Lower Back PainOsteop-COPNCT02518360
Osteopathic Treatment in Patients With Low Back Pain: Stabilometry
A study testing Osteopathic and Auto Stretching in people with Lower Back Pain, run by Universidad Miguel Hernandez de Elche.
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®). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Osteopathic and Auto Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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®).
Read the 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
- Conditions
- Lower Back Pain
- Being tested
- Osteopathic, Auto Stretching
- Keywords
- NON SPECIFIC LOW BACK PAIN, OSTEOPATHY, FOOT PRESSURE PLATFORM, POSTURAL BALANCE
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteopathicOther
Also called Manual Therapy, Muscle chains
Body adjustment in three sessions (20 minutes/session).
Auto StretchingOther
Also called Muscle chains
The patients realize auto stretching in three sessions (20 minutes/session).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Auto Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Secondary outcomes (1)
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio-José Poveda-Pagán, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518360
- Sponsor's protocol ID
- UniversidadMHE
- Acronym
- Osteop-COP
- Status last verified
- Jun 2016
- First submitted
- 2 Aug 2015
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathic Treatment in Patients With Nonspecific Low Back Pain: Stabilometry
- ClinicalTrials.gov ID
- NCT02518360
- Acronym / sponsor ID
- Osteop-COP / UniversidadMHE
- Conditions
- Lower Back Pain
- Keywords
- NON SPECIFIC LOW BACK PAIN, OSTEOPATHY, FOOT PRESSURE PLATFORM, POSTURAL BALANCE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSTEOPATHIC PROTOCOL | Experimental | Other: OsteopathicPhysiotherapist 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. |
| Auto Stretching | Active comparator | Other: Auto StretchingThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsteopathicAlso: Manual Therapy, Muscle chainsBody adjustment in three sessions (20 minutes/session). | Other | OSTEOPATHIC PROTOCOL |
| Auto StretchingAlso: Muscle chainsThe patients realize auto stretching in three sessions (20 minutes/session). | Other | Auto Stretching |
Primary outcome
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.
1 secondary outcome
Centre of Pressure Displacement
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic and Auto Stretching in people with Lower Back Pain, run by Universidad Miguel Hernandez de Elche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Questionnaire (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.