Regional Manual Therapy and Motor Control Exercise for Chronic Low Back Pain
Primary Purpose
Low Back Pain, Musculoskeletal Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regional manual therapy
Standard physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- between the ages of 18 and 65
- have an active complaint of non-specific low back pain for at least three months
- demonstrate hypomobility of the thoracic or lumbar regions on at least one spinal level
- demonstrate at least two of the following unilateral or bilateral hip ROM deficits: hip flexion < 110°, hip extension loss > 6°, or hip rotation < 30° internally or externally
- demonstrate any one of the following: pain that worsens with sustained end- range movements or positions, lumbar hypermobility, diminished trunk or pelvic muscle strength and endurance, or movement coordination impairments during community/work activities
- Modified Oswestry Score ≥ 30%
Exclusion Criteria:
- evidence of red flags, including fracture, infection, spinal tumor, or cauda equina syndrome
- pain that can be centralized through repeated movements
- signs of hyporeflexia, hypoesthesia, and myotomal weakness indicative of nerve root compression
- pregnancy
- systemic inflammatory conditions such as rheumatoid arthritis or ankylosing spondylitis
- inability to safely tolerate manual therapy to the spine or hips
- injections to the low back within the 2 weeks preceding the initial evaluation
Sites / Locations
- Health Professions Physical Therapy Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Regional manual therapy
Standard physical therapy
Arm Description
The experimental group will receive regional thoracic, pelvic, and hip manual therapy and a standard physical therapy approach including motor control exercise and local lumbar spine manual therapy
The control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy.
Outcomes
Primary Outcome Measures
Change in Disability level
A subjective report of the participant's average level of perceived disability with functional tasks due to LBP as measured by the Modified Oswestry Low Back Pain Disability Questionnaire (ODQ).
Secondary Outcome Measures
Change in Thoracolumbar spine range of motion
Testing for this study will be performed using the Valedo Shape, which is a wheeled skin-surface device containing accelerometers that record inter-segmental distance and change of inclination of spinous processes.
Change in Hip range of motion
An inclinometer will be used to measure hip range of motion in the sagittal and transverse planes as measured in degrees.
Change in Pain intensity
A subjective report of the participant's average low back pain intensity over the previous 24 hours as measured by the Numeric Pain Rating Scale (NPRS).
Change in Perceived change
A subjective report of the participant's perceived level of improvement from the point that they began treatment as measured by the Global Rating of Change (GROC) scale.
Full Information
NCT ID
NCT02170753
First Posted
June 18, 2014
Last Updated
June 24, 2016
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Texas Physical Therapy Association
1. Study Identification
Unique Protocol Identification Number
NCT02170753
Brief Title
Regional Manual Therapy and Motor Control Exercise for Chronic Low Back Pain
Official Title
Regional Manual Therapy and Motor Control Exercise for the Management of Chronic Low Back Pain With Hip and Spine Motion Loss: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Texas Physical Therapy Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Purpose: The primary purpose of this study is to determine whether or not the addition of thoracic, pelvic, and hip manual therapy to a standard physical therapy (PT) approach consisting of motor control exercises and lumbar spine manual therapy is better than standard PT alone at improving thoracolumbar spine range of motion (ROM), hip ROM, pain intensity, disability level, and perceived change in patients with chronic low back pain (CLBP) and movement coordination impairments.
Hypothesis: In a CLBP subgroup with movement coordination impairments, participants receiving thoracic, pelvic, and hip manual therapy with standard PT will be superior to participants receiving standard PT alone at improving thoracolumbar spine ROM, hip ROM, pain intensity, physical disability level, and perceived change at two, four, and 12 weeks after initiating treatment.
Detailed Description
This study will use a 2x4 factorial mixed design with a between-factor independent variable (IV) of group and a within-factor IV of time. The dependent variables include hip ROM, segmental mobility of the thoracolumbar spine, pain, disability level, and patients' perceived rating of change (GROC). Hip ROM and spinal mobility variables will be measured by the researchers, while pain, disability level, and GROC score will be measured by self-reported questionnaires.
The experimental group will receive a motor control exercise program and manual therapy to the hips and spine corresponding to the individual's unique mobility impairments. The comparison group will receive a motor control exercise program and manual therapy to the lumbar spine only. Both groups will receive treatments at an outpatient clinic 2 times a week for 4 weeks. All outcome measures will be collected at baseline (except the GROC), and then at two weeks, four weeks, and twelve weeks after beginning treatment.
