Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain

NCT01539863 | Completed Results

• 1 other identifier: KIIMMIIR
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

As low back pain is often a recurrent and sometime persistent problem, research into prevention is important. Chiropractors have traditionally treated patients with maintenance care, which means that patients are seen on a regular basis to prevent recurrences or to stop a persistent problem getting worse. However, it is not known if this has the expected effect. This study will test the effectiveness of the maintenance care approach. Patients with recurrent or persistent low back pain will be treated in accordance with two different models. The first model is the maintenance care model, meaning that chiropractors will see the patient on a regular basis, regardless symptoms. The other model means that patients should be treated patients only when they themselves experience symptoms bad enough to seek care. After one year, it will be possible to see if there has been any difference between the groups in terms of pain, disability, quality of life and total number of treatments over the study period and to investigate if there is any difference in the cost-effectiveness between the two treatment models.Thus, the study hypothesis is that there is no difference between the two models regarding the number of days with pain. This study will be a multi-centre trial, and as part of the study, it will be necessary to formalize a network of research clinics all over Sweden in which participating chiropractors accept to perform complex data collection. This network will then have the expertise and potential to perform future clinical studies together with networks in other countries, allowing large clinical trials across countries.

Conditions

Recurrent Low Back Pain; Persistent Low Back Pain; Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Number of Days With Bothersome Low Back Pain

  Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks.

  12 months

Secondary Outcomes (1)

• Cost-effectiveness

  12 months

Study Arms (2)

Treatment at regular intervals

EXPERIMENTAL

Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management

Other: maintenance care

Treatment as needed

ACTIVE COMPARATOR

Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration

Other: Treatment as needed

Interventions

maintenance care OTHER

Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor

Treatment at regular intervals

Treatment as needed OTHER

Participants may never receive treatment, there is no upper limit

Treatment as needed

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-specific low back pain \> 30 days previous year
• non-specific low back pain with previous episodes
• age 18-65
• access to a mobile phone
• knowledge of how to text message
• proficiency in the Swedish language
• must rate themselves as "definitely improved" by the 4th visit

You may not qualify if:

• pregnancy
• contraindication to spinal manipulative therapy
• liability issues

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, 171 77, Sweden

Location

Related Publications (5)

• Eklund A, Palmgren PJ, Jakobsson U, Axen I. Development and evaluation of the MAINTAIN instrument, selecting patients suitable for secondary or tertiary preventive manual care: the Nordic maintenance care program. Chiropr Man Therap. 2022 Mar 17;30(1):15. doi: 10.1186/s12998-022-00424-6.

  PMID: 35300729 DERIVED

• Eklund A, Hagberg J, Jensen I, Leboeuf-Yde C, Kongsted A, Lovgren P, Jonsson M, Petersen-Klingberg J, Calvert C, Axen I. The Nordic maintenance care program: maintenance care reduces the number of days with pain in acute episodes and increases the length of pain free periods for dysfunctional patients with recurrent and persistent low back pain - a secondary analysis of a pragmatic randomized controlled trial. Chiropr Man Therap. 2020 Apr 21;28(1):19. doi: 10.1186/s12998-020-00309-6.

  PMID: 32316995 DERIVED

• Eklund A, Bergstrom G, Bodin L, Axen I. Do psychological and behavioral factors classified by the West Haven-Yale Multidimensional Pain Inventory (Swedish version) predict the early clinical course of low back pain in patients receiving chiropractic care? BMC Musculoskelet Disord. 2016 Feb 12;17:75. doi: 10.1186/s12891-016-0933-y.

  PMID: 26867930 DERIVED

• Eklund A, Bergstrom G, Bodin L, Axen I. Psychological and behavioral differences between low back pain populations: a comparative analysis of chiropractic, primary and secondary care patients. BMC Musculoskelet Disord. 2015 Oct 19;16:306. doi: 10.1186/s12891-015-0753-5.

  PMID: 26483193 DERIVED

• Eklund A, Axen I, Kongsted A, Lohela-Karlsson M, Leboeuf-Yde C, Jensen I. Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial. Trials. 2014 Apr 2;15:102. doi: 10.1186/1745-6215-15-102.

  PMID: 24690201 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Long-Term Care; Therapeutics; Health Services Needs and Demand

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Health Services; Health Care Facilities Workforce and Services; Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Ass professor Iben Axén
• Organization: Karolinska Institutet

iben.axen@ki.se

+46704400618

Study Officials

• Irene Jensen, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: February 28, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 16, 2023
• Results First Posted: March 12, 2021

Record last verified: 2023-10

Locations

SE (1)