Recruiting

Prescriptive & Pragmatic

Sponsor:

Walsh University

Code:

NCT01940744

Conditions

Mechanical Low Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prescriptive Mobilization

Pragmatic Mobilization

Study Details

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

Study ID

NCT01940744

Start date

Oct, 2013

Status verified date

Nov, 2013

Completion date

Dec, 2014

Anticipated

Primary completion date

Oct, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prescriptive Mobilization

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.

active comparator: 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). Patients will be seen for 4 visits.

Interventions

Prescriptive Mobilization

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.

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.

Primary outcome measure

  • Modified Oswestry Disability Index [ Time Frame: Multiple points, up to 6 months ]

Central Contacts and Locations

Locations

Walsh University

Recruiting

North Canton, Ohio, United States, 44720

Contacts

Chad E Cook, PhD, PT

330-490-7370ccook@walsh.edu

Principal Investigator:

Chad E Cook, PhD, PT

More Information

Sponsor

Walsh University

Last update posted

Nov 13, 2013

Last verified

Nov, 2013

Keywords

  • Low back pain
  • Non-specific Low back pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walsh University on 2013-11-13.