Chiropractic and Self-Care for Back-Related Leg Pain - Full Text View

Sponsor:	Northwestern Health Sciences University
Collaborator:	Department of Health and Human Services
Information provided by:	Northwestern Health Sciences University
ClinicalTrials.gov Identifier:	NCT00494065

Purpose

The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192 patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome variable is leg pain and secondary outcome variables include low back pain, disability, bothersomeness and frequency of symptoms, general health status, and fear avoidance behavior.

Secondary aims are to describe and estimate between group differences in patient satisfaction, improvement, medication use, straight leg raise, torso endurance, and three biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response to sudden load. Patient perceptions of treatment will also be assessed.

Condition	Intervention
Sub-Acute and Chronic Back-Related Leg Pain	Other: Home exercise Other: Chiropractic Spinal Manipulative Therapy + Home exercise

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Chiropractic and Self-Care for Back-Related Leg Pain

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Northwestern Health Sciences University:

Primary Outcome Measures:

Patient-rated leg pain [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bothersomeness [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
Frequency [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
Disability [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
General Health Status [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
Fear Avoidance [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
Patient Satisfaction [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
Improvement [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
Medication Use [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
Biomechanical test measures: Continuous lumbar motion, Standing postural sway, Neuromuscular response to a sudden load, Straight leg raise test, Torso muscle endurance [ Time Frame: short-term = 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	192
Study Start Date:	June 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Chiropractic Spinal Manipulative Therapy + Home exercise	Other: Chiropractic Spinal Manipulative Therapy + Home exercise The number and frequency of treatments will be determined by the individual chiropractor, based on patient-rated symptoms, disability, palpation, and pain provocation tests. Up to 20 treatments will be provided over the 12 week treatment period, each treatment visit lasting from 10-20 minutes. Treatment will include manual spinal manipulation and mobilization.
2: Active Comparator Home exercise	Other: Home exercise Patient education will be provided by trained therapists under the supervision of licensed chiropractic clinicians. Patients will attend four, 1 hour, one-on-one sessions.

Arms

Assigned Interventions

1: Experimental

Chiropractic Spinal Manipulative Therapy + Home exercise

Other: Chiropractic Spinal Manipulative Therapy + Home exercise

The number and frequency of treatments will be determined by the individual chiropractor, based on patient-rated symptoms, disability, palpation, and pain provocation tests. Up to 20 treatments will be provided over the 12 week treatment period, each treatment visit lasting from 10-20 minutes. Treatment will include manual spinal manipulation and mobilization.

2: Active Comparator

Home exercise

Other: Home exercise

Patient education will be provided by trained therapists under the supervision of licensed chiropractic clinicians. Patients will attend four, 1 hour, one-on-one sessions.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Back-related leg pain > 3 on 0 to 10 scale.
Sub-acute or chronic back-related leg pain defined as current episode > 4 weeks duration.
Back-related leg pain classified as 2, 3, 4, or 6 using the Quebec Task Force (QTF) Classification system. This includes radiating pain into the proximal or distal part of the lower extremity, with or without neurological signs, with possible compression of a nerve root.
21 years of age and older.
Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in the previous month).

Exclusion Criteria:

Ongoing treatment for leg or low back pain by other health care providers.
Progressive neurological deficits or cauda equina syndrome.
QTF classifications 5 (spinal fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). These are serious conditions not amenable to the conservative treatments proposed.
QTF 7 (spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking).
Uncontrolled hypertension or metabolic disease.
Blood clotting disorders.
Severe osteoporosis.
Inflammatory or destructive tissue changes of the spine.
Patients with surgical lumbar spine fusion or patients with multiple incidents of lumbar surgery. This is a subgroup of low back pain patients which generally have a poorer prognosis.
Pregnant or nursing women.
Current or pending litigation. Patients seeking financial compensation tend to respond differently to treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494065

Contacts

Contact: Gert Bronfort, DC, PhD

(952) 885-5413

gbronfort@nwhealth.edu

Locations

United States, Iowa
Palmer Center for Chiropractic Research	Recruiting
Davenport, Iowa, United States, 52803
Principal Investigator: Maria Hondras, DC, MPH
United States, Minnesota
Northwestern Health Sciences University	Recruiting
Bloomington, Minnesota, United States, 55337
Contact: Craig Schulz, DC, MS 952-888-4777 ext 159 cschulz@nwhealth.edu
Principal Investigator: Gert Bronfort, DC, PhD

Sponsors and Collaborators

Northwestern Health Sciences University

Department of Health and Human Services

Investigators

Principal Investigator:

Gert Bronfort, DC, PhD

Northwestern Health Sciences University

More Information

Additional Information:

Chiropractic and Self-Care for Back-Related Leg Pain This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Northwestern Health Sciences University ( Gert Bronfort, DC, PhD )
Study ID Numbers:	R18HP07638, R18HP07638
Study First Received:	June 27, 2007
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00494065 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2009