Regional Manual Therapy and Motor Control Exercise for Chronic Low Back Pain

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170753
• Other study ID #: STU 042014-066
• Status: Completed
• Phase: N/A
• First received: June 18, 2014
• Last updated: June 24, 2016
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Musculoskeletal Pain

Intervention

Procedure:
• Regional manual therapy
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.
• Standard physical therapy
The control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy.

Locations

Country	Name	City	State
United States	Health Professions Physical Therapy Clinic	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Texas Physical Therapy Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment	No
Secondary	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.	Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment	No
Secondary	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.	Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment	No
Secondary	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).	Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment	No
Secondary	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.	2 weeks, 4 weeks, and 12 weeks after beginning treatment	No