- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02518360
Osteopathic Treatment in Patients With Low Back Pain: Stabilometry (Osteop-COP)
Effect of Osteopathic Treatment in Patients With Nonspecific Low Back Pain: Stabilometry
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
|
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:
|
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UniversidadMHE
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