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Completed

NCT Number: NCT00494065

Chiropractic and Self-care for Back-Related Leg Pain

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.

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Key information

Conditions

Sub-acute and Chronic Back-related Leg Pain

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palmer Center for Chiropractic Research, Davenport, Iowa, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home exercise

Other

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.

Chiropractic Spinal Manipulative Therapy + Home exercise

Other

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.

Primary outcomes

  1. Patient-rated leg pain

    Time frame: short-term = 12 weeks; long-term = 52 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Northwestern Health Sciences University

Other

Collaborators

  • Department of Health and Human Services

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 29, 2007
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.