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Study of the Efficacy of Manual Therapy for a Subgroup of Acute Non-specific Low Back Pain

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ClinicalTrials.gov Identifier: NCT01801553
Recruitment Status : Terminated (problem of recruitment (not enough patients))
First Posted : March 1, 2013
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Benjamin Hidalgo, Université Catholique de Louvain

Brief Summary:

The purpose of this study is:

- To validate or not the interest of the classification using the pragmatic application of clinical predictive rule for low back pain to identify patients with good prognosis following a brief spinal manipulation intervention.

Patients (n = 100 to 150) :

Recruited from emergency department of Saint-Luc hospital by medical doctors

Inclusion criteria:

A. Non-specific (No red flags) acute low back with mobility deficit (limitation in bending) and a pain duration < 16 days and no symptoms distal to the knees, male and female patients aged 19-55 years.

Exclusion criteria:

  • Specific LBP (red flags) and radiating beyond the knee
  • Low Back Pain Non-specific subacute and chronic
  • Recurrent low back pain (more than 3 painful episodes)
  • Lumbar instability or hyper laxity (instability catch, active straight leg raise (SLR) > 90°, aberrant movement,range of motion (ROM) of le lower lumbar spine > 50° during standing flexion), pregnancy and post-partum status
  • High irritability = necessity of opioid medication or intravenous injection of medication in the emergency department
  • previous history of surgical intervention in the low back area

Intervention:

- 3 sessions within one week of spinal manipulation (thrusts, grade V)

comparison:

- 3 sessions of false/sham manipulation (placebo) in side lying on thoraco-lumbar hinge in a grade II

Co-intervention similar in both group:

= traditional medical care (TMC)

- Reassure patients, avoid bed rest, advise them to stay active and to take analgesics (if needed such as paracetamol) (European Guidelines for non-specific acute low back pain ; van Tulder et al. 2006 ; Koes et al. 2010).

Outcomes:

Use of effect sizes by standardized mean of difference. ANOVA one and Two Way, number needed to treat (NNT) analysis and intention to treat analysis on all outcome variables:

  • Primary: Kinematic Variables: two indices, logit score for the amplitude and velocity (Hidalgo et al., 2012) and patient's expectation from manual therapy (MT) treatment to improve his LBP
  • Secondary: Pain in the presentation with visual analogical scale (VAS) and the repartition (body diagram), Oswestry Disability Index (ODI, questionnaire on pain and function), patient specific function (PSF), fear avoidance beliefs questionnaire (FABQ), Start back tool, physical examination, medication use, return to work and treatment side effects, patient's belief in a real MT intervention or not (at the end of the follow-up)

Study design:

  • Double blind ie: patients and assessors blind.
  • The methodological quality of the study is the 8-9/10 on the PEDro scale, we will strictly follow the CONSORT statement and will be register in clinical.trials gov

Evaluators:

Christine Detrembleur (PT-PhD-UCL), Maxime Gilliaux (PT-PhD-student-UCL)

Responsible for the study: Henri Nielens (MD-PhD-UCL)

Practitioner and investigator:

Benjamin Hidalgo PE, PT-MT, DO, PhD-student Certificate in Orthopedic Manual Therapy (Manual Concepts, Curtin University) Assistant-Professor Faculty of Physical therapy (FSM-UCL) Belgium

International collaborator:

Timothy Flynn (PT-PhD), Regis University, Denver, USA


Condition or disease Intervention/treatment Phase
Low Back Pain Other: Spinal manipulation Other: sham spinal manipulation Other: Usual medical care Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Double Blind Study on the Pragmatic Application of a Clinical Prediction Rule in Primary Care to Treat Low Back Pain Patients With a Brief Spinal Manipulation Intervention: a Validation Study
Study Start Date : May 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: spinal manipulation intervention group
Spinal manipulation: 3 sessions within one week of true lumbopelvic manipulation
Other: Spinal manipulation

-In the intervention group :

True Lumbopelvic manipulation in supine (A) or in lateral side lying (B) for subjects with LBP:

If for example, A is the best position for both patient-practitioner but after a maximum of two trials doesn't produce a pop sound then the practitioner will move to the B position for a maximum of two trials as well.

