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Low Back PainPhase 2NCT00269347

Manipulation, Exercise, and Self-Care for Low Back Pain

A Phase 2 study testing Chiropractic Spinal Manipulation, Exercise and Self-care in people with Low Back Pain, run by Northwestern Health Sciences University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The broad, long term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and to increase our understanding of this important condition. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Low Back Pain
What is being tested?
Chiropractic Spinal Manipulation, Exercise and Self-care
How many people
300 participants
Where
1 siteUnited States
Study dates
Jan 2001to Apr 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • previous lumbar spine surgery; back pain referred from local joint lesions of the lower extremities or from visceral diseases; progressive neurological deficits due to nerve root or spinal cord compression; aortic and peripheral vascular disease; existing cardiac disease requiring medical treatment; blood clotting disorders; diffuse idiopathic hyperostosis; infectious and noninfectious inflammatory or destructive tissue changes of the lumbar spine; presence of significant infectious disease, or other severe debilitating health problems; substance abuse; ongoing treatment for back pain by other health care providers; pregnant or nursing women; pain score of less than 30 percentage points; pending our current litigation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern Health Sciences University

    Bloomington, Minnesota, 55431

Other trials in United States

About this study

The broad, long term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and to increase our understanding of this important condition. The primary aim is to examine the relative efficacy of chiropractic spinal manipulation, rehabilitative exercise, and self-care education in terms of patient-rated outcomes in the short and long term for non-acute low back pain.

Read the detailed description

Low back pain remains an important public health problem with serious socioeconomic consequences. Despite the considerable amount of research that has been preformed, there is still a dire need for randomized clinical tiles of high methodological quality. The broad, long-term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and increased understanding of this important condition. Building upon the principal investigators' previous collaborative research, this randomized observer-blinded clinical trial will compare the following treatment for patients with nonacute low back pain:

  1. chiropractic spinal manipulation
  2. rehabilitative exercise
  3. self care education Theprimary aim is to examine the relative efficacy of the three interventions in terms of patient rated outcomes in the short-term (after 12 weeks) and the long-term (after 52 weeks) for nonacute low back pain.

Secondary aims include:

  1. To examine the short and long-term relative cost effectiveness and cost utility of the three treatments.
  2. To assess if there are clinically important differences between pre-specified subgroups of low back pain patients. Subgroups are based on duration and current episode and radiating leg pain.
  3. To evaluate if there treatment group differences in objective lumbar spine function (range of motion, strength and endurance) after 12 weeks of treatment and if changes in lumbar function are associated with changes in patient rated short and long-term outcomes.
  4. To identify if baseline demographic or clinical variables can predict short or long-term outcome.
  5. To describe patients' interpretations and perceptions of outcome measures used in clinical trials.
Conditions
Low Back Pain
Being tested
Chiropractic Spinal Manipulation, Exercise, Self-care
Keywords
Chiropractic, Manual Therapy, Exercise, Randomized, Clinical Trial, Back Pain
Medical subject headings
Low Back Pain, Motor Activity, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chiropractic Spinal ManipulationProcedure or surgery

  • ExerciseProcedure or surgery

  • Self-careBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52

Secondary outcomes (13)

  1. Disability (Modified Roland Scale) at baseline, weeks 4,12,26,52

  2. General Health (SF-36) at baseline, weeks 4,12,26,52

  3. Improvement (7 point scale) at baseline, weeks 4,12,26,52

  4. Disability (NHIS) at baseline, weeks 4,12,26,52

  5. Bothersomeness (7 point scale) at baseline, weeks 4,12,26,52

  6. Frequency (7 point scale) at baseline, weeks 4,12,26,52

  7. Satisfaction (5 point scale) at baseline, weeks 4,12,26,52

  8. Depression (CES-D) at baseline, weeks 4,12,26,52

  9. Medication use at baseline, weeks 4,12,26,52

  10. Fear-avoidance (FABQ) at baseline, weeks 4,12,26,52

  11. Lumbar range of motion at baseline, weeks 4,12,26,52

  12. Lumbar strength and endurance at baseline, weeks 4,12,26,52

  13. Health care costs and utilization at baseline, weeks 4,12,26,52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2005 (estimated)
  2. Study startJan 2001
  3. Study completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00269347
Sponsor's protocol ID
R18HP10009
Status last verified
Dec 2005
First submitted
21 Dec 2005
Last updated
23 Dec 2005
Results posted
No

Publications

  • Haanstra TM, Hanson L, Evans R, van Nes FA, De Vet HC, Cuijpers P, Ostelo RW. How do low back pain patients conceptualize their expectations regarding treatment? Content analysis of interviews. Eur Spine J. 2013 Sep;22(9):1986-95. doi: 10.1007/s00586-013-2803-8. Epub 2013 May 10.

    PubMed 23661035

  • Bronfort G, Maiers MJ, Evans RL, Schulz CA, Bracha Y, Svendsen KH, Grimm RH Jr, Owens EF Jr, Garvey TA, Transfeldt EE. Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial. Spine J. 2011 Jul;11(7):585-98. doi: 10.1016/j.spinee.2011.01.036. Epub 2011 May 31.

    PubMed 21622028

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chiropractic Spinal Manipulation, Exercise and Self-care in people with Low Back Pain, run by Northwestern Health Sciences University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00269347, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2005.

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