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.

Study Overview

• Status: Completed
• Conditions: Sub-acute and Chronic Back-related Leg Pain
• Intervention / Treatment: Other: Chiropractic Spinal Manipulative Therapy + Home exercise; Other: Home exercise

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Palmer Center for Chiropractic Research
  • Minnesota
    • Bloomington, Minnesota, United States, 55337
      • Northwestern Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient-rated leg pain	short-term = 12 weeks; long-term = 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Patient Satisfaction	short-term = 12 weeks; long-term = 52 weeks
Improvement	short-term = 12 weeks; long-term = 52 weeks
Medication Use	short-term = 12 weeks; long-term = 52 weeks
Biomechanical test measures: Continuous lumbar motion, Standing postural sway, Neuromuscular response to a sudden load, Straight leg raise test, Torso muscle endurance	short-term = 12 weeks

Collaborators and Investigators

• Sponsor: Northwestern Health Sciences University
• Collaborators: Department of Health and Human Services

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: June 27, 2007
• First Submitted That Met QC Criteria: June 28, 2007
• First Posted (Estimate): June 29, 2007

Study Record Updates

• Last Update Posted (Estimate): January 31, 2014
• Last Update Submitted That Met QC Criteria: January 30, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: R18HP07638