Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain (LC OSTEO)

• ClinicalTrials.gov Identifier: NCT02034864
• Recruitment Status: Completed
• First Posted: January 14, 2014
• Last Update Posted: January 23, 2019
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Université Paris Cité; University of Paris 5 - Rene Descartes; Institut Universitaire Romand de Sante au Travail
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: January 10, 2014
• First Posted Date: January 14, 2014
• Last Update Posted Date: January 23, 2019
• Actual Study Start Date: February 17, 2014
• Actual Primary Completion Date: October 23, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 2, 2018)

Mean improvement from baseline in mean activity limitation [ Time Frame: 3 months after randomization ]

Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)

Original Primary Outcome Measures (submitted: January 10, 2014)

Quebec back pain disability scale [ Time Frame: 3 months ]

This is a 20-item condition-specific questionnaire to assess the degree of disability in patient. It evaluates the following daily tasks: sleeping, walking, sitting, standing, lifting large or heavy objects, bending and stooping

Current Secondary Outcome Measures (submitted: January 18, 2019)

• Mean reduction from baseline in mean lumbar pain in the previous 48 hrs [ Time Frame: 3 months after randomization ]
  assessed with a self-administered 11-class numeric scale (from 0 no pain to 100, maximal pain)
• Mean reduction from baseline in mean lumbar pain in the previous 48 hrs [ Time Frame: 12 months after randomization ]
  assessed with a self-administered 11-class numeric scale (from 0, no pain to 100, maximal pain)
• Number of sick leaves [ Time Frame: 12 months after randomization ]
  self-reported number of sick leaves
• Duration of sick leaves [ Time Frame: 12 months after randomization ]
  self-reported total duration (days) of sick leaves
• Recurrence of pain [ Time Frame: 12 months after randomization ]
  self-reported number of low back pain episodes
• Mean improvement from baseline in mean activity limitation [ Time Frame: 12 months after randomization ]
  Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)
• Mean improvement from baseline in mean quality of life [ Time Frame: 3 months after randomization ]
  Assessed with the physical and mental components of the self-administered MOS SF-12 questionnaire (from 0, worse quality of life to 100, best quality of life)
• Mean improvement from baseline in mean quality of life [ Time Frame: 12 months after randomization ]
  Assessed with the physical and mental components of the self-administered MOS SF-12 questionnaire (from 0, worse quality of life to 100, best quality of life)
• Pain killer and non-steroidal anti-inflammatory drug consumption [ Time Frame: 3 months after randomization ]
  self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)
• Pain killer and non-steroidal anti-inflammatory drug consumption [ Time Frame: 12 months after randomization ]
  self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)

Original Secondary Outcome Measures (submitted: January 10, 2014)

• numerical scale [ Time Frame: 3 months ]
  Pain is evaluated on a numeric scale (from 1 to 10)
• numerical scale [ Time Frame: 12 months ]
  Pain is evaluated on a numeric scale (from 1 to 10)
• number of sick leave [ Time Frame: at 6 months ]
• duration of sick leave [ Time Frame: at 6 months ]
• Number of low back pain episodes [ Time Frame: 12 mois ]
  evaluation of recurrence of pain
• Quebec back pain disability scale [ Time Frame: 12 months ]
  This is a 20-item condition-specific questionnaire to assess the degree of disability in patient. It evaluates the following daily tasks: sleeping, walking, sitting, standing, lifting large or heavy objects, bending and stooping
• Mo SF12 [ Time Frame: 3 months ]
  Modified form of "Medical Outcomes Study Short-Form General Health Survey" (SF 36), comprising 12 questions. It includes one multi-item scale that assesses eight health concepts: includes one multi-item scale that assesses eight health concepts.
• Mo SF12 [ Time Frame: 12 months ]
  Modified form of "Medical Outcomes Study Short-Form General Health Survey" (SF 36), comprising 12 questions. It includes one multi-item scale that assesses eight health concepts: includes one multi-item scale that assesses eight health concepts.
• Number of pain killer and Non-steroidal anti-inflammatory drug consumption [ Time Frame: 3 months ]
• frequency of pain killer and Non-steroidal anti-inflammatory drug consumption [ Time Frame: 3 months ]
• Type of Pain killer and Non-steroidal anti-inflammatory drug consumption [ Time Frame: 3 months ]
• Number of pain killer and Non-steroidal anti-inflammatory drug consumption [ Time Frame: 12 months ]
• frequency of pain killer and Non-steroidal anti-inflammatory drug consumption [ Time Frame: 12 months ]
• Type of Pain killer and Non-steroidal anti-inflammatory drug consumption [ Time Frame: 12 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain
• Official Title: Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain at 3 Months : a Randomised Controlled Trial
• Brief Summary: The purpose of this study is to determine whether a standardised osteopathic manipulative treatment is more effective than a placebo of osteopathic manipulative treatment, in sub-acute and chronic non-specific low back pain on functional recovery at 3 months.
• Detailed Description: Sub-acute (4-12-week duration) and chronic (more than 3-month duration) non-specific low back pain (LBP) is frequent, disabling and costly. The effectiveness of usual treatments (including pain killers, anti-inflammatory drugs, spinal injections, physiotherapy, spinal traction, transcutaneous electrical nerve stimulation, etc) may be not sufficient, and many patients resort to alternative therapies. Manipulative treatments represent en emerging therapy in this area, although studies assessing their effectiveness are limited and often biased. The purpose of this study is to evaluate the efficacy of two manual therapies on improving functional recovery in sub-acute and chronic non-specific low back pain at 3 months. A standardised osteopathic manipulative treatment is compare to a placebo of osteopathic manipulative treatment.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Subacute and Chronic Non-specific Low Back Pain

Intervention

• Other: Osteopathic manipulative treatment
  A standardized manipulative treatment according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized manipulative treatment.
• Other: Placebo of osteopathic manipulative treatment
  A standardized placebo of manipulative treatment consisting in "light touch" and according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized placebo of manipulative treatment.

