Osteopathic Treatment in Patients With Low Back Pain: Stabilometry (Osteop-COP)

June 21, 2016 updated by: Emilio-José Poveda-Pagán, Universidad Miguel Hernandez de Elche

Effect of Osteopathic Treatment in Patients With Nonspecific Low Back Pain: Stabilometry

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®).

Study Overview

Status

Completed

Conditions

Detailed Description

Fifty patients participate in this study (25 experimental group with body adjustment protocol of osteopathy and 25 control group). For a first objective of this study, all the patients determine if the osteopathic approach to the body adjustment approach will improve low back pain (Oswestry Questionnaire). For the second aim, the investigators want to know if there are changes in the distribution of body weight in lower limbs in group experimental and control group, analyzed with a stabilometric platform (Footscan®).

The experimental group is treated with osteopathy, three sessions (20 minutes/session) and a frequency one session/week. The treatment osteopathic is the body adjustment protocol. In the other hand, the control group made 2 stretching global postures once a week (10 minutes for each posture) for three weeks: the first was for the anterior muscular chain and the second posture to stretch the posterior muscle chain. Before treatment, immediately after the last session and a month later, are measured stabilometric parameters, height and Oswestry.

The analysis will be made with Statistical Package for the Social Sciences (SPSS Statistics) 22.0

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OSTEOPATHIC PROTOCOL

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.

Body adjustment in three sessions (20 minutes/session).
Other Names:
  • Manual Therapy
  • Muscle chains
Active Comparator: Auto Stretching
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.
The patients realize auto stretching in three sessions (20 minutes/session).
Other Names:
  • Muscle chains

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Questionnaire
Time Frame: 5 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Centre of Pressure Displacement
Time Frame: 5 minutes

Stabilometry used to assess Centre of Pressure Displacement. The stabilometric results will be obtained in percentages. The most important variables are the percentage of load anterior, load posterior, load right side and load left side.

Results of the initial measurement, final month of treatment and compared.

5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 2, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniversidadMHE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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