Chiropractic and Self-care for Back-Related Leg Pain

NCT00494065 | Completed

• 1 other identifier: R18HP07638
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 2

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.

Conditions

Sub-acute and Chronic Back-related Leg Pain

Outcome Measures

Primary Outcomes (1)

• Patient-rated leg pain

  short-term = 12 weeks; long-term = 52 weeks

Secondary Outcomes (9)

• Bothersomeness

  short-term = 12 weeks; long-term = 52 weeks

• Frequency

  short-term = 12 weeks; long-term = 52 weeks

• Disability

  short-term = 12 weeks; long-term = 52 weeks

• General Health Status

  short-term = 12 weeks; long-term = 52 weeks

• Fear Avoidance

  short-term = 12 weeks; long-term = 52 weeks

Study Arms (2)

1

EXPERIMENTAL

Chiropractic Spinal Manipulative Therapy + Home exercise

Other: Chiropractic Spinal Manipulative Therapy + Home exercise

2

ACTIVE COMPARATOR

Home exercise

Other: Home exercise

Interventions

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.

2

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.

1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age and older.
• Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in the previous month).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern Health Sciences University: lead
• Department of Health and Human Services: collaborator

Study Sites (2)

Palmer Center for Chiropractic Research

Davenport, Iowa, 52803, United States

Location

Northwestern Health Sciences University

Bloomington, Minnesota, 55337, United States

Location

Related Publications (2)

• Bronfort G, Hondras MA, Schulz CA, Evans RL, Long CR, Grimm R. Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain: a trial with adaptive allocation. Ann Intern Med. 2014 Sep 16;161(6):381-91. doi: 10.7326/M14-0006.

  PMID: 25222385 DERIVED

• Schulz CA, Hondras MA, Evans RL, Gudavalli MR, Long CR, Owens EF, Wilder DG, Bronfort G. Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial. Chiropr Man Therap. 2011 Mar 22;19:8. doi: 10.1186/2045-709X-19-8.

  PMID: 21426558 DERIVED

Study Officials

• Gert Bronfort, DC, PhD

  Northwestern Health Sciences University

  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 27, 2007
• First Posted: June 29, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

US (2)