Study Arms

• Experimental: Osteopathic manipulative treatment
  6 sessions of standardized manipulative treatment
  Intervention: Other: Osteopathic manipulative treatment
• Sham Comparator: Placebo of osteopathic manipulative treatment
  6 sessions of standardized placebo of manipulative treatment
  Intervention: Other: Placebo of osteopathic manipulative treatment

Publications *

• 1. Poiraudeau S, Lefèvre-Colau M.-M, Fayad F., Rannou F, Revel M. Lombalgie. Encyclopédie Médico-Chirurgicale 15-840-C-10 (2004)
• Chou R, Huffman LH; American Pain Society; American College of Physicians. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):505-14. doi: 10.7326/0003-4819-147-7-200710020-00008. Erratum In: Ann Intern Med. 2008 Feb 5;148(3):247-8.
• Nelemans PJ, de Bie RA, de Vet HC, Sturmans F. WITHDRAWN: Injection therapy for subacute and chronic benign low-back pain. Cochrane Database Syst Rev. 2007 Jul 18;(2):CD001824. doi: 10.1002/14651858.CD001824.pub2.
• Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.
• Costa LO, Maher CG, Latimer J, Hodges PW, Herbert RD, Refshauge KM, McAuley JH, Jennings MD. Motor control exercise for chronic low back pain: a randomized placebo-controlled trial. Phys Ther. 2009 Dec;89(12):1275-86. doi: 10.2522/ptj.20090218. Epub 2009 Nov 5.
• Lambeek LC, van Mechelen W, Knol DL, Loisel P, Anema JR. Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life. BMJ. 2010 Mar 16;340:c1035. doi: 10.1136/bmj.c1035.
• Lindell O, Johansson SE, Strender LE. Subacute and chronic, non-specific back and neck pain: cognitive-behavioural rehabilitation versus primary care. A randomized controlled trial. BMC Musculoskelet Disord. 2008 Dec 30;9:172. doi: 10.1186/1471-2474-9-172.
• Macario A, Pergolizzi JV. Systematic literature review of spinal decompression via motorized traction for chronic discogenic low back pain. Pain Pract. 2006 Sep;6(3):171-8. doi: 10.1111/j.1533-2500.2006.00082.x.
• Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. Ann Intern Med. 2003 Jun 3;138(11):871-81. doi: 10.7326/0003-4819-138-11-200306030-00008.
• Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun;4(3):335-56. doi: 10.1016/j.spinee.2003.06.002.
• Manheimer E, White A, Berman B, Forys K, Ernst E. Meta-analysis: acupuncture for low back pain. Ann Intern Med. 2005 Apr 19;142(8):651-63. doi: 10.7326/0003-4819-142-8-200504190-00014. Erratum In: Ann Intern Med. 2005 Jun 7;142(11):950-1.
• Rubinstein SM, van Middelkoop M, Kuijpers T, Ostelo R, Verhagen AP, de Boer MR, Koes BW, van Tulder MW. A systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain. Eur Spine J. 2010 Aug;19(8):1213-28. doi: 10.1007/s00586-010-1356-3. Epub 2010 Mar 14.
• Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.
• Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. N Engl J Med. 1999 Nov 4;341(19):1426-31. doi: 10.1056/NEJM199911043411903.
• Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, Swift J Jr. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1355-62. doi: 10.1097/01.BRS.0000067110.61471.7D.
• Hoehler FK, Tobis JS, Buerger AA. Spinal manipulation for low back pain. JAMA. 1981 May 8;245(18):1835-8.
• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
• Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008 Feb 19;148(4):295-309. doi: 10.7326/0003-4819-148-4-200802190-00008.
• Nguyen C, Boutron I, Zegarra-Parodi R, Baron G, Alami S, Sanchez K, Daste C, Boisson M, Fabre L, Krief P, Krief G, Lefevre-Colau MM, Rannou F. Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2021 May 1;181(5):620-630. doi: 10.1001/jamainternmed.2021.0005.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 10, 2014): 400
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 23, 2017
• Actual Primary Completion Date: October 23, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient consulting for subacute and chronic non-specific low
• Male or female aged from 18 to 65 years (included)
• Patient can speak and understand French
• Patient giving his informed consent to participate in the study
• Patient affiliated to or beneficiary of social insurance

Exclusion Criteria:

• Specific low-back pain caused by inflammatory, tumoral, infectious disease or a back traumatism in the 3 past months
• History of back surgery and/or vertebral fracture in the previous 6 months
• Presence of a motor impairment related to the reason for consultation
• The patient is a student or a practitioner in manipulative therapies
• Pregnancy
• Inability to understand the process of the study
• The patient is already included in another clinical study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02034864
• Other Study ID Numbers: P110142
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current

Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France
• Université Paris Cité
• University of Paris 5 - Rene Descartes
• Institut Universitaire Romand de Sante au Travail

Investigators

• Principal Investigator: Francois Rannou, MD PhD; AP-HP, Descartes University, INSERM

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: January 2019