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

Sponsor

Kevin Farrell (Other)

Overall Status

Completed

CT.gov ID

NCT02757378

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

12.4

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Procedure: Neuroplasticity Explanation (Experimental) Procedure: Biomechanical Explanation (Control)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neuroplasticity Education Group Patients who receive manual physical therapy treatment with a neuroplasticity explanation of the basis for the technique	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.
Active Comparator: Biomechanical Education Group Patients who receive manual physical therapy treatment with a traditional, biomechanical explanation of the basis for the technique	Procedure: Biomechanical Explanation (Control) Patients were given an explanation of how the manual therapy technique affects the anatomy and physiology of the back.

Arm

Intervention/Treatment

Experimental: Neuroplasticity Education Group

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

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.

Active Comparator: Biomechanical Education Group

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

Procedure: Biomechanical Explanation (Control)

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

Outcome Measures

Primary Outcome Measures

Low back pain rating change [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
Leg pain rating [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.
Active trunk forward flexion [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).
Straight Leg Raise [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rock Valley Physical Therapy	Moline	Illinois	United States	61265
2	Rock Valley Physical Therapy	Silvis	Illinois	United States	61282-4700
3	Edward Health & Fitness Center & Spa at Seven Bridges	Woodridge	Illinois	United States	60517
4	Rock Valley Physical Therapy	Davenport	Iowa	United States	52806
5	Genesis Physical Therapy and Sports Medicine	Davenport	Iowa	United States	52807