NCT02123693

Brief Summary

The aim of the present study is to determine whether there is a relationship between osteopathic treatment and the change of physiological axes of the lumbar spine, through the use of Dynamic Magnetic Resonance Imaging.

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
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

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

April 24, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

April 24, 2014

Last Update Submit

September 15, 2014

Conditions

Low Back Pain

Keywords

Osteopathic manipulative treatmentLow back painDynamic MRI

Outcome Measures

Primary Outcomes (1)

  • Baseline changes in degree of flection of lumbar spine

    at entry and after 8 weeks

Secondary Outcomes (2)

  • Baseline changes in Visual Analogue Scale

    at entry and after 8 weeks

  • Baseline changes in Roland-Morris questionnaire

    at entry and after 8 weeks

Study Arms (3)

Osteopathic Manipulative Treatment

EXPERIMENTAL

5 sessions of treatment will be carried out: the first 3 weekly, and the remaining 2 after 15 days. The type of treatment will be based on indirect techniques

Other: Osteopathic manipulative treatment

Sham therapy

SHAM COMPARATOR

5 sessions of treatment will be carried out: the first 3 weekly, and the remaining 2 after 15 days. The type of treatment will be based on specific parameters set out previously based on a predetermined protocol

Other: Sham Therapy

No intervention

OTHER

Patients in this group will not receive any type of intervention, both therapeutic than fictitious, and will not be evaluated by any operator

Other: No Intervention

Interventions

Osteopathic manipulative treatmentOTHER
Osteopathic Manipulative Treatment
Sham TherapyOTHER
Sham therapy
No InterventionOTHER
No intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • will be admitted patients of both genders
  • patients with chronic low back pain at baseline
  • patients aged between 18 and 35 years

You may not qualify if:

  • patients diagnosed with the disease of the musculoskeletal system or congenital malformation of the column
  • patients with disorders of the pelvic floor, or who have undergone surgery of the reproductive system
  • patients with neurological disorders that can cause painful symptoms of lumbar segment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiology Unit II, University Hospital San Salvatore L'Aquila

L’Aquila, Abruzzo, 67100, Italy

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

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
SPONSOR

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 25, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

IT(1)