Chiropractic and Self-care for Back-Related Leg Pain

NCT ID: NCT00494065

Last Updated: 2014-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Chiropractic Spinal Manipulative Therapy + Home exercise

Group Type: EXPERIMENTAL

Chiropractic Spinal Manipulative Therapy + Home exercise

Intervention Type: 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.

2

Home exercise

Group Type: ACTIVE_COMPARATOR

Home exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

Northwestern Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gert Bronfort, DC, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Health Sciences University

Locations

Palmer Center for Chiropractic Research

Davenport, Iowa, United States

Northwestern Health Sciences University

Bloomington, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25222385 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21426558 (View on PubMed)

Other Identifiers

R18HP07638

Identifier Type: -

Identifier Source: secondary_id

R18HP07638

Identifier Type: -

Identifier Source: org_study_id