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

Primary Purpose

Lower Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Osteopathic
Auto Stretching
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain focused on measuring NON SPECIFIC LOW BACK PAIN, OSTEOPATHY, FOOT PRESSURE PLATFORM, POSTURAL BALANCE

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    OSTEOPATHIC PROTOCOL

    Auto Stretching

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Centre of Pressure Displacement
    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.

    Full Information

    First Posted
    August 2, 2015
    Last Updated
    June 21, 2016
    Sponsor
    Universidad Miguel Hernandez de Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02518360
    Brief Title
    Osteopathic Treatment in Patients With Low Back Pain: Stabilometry
    Acronym
    Osteop-COP
    Official Title
    Effect of Osteopathic Treatment in Patients With Nonspecific Low Back Pain: Stabilometry
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Miguel Hernandez de Elche

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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®).
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lower Back Pain
    Keywords
    NON SPECIFIC LOW BACK PAIN, OSTEOPATHY, FOOT PRESSURE PLATFORM, POSTURAL BALANCE

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OSTEOPATHIC PROTOCOL
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Auto Stretching
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Osteopathic
    Other Intervention Name(s)
    Manual Therapy, Muscle chains
    Intervention Description
    Body adjustment in three sessions (20 minutes/session).
    Intervention Type
    Other
    Intervention Name(s)
    Auto Stretching
    Other Intervention Name(s)
    Muscle chains
    Intervention Description
    The patients realize auto stretching in three sessions (20 minutes/session).
    Primary Outcome Measure Information:
    Title
    Oswestry Questionnaire
    Description
    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.
    Time Frame
    5 minutes
    Secondary Outcome Measure Information:
    Title
    Centre of Pressure Displacement
    Description
    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.
    Time Frame
    5 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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    Osteopathic Treatment in Patients With Low Back Pain: Stabilometry

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