Low Back PainMassageNCT01315197
Massage for Low Back Pain in Nursing Staff
A study testing Massage in people with Low Back Pain, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Objectives: Semi experimental Clinical Trial aimed at verifying the effectiveness of massage for lower back pain occupational as well as to assess the influence of technique in performing work activities and life in the team nursing. Read more about this study
- Who is it for?
- Ages 21 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Dec 2010
- 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 21 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary participation in the study of employees with availability of time for submission to the sessions
- Not be pregnant
- Hold shift of at least 6 hours daily
- Do not go on vacation or leave care during the study period
- Reporting back pain self-reported or confirmed by medical diagnosis
- Not having passed off due to back pain in past 6 months
Show all 9Show fewer
- Do not submit spondylolisthesis, disc herniation and sciatic pain self-reported or confirmed by medical diagnosis
- Do not use anti-inflammatory drugs
- Individuals that showed greater than 0 (zero) in the Numerical Pain Scale (10) Score higher than 15 on the Functional Assessment Questionnaire Oswestry
Who cannot join
- Employees who left the study or that lost more than one session
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo
About this study
Official title: Application of Massage for Low Back Pain in Nursing Staff
Objectives: Semi experimental Clinical Trial aimed at verifying the effectiveness of massage for lower back pain occupational as well as to assess the influence of technique in performing work activities and life in the team nursing.
Read the detailed description
Method: 18 officials received 7-8 massage sessions, twice per week, with the same protocol points. Data were collected on baseline, after one and two months and they responded 2 questionnaires (Functional Assessment of Oswestry and Risk Assessment in Movement and Transfer Scale) and the Numeric Pain Scale.
- Conditions
- Low Back Pain
- Being tested
- Massage
- Keywords
- 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.
MassageOther
Also called Anmá, Oriental Massage, Acupressure
Massage Anmá: 7-8 sessions, twice per week, kneading and pressure points on the bladder meridian
| Study group | Role | What they receive |
|---|---|---|
| massage | Experimental | The massage Anma has Japanese origin and a protocol was used with smoothing, kneading and pressure points on the bladder meridian. Receives: Other: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Application of Massage for Low Back Pain in Nursing Staff
Effectiveness of massage in alleviating lower back pain through response to 2 questionnaires (Functional Assessment of Oswestry and Risk Assessment in Movement and Transfer Scale) and the Numeric Pain Scale.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Talita P Borges, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315197
- Sponsor's protocol ID
- Talita Pavarini Borges
- Other IDs
- Universidade de São Paulo
- Acronym
- Massage
- Status last verified
- Oct 2010
- First submitted
- 14 Mar 2011
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Borges TP, Greve JM, Monteiro AP, da Silva RE, Giovani AM, da Silva MJ. Massage application for occupational low back pain in nursing staff. Rev Lat Am Enfermagem. 2012 May-Jun;20(3):511-9. doi: 10.1590/s0104-11692012000300012. English, Portuguese, Spanish.
PubMed 22991113
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Massage for Low Back Pain in Nursing Staff
- ClinicalTrials.gov ID
- NCT01315197
- Acronym / sponsor ID
- Massage / Talita Pavarini Borges
- Conditions
- Low Back Pain
- Keywords
- Low back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Mar 2011 (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.
Objectives: Semi experimental Clinical Trial aimed at verifying the effectiveness of massage for lower back pain occupational as well as to assess the influence of technique in performing work activities and life in the team nursing.
Detailed description
Method: 18 officials received 7-8 massage sessions, twice per week, with the same protocol points. Data were collected on baseline, after one and two months and they responded 2 questionnaires (Functional Assessment of Oswestry and Risk Assessment in Movement and Transfer Scale) and the Numeric Pain Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| massage | Experimental | Other: MassageThe massage Anma has Japanese origin and a protocol was used with smoothing, kneading and pressure points on the bladder meridian. |
Who may qualify
- Ages
- 21 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Voluntary participation in the study of employees with availability of time for submission to the sessions
- Not be pregnant
- Hold shift of at least 6 hours daily
- Do not go on vacation or leave care during the study period
- Reporting back pain self-reported or confirmed by medical diagnosis
Key exclusion criteria (1 listed)
- Employees who left the study or that lost more than one session
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 |
|---|---|---|
| MassageAlso: Anmá, Oriental Massage, AcupressureMassage Anmá: 7-8 sessions, twice per week, kneading and pressure points on the bladder meridian | Other | massage |
Primary outcome
Application of Massage for Low Back Pain in Nursing Staff
Time frame: two months
Effectiveness of massage in alleviating lower back pain through response to 2 questionnaires (Functional Assessment of Oswestry and Risk Assessment in Movement and Transfer Scale) and the Numeric Pain Scale.
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 15 Mar 2011.
- Derived from this study: PubMed 22991113Borges TP, Greve JM, Monteiro AP, da Silva RE, Giovani AM, da Silva MJ. Massage application for occupational low back pain in nursing staff. Rev Lat Am Enfermagem. 2012 May-Jun;20(3):511-9. doi: 10.1590/s0104-11692012000300012. English, Portuguese, Spanish.
- This is a field study, blind and clinical trial of Before and After kind, which aimed to verify the effectiveness of massage for occupational low back pain as well as to assess the influence of technique in performing work activities and lifestyles.Link 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.
Talita P Borges principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Low Back Pain, run by University of Sao Paulo 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 9 inclusion and 1 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 15 Mar 2011. 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?
Application of Massage for Low Back Pain in Nursing Staff (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01315197, which also lists 1 linked publication.
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 15 Mar 2011.