Myofascial DysfunctionNCT01872676
Immediate Effects of Upper Thoracic Manipulation on Skin Surface Temperature of T3 Vertebral Region and Biceps Brachii Muscle
A study testing Spine manipulation in people with Myofascial Dysfunction, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
The aim of the present study was to assess the immediate effects of upper thoracic manipulation on skin surface temperature in the region of the T3 vertebra and biceps brachii muscle in healthy women. It is a randomized controlled blind study. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myofascial Dysfunction
- What is being tested?
- Spine manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Dec 2012
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women
- 18 and 30 years of age
Who cannot join
- use of vasoactive medication
- body mass index greater than 25 kg/m2
- having undergone spinal manipulation in previous month
- and any red flag sign, such as malignant tumor, inflammatory or infectious disease that contraindicated manual therapy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Methodist University of Piracicaba
Piracicaba, São Paulo, 13.423-170
About this study
The aim of the present study was to assess the immediate effects of upper thoracic manipulation on skin surface temperature in the region of the T3 vertebra and biceps brachii muscle in healthy women. It is a randomized controlled blind study. Twenty-six healthy women of the university community were randomly allocated to an experimental group (n = 13) and a placebo group (n = 13). A single session of the upper thoracic spine manipulation (segment T3)was performed. Infrared thermography was used to determine changes in skin surface temperature in the region of T3 and the biceps brachii muscle, which would indirectly reflect sympathetic activity. Images were taken prior to manipulation, immediately after and both five and 10 minutes after manipulation. Repeated measures ANOVA with the post hoc Bonferroni test and the independent samples t-test were used for the intragroup and intergroup comparisons, respectively, with the level of significance set to 5%.
- Conditions
- Myofascial Dysfunction
- Being tested
- Spine manipulation, Manipulation sham
- Keywords
- Thermography, Skin Temperature, Manipulation, Spinal, Physical Therapy Modalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine manipulationOther
Manipulation shamOther
| Study group | Role | What they receive |
|---|---|---|
| Manipulation | Experimental | The experimental group received upper thoracic manipulation of the T3 vertebra. The volunteer was instructed to lie in the supine position, interlace her fingers and position her hands in the posterior region of the base of the neck. The therapist than positioned a stabilizing hand in a pistol grip immediately caudal to the T3 vertebra, pushing the volunteer's arms downward to generate flexion of the upper thoracic spine. Receives: Other: Spine manipulation |
| Sham | Sham comparator | The placebo group was placed precisely as the experimental group, with the exception of the positioning of the therapist's hand, which remained with the palm open and not in a pistol grip. Once positioned, the volunteers were instructed to breathe deeply. The maneuver was terminated after one cycle of deep breathing. Receives: Other: Manipulation sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin temperature
Infrared thermography was used to determine changes in skin surface temperature in the region of T3 and the biceps brachii muscle, which would indirectly reflect sympathetic activity. Images were taken prior to manipulation, immediately after and both five and 10 minutes after manipulation.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial DysfunctionStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Carine Packer, Universidade Metodista de Piracicaba
- Investigators
- Amanda Packer, MSc, Principal investigator, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872676
- Sponsor's protocol ID
- U1111-1144-0316
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Upper Thoracic Manipulation on Skin Surface Temperature of T3 Vertebral Region and Biceps Brachii Muscle
- ClinicalTrials.gov ID
- NCT01872676
- Acronym / sponsor ID
- U1111-1144-0316
- Conditions
- Myofascial Dysfunction
- Keywords
- Thermography, Skin Temperature, Manipulation, Spinal, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Jun 2013 (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.
The aim of the present study was to assess the immediate effects of upper thoracic manipulation on skin surface temperature in the region of the T3 vertebra and biceps brachii muscle in healthy women. It is a randomized controlled blind study. Twenty-six healthy women of the university community were randomly allocated to an experimental group (n = 13) and a placebo group (n = 13). A single session of the upper thoracic spine manipulation (segment T3)was performed. Infrared thermography was used to determine changes in skin surface temperature in the region of T3 and the biceps brachii muscle, which would indirectly reflect sympathetic activity. Images were taken prior to manipulation, immediately after and both five and 10 minutes after manipulation. Repeated measures ANOVA with the post hoc Bonferroni test and the independent samples t-test were used for the intragroup and intergroup comparisons, respectively, with the level of significance set to 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manipulation | Experimental | Other: Spine manipulationThe experimental group received upper thoracic manipulation of the T3 vertebra. The volunteer was instructed to lie in the supine position, interlace her fingers and position her hands in the posterior region of the base of the neck. The therapist than positioned a stabilizing hand in a pistol grip immediately caudal to the T3 vertebra, pushing the volunteer's arms downward to generate flexion of the upper thoracic spine. |
| Sham | Sham comparator | Other: Manipulation shamThe placebo group was placed precisely as the experimental group, with the exception of the positioning of the therapist's hand, which remained with the palm open and not in a pistol grip. Once positioned, the volunteers were instructed to breathe deeply. The maneuver was terminated after one cycle of deep breathing. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women
- 18 and 30 years of age
Key exclusion criteria (4 listed)
- use of vasoactive medication
- body mass index greater than 25 kg/m2
- having undergone spinal manipulation in previous month
- and any red flag sign, such as malignant tumor, inflammatory or infectious disease that contraindicated 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 |
|---|---|---|
| Spine manipulation | Other | Manipulation |
| Manipulation sham | Other | Sham |
Primary outcome
Skin temperature
Time frame: 1 years
Infrared thermography was used to determine changes in skin surface temperature in the region of T3 and the biceps brachii muscle, which would indirectly reflect sympathetic activity. Images were taken prior to manipulation, immediately after and both five and 10 minutes after manipulation.
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 7 Jun 2013.
- Related InfoLink provided by the sponsor.
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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.
Amanda Packer, MSc principal investigator
Universidade Metodista de Piracicaba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spine manipulation in people with Myofascial Dysfunction, run by Universidade Metodista de Piracicaba 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 4 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 7 Jun 2013. 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?
Skin temperature (time frame: 1 years). 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 7 Jun 2013.