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Chiropractic and Self-care for Back-Related Leg Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00494065
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : January 31, 2014
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Northwestern Health Sciences University

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Sub-acute and Chronic Back-related Leg Pain Other: Home exercise Other: Chiropractic Spinal Manipulative Therapy + Home exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chiropractic and Self-care for Back-Related Leg Pain
Study Start Date : June 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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.
Active Comparator: 2
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.


Outcome Measures
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Primary Outcome Measures :
  1. Patient-rated leg pain [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]

Secondary Outcome Measures :
  1. Bothersomeness [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  2. Frequency [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  3. Disability [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  4. General Health Status [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  5. Fear Avoidance [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  6. Patient Satisfaction [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  7. Improvement [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  8. Medication Use [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  9. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494065


Locations
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United States, Iowa
Palmer Center for Chiropractic Research
Davenport, Iowa, United States, 52803
United States, Minnesota
Northwestern Health Sciences University
Bloomington, Minnesota, United States, 55337
Sponsors and Collaborators
Northwestern Health Sciences University
Department of Health and Human Services
Investigators
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Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Northwestern Health Sciences University
ClinicalTrials.gov Identifier: NCT00494065    
Other Study ID Numbers: R18HP07638
R18HP07638
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014