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Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
osteopathic treatment + cognitive training
osteopathic treatment
usual care
Sponsored by
Come Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring osteopathic manipulative treatment, cognitive therapy, chronic low back pain, pain, disability

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Santa Lucia Foundation
  • Niguarda hospital
  • Orthoplus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

OMT+CT

osteopathic treatment

usual care

Arm Description

It consists of 8 sessions of osteopathic treatment and two 20-min sessions of cognitive training per week per 2 months

It consists of 8 sessions of osteopathic treatment throughout the 2-month study period

patients will continue the routine care as established by international guidelines

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

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.
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
BPQ
Baseline Changes in Body Perception Questionnaire
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
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.
Rate of AER
Number of participants with Adverse Events Reporting (AER) calculated by the rates
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."
TMT
Trail Making Test
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
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
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)
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)

Full Information

First Posted
February 14, 2020
Last Updated
February 18, 2020
Sponsor
Come Collaboration
Collaborators
Hospital General Universitario Santa Lucia, Niguarda Hospital, Orthoplus
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1. Study Identification

Unique Protocol Identification Number
NCT04277039
Brief Title
Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain
Official Title
Effects of Osteopathic Treatment in Combination With Cognitive Training on Low Back Pain Patients: a Randomised Sham-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Come Collaboration
Collaborators
Hospital General Universitario Santa Lucia, Niguarda Hospital, Orthoplus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
osteopathic manipulative treatment, cognitive therapy, chronic low back pain, pain, disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OMT+CT
Arm Type
Experimental
Arm Description
It consists of 8 sessions of osteopathic treatment and two 20-min sessions of cognitive training per week per 2 months
Arm Title
osteopathic treatment
Arm Type
Active Comparator
Arm Description
It consists of 8 sessions of osteopathic treatment throughout the 2-month study period
Arm Title
usual care
Arm Type
Other
Arm Description
patients will continue the routine care as established by international guidelines
Intervention Type
Other
Intervention Name(s)
osteopathic treatment + cognitive training
Intervention Description
This intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period
Intervention Type
Other
Intervention Name(s)
osteopathic treatment
Intervention Description
manual treatment using osteopathic procedure. 8 sessions for a 12 week study period
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
administration of non-steroid inflammatory drug according to international guidelines
Primary Outcome Measure Information:
Title
Change in NRS at 3 months
Description
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
Time Frame
3 months
Title
Change in RMDQ at 3 months
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in CSI
Description
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.
Time Frame
1 month - 3 month - 6 month
Title
Changes in Oswestry
Description
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
Time Frame
1 month - 3 month - 6 month
Title
BPQ
Description
Baseline Changes in Body Perception Questionnaire
Time Frame
1 month - 3 month - 6 month
Title
Changes in DASS-21
Description
Baseline changes in Depression Anxiety Stress Scales-21. The scale ranges from 0 to 36, where 36 indicates severe depression, anxiety and stress
Time Frame
1 month - 3 month - 6 month
Title
Changes in SF-36
Description
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.
Time Frame
1 month - 3 month - 6 month
Title
Rate of AER
Description
Number of participants with Adverse Events Reporting (AER) calculated by the rates
Time Frame
1 month - 3 month - 6 month
Title
Changes in SCWT
Description
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."
Time Frame
1 month - 3 month - 6 month
Title
TMT
Description
Trail Making Test
Time Frame
1 month - 3 month - 6 month
Title
Change in NRS at 1 month
Description
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
Time Frame
1 month
Title
Change in NRS at 6 months
Description
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
Time Frame
6 months
Title
Change in RMDQ at 1 month
Description
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)
Time Frame
1 month
Title
Change in RMDQ at 6 months
Description
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)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Cerritelli, PhD
Phone
+393394332801
Email
francesco.cerritelli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Cerritelli, PhD
Organizational Affiliation
Come Collaboration
Official's Role
Study Chair
Facility Information:
Facility Name
Santa Lucia Foundation
City
Roma
State/Province
Lazio
ZIP/Postal Code
00179
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Tramontano
Phone
0651501420
Email
m.tramontano@hsantalucia.it
Facility Name
Niguarda hospital
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20161
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Uberti
Phone
3492624521
Email
stefano.uberti@isoi.it
Facility Name
Orthoplus
City
Bolzano
State/Province
Trentino
ZIP/Postal Code
39100
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Ghedina
Phone
0471976433
Email
ghedinaosteopatia@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
available upon request

Learn more about this trial

Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain

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