Osteopathic Treatment in Patients With Low Back Pain: Stabilometry

Lower Back Pain Clinical Trial

— Osteop-COP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518360
• Other study ID #: UniversidadMHE
• Status: Completed
• Phase: N/A
• First received: August 2, 2015
• Last updated: June 21, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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®).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

Other:
• Osteopathic
Body adjustment in three sessions (20 minutes/session).
• Auto Stretching
The patients realize auto stretching in three sessions (20 minutes/session).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	5 minutes	No