Low Back PainNCT02276794
Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain
A study testing Thrust Manipulation and Non-thrust manipulation (NTM) in people with Low Back Pain and Mechanical Low Back Pain, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
This study aims to verify the effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain, Mechanical Low Back Pain, Backache
- What is being tested?
- Thrust Manipulation and Non-thrust manipulation (NTM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Nov 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Chronic Low back pain (pain lasting for at least 12 weeks)
- NPRS ≥ 3
Who cannot join
- Previous surgery or fracture at the lumbar spine
- Pregnancy
- Inflammatory disorders
- Symptoms distal to the gluteal line
- Having received manipulative treatment in the past four weeks
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
Official title: The Effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain
This study aims to verify the effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain.
Read the detailed description
Forty individuals with chronic low back pain will be randomly assigned, by a researcher not involved in data collection, to two treatment groups: Thrust manipulation (side-lying rotational manipulation standardized to the L4-L5 level) or non-thrust manipulation (side-lying grade III rotational non-thrust manipulation). A single treatment session will be provided.
Outcome measurement will be conducted immediately after the treatment session. Data will be collected by a blinded assessor. Between-group differences will be calculated by constructing mixed linear models following an intention-to-treat principle.
- Conditions
- Low Back Pain, Mechanical Low Back Pain, Backache
- Being tested
- Thrust Manipulation, Non-thrust manipulation (NTM)
- Keywords
- Low back pain, Thrust manipulation, Spinal manipulation, Joint mobilization, Non-thrust manipulation, proprioception, Postural stability, Baropodometry
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrust ManipulationOther
Also called Spinal manipulation, Lumbar manipulation, Lumbar thrust, Manual Therapy
After positioning patients in right side-lying, a rotational TM technique will be addressed at the L4-L5 lumbar segments. The treating therapist will have up to two attempts to apply the TM.
Non-thrust manipulation (NTM)Other
Also called Mobilization, Joint mobilization, lumbar mobilization, Manual therapy
A grade III rotational non-thrust manipulation will be addressed at the L4-L5 lumbar segments. Thirty oscilations will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Thrust manipulation (TM) | Experimental | The patients allocated to the TM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive a rotational TM technique. The treating therapist will have up to two attempts to perform the TM in each patient.
There is no need for cavitation in order to consider the TM successful; the occurence of cavitation, however, will be recorded.
A single treatment will be provided. Receives: Other: Thrust Manipulation |
| Non-thrust manipulation (NTM) | Experimental | The patients allocated to the NTM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive 30 oscilations of a grade III rotational NTM.
A single treatment will be provided Receives: Other: Non-thrust manipulation (NTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain will me measured Up to 10 minutes after intervention by an 11 point (0-11) Numeric Pain Rating Scale (NPRS)
Measured: Up to 10 minutes after intervention
Secondary outcomes (4)
Global Perceived Effect
Global Perceived effect will be measured by an 11 point (-5-+5) Global Perceived Effect (GPE)
Measured: Up to 10 minutes after intervention
Lumbar joint position sense
Lumbar joint position sense will be measured by a isokinetic dynamometer (BIODEX System 4 Pro™, Shirley, NY)
Measured: Up to 10 minutes after intervention
Peak plantar pressure
Peak plantar pressure will be measured by a digital baropodometer (FootWork Pro)
Measured: Up to 10 minutes after intervention
Center of Pressure displacement
CoP displacement will be measured by a digital baropodometer (FootWork Pro) by means of stabilometry
Measured: Up to 10 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionNov 2015
Why it stopped: Time and funding constraints
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Esteves Ferreira, Federal University of Health Science of Porto Alegre
- Investigators
- Marcelo F Silva, PhD, Study chair, Adjunct professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276794
- Sponsor's protocol ID
- 19051513.5.0000.5345
- Status last verified
- Feb 2017
- First submitted
- 22 Oct 2014
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02276794
- Acronym / sponsor ID
- 19051513.5.0000.5345
- Conditions
- Low Back Pain, Mechanical Low Back Pain, Backache
- Keywords
- Low back pain, Thrust manipulation, Spinal manipulation, Joint mobilization, Non-thrust manipulation, proprioception, Postural stability, Baropodometry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Time and funding constraints
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 28 Oct 2014 (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 aims to verify the effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain.
Detailed description
Forty individuals with chronic low back pain will be randomly assigned, by a researcher not involved in data collection, to two treatment groups: Thrust manipulation (side-lying rotational manipulation standardized to the L4-L5 level) or non-thrust manipulation (side-lying grade III rotational non-thrust manipulation). A single treatment session will be provided.
Outcome measurement will be conducted immediately after the treatment session. Data will be collected by a blinded assessor. Between-group differences will be calculated by constructing mixed linear models following an intention-to-treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrust manipulation (TM) | Experimental | Other: Thrust ManipulationThe patients allocated to the TM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive a rotational TM technique. The treating therapist will have up to two attempts to perform the TM in each patient. There is no need for cavitation in order to consider the TM successful; the occurence of cavitation, however, will be recorded. A single treatment will be provided. |
| Non-thrust manipulation (NTM) | Experimental | Other: Non-thrust manipulation (NTM)The patients allocated to the NTM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive 30 oscilations of a grade III rotational NTM. A single treatment will be provided |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 years
- Chronic Low back pain (pain lasting for at least 12 weeks)
- NPRS ≥ 3
Key exclusion criteria (5 listed)
- Previous surgery or fracture at the lumbar spine
- Pregnancy
- Inflammatory disorders
- Symptoms distal to the gluteal line
- Having received manipulative treatment in the past four weeks
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 |
|---|---|---|
| Thrust ManipulationAlso: Spinal manipulation, Lumbar manipulation, Lumbar thrust, Manual TherapyAfter positioning patients in right side-lying, a rotational TM technique will be addressed at the L4-L5 lumbar segments. The treating therapist will have up to two attempts to apply the TM. | Other | Thrust manipulation (TM) |
| Non-thrust manipulation (NTM)Also: Mobilization, Joint mobilization, lumbar mobilization, Manual therapyA grade III rotational non-thrust manipulation will be addressed at the L4-L5 lumbar segments. Thirty oscilations will be performed. | Other | Non-thrust manipulation (NTM) |
Primary outcome
Pain
Time frame: Up to 10 minutes after intervention
Pain will me measured Up to 10 minutes after intervention by an 11 point (0-11) Numeric Pain Rating Scale (NPRS)
4 secondary outcomes
Global Perceived Effect
Time frame: Up to 10 minutes after intervention
Lumbar joint position sense
Time frame: Up to 10 minutes after intervention
Peak plantar pressure
Time frame: Up to 10 minutes after intervention
Center of Pressure displacement
Time frame: Up to 10 minutes after intervention
Results and safety
The study was stopped early (reason given: Time and funding constraints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
Related trials for Low Back Pain
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific 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.
Marcelo F Silva, PhD study chair
Adjunct professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrust Manipulation and Non-thrust manipulation (NTM) in people with Low Back Pain and Mechanical Low Back Pain, run by Federal University of Health Science of Porto Alegre 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Feb 2017. 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 was stopped early (reason given: Time and funding constraints). Results are not available in the source record.
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: Up to 10 minutes after intervention). 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 16 Feb 2017; AzTrials last refreshed its copy on 27 Oct 2026.