Manual Therapy as a Form of Sensory Discrimination in Chronic Low Back Pain

April 27, 2016 updated by: Kevin Farrell

A Randomized Controlled Trial of Manual Therapy as a Form of Sensory Discrimination in Chronic Low Back Pain

This study evaluates whether different explanations given to patients with long lasting back pain influence a physical therapy treatment technique. Half of the patients will receive an explanation of the proposed treatment technique focusing on how their joints are moving and not moving. The second half of the group will receive the same treatment technique as the first group, but their explanation of the technique's purpose will focus on how their brain interprets the information. The study aims to determine if patients have a different response to the treatment based on the words chosen to explain the technique.

Study Overview

Detailed Description

Traditional treatment provided by physical therapists to patients with chronic low back pain focuses on the biomechanical or anatomical impact to local tissues. Recent research has shown that treatment effects may be more related to the understanding of the structural and functional changes in the brain of someone suffering from chronic low back pain. This research implicates that the patients understanding and interpretation of input to the brain may change the patient's perceived representation and interpretation of output of pain within the brain.

Study Type

Interventional

Enrollment (Actual)

62

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

    • Illinois
      • Moline, Illinois, United States, 61265
        • Rock Valley Physical Therapy
      • Silvis, Illinois, United States, 61282-4700
        • Rock Valley Physical Therapy
      • Woodridge, Illinois, United States, 60517
        • Edward Health & Fitness Center & Spa at Seven Bridges
    • Iowa
      • Davenport, Iowa, United States, 52806
        • Rock Valley Physical Therapy
      • Davenport, Iowa, United States, 52807
        • Genesis Physical Therapy and Sports Medicine

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults over the age of 18
  • Presenting at Physical Therapy with a primary complaint of Low Back Pain
  • Low Back Pain being present for 6 months or more
  • Fluent in English and willing to participate in the study.

Exclusion Criteria:

  • 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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuroplasticity Education Group
Patients who receive manual physical therapy treatment with a neuroplasticity explanation of the basis for the technique
Patients were given an explanation of how the brain uses the information from a manual therapy technique to help it remain sharp in identifying where this input is coming from.
Active Comparator: Biomechanical Education Group
Patients who receive manual physical therapy treatment with a traditional, biomechanical explanation of the basis for the technique
Patients were given an explanation of how the manual therapy technique affects the anatomy and physiology of the back.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low back pain rating change
Time Frame: Within a single, one hour session
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of the patient's pain in low back on a numeric pain rating scale of 0 to 10
Within a single, one hour session
Leg pain rating
Time Frame: Within a single, one hour session
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement, level of patient's leg pain on a numeric pain rating scale of 0 to 10.
Within a single, one hour session
Active trunk forward flexion
Time Frame: Within a single, one hour session
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of distance from longest finger to the floor when patient bends forward (in cm).
Within a single, one hour session
Straight Leg Raise
Time Frame: Within a single, one hour session
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of angle to which the patient's most affected leg can be lifted (measured in degrees using an inclinometer).
Within a single, one hour session

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Adriaan Louw, PT, PhD, International Spine Pain Institute

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

May 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StAmbroseU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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