NCT02518360

Brief Summary

Determine the improvement in nonspecific low back pain patients with osteopathic techniques (Body Adjustment Protocol) and know changes in stabilometric measures analyzed with a stabilometric platform (Footscan®).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

Same day

First QC Date

August 2, 2015

Last Update Submit

June 21, 2016

Conditions

Keywords

NON SPECIFIC LOW BACK PAINOSTEOPATHYFOOT PRESSURE PLATFORMPOSTURAL BALANCE

Outcome Measures

Primary Outcomes (1)

  • Oswestry Questionnaire

    Improvement of low back pain measured by Oswestry Questionnaire: The results of the lumbar scale Oswestry disability percentage will be obtained. Results of the initial measurement, final month of treatment and compared.

    5 minutes

Secondary Outcomes (1)

  • Centre of Pressure Displacement

    5 minutes

Study Arms (2)

OSTEOPATHIC PROTOCOL

EXPERIMENTAL

Physiotherapist applies an osteopathic treatment in non-specific low back pain patients. The experimental group is treated with osteopathy, three sessions (20 minutes/session) and a frequency one session/week. Osteopathic treatment osteopathic is a body adjustment protocol. This protocol adjusts the musculoskeletal disorders since neck to lower limbs in the experimental group. Before treatment, immediately after the last session and a month later, are measured stabilometric parameters, height and Oswestry.

Other: Osteopathic

Auto Stretching

ACTIVE COMPARATOR

The patients realizes stretching protocol: two stretching global postures once a week (10 minutes for each posture) for three weeks: the first is for the anterior muscular chain and the second posture to stretch the posterior muscle chain. Before three stretching, immediately after the last session and a month later, are measured stabilometric parameters, height and Oswestry.

Other: Auto Stretching

Interventions

Body adjustment in three sessions (20 minutes/session).

Also known as: Manual Therapy, Muscle chains
OSTEOPATHIC PROTOCOL

The patients realize auto stretching in three sessions (20 minutes/session).

Also known as: Muscle chains
Auto Stretching

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 65 years.
  • Patients with non-specific low back pain.
  • Patients with alteration in the distribution of loads in a podiatric platform.

You may not qualify if:

  • Specific low back pain diagnosed.
  • Pregnancy.
  • Recent surgery in the last year.
  • Acute musculoskeletal disorders out of the lumbar region.
  • Patients with vestibular and instability problems.
  • Meniere syndrome.
  • Oncologic patients.
  • Patients with manual therapy treatment during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT - PhD

Study Record Dates

First Submitted

August 2, 2015

First Posted

August 7, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

June 22, 2016

Record last verified: 2016-06