Chiropractic and Exercise for Low Back Pain in Adolescents

NCT01096628 | Completed Phase 2 DMC

• 1 other identifier: R18HP15124
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 2

Brief Summary

Recent research has confirmed that low back pain (LBP) is a significant health problem not only for adults, but also for children and adolescents. Given the enormous social and economic costs associated with LBP, it is critical that attempts be made to decrease the burden of LBP for patients and society. The primary aim of this project is to determine the relative clinical effectiveness of 3 months of chiropractic care and supervised exercise versus supervised exercise in 184 adolescents with sub-acute recurrent, or chronic LBP. Relative effectiveness will be evaluated in the short, intermediate and long term using pain as the primary outcome measure. Secondary aims are to assess group differences in patient self-reported disability, quality of life, perceived improvement, satisfaction, activity levels, lumbar dynamic motion, and trunk muscle endurance. Patients' and caregivers' perceptions of treatment using qualitative interviews will also be assessed.

Conditions

Low Back Pain

Keywords

adolescent; low back pain; chiropractic; exercise

Outcome Measures

Primary Outcomes (1)

• PATIENT-RATED LOW BACK PAIN

  Patients will be asked to rate their typical low back pain over the last week on an 11-box numerical rating scale (0=no pain, 10=the worst pain possible).

  3 and 12 months

Secondary Outcomes (10)

• Disability

  3 and 12 months

• Quality of Life

  3 and 12 months

• Satisfaction with care

  3 and 12 months

• Patient-rated improvement

  3 and 12 months

• Guardian's satisfaction with care

  3 and 12 months

Study Arms (2)

Chiropractic + Exercise

EXPERIMENTAL

Other: Chiropractic + Exercise

Exercise

ACTIVE COMPARATOR

Other: Exercise

Interventions

Chiropractic + Exercise OTHER

Treatment will include eight to 16 treatments provided over the 12-week period. Each treatment visit will last from 10-20 minutes and consist of manual spinal manipulation and mobilization. Light soft tissue techniques (i.e., active and passive muscle stretching, hot and cold packs, and ischemic compression of tender points) will be used as indicated to facilitate the manual therapy. Patients will attend 8 to 16, one-on-one, 45-minute sessions over the course of 3 months. The sessions will follow a standardized approach but will be individualized to meet the patient's needs specific to their lifestyle, fitness level, and clinical characteristics. The exercise program will be comprised of three parts: 1) education, 2) supervised exercise, and 3) home exercise.

Chiropractic + Exercise

Exercise OTHER

Patients will attend 8 to 16, one-on-one, 45-minute sessions over the course of 3 months. The sessions will follow a standardized approach but will be individualized to meet the patient's needs specific to their lifestyle, fitness level, and clinical characteristics. The exercise program will be comprised of three parts: 1) education, 2) supervised exercise, and 3) home exercise.

Exercise

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in the previous month)
• Primary complaint of low back pain \> 3 on 0 to 10 scale
• Either:
• Recurrent, sub-acute low back pain defined as current episode of 2-12 weeks duration AND at least an additional 10 days of back pain in the past year OR
• Chronic low back pain defined as current episode \>12 weeks duration

You may not qualify if:

• Chiropractic care or exercise therapy in the previous month
• Ongoing treatment for low back pain by other health care providers
• Other serious physical or mental health care conditions (for example diabetes, cancer, etc.)
• Contraindications to study therapies including acute disc herniation, spondylolysis, spondylolithesis, or inflammatory arthritides
• Benign joint hypermobility syndrome

Sponsors & Collaborators

• Northwestern Health Sciences University: lead
• University of Western States: collaborator
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (2)

Northwestern Health Sciences University

Bloomington, Minnesota, 55431, United States

Location

University of Western States

Portland, Oregon, United States

Location

Related Publications (2)

• Leininger B, Schulz C, Gao Z, Bronfort G, Evans R, Pope Z, Zeng N, Haas M. Accelerometer-Determined Physical Activity and Clinical Low Back Pain Measures in Adolescents With Chronic or Subacute Recurrent Low Back Pain. J Orthop Sports Phys Ther. 2017 Oct;47(10):769-774. doi: 10.2519/jospt.2017.7345. Epub 2017 Sep 12.

  PMID: 28898136 DERIVED

• Schulz C, Leininger B, Evans R, Vavrek D, Peterson D, Haas M, Bronfort G. Spinal manipulation and exercise for low back pain in adolescents: study protocol for a randomized controlled trial. Chiropr Man Therap. 2014 May 23;22:21. doi: 10.1186/2045-709X-22-21. eCollection 2014.

  PMID: 24904748 DERIVED

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gert Bronfort, DC, PhD

  Northwestern Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 31, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

US (2)