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

NCT02757378 | Completed

• 1 other identifier: StAmbroseU
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Pain; Brain; Plasticity; Education; Manual Therapy; Straight Leg Raise; Remapping

Outcome Measures

Primary Outcomes (4)

• Low back pain rating change

  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

  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

  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

  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

Study Arms (2)

Neuroplasticity Education Group

EXPERIMENTAL

Patients who receive manual physical therapy treatment with a neuroplasticity explanation of the basis for the technique

Procedure: Neuroplasticity Explanation (Experimental)

Biomechanical Education Group

ACTIVE COMPARATOR

Patients who receive manual physical therapy treatment with a traditional, biomechanical explanation of the basis for the technique

Procedure: Biomechanical Explanation (Control)

Interventions

Neuroplasticity Explanation (Experimental) PROCEDURE

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.

Neuroplasticity Education Group

Biomechanical Explanation (Control) PROCEDURE

Patients were given an explanation of how the manual therapy technique affects the anatomy and physiology of the back.

Biomechanical Education Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Medical precautions to the use of manual therapy (metal, skin lesions, etc.)
• Prior spine surgery
• Unable to lay prone for the treatment.

Sponsors & Collaborators

• Kevin Farrell: lead

Study Sites (5)

Rock Valley Physical Therapy

Moline, Illinois, 61265, United States

Location

Rock Valley Physical Therapy

Silvis, Illinois, 61282-4700, United States

Location

Edward Health & Fitness Center & Spa at Seven Bridges

Woodridge, Illinois, 60517, United States

Location

Rock Valley Physical Therapy

Davenport, Iowa, 52806, United States

Location

Genesis Physical Therapy and Sports Medicine

Davenport, Iowa, 52807, United States

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adriaan Louw, PT, PhD

  International Spine Pain Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chair, Clinical Residency Program in Orthopaedic Physical Therapy

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: May 2, 2016
• Study Start: May 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 2, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)