A Comparison of Two Different Methods of Physical Therapy to Treat Acute and Subacute Low Back Pain

NCT02060617 | Completed

• 1 other identifier: 13-7
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Recent research has shown that classifying patients with low back pain into treatment subgroups results in better improvements than treating all patients with low back pain the same. However, physical therapists may use different types of information to determine how to classify their patients. One method uses patient characteristics that have been shown by research to predict good results from a certain type of treatment. Another method uses specific impairments that the physical therapist identifies in a clinical exam to determine which treatment to provide. It is not currently known if one of these methods is better than the other. The purpose of this study is to determine if research-based classification or impairment-based treatment is more effective for treating patients with low back pain that has lasted less than 90 days in terms of improvements in pain and disability. The results of this study may help reduce the high financial cost associated with low back pain.

Conditions

Low Back Pain

Keywords

low back pain; physical therapy; manual therapy; manipulation; exercise; motor control; regional interdependence

Outcome Measures

Primary Outcomes (1)

• Change in Modified Oswestry Disability Questionnaire (ODQ) score

  A measure of self-reported disability with scores ranging from 0% to 100% disability.

  Baseline, 4 weeks, 6 months

Secondary Outcomes (3)

• Change in Numeric Pain Rating Scale (NPRS) score

  Baseline, 4 weeks, 6 months

• Global Rating of Change (GRC)

  4 weeks, 6 months

• Overall Treatment Success

  4 weeks, 6 months

Other Outcomes (4)

• Total Number of Visits

  At discharge, which will be approximately 4 weeks

• Duration of Care

  At discharge, which will be approximately 4 weeks

• Number of adverse events from treatment

  up to 6 months

Study Arms (2)

Impairment-Based Group

EXPERIMENTAL

The impairment-based intervention will be a multi-modal treatment approach utilizing manual therapy of the thoracolumbosacral spine and hips as well as motor control exercises. Patient education will also be provided.

Behavioral: Patient Education; Procedure: Manual therapy of the thoracolumbosacral spine and hips; Procedure: Motor control exercises

Classification-Based Group

ACTIVE COMPARATOR

Patients in this group will be categorized into subgroups according to the Treatment-Based Classification (TBC) Algorithm and treated accordingly. Patient education will also be provided.

Behavioral: Patient Education; Procedure: Treatment-Based Classification intervention

Interventions

Patient Education BEHAVIORAL

All subjects will receive education that back pain is common but rarely harmful in nature, that pain does not necessarily mean that there is structural damage to their back, and that they should try to remain as active as they are able within the limits of their pain. In addition, individualized education regarding posture, body mechanics, sleeping positions, or other concerns of the patient will be provided on a pragmatic basis as deemed appropriate by the treating clinician.

Classification-Based Group; Impairment-Based Group

Manual therapy of the thoracolumbosacral spine and hips PROCEDURE

Thrust and/or non-thrust manipulation and soft tissue mobilization as determined by mobility impairments identified on clinical examination.

Impairment-Based Group

Motor control exercises PROCEDURE

Motor control exercises as determined by motor control impairments identified on clinical examination.

Impairment-Based Group

Treatment-Based Classification intervention PROCEDURE

Lumbopelvic manipulation and range of motion exercise, spinal stabilization exercises, direction specific exercises, and/or traction will be applied as determined by the Treatment-Based Classification (TBC) Algorithm.

Classification-Based Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary complaint of low back pain with or without leg symptoms
• duration of symptoms 24 hours to 90 days
• modified Oswestry score of 20 or greater
• able to read and speak English.

You may not qualify if:

• current pregnancy
• spinal steroid injections within the past month
• spinal surgery in the past 6 months
• current worker's compensation or motor vehicle accident claim
• presence of any red flag symptoms indicating possible serious pathology or non-musculoskeletal pain

Sponsors & Collaborators

• Hendricks Regional Health: lead

Study Sites (1)

Hendricks Regional Health

Plainfield, Indiana, 46168, United States

Location

Related Publications (5)

• Delitto A, Erhard RE, Bowling RW. A treatment-based classification approach to low back syndrome: identifying and staging patients for conservative treatment. Phys Ther. 1995 Jun;75(6):470-85; discussion 485-9. doi: 10.1093/ptj/75.6.470.

  PMID: 7770494 BACKGROUND

• Fritz JM, Brennan GP, Clifford SN, Hunter SJ, Thackeray A. An examination of the reliability of a classification algorithm for subgrouping patients with low back pain. Spine (Phila Pa 1976). 2006 Jan 1;31(1):77-82. doi: 10.1097/01.brs.0000193898.14803.8a.

  PMID: 16395181 BACKGROUND

• Fritz JM, Cleland JA, Childs JD. Subgrouping patients with low back pain: evolution of a classification approach to physical therapy. J Orthop Sports Phys Ther. 2007 Jun;37(6):290-302. doi: 10.2519/jospt.2007.2498.

  PMID: 17612355 BACKGROUND

• Wainner RS, Whitman JM, Cleland JA, Flynn TW. Regional interdependence: a musculoskeletal examination model whose time has come. J Orthop Sports Phys Ther. 2007 Nov;37(11):658-60. doi: 10.2519/jospt.2007.0110. No abstract available.

  PMID: 18057674 BACKGROUND

• Fritz JM, Delitto A, Erhard RE. Comparison of classification-based physical therapy with therapy based on clinical practice guidelines for patients with acute low back pain: a randomized clinical trial. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1363-71; discussion 1372. doi: 10.1097/01.BRS.0000067115.61673.FF.

  PMID: 12838091 BACKGROUND

Related Links

• Hendricks Regional Health

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David W Candy, DPT

  Hendricks Regional Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: December 1, 2013
• First Posted: February 12, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

US (1)