NCT03758807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

April 23, 2019

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

November 26, 2018

Last Update Submit

April 22, 2019

Conditions

Low Back PainManual TherapyEducation

Keywords

Low back painManual TherapyEducationNeuroplasticiy

Outcome Measures

Primary Outcomes (6)

  • Low Back Pain Rating

    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

    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

    Active trunk forward flexion in cm (distance finger tips to floor)

    Change from baseline to initial treatment

  • Lumbar flexion

    Active trunk forward flexion in cm (distance finger tips to floor)

    Change from initial treatment to 2-4 days

  • Straight Leg Raise

    Neurodynamic Measurement of Leg Raise (lower limb tension test)

    Change from baseline to initial treatment

  • Straight Leg Raise

    Neurodynamic Measurement of Leg Raise (lower limb tension test)

    Change from initial treatment to 2-4 days

Study Arms (2)

Passive treatment

SHAM COMPARATOR

Passive treatment will consist of Manual Therapy with biomechanical explanation of the technique.

Other: Manual Therapy with Traditional Biomechanical Explanation

Active Treatment

EXPERIMENTAL

Active treatment will consist of Manual Therapy with a neuroplasticity explanation of the technique.

Other: Manual Therapy with Neuroplastiicity Explanation

Interventions

Manual Therapy with Traditional Biomechanical ExplanationOTHER

Patients will lie prone and receive lumbar Posterior to Anterior (AP) Pressure with a traditional biomechanical or anatomic explanation of the technique..

Passive treatment
Manual Therapy with Neuroplastiicity ExplanationOTHER

Patients will lie prone and receive lumbar Posterior to Anterior (PA) Pressure with a neuroplastic explanation of the technique.

Active Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kevin Farrell

Davenport, Iowa, 52803, United States

Location

Related Publications (2)

  • 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.

    RESULT

  • Louw A, Farrell K, Landers M, Barclay M, Goodman E, Gillund J, McCaffrey S, Timmerman L. The effect of manual therapy and neuroplasticity education on chronic low back pain: a randomized clinical trial. J Man Manip Ther. 2017 Dec;25(5):227-234. doi: 10.1080/10669817.2016.1231860. Epub 2016 Sep 22.

    PMID: 29449764RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Kevin Farrell

    St. Ambrose University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients were randomly assigned to one of two treatment groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 29, 2018

Study Start

June 1, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

April 23, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)