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

NCT02170753 | Completed DMC

• 1 other identifier: STU 042014-066
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in Thoracolumbar spine range of motion

  Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment

• Change in Hip range of motion

  Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment

• Change in Pain intensity

  Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment

• Change in Perceived change

  2 weeks, 4 weeks, and 12 weeks after beginning treatment

Study Arms (2)

Regional manual therapy

EXPERIMENTAL

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

Procedure: Regional manual therapy; Procedure: Standard physical therapy

Standard physical therapy

ACTIVE COMPARATOR

The control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy.

Procedure: Standard physical therapy

Interventions

Regional manual therapy PROCEDURE

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.

Regional manual therapy

Standard physical therapy PROCEDURE

The control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy.

Regional manual therapy; Standard physical therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Texas Physical Therapy Association: collaborator

Study Sites (1)

Health Professions Physical Therapy Clinic

Dallas, Texas, 75390-8876, United States

Location

MeSH Terms

Conditions

Low Back Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Jason A Zafereo, MPT

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 27, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)