Chiropractic and Exercise for Low Back Pain in Adolescents

Low Back Pain Clinical Trial

Official title:

Chiropractic and Exercise for Low Back Pain in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096628
• Other study ID #: R18HP15124
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 29, 2010
• Last updated: January 30, 2014
• Start date: March 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Northwestern Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a two-site, prospective, parallel group, observer-blinded randomized controlled trial (RCT). The objective of this study is to determine the relative clinical effectiveness of 1) chiropractic care and supervised exercise; and 2) supervised exercise in adolescents with sub-acute recurrent LBP (2-12 weeks duration) or chronic LBP (>12 weeks duration ).

A total of 184 participants 12-18 years of age will be recruited from the Twin Cities of Minneapolis/St.Paul and Portland metropolitan areas to the research clinics at Northwestern Health Sciences University (NWHSU) and the University of Western States Portland(UWS). Data collection measures and study protocols will be standardized across sites. The Office of Data Management at NWHSU will serve as the central data coordinating center, with a web-based interface for centralized data handling and treatment assignment.

Self-reported outcome measures assessing pain and disability, will be collected at baseline, 1, 2, 3, 4, 5, 6, and 12 months post-randomization. In addition, quality of life, improvement, and satisfaction will be measured at months 3, 6 and 12. Objective outcome measures including lumbar dynamic motion and trunk muscle endurance will be assessed by blinded examiners at baseline and post-treatment phase (3 and 6 months). Patients will wear accelerometers for the 7 days preceding follow up visits for months 3 and 6. Qualitative patient interviews assessing patient and care-giver perceptions of care will be also be conducted at 3 and 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• 12-18 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Chiropractic + Exercise
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.
• Exercise
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.

Locations

Country	Name	City	State
United States	Northwestern Health Sciences University	Bloominton	Minnesota
United States	University of Western States	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern Health Sciences University	Health Resources and Services Administration (HRSA), University of Western States

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Disability	Disability will be measured with the Roland-Morris- 18 Scale, an 18-item questionnaire that measures the degree to which low back pain restricts patients' daily activities	3 and 12 months	No
Secondary	Quality of Life	Measured using the 23-item PedsQL instrument which is a developmentally appropriate questionnaire for individuals 8-12 and 13-18 years of age and measures physical, emotional, social and school functioning domains.	3 and 12 months	No
Secondary	Satisfaction with care	Satisfaction will be measured with a 7-item questionnaire addressing different aspects of patient care including information regarding cause, prognosis, activities, and prevention. Other aspects are concern shown by care provider, quality of recommendations and finally an overall rating of care. Each question will be evaluated on a 5-point Likert scale (1=poor, 5=excellent).	3 and 12 months	No
Secondary	Patient-rated improvement	Patients will be asked to compare their low back pain condition to what it was before study treatment on a 9-point scale (100% worse to 100% better).	3 and 12 months	No
Secondary	Guardian's satisfaction with care	Satisfaction will be measured with a 5-item questionnaire addressing concern shown by care provider, quality of recommendations and finally an overall rating of care. Each question will be evaluated on a 5-point Likert scale (1=poor, 5=excellent).	3 and 12 months	No
Secondary	Guardian's impression of Improvement	Guardians will be asked to compare their child's low back pain condition to what it was before study treatment on a 9-point scale (100% worse to 100% better).	3 and 12 months	No
Secondary	Lumbar Range of Motion	Lumbar spinal motion will be assessed using the Zebris CMS-HS Spine Motion Analyzer for (1)maximum ranges of motion in the sagittal, coronal, and axial planes and (2) maximum and average velocities and accelerations in the sagittal, coronal, and axial planes from neutral to end-ranges.	3 and 6 months	No
Secondary	Lumbar muscle endurance	Blinded examiners will measure muscle endurance of the trunk flexors, lateral flexors, and extensors. Specifically, trunk extensors will be measured with the commonly used Biering-Sorensen Test and flexors will be assessed using protocols described by McGill.	3 and 6 months	No
Secondary	Physical activity Level	Physical activity will be measured by having participants wear a GT1M accelerometer (Actigraph, Inc., Pensacola, FL) for 7 consecutive days. The GT1M is an electronic motion sensor accelerometer.	3 and 6 months	No
Secondary	Expectations	Expectations will be evaluated pre-treatment based on questions that have been used in previous studies by the investigators. Prior to randomization, patients will be asked to rate how helpful they believe each treatment to be on an 11-box scale (0=not at all helpful, 10=extremely helpful). They will also be asked if they had a choice, which treatment would they choose.	Baseline	No