Status unknownNCT02123693Updated Sep 16, 2014

The Role of Osteopathic Treatment in the Axial Variations of the Lumbar Spine: RCT

An interventional study of Osteopathic manipulative treatment and Sham Therapy in Low Back Pain, sponsored by European Institute for Evidence Based Osteopathic Medicine. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2014-09-16.

Sponsored by European Institute for Evidence Based Osteopathic Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 35 Years
Sex: All

Study 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.

Conditions studied

Low Back Pain

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Keywords

Osteopathic manipulative treatment
Low back pain
Dynamic MRI

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

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Lead sponsor

European Institute for Evidence Based Osteopathic Medicine is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 35 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 30 participants (estimated)

Study arms

Experimental
Osteopathic Manipulative Treatment
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 comparator
Sham therapy
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
Other
No intervention
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

OtherOsteopathic manipulative treatment
OtherSham Therapy
OtherNo Intervention

What researchers measure

Primary outcomes

Baseline changes in degree of flection of lumbar spine
Time frame: at entry and after 8 weeks

Secondary outcomes

Baseline changes in Visual Analogue Scale
Time frame: at entry and after 8 weeks
Baseline changes in Roland-Morris questionnaire
Time frame: at entry and after 8 weeks

Study locations

1 of 1 sites recruiting

Radiology Unit II, University Hospital San Salvatore L'Aquila
L'Aquila, Abruzzo 67100, Italy
- Luca Cicchitti, DO · Contact · cicchittiluca@gmail.com · 3925263387
- Luca Cicchitti, DO · Sub investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02123693
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Responsible party: Sponsor
First posted: Apr 25, 2014
Start date: Jun 2014
Primary completion: Dec 2014 (estimated)
Completion: Feb 2015 (estimated)
Last update: Sep 16, 2014

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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