Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000922976
Ethics application status
Approved
Date submitted
26/08/2011
Date registered
29/08/2011
Date last updated
29/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immediate effects after the application of the suboccipital muscles inhibition technique in women with fibromyalgia
Scientific title
Suboccipital inhibition technique applied to women suffering from fibromyalgia causing cervical mobility improvement to the rotations and extension
Secondary ID [1] 262907 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia disease 270633 0
suboccipital inhibition technique 270634 0
Condition category
Condition code
Musculoskeletal 270804 270804 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 270805 270805 0 0
Other alternative and complementary medicine
Anaesthesiology 270829 270829 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Apply a manual technique known as suboccipital inhibition technique. With the patient lying supine and the practitioner seated at the head of it, place their hands under the occipital region and pushes his fingers on the suboccipital region anteriorly. The technique was applied for five minutes.
The technique is applied once.
Intervention code [1] 269254 0
Treatment: Other
Comparator / control treatment
the control group received placebo a technique consisting of the support of the therapist's hands on the arms of the participant for five minutes.
Not simulate any other technique with this maneuver. The hands just resting on the patient without any pressure or movement.
Control group
Placebo

Outcomes
Primary outcome [1] 279515 0
Improvement in the movements of the cervical spine. To perform these steps using the device "CROM SP-5060" (Cervical Range of Movement).
Timepoint [1] 279515 0
immediately after intervention
Secondary outcome [1] 287778 0
Assessing pain thresholds of tender points of fibromyalgia after the intervention with the technique of inhibition. The algometer used by us will be analog, brand Baseline, which has a precision of 0.1 kg.
Timepoint [1] 287778 0
inmediately after intervention
Secondary outcome [2] 287779 0
Set different correlations between variables measuring pain thresholds and direction finding with the impact of fibromyalgia using surveys of quality of life SF-36 and of fibromyalgia impact FIQ
Timepoint [2] 287779 0
before the intervention

Eligibility
Key inclusion criteria
Acceptance of voluntary participation in the study by signing the informed consent.
Being female.
Be diagnosed by a medical professional, fibromyalgia, according to the criteria of the American College of Reumathology, 1990
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects presenting a febrile or infectious process at the time of the study.
Subjects who have suffered whiplash in the suboccipital muscle involvement.
Having an Arnold-Chiari syndrome, which can lead to balance disturbances.
Present some of the contraindications for the application of the technique.
Having an illness or injury of the vestibular system for balance disturbances they generate.
Having a significant deterioration in uncorrected vision with glasses and that the limitation in vision alters the balance.
Having an injury to the temporomandibular joint, as it relates to the suboccipital muscles.
Subjects who are unable to maintain a standing position without outside help.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomitazion.com website
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 3807 0
Spain
State/province [1] 3807 0

Funding & Sponsors
Funding source category [1] 269742 0
Self funded/Unfunded
Name [1] 269742 0
Country [1] 269742 0
Primary sponsor type
Charities/Societies/Foundations
Name
AFIXA
Address
Plaza Luz del Valle, s/n, Jaen
Country
Spain
Secondary sponsor category [1] 268782 0
None
Name [1] 268782 0
Address [1] 268782 0
Country [1] 268782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271707 0
Comite de Etica de la Universidad de Sevilla
Ethics committee address [1] 271707 0
Ethics committee country [1] 271707 0
Date submitted for ethics approval [1] 271707 0
Approval date [1] 271707 0
Ethics approval number [1] 271707 0

Summary
Brief summary
Fibromyalgia is a disease with a high prevalence, and today presents difficulties, both for initial assessment and diagnosis, especially for further processing, for which have not yet been clearly defined action protocols with significant benefit in symptoms in the disease.
The primary objective of this study will determine whether the application of the inhibition technique causes immediate changes in cervical mobility in women with fibromyalgia.
The conceptual hypothesis of our study is that the inhibition suboccipital muscle technique applied to women suffering from fibromyalgia will cause changes in cervical mobility on the pain of fibromyalgia tender points located in the suboccipital region and the traps and the perception of the intensity of spontaneous pain in the cervical and cephalic region.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33066 0
Address 33066 0
Country 33066 0
Phone 33066 0
Fax 33066 0
Email 33066 0
Contact person for public queries
Name 16313 0
Miguel Angel Lerida Ortega
Address 16313 0
C/ Polonia, 24
23.700 Linares
Country 16313 0
Spain
Phone 16313 0
+34 659333657
Fax 16313 0
Email 16313 0
[email protected]
Contact person for scientific queries
Name 7241 0
Miguel Angel Lerida Ortega
Address 7241 0
C/ Polonia, 24
23.700 Linares
Country 7241 0
Spain
Phone 7241 0
+34 659333657
Fax 7241 0
Email 7241 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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