specific Aim 2 examines longer-term differences between a pragmatically applied localized non-thrust manipulation versus a prescriptively applied, non-localized non-thrust manipulation in subjects with mechanical low back pain. The investigators hypothesize there will be no differences between the two applied treatment techniques in immediate and longer-term assessments.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• The presence of any red flags (i.e., tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy. Lastly, if patients are enrolled in the study but do not receive a second outcome measure (follow up visit) they will be excluded from the final analyses.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Prescriptive Mobilization

Experimental group

Description:

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.

Treatment:

Procedure: Prescriptive Mobilization

Pragmatic Mobilization

Active Comparator group

Description:

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.

Treatment:

Procedure: Pragmatic Mobilization