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A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain

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ClinicalTrials.gov Identifier: NCT03758807
Recruitment Status : Completed
First Posted : November 29, 2018
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin Farrell, St. Ambrose University

Brief Summary:
To determine if there is any carry over difference between the type of education provided about common treatment techniques for patients with low back pain. This will be looked at right after treatment and when patients return on their second visit after they do a common exercise program for a few days.

Condition or disease Intervention/treatment Phase
Low Back Pain Manual Therapy Education Other: Manual Therapy with Traditional Biomechanical Explanation Other: Manual Therapy with Neuroplastiicity Explanation Not Applicable

Detailed Description:
Prior clinical trials have shown that patients respond differently to different explanations about interventions performed. A recent randomized clinical trial demonstrated that a 10-minute manual therapy treatment (prone lumbar Posterior to Anterior mobilization (PA's) with a neuroplasticity vs. traditional biomechanical explanation) produced an immediate, significant improvement in straight leg raise (SLR) and pain for patients with chronic low back pain. However, there is a need to examine whether there is any carry over (48-96 hours) or if utilizing a home exercise program (HEP), aimed at increasing the various sensory process applied in the clinic, produces any carry over. This will be looked at in patients with who are provided different explanations about common back treatment techniques to see if there will be any change in pain rating or back and leg movement.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Control Trial
Masking: Single (Participant)
Masking Description: Patients were randomly assigned to one of two treatment groups
Primary Purpose: Treatment
Official Title: A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain: a Randomized Control Trial
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Sham Comparator: Passive treatment
Passive treatment will consist of Manual Therapy with biomechanical explanation of the technique.
Other: Manual Therapy with Traditional Biomechanical Explanation
Patients will lie prone and receive lumbar Posterior to Anterior (AP) Pressure with a traditional biomechanical or anatomic explanation of the technique..

Experimental: Active Treatment
Active treatment will consist of Manual Therapy with a neuroplasticity explanation of the technique.
Other: Manual Therapy with Neuroplastiicity Explanation
Patients will lie prone and receive lumbar Posterior to Anterior (PA) Pressure with a neuroplastic explanation of the technique.




Primary Outcome Measures :
  1. Low Back Pain Rating [ Time Frame: Change from baseline to initial treatment ]

    Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.

    LBP is reported to be 2.0.


  2. Low Back Pain Rating [ Time Frame: Change from initial treatment to 2-4 days ]
    Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.

  3. Lumbar flexion [ Time Frame: Change from baseline to initial treatment ]
    Active trunk forward flexion in cm (distance finger tips to floor)

  4. Lumbar flexion [ Time Frame: Change from initial treatment to 2-4 days ]
    Active trunk forward flexion in cm (distance finger tips to floor)

  5. Straight Leg Raise [ Time Frame: Change from baseline to initial treatment ]
    Neurodynamic Measurement of Leg Raise (lower limb tension test)

  6. Straight Leg Raise [ Time Frame: Change from initial treatment to 2-4 days ]
    Neurodynamic Measurement of Leg Raise (lower limb tension test)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults over the age of 18
  • patients presenting at PT with a primary complaint of LBP
  • LBP being present for 6 months or more
  • fluent in English
  • willing to participate in the study.

Exclusion Criteria:

  • under age 18
  • not able to read/understand the English language
  • prisoners
  • no medical issues precluding physical therapy treatment (red flags)
  • no medical precautions to the use of manual therapy (metal, skin lesions, etc.)
  • prior spine surgery
  • unable to lay prone for the treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758807


Locations
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United States, Iowa
Kevin Farrell
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
St. Ambrose University
Investigators
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Principal Investigator: Kevin Farrell St. Ambrose University

Publications of Results:
Louw A, Farrell K, Wettach L, Uhl J, Majkowski K, Wedling M. Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy. 2015;43(2):58-63.

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Responsible Party: Kevin Farrell, Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy, St. Ambrose University
ClinicalTrials.gov Identifier: NCT03758807     History of Changes
Other Study ID Numbers: StAmbroseUactive passive
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kevin Farrell, St. Ambrose University:
Low back pain
Manual Therapy
Education
Neuroplasticiy

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms