Clinical trial NCT00269321: Chiropractic and Exercise for Seniors With Low Back Pain
Official title: Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individuals 65 and Over With Chronic Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Keywords: Randomized
Clinical Trial
Low Back Pain
Chiropractic
Manual Therapies
Exercise
Lead sponsor: Northwestern Health Sciences University
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: Berman Center for Outcomes and Clinical Research
First posted: 2005-12-23
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.

Detailed description: Low back pain (LBP) is a significant health problem for both young and geriatric individuals. Of particular concern is that conditions associated with LBP, such as impaired strength and flexibility, can have very serious consequences for an older individual's independence and overall health.

The broad, long-term objective of this research is to identify effective therapies for low back pain (LBP) and to discover the best methods for enhancing health and functional capacity in the elderly population. This study is a multi-methods clinical trial consisting of a randomized clinical trial (RCT), a cost-effectiveness study alongside the RCT, and a qualitative study nested in the RCT.

This trial builds upon a previous study of chiropractic and exercise funded by HRSA, and focuses on elderly patients with sub-acute and chronic low back pain.

PRIMARY AIMS

* To determine the relative clinical effectiveness the following treatments for LBP patients 65 years and older in both the short-term (after 12 weeks) and long-term (after 52 weeks), using low back pain as the main outcome measure

  1. chiropractic manual treatment plus home exercise
  2. supervised rehabilitative exercise plus home exercise
  3. home exercise

     SECONDARY AIMS
* To estimate the short- and long-term relative effectiveness of the three interventions using:
* Patient-rated outcomes: low back disability, general health status, patient satisfaction, improvement, and medication use measured by self-report questionnaires
* Objective functional performance outcomes: spinal motion, trunk strength and endurance, and functional ability measured by examiners masked to treatment group assignment
* Cost measures: direct and indirect costs of treatment measured by questionnaires, phone interviews, and medical records.
* To describe elderly LBP patients' perceptions of treatment and the issues they consider when determining their satisfaction with care using qualitative methods nested within the RCT.

Eligibility criteria: Inclusion Criteria:

* Sub-Acute and chronic low back pain (Defined as current episode more than 6 weeks duration.)
* Quebec Task Force classifications 1, 2, 3 and 4. (This includes patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs.{1570})
* 65 years of age and older
* Independent ambulation
* Community dwelling (residency outside nursing home)
* Score of 20 or more on Folstein Mini-Mental State Examination{13246}
* Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in previous month)

Exclusion Criteria:

* Referred low back pain from local joint lesions of the lower extremities or from visceral diseases
* Significant infectious disease Determined by history or by referral to supplementary diagnostic tests
* Ongoing treatment for low back pain by other health care providers
* Mean baseline low back pain score of 20 percentage points or less
* Contraindications to exercise Determined by history or by referral to supplementary diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled metabolic disease
* Contraindications to spinal manipulation (i.e. Progressive neurological deficits blood clotting disorders; infectious and non-infectious inflammatory or destructive tissue changes of the spine; severe osteoporosis)

Primary outcomes:
measure: Patient-rated pain (0-11 box scale)
timeFrame: short term = 12 weeks; long term = 52 weeks
Secondary outcomes:
measure: General Health
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Disability
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Improvement
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Satisfaction
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Medication use
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Biomechanical test: Lumbar spinal motion Trunk strength & endurance Functional Ability Observed Pain Behavior
timeFrame: short term = 12 weeks
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University
state: Minnesota
Study officials:
affiliation: Northwestern Health Sciences University
name: Gert Bronfort, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern Health Sciences University
name: Roni Evans, MS
role: STUDY_DIRECTOR
References:
citation: Schulz C, Evans R, Maiers M, Schulz K, Leininger B, Bronfort G. Spinal manipulative therapy and exercise for older adults with chronic low back pain: a randomized clinical trial. Chiropr Man Therap. 2019 May 15;27:21. doi: 10.1186/s12998-019-0243-1. eCollection 2019.
citation: Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007 Sep 18;8:94. doi: 10.1186/1471-2474-8-94.