- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02757378
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
Status
Completed
Conditions
Intervention / Treatment
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.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
-
Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on Neuroplasticity Explanation (Experimental)
-
University of RochesterAmerican Orthopaedic Foot and Ankle SocietyCompleted
-
Valduce HospitalCompleted
-
Milton S. Hershey Medical CenterCompletedPatient Education
-
Partners in Internal MedicineCompleted
-
London North West Healthcare NHS TrustCompletedFistula in Ano | Ano FistulaUnited Kingdom
-
St. Ambrose UniversityCompletedLow Back Pain | Education | Manual TherapyUnited States
-
Vanderbilt University Medical CenterUniversity of UtahRecruitingChemotherapy-Related Cognitive Impairment | Chemo-brainUnited States
-
University of Texas at AustinCompleted
-
Institute of Gastroenterology and Advance EndoscopyNot yet recruitingColonic Polyp | Colonic Neoplasms | Colonic Adenoma | Colonic DiseaseArgentina
-
Vanderbilt University Medical CenterRecruiting