Spine StiffnessNCT02163590
Immediate Effects of Different Rates of Thoracic Mobilization on Pressure Pain Thresholds in Asymptomatic Individuals
A study testing 2Hz mobilisation and 0,5Hz mobilisation in people with Spine Stiffness, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Passive mobilizations of the spine are widely used by physiotherapists in the management of neuromusculoskeletal disorders. There is a nascent body of work of the mechanical properties of joint mobilizations. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Spine Stiffness
- What is being tested?
- 2Hz mobilisation and 0,5Hz mobilisation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Jul 2014
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy asymptomatic subjects
- Manual therapy naive
Who cannot join
- Any kind of history of trauma or surgery to the spine
- Contraindications or precautions to manual therapy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
Official title: A Preliminary Investigation Into the Immediate Effects of Different Rates of Thoracic Mobilization on Pressure Pain Thresholds in Asymptomatic Individuals
Passive mobilizations of the spine are widely used by physiotherapists in the management of neuromusculoskeletal disorders.
There is a nascent body of work of the mechanical properties of joint mobilizations. Treatment dose is characterized by the direction of force applied, magnitude of force applied, frequency of oscillation, amplitude of displacement, repetition and time. Although the choice of better treatment dose is based on patient complaints and clinical reasoning, the comprehension of the effects of different parameters of joint mobilization will improve the decision making process. The optimal dose of treatment, however, is not already known.
The primary aim of this study is to determine whether different rates of thoracic mobilization are capable to produces hypoalgesic effects, and secondarily investigate if such effects are local or widespread.
Read the detailed description
Healthy volunteers will be recruited and randomized into 3 groups. A 2Hz mobilisation group, a 0,5Hz mobilisation group and a Placebo group. The pressure pain threshold will be measured before, immediately after and 15 minutes after the intervention.
- Conditions
- Spine Stiffness
- Being tested
- 2Hz mobilisation, 0,5Hz mobilisation, Placebo
- Keywords
- Spinal mobilisation, Pressure pain threshold, Thoracic spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2Hz mobilisationOther
Also called Bilateral postero-anterior thoracic mobilisation
This intervention will be applied for 3 sets of 1 minute, with 1 minute rest period in between each set.
0,5Hz mobilisationOther
Also called Bilateral postero-anterior thoracic mobilisation
This intervention will be applied for 3 sets of 1 minute, with 1 minute rest period in between each set.
PlaceboOther
Also called Manual contact without oscillation
Intervention that mimics the experimental procedures
| Study group | Role | What they receive |
|---|---|---|
| 2Hz mobilisation | Experimental | A bilateral postero-anterior mobilisation applied to the fourth thoracic vertebra, at a 2Hz frequency. Receives: Other: 2Hz mobilisation |
| 0,5Hz mobilisation | Experimental | A bilateral postero-anterior mobilisation applied to the fourth thoracic vertebra, at a 0,5Hz frequency. Receives: Other: 0,5Hz mobilisation |
| Placebo | Placebo comparator | A simulation technique, that mimic the other groups, in this case only manual contact will be applied, without any oscillation. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold
Pressure pain threshold will be measured in five anatomic points on the spine, upper and lower limbs
Measured: Change from baseline imediately after, and 15 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine StiffnessStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 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, Francisco Xavier de Araujo, Pt, Federal University of Health Science of Porto Alegre
- Investigators
- Francisco D Araujo, Pt, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163590
- Sponsor's protocol ID
- UFCSPA-FXA-02
- Status last verified
- Mar 2015
- First submitted
- 10 Jun 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Investigation Into the Immediate Effects of Different Rates of Thoracic Mobilization on Pressure Pain Thresholds in Asymptomatic Individuals
- ClinicalTrials.gov ID
- NCT02163590
- Acronym / sponsor ID
- UFCSPA-FXA-02
- Conditions
- Spine Stiffness
- Keywords
- Spinal mobilisation, Pressure pain threshold, Thoracic spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Jun 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.
Passive mobilizations of the spine are widely used by physiotherapists in the management of neuromusculoskeletal disorders.
There is a nascent body of work of the mechanical properties of joint mobilizations. Treatment dose is characterized by the direction of force applied, magnitude of force applied, frequency of oscillation, amplitude of displacement, repetition and time. Although the choice of better treatment dose is based on patient complaints and clinical reasoning, the comprehension of the effects of different parameters of joint mobilization will improve the decision making process. The optimal dose of treatment, however, is not already known.
The primary aim of this study is to determine whether different rates of thoracic mobilization are capable to produces hypoalgesic effects, and secondarily investigate if such effects are local or widespread.
Detailed description
Healthy volunteers will be recruited and randomized into 3 groups. A 2Hz mobilisation group, a 0,5Hz mobilisation group and a Placebo group. The pressure pain threshold will be measured before, immediately after and 15 minutes after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2Hz mobilisation | Experimental | Other: 2Hz mobilisationA bilateral postero-anterior mobilisation applied to the fourth thoracic vertebra, at a 2Hz frequency. |
| 0,5Hz mobilisation | Experimental | Other: 0,5Hz mobilisationA bilateral postero-anterior mobilisation applied to the fourth thoracic vertebra, at a 0,5Hz frequency. |
| Placebo | Placebo comparator | Other: PlaceboA simulation technique, that mimic the other groups, in this case only manual contact will be applied, without any oscillation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy asymptomatic subjects
- Manual therapy naive
Key exclusion criteria (2 listed)
- Any kind of history of trauma or surgery to the spine
- Contraindications or precautions to manual therapy
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 |
|---|---|---|
| 2Hz mobilisationAlso: Bilateral postero-anterior thoracic mobilisationThis intervention will be applied for 3 sets of 1 minute, with 1 minute rest period in between each set. | Other | 2Hz mobilisation |
| 0,5Hz mobilisationAlso: Bilateral postero-anterior thoracic mobilisationThis intervention will be applied for 3 sets of 1 minute, with 1 minute rest period in between each set. | Other | 0,5Hz mobilisation |
| PlaceboAlso: Manual contact without oscillationIntervention that mimics the experimental procedures | Other | Placebo |
Primary outcome
Pressure pain threshold
Time frame: Change from baseline imediately after, and 15 minutes after the intervention
Pressure pain threshold will be measured in five anatomic points on the spine, upper and lower limbs
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 6 Mar 2015.
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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.
Francisco D Araujo, Pt principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2Hz mobilisation and 0,5Hz mobilisation in people with Spine Stiffness, 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 2 inclusion and 2 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 6 Mar 2015. 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. Some participants in this study may receive a placebo. 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?
Pressure pain threshold (time frame: Change from baseline imediately after, and 15 minutes after the 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 6 Mar 2015.