Regional Manual Therapy and Motor Control Exercise for Chronic Low Back Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Back Pain, Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/2/2016 |
| Start Date: | June 2014 |
| End Date: | May 2017 |
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
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.
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.
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.
(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.
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
We found this trial at
1
site
Dallas, Texas 75390
Principal Investigator: Jason Zafereo, PT, MPT
Phone: 214-648-1002
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