-In the control group:

Sham spinal manipulation will realize to mimic (i) the same time, (ii) interaction and (iii) action with the manual therapist but without any efficacy in the position B using the upper body of the patient to target the thoraco-lumbar hinge and not the lumbopelvic region and take the time of handling the patient like in a true SM and mimic a high velocity and short ROM action moving fast his body but with a minimal action on the patient's body.


Other: Usual medical care
Sham Comparator: Spinal manipulation control group
Sham spinal manipulation: 3 sessions within one week of sham lumbopelvic manipulation
Other: sham spinal manipulation
Other: Usual medical care



Primary Outcome Measures :
  1. Kinematic spine model (Hidalgo et al. 2012 Journal of Rehabilitation medicine) [ Time Frame: Change from baseline and 1 week after discharge of treatment ]
    Use of quantitative variables for ROM and SPEED using two Logit Score Index (ROM and SPEED)


Secondary Outcome Measures :
  1. Start back tool (screening questionnaire) [ Time Frame: change from baseline until 1 month after discharge of treatment ]

    The 9-item tool is designed to classify patients into one of three subgroups for targeted primary care management:

    • low risk
    • medium risk (physical indicators)
    • high risk (physical & psychosocial indicators)

    http://www.keele.ac.uk/sbst/downloadthetool/


  2. Oswestry Disability questionnaire [ Time Frame: change from baseline until 1 month after discharge of treatment ]
    http://orthopluspt.com/beta/wp-content/uploads/2012/03/OPPT-Modified-Oswestry-Low-Back-Pain-Disability-Questionnaire.pdf

  3. Fear avoidance belief questionnaire [ Time Frame: change from baseline until 1 month after discharge of treatment ]
    http://etd.library.pitt.edu/ETD/available/etd-08222003-013408/unrestricted/ChildsH.pdf

  4. present pain with visual analog scale (VAS) [ Time Frame: change from baseline until 1 month after discharge of treatment ]
  5. medication consumption / return to work / side effects [ Time Frame: change from baseline until 1 week after discharge of treatment ]
    • Recording of medication consumption from the beginning until 1 week after treatment (discharge) (number of antalgic and/or AINS per day)
    • number of sick days
    • number of patients and description and duration of side effects

  6. body diagram/chart of pain symptoms [ Time Frame: change from baseline until 1 month after discharge of treatment ]

    The patient is asked to complete a body chart diagram depicting the area and intensity of pain and other symptoms.

    http://www.docstoc.com/docs/33916028/Body-Diagram


  7. patient specific functional scale PSFs [ Time Frame: change from baseline until 1 month after discharge of treatment ]

    This useful questionnaire can be used to quantify activity limitation and measure functional outcome for patients with any orthopaedic condition.

    http://www.deancare.com/pdf/providers/PSFS_patient_specific.pdf


  8. Patient's belief that spinal manipulation will improve the LBP status / Patient's belief that he received an effective spinal manipulation treatment ? [ Time Frame: baseline and after 1 week (discharge of treatment) ]
    Binary response Yes or No to both questions

  9. physical examination [ Time Frame: During the 2 sessions of treatment within one week ]
    • According to the clinical predictive rule, the patient will have some physical outcome measures (hips rotation, lumbar hypomobility)(Flynn et al. 2002)
    • According to pain provocative tests to determine specific pattern direction and levels of vertebral involvement. (Hidalgo et al. 2013 under submission in JMPT)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • non specific acute low back pain < 16 days,
  • no pain below the knee,
  • mobility deficit

Exclusion Criteria:

  • specific low back pain (red flags),
  • subacute or chronic non-specific LBP,
  • previous history of surgery,
  • high irritability,
  • hyperlaxity - aberrant movement when standing flexion,
  • post part um and pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801553


Locations
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Belgium
Emergency department of Saint-Luc University Hospital
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain
Investigators
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Study Director: Henri Nielens, MD-PhD IoNS-UCL
Principal Investigator: Benjamin Hidalgo, PhD-s IoNS-UCL
Publications:

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Responsible Party: Benjamin Hidalgo, PhD-student, assistant of teaching, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01801553    
Other Study ID Numbers: IoNS-UCL-Hidalgo-01
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014
Keywords provided by Benjamin Hidalgo, Université Catholique de Louvain:
spinal manipulation
low back pain
manual therapy
clinical predictive rule
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations