Low Back PainNCT02752620
Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain
A study testing Osteopathic Manipulative Treatment and Exercise Therapy in people with Low Back Pain, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
This study evaluates the effectiveness of treatment osteopathic manipulation in the treatment of subjects with chronic nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Osteopathic Manipulative Treatment and Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to Oct 2016
- 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 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with constant or intermittent low back pain with intensity greater than 30 mm visual analog scale (VAS) for at least three months duration, with a diagnosis of chronic low back pain
Who cannot join
- Subjects who have spine fractures,
- Dislocations
- Ligament ruptures
- Muscle ruptures
- Skin lacerations
- Sacroiliitis
Show all 17Show fewer
- Vertebral osteomyelitis
- Infection
- Disc herniations with radicular symptoms
- Rheumatic disorders
- Cauda equina syndrome
- Tumors
- Referred pain visceral
- Red flags
- Lower limb discrepancy greater than 2 cm
- Several conditions requiring participants to be absent for more than two weeks of activities in the experiment
- Positioning itself as not volunteer the same.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain: a Randomized Controlled and Double-blind Trial
This study evaluates the effectiveness of treatment osteopathic manipulation in the treatment of subjects with chronic nonspecific low back pain.
- Conditions
- Low Back Pain
- Being tested
- Osteopathic Manipulative Treatment, Exercise Therapy
- Keywords
- osteopathic manipulative treatment, Chronic nonspecific low back pain, low back pain
- 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.
Osteopathic Manipulative TreatmentOther
Exercise TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | We selected two types of osteopathic techniques for this study:
Technical articulation: rhythmic technique with low speed in which the goal is the full gain range of motion.
Myofascial techniques (Neuromuscular): techniques involving lateral stretching, linear, deep pressures and pulls of the origins and insertions aiming at a myofascial relaxation.
Sacroiliac articulatory technique; Dorsal articulatory technique; Lumbar paraspinal muscles stretching technique; Lumbar myofascial technique (inhibitory). Receives: Other: Osteopathic Manipulative Treatment |
| Exercise Therapy | Active comparator | 2 types of therapeutic exercises techniques were used:
* Stabilization exercises
* Stretches
Stabilization exercises:
Bridge on the ball 10 - 15 sec Side plank 10 - 15 sec Front board 10 - 15 sec active mobilization lumbopelvic 3 x 6 rep Squats with the ball on the wall 3 x 8 rep
Static-passive stretch (2 x 30 sec):
Paraspinal; Abdominals; Quadratus lumborum; Hip extenders; Hip flexors; Hip abductors; Hip adductors. Receives: Other: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
VAS (VISUAL ANALOGUE SCALE)
Measured: 5 weeks
Secondary outcomes (3)
Disability
Oswestry Disability Index 2.0
Measured: 5 weeks
kinesiophobia
Tampa Scale for Kinesiophobia
Measured: 5 weeks
Depression
Beck Scale for Depression
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low 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
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Estácio S.A.
- Responsible party
- Principal investigator, Frederico de Oliveira Meirelles, Rio de Janeiro State University
- Investigators
- Frederico Meirelles, Master /PT, Principal investigator, UERJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752620
- Sponsor's protocol ID
- 46194215.9.0000.5284
- Status last verified
- Oct 2016
- First submitted
- 23 Apr 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain: a Randomized Controlled and Double-blind Trial
- ClinicalTrials.gov ID
- NCT02752620
- Acronym / sponsor ID
- 46194215.9.0000.5284
- Conditions
- Low Back Pain
- Keywords
- osteopathic manipulative treatment, Chronic nonspecific low back pain, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Estácio S.A.
- Study start
- May 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Apr 2016 (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.
This study evaluates the effectiveness of treatment osteopathic manipulation in the treatment of subjects with chronic nonspecific low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Other: Osteopathic Manipulative TreatmentWe selected two types of osteopathic techniques for this study: Technical articulation: rhythmic technique with low speed in which the goal is the full gain range of motion. Myofascial techniques (Neuromuscular): techniques involving lateral stretching, linear, deep pressures and pulls of the origins and insertions aiming at a myofascial relaxation. Sacroiliac articulatory technique; Dorsal articulatory technique; Lumbar paraspinal muscles stretching technique; Lumbar myofascial technique (inhibitory). |
| Exercise Therapy | Active comparator | Other: Exercise Therapy2 types of therapeutic exercises techniques were used: * Stabilization exercises * Stretches Stabilization exercises: Bridge on the ball 10 - 15 sec Side plank 10 - 15 sec Front board 10 - 15 sec active mobilization lumbopelvic 3 x 6 rep Squats with the ball on the wall 3 x 8 rep Static-passive stretch (2 x 30 sec): Paraspinal; Abdominals; Quadratus lumborum; Hip extenders; Hip flexors; Hip abductors; Hip adductors. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects with constant or intermittent low back pain with intensity greater than 30 mm visual analog scale (VAS) for at least three months duration, with a diagnosis of chronic low back pain
Key exclusion criteria (17 listed)
- Subjects who have spine fractures,
- Dislocations
- Ligament ruptures
- Muscle ruptures
- Skin lacerations
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 |
|---|---|---|
| Osteopathic Manipulative Treatment | Other | Osteopathic Manipulative Treatment |
| Exercise Therapy | Other | Exercise Therapy |
Primary outcome
Pain
Time frame: 5 weeks
VAS (VISUAL ANALOGUE SCALE)
3 secondary outcomes
Disability
Time frame: 5 weeks
kinesiophobia
Time frame: 5 weeks
Depression
Time frame: 5 weeks
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 12 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Frederico Meirelles, Master /PT principal investigator
UERJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment and Exercise Therapy in people with Low Back Pain, run by Rio de Janeiro State University at 1 site in Brazil.
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 1 inclusion and 17 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 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pain (time frame: 5 weeks). 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 12 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.