Identification of Prognostic Indicators for Rehabilitation in Chronic Nonspecific Low Back Pain Patients

NCT02063503 | Unknown DMC

• 1 other identifier: B300201215600
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There is a consensus that exercise therapy should be used as a therapy approach in CLBP but little consensus has been reached about the preferential type of therapy. There occurs to be a wash out effect because of the heterogeneous character of CLBP patients. As a result, no effect can be demonstrated for the entire sample. This is why one should consider creating subgroups based on prognostic indicators. Objectives for this trial is to possibly identify prognostic indicators for treatment response to three forms of exercise therapy for patients with nonspecific chronic low back pain (CLBP). The study design is a multicenter cohort design. Patients with nonspecific low back pain of more than three months duration are recruited in two different hospitals (Antwerp University Hospital and Sint Vincentius Hospital). After examination patients are assigned to one of three intervention groups: motor control therapy, isometric training therapy and a combination therapy. All patients will undergo eighteen treatment sessions during nine weeks. Measurements will be taken at baseline and after nine weeks of treatment. The primary outcome used is the Modified Oswestry Disability Questionnaire (MDQ). For each type of exercise therapy prognostic indicators will be investigated. Never before a multi-arm design was performed for the identification of prognostic indicators for exercise therapy in patients with nonspecific CLBP.

Conditions

Chronic Low Back Pain

Keywords

prognostic indicator; nonspecific; chronic; low back pain; Non specific chronic low back pain

Outcome Measures

Primary Outcomes (1)

• Measurement of functional disability

  Modified Oswestry Low Back Pain Disability Questionnaire (MDQ): the patient questionnaire contains topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. Zero is equated with no disability and 100 being maximum disability.

  2 years

Secondary Outcomes (3)

• patient characteristics

  2 years

• clinical testing

  2 years

• patient reported outcome measures

  2 years

Study Arms (3)

Motor control therapy

EXPERIMENTAL

physiotherapy

Other: physiotherapy

Isometric training therapy

EXPERIMENTAL

physiotherapy

Other: physiotherapy

Combination therapy

EXPERIMENTAL

physiotherapy

Other: physiotherapy

Interventions

physiotherapy OTHER

every group receives 2 treatments every week during 9 consecutive weeks

Also known as: - Motor control therapy, - Isometric training devices, - Combination therapy

Combination therapy; Isometric training therapy; Motor control therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• at least 3 months low back pain
• consulted a medical doctor during last month because of persistent low back pain
• age between 18 - 60

You may not qualify if:

• vestibular dysfunction
• a history of known spinal fractures
• spondylolysis and spondylolisthesis
• radiating pain below the knee
• muscle, nerve, skin, joint diseases
• pregnancy

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Related Publications (1)

• Denteneer L, Stassijns G, De Hertogh W, Truijen S, Jansen N, Van Daele U. Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial. Trials. 2015 Jan 6;16:4. doi: 10.1186/1745-6215-16-4.

  PMID: 25558975 DERIVED

Related Links

• official website of the University of Antwerp

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Low Back Pain

Interventions

Physical Therapy Modalities; Combined Modality Therapy

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Ulrike Van Daele, Professor

  Universiteit Antwerpen

  STUDY DIRECTOR

• Gaetane Stassijns, Professor

  Universiteit Antwerpen, Universitair Ziekenhuis Antwerpen

  STUDY DIRECTOR

• Lenie Denteneer, phd student

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lenie Denteneer, phd student

CONTACT

0032494884189; lenie.denteneer@uantwerpen.be

Ulrike Van Daele, Professor

CONTACT

003236418265; ulrike.vandaele@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dra. Denteneer Lenie

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 14, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

BE (1)