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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757378
• Other study ID #: StAmbroseU
• Status: Completed
• Phase: N/A
• First received: April 12, 2016
• Last updated: April 27, 2016
• Start date: May 2015
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: St. Ambrose University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• Neuroplasticity Explanation (Experimental)
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.
• Biomechanical Explanation (Control)
Patients were given an explanation of how the manual therapy technique affects the anatomy and physiology of the back.

Locations

Country	Name	City	State
United States	Genesis Physical Therapy and Sports Medicine	Davenport	Iowa
United States	Rock Valley Physical Therapy	Davenport	Iowa
United States	Rock Valley Physical Therapy	Moline	Illinois
United States	Rock Valley Physical Therapy	Silvis	Illinois
United States	Edward Health & Fitness Center & Spa at Seven Bridges	Woodridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Kevin Farrell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No