Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain

Effects of Osteopathic Treatment in Combination With Cognitive Training on Low Back Pain Patients: a Randomised Sham-controlled Trial

The objective of this study is to verify whether the combined approach (osteopathic manipulative treatment -OMT- and cognitive training -CT) is more effective in the long term than the individual approaches (OMT or CT) in patients with chronic lumbar pain, evaluating the Numeric Rating Scale (NRS) and the Rolland-Morris Disability Questionnaire (RMDQ) questionnaire

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Other: osteopathic treatment + cognitive training; Other: osteopathic treatment; Other: usual care

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00179
      • Santa Lucia foundation
  • Lombardia
    • Milan, Lombardia, Italy, 20161
      • Niguarda hospital
  • Trentino
    • Bolzano, Trentino, Italy, 39100
      • Orthoplus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• aged between 30 and 65 y
• diagnosis of aspecific chronic low back pain
• minimum of 3 on the NRS score

Exclusion Criteria:

• Neuropathic pain or chronic widespread pain
• Low back spinal surgery in the last three years
• Low back spinal surgery to osteoporosis and/or traumatic fractures
• Rheumatic disease
• Pregnancy or having a baby in the last 12 months
• Painful disease in evidence through RX, MRI or CT in the last 6 months (listesis, moderate arthrosis, severe, algodystrophy etc.).
• The subjects have not to be treated with physical or manual therapies or psychotherapy in the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OMT+CT; It consists of 8 sessions of osteopathic treatment and two 20-min sessions of cognitive training per week per 2 months	Other: osteopathic treatment + cognitive training; This intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period
Active Comparator: osteopathic treatment; It consists of 8 sessions of osteopathic treatment throughout the 2-month study period	Other: osteopathic treatment; manual treatment using osteopathic procedure. 8 sessions for a 12 week study period
Other: usual care; patients will continue the routine care as established by international guidelines	Other: usual care; administration of non-steroid inflammatory drug according to international guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NRS at 3 months	Change from Baseline Numeric Rating Scale (NRS) of Pain at 3 months. NRS values range from 0-10, where 10 means highest pain and 0 no pain	3 months
Change in RMDQ at 3 months	Change from Baseline Rolland Morris Disability Questionnaire (RMDQ) at 3 months. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in CSI	Baseline changes in Central Sensitization index (CSI). CSI values ranges from 0 to 100. A score of more than 40 indicates the presence of central sensitisation.	1 month - 3 month - 6 month
Changes in Oswestry	Baseline changes in Oswestry Low Back Pain Disability Questionnaire. The questionnaire range is from 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible	1 month - 3 month - 6 month
BPQ	Baseline Changes in Body Perception Questionnaire	1 month - 3 month - 6 month
Changes in DASS-21	Baseline changes in Depression Anxiety Stress Scales-21. The scale ranges from 0 to 36, where 36 indicates severe depression, anxiety and stress	1 month - 3 month - 6 month
Changes in SF-36	Baseline changes in the Short Form-36. The questionnaire is a health survey ranging from 0 to 100. The lower the score the more disability.	1 month - 3 month - 6 month
Rate of AER	Number of participants with Adverse Events Reporting (AER) calculated by the rates	1 month - 3 month - 6 month
Changes in SCWT	Baseline changes in Stroop Color and Word Test. Word, color, and color-word T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal."	1 month - 3 month - 6 month
TMT	Trail Making Test	1 month - 3 month - 6 month
Change in NRS at 1 month	Change from Baseline Numeric Rating Scale (NRS) of Pain at 1 month. NRS values range from 0-10, where 10 means highest pain and 0 no pain	1 month
Change in NRS at 6 months	Change from Baseline Numeric Rating Scale (NRS) of Pain at 6 months. NRS values range from 0-10, where 10 means highest pain and 0 no pain	6 months
Change in RMDQ at 1 month	Change from Baseline Rolland Morris Disability Questionnaire (RMDQ) at 1 month. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)	1 month
Change in RMDQ at 6 months	Change from Baseline Rolland Morris Disability Questionnaire (RMDQ) at 6 months. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)	6 months

Collaborators and Investigators

• Sponsor: Come Collaboration
• Collaborators: Niguarda Hospital; Hospital General Universitario Santa Lucia; Orthoplus
• Investigators: Study Chair: Francesco Cerritelli, PhD, Come Collaboration

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: pain; chronic low back pain; disability; cognitive therapy; osteopathic manipulative treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: COME-01-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No