NCT04277039

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

February 14, 2020

Last Update Submit

February 18, 2020

Conditions

Low Back Pain

Keywords

osteopathic manipulative treatmentcognitive therapychronic low back painpaindisability

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Changes in CSI

    1 month - 3 month - 6 month

  • Changes in Oswestry

    1 month - 3 month - 6 month

  • BPQ

    1 month - 3 month - 6 month

  • Changes in DASS-21

    1 month - 3 month - 6 month

  • Changes in SF-36

    1 month - 3 month - 6 month

  • +7 more secondary outcomes

Study Arms (3)

OMT+CT

EXPERIMENTAL

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

osteopathic treatment

ACTIVE COMPARATOR

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

Other: osteopathic treatment

usual care

OTHER

patients will continue the routine care as established by international guidelines

Other: usual care

Interventions

osteopathic treatment + cognitive trainingOTHER

This intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period

OMT+CT
osteopathic treatmentOTHER

manual treatment using osteopathic procedure. 8 sessions for a 12 week study period

osteopathic treatment
usual careOTHER

administration of non-steroid inflammatory drug according to international guidelines

usual care

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Santa Lucia Foundation

Rome, Lazio, 00179, Italy

Location

Niguarda hospital

Milan, Lombardy, 20161, Italy

Location

Orthoplus

Bolzano, Trentino-Alto Adige, 39100, Italy

Location

MeSH Terms

Conditions

Low Back PainPain

Interventions

Cognitive TrainingManipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesMusculoskeletal ManipulationsComplementary TherapiesPhysical Therapy Modalities

Study Officials

  • Francesco Cerritelli, PhD

    Come Collaboration

    STUDY CHAIR

Central Study Contacts

Francesco Cerritelli, PhD

CONTACT

+393394332801francesco.cerritelli@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 20, 2020

Study Start

March 1, 2020

Primary Completion

March 30, 2021

Study Completion

June 30, 2021

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

available upon request

Locations

IT(3)