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

April 22, 2019 updated by: Kevin Farrell, St. Ambrose University

A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain: a Randomized Control Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Kevin Farrell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to initial treatment
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.
Change from initial treatment to 2-4 days
Lumbar flexion
Time Frame: Change from baseline to initial treatment
Active trunk forward flexion in cm (distance finger tips to floor)
Change from baseline to initial treatment
Lumbar flexion
Time Frame: Change from initial treatment to 2-4 days
Active trunk forward flexion in cm (distance finger tips to floor)
Change from initial treatment to 2-4 days
Straight Leg Raise
Time Frame: Change from baseline to initial treatment
Neurodynamic Measurement of Leg Raise (lower limb tension test)
Change from baseline to initial treatment
Straight Leg Raise
Time Frame: Change from initial treatment to 2-4 days
Neurodynamic Measurement of Leg Raise (lower limb tension test)
Change from initial treatment to 2-4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Ambrose University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ACTUAL)

December 30, 2018

Study Completion (ACTUAL)

December 30, 2018

Study Registration Dates

First Submitted

November 26, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (ACTUAL)

November 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StAmbroseUactive passive

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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