All study participants will receive a motor control exercise program consistent with standard of care. Exercises will be targeted to the abdominals, hip flexors, back extensors, hip extensors, hip flexors, hip abductors, and hip adductors, but will begin with those muscles that test weakest in the clinical exam. Generally, exercises for each subject begin with isolated isometric contractions to ensure adequate motor control, and progress through various degrees of agonist loading with co-contraction of synergists using isotonic open or closed chain movements. Instructions to gradually increase time under tension to a maximum of 30 seconds for four repetitions will be used in order to provide an element of graded-activity exposure and to reflect the tonic nature of stabilizing muscles. Participants unable to complete all exercises by the end of the fourth week will be instructed on how to progress to the final exercises with their independent home exercise program.
In addition to a motor control exercise program, all participants will receive manual therapy to the lumbar spine. Standard PT manual therapy will be limited to non-thrust passive accessory (PA) mobilizations from L1-L5 or soft tissue mobilization to the lumbar paraspinals or quadratus lumborum. Only the participants in the experimental group will receive manual therapy to the hips and thoracic spine according to the mobility impairments identified during the initial testing session. The manual therapy interventions utilized at the hips and thoracic spine are considered standard of care for treatment of those regions, but could be considered experimental for treatment of low back pain. Regional manual therapy will include a variety of thrust and non-thrust techniques targeting the thoracic, lumbopelvic, or hip joints. Hip-based techniques including anterior-posterior hip mobilization, caudal thrust or non-thrust mobilization, and posterior-to-anterior mobilization will be performed. The choice of initiating or suspending a specific manual therapy technique and the grade of treatment will be left to the discretion of the treating therapist (other than the PI). Prior to the commencement of the study, all treating physical therapists will be trained in administration of standard motor control exercises and manual therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Musculoskeletal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regional manual therapy
Arm Type
Experimental
Arm Description
The experimental group will receive regional thoracic, pelvic, and hip manual therapy and a standard physical therapy approach including motor control exercise and local lumbar spine manual therapy
Arm Title
Standard physical therapy
Arm Type
Active Comparator
Arm Description
The control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy.
Intervention Type
Procedure
Intervention Name(s)
Regional manual therapy
Intervention Description
The experimental group will receive regional thoracic, pelvic, and hip manual therapy and a standard physical therapy approach including motor control exercise and local lumbar spine manual therapy.
Intervention Type
Procedure
Intervention Name(s)
Standard physical therapy
Intervention Description
The control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy.
Primary Outcome Measure Information:
Title
Change in Disability level
Description
A subjective report of the participant's average level of perceived disability with functional tasks due to LBP as measured by the Modified Oswestry Low Back Pain Disability Questionnaire (ODQ).
Time Frame
Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Secondary Outcome Measure Information:
Title
Change in Thoracolumbar spine range of motion
Description
Testing for this study will be performed using the Valedo Shape, which is a wheeled skin-surface device containing accelerometers that record inter-segmental distance and change of inclination of spinous processes.
Time Frame
Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Title
Change in Hip range of motion
Description
An inclinometer will be used to measure hip range of motion in the sagittal and transverse planes as measured in degrees.
Time Frame
Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Title
Change in Pain intensity
Description
A subjective report of the participant's average low back pain intensity over the previous 24 hours as measured by the Numeric Pain Rating Scale (NPRS).
Time Frame
Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Title
Change in Perceived change
Description
A subjective report of the participant's perceived level of improvement from the point that they began treatment as measured by the Global Rating of Change (GROC) scale.
Time Frame
2 weeks, 4 weeks, and 12 weeks after beginning treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between the ages of 18 and 65
have an active complaint of non-specific low back pain for at least three months
demonstrate hypomobility of the thoracic or lumbar regions on at least one spinal level
demonstrate at least two of the following unilateral or bilateral hip ROM deficits: hip flexion < 110°, hip extension loss > 6°, or hip rotation < 30° internally or externally
demonstrate any one of the following: pain that worsens with sustained end- range movements or positions, lumbar hypermobility, diminished trunk or pelvic muscle strength and endurance, or movement coordination impairments during community/work activities
Modified Oswestry Score ≥ 30%
Exclusion Criteria:
evidence of red flags, including fracture, infection, spinal tumor, or cauda equina syndrome
pain that can be centralized through repeated movements
signs of hyporeflexia, hypoesthesia, and myotomal weakness indicative of nerve root compression
pregnancy
systemic inflammatory conditions such as rheumatoid arthritis or ankylosing spondylitis
inability to safely tolerate manual therapy to the spine or hips
injections to the low back within the 2 weeks preceding the initial evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason A Zafereo, MPT
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Professions Physical Therapy Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8876
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Regional Manual Therapy and Motor Control Exercise for Chronic Low Back Pain
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