Clinical trial NCT02170753: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Musculoskeletal Pain
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Texas Physical Therapy Association
First posted: 2014-06-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Disability level
timeFrame: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Secondary outcomes:
measure: Change in Thoracolumbar spine range of motion
timeFrame: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
measure: Change in Hip range of motion
timeFrame: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
measure: Change in Pain intensity
timeFrame: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
measure: Change in Perceived change
timeFrame: 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Health Professions Physical Therapy Clinic
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Jason A Zafereo, MPT
role: PRINCIPAL_INVESTIGATOR
References: