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

NCT01801553 | Terminated DMC

• 1 other identifier: IoNS-UCL-Hidalgo-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain

Keywords

spinal manipulation; low back pain; manual therapy; clinical predictive rule

Outcome Measures

Primary Outcomes (1)

• Kinematic spine model (Hidalgo et al. 2012 Journal of Rehabilitation medicine)

  Use of quantitative variables for ROM and SPEED using two Logit Score Index (ROM and SPEED)

  Change from baseline and 1 week after discharge of treatment

Secondary Outcomes (9)

• Start back tool (screening questionnaire)

  change from baseline until 1 month after discharge of treatment

• Oswestry Disability questionnaire

  change from baseline until 1 month after discharge of treatment

• Fear avoidance belief questionnaire

  change from baseline until 1 month after discharge of treatment

• present pain with visual analog scale (VAS)

  change from baseline until 1 month after discharge of treatment

• medication consumption / return to work / side effects

  change from baseline until 1 week after discharge of treatment

Study Arms (2)

spinal manipulation intervention group

ACTIVE COMPARATOR

Spinal manipulation: 3 sessions within one week of true lumbopelvic manipulation

Other: Spinal manipulation; Other: Usual medical care

Spinal manipulation control group

SHAM COMPARATOR

Sham spinal manipulation: 3 sessions within one week of sham lumbopelvic manipulation

Other: sham spinal manipulation; Other: Usual medical care

Interventions

Spinal manipulation OTHER

-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.

spinal manipulation intervention group

sham spinal manipulation OTHER

Spinal manipulation control group

Usual medical care OTHER

Spinal manipulation control group; spinal manipulation intervention group

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Emergency department of Saint-Luc University Hospital

Brussels, 1200, Belgium

Location

Related Publications (10)

• Childs JD, Fritz JM, Piva SR, Erhard RE. Clinical decision making in the identification of patients likely to benefit from spinal manipulation: a traditional versus an evidence-based approach. J Orthop Sports Phys Ther. 2003 May;33(5):259-72. doi: 10.2519/jospt.2003.33.5.259. No abstract available.

  PMID: 12775000 BACKGROUND

• Cleland JA, Fritz JM, Kulig K, Davenport TE, Eberhart S, Magel J, Childs JD. Comparison of the effectiveness of three manual physical therapy techniques in a subgroup of patients with low back pain who satisfy a clinical prediction rule: a randomized clinical trial. Spine (Phila Pa 1976). 2009 Dec 1;34(25):2720-9. doi: 10.1097/BRS.0b013e3181b48809.

  PMID: 19940729 BACKGROUND

• Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.

  PMID: 22466247 BACKGROUND

• Flynn T, Fritz J, Whitman J, Wainner R, Magel J, Rendeiro D, Butler B, Garber M, Allison S. A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation. Spine (Phila Pa 1976). 2002 Dec 15;27(24):2835-43. doi: 10.1097/00007632-200212150-00021.

  PMID: 12486357 BACKGROUND

• Fritz JM, Delitto A, Erhard RE. Comparison of classification-based physical therapy with therapy based on clinical practice guidelines for patients with acute low back pain: a randomized clinical trial. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1363-71; discussion 1372. doi: 10.1097/01.BRS.0000067115.61673.FF.

  PMID: 12838091 BACKGROUND

• Fritz JM, Childs JD, Flynn TW. Pragmatic application of a clinical prediction rule in primary care to identify patients with low back pain with a good prognosis following a brief spinal manipulation intervention. BMC Fam Pract. 2005 Jul 14;6(1):29. doi: 10.1186/1471-2296-6-29.

  PMID: 16018809 BACKGROUND

• Hidalgo B, Gilliaux M, Poncin W, Detrembleur C. Reliability and validity of a kinematic spine model during active trunk movement in healthy subjects and patients with chronic non-specific low back pain. J Rehabil Med. 2012 Sep;44(9):756-63. doi: 10.2340/16501977-1015.

  PMID: 22847223 BACKGROUND

• Hidalgo B, Hall T, Nielens H, Detrembleur C. Intertester agreement and validity of identifying lumbar pain provocative movement patterns using active and passive accessory movement tests. J Manipulative Physiol Ther. 2014 Feb;37(2):105-15. doi: 10.1016/j.jmpt.2013.09.006. Epub 2014 Jan 6.

  PMID: 24401656 BACKGROUND

• Hidalgo B, Gobert F, Bragard D, Detrembleur C. Effects of proprioceptive disruption on lumbar spine repositioning error in a trunk forward bending task. J Back Musculoskelet Rehabil. 2013;26(4):381-7. doi: 10.3233/BMR-130396.

  PMID: 23948825 BACKGROUND

• Hidalgo B, Detrembleur C, Hall T, Mahaudens P, Nielens H. The efficacy of manual therapy and exercise for different stages of non-specific low back pain: an update of systematic reviews. J Man Manip Ther. 2014 May;22(2):59-74. doi: 10.1179/2042618613Y.0000000041.

  PMID: 24976749 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Henri Nielens, MD-PhD

  IoNS-UCL

  STUDY DIRECTOR

• Benjamin Hidalgo, PhD-s

  IoNS-UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-student, assistant of teaching

Study Record Dates

• First Submitted: February 23, 2013
• First Posted: March 1, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

BE (1)