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Trial registered on ANZCTR


Registration number
ACTRN12615000214538
Ethics application status
Approved
Date submitted
18/12/2014
Date registered
5/03/2015
Date last updated
12/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation and analysis of postural influence of rotation manipulation of atlas in patients with chronic mechanical neck pain
Scientific title
Immediate, short and medium-term effects of rotation manipulation of atlas on standing stability and cervical rotation range of motion in chronic mechanical neck pain
Secondary ID [1] 285877 0
“Nil known”
Universal Trial Number (UTN)
U1111-1165-2071
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic mechanical neck pain 293796 0
posture and standing instability 293797 0
limited cervical rotation range of motion 293798 0
Condition category
Condition code
Musculoskeletal 294099 294099 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294101 294101 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two groups, experimental and control group. Patients will receive a single intervention and different in each group. The duration of te intervention in the two groups is one minute, and the patient will remain during that minute supine until to sound an alarm.
(experimental group):
The intervention will be apply by a physiotherapist and osteopath with enough experience. The rotation manipulation of atlas is applied for restricted cervical rotation, evaluated by the cervical flexion-rotation test. The procedure for restricted left cervical rotation is a left rotation manipulation of atlas:
The patient is lying supine. The therapist is located at the patient's head looking at the patient's feet. The left hand holds the patient's head with a contact on the temporal bone, and the right hand makes contact with the third phalanx of the index behind the right transverse process of the atlas. The head is gently flexed laterally to the right and rotated to the left, until slight tension is perceived in the tissues of the right contact. A high-velocity low-amplitude thrust is applied forward in the right transverse process of the atlas for a left rotation atlas.
Intervention code [1] 290858 0
Rehabilitation
Intervention code [2] 291227 0
Treatment: Other
Comparator / control treatment
(control group):
The patient is evaluated by the cervical flexion-rotation test. For restricted left rotation:
The patient is lying supine with a little cervical left rotation, the therapist applies a disconnected ultrasound (US) without head motion behind the right transverse process of the atlas during one minute, simulating a static application of the US.
Control group
Placebo

Outcomes
Primary outcome [1] 293891 0
Primary outcomes are four variables of the stabilometry on force platform: Patients are standing with eyes closed and without contact between the teeth during 90 seconds.

Primary Outcome 1: Surface length ratio L / S (1 / mm) (factor measuring energy costs to maintain posture) (assessed with a force platform on standing position with eyes closed. Is the relationship between the area and the length which describes the projection of the center of gravity, that quantifies the energy cost to maintain the posture)
Timepoint [1] 293891 0
Timepoints of all variables: at baseline, immediately postintervention and at 7 and 15 days after intervention.
Primary outcome [2] 293892 0
Primary Outcome 2: Surface area (mm2) (assessed with a force platform on standing position with eyes closed. Is the area that covers the path of the projection of the center of gravity)
Timepoint [2] 293892 0
at baseline, immediately postintervention and at 7 and 15 days after intervention.
Primary outcome [3] 293893 0
Primary Outcome 3: mean velocity (mm / s) (assessed with a force platform on standing position with eyes closed. Is the velocity with which the path of the projection of the center of gravity moves)
Timepoint [3] 293893 0
at baseline, immediately postintervention and at 7 and 15 days after intervention.
Secondary outcome [1] 312103 0
Secondary Outcome 1: Range of motion of the limited cervical rotation (degrees) with the cervical flexion-rotation test.

With patients supine cervical range of motion (CROM) is measured during the cervical flexion-rotation test. The CROM is a floating compass (Plastimo Airguide Inc. (Compasses), Buffalo Groove, IL, USA) attached to the apex of the head by velcro straps. (positive below 33 degrees)
Timepoint [1] 312103 0
at baseline, immediately postintervention and at 7 and 15 days after intervention.

Eligibility
Key inclusion criteria
Patients with non-traumatic cervical chronic pain over 12 weeks or more.
Positive cervical flexion-rotation test. (below 33 degrees)
Age between 18 and 60 years.
Voluntary acceptance.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Having vertebrobasilar insufficiency, vascular pathology, traumatological, neurological and congenital malformations.
Dizziness, fractures, sprains, whiplash, rheumatoid arthritis, Reiter's syndrome, psoriasis.
Klein test positive.
Suffering from numbness or irradiation in the upper limbs.
Having a myelinic disease.
Having a malformation of the skull base and cervical spine.
Having an illness at the central level that may affect the balance.
Patients who have suffered a big traumatism (car accident, sharp drops ...)
Having at the time of measured some form of joint or muscle pain in other region different of the neck or head. (The rest of the spine, pelvis, legs or feet).
Having aftermath of a stroke.
Drug treatment: muscle relaxants (diazepam, benzodiazepines) or stimulant ( inosine monophosphate, nicotine).

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)
The allocation is with a randomised controlled trial. Double blind with sealed opaque envelopes guarded by an external agent.
The patients will be enrolling when they arrive at the therapists clinic.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order for the allocation of patients into different groups:
Simple randomisation where the patients choose a sealed opaque envelope with the group (guarded by an external agent).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size was based on a pilot study, using the free software “GRANMO simple size calculator” (7.12 version).
Considering the Primary Outcome 1: Surface length ratio L / S (1 / mm), we determined that accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, a minimum of 22 subjects will be required in the first group and 22 in the second to detect a difference equal or greater than 0.44 (1 / mm). It is assumed that the common standard deviation is 0.4. It has been estimated rate of loss to follow 10%.
Data will be analysed by using the IBM-SPSS software package (version 21.0). Means and standard deviations will be calculated for each variable. A normal distribution of quantitative data will be assessed by means of the Kolmogorov-Smirnov test ( p > 0.05), a T-student test will be used at baseline to compare quantitative data of groups and a chi square test will be used for categorical data. Multivariate analysis of repeated measures (ANOVA) will be used to assess differences between groups, with covariants. The statistical analysis will be conducted at a 95% confidence level. A p-value < 0.05 will be considered to indicate statistical significance in all analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6559 0
Spain
State/province [1] 6559 0
Valencia

Funding & Sponsors
Funding source category [1] 290459 0
Self funded/Unfunded
Name [1] 290459 0
Francisco Gomez Moreno.
The School of Osteopathy of Madrid only supervises the research, without funding.
Address [1] 290459 0
San Felix de Alcala 4
CP 28807
Alcala de Henares – Madrid - Spain
Country [1] 290459 0
Spain
Primary sponsor type
Other
Name
School of Osteopathy of Madrid
Address
San Felix de Alcala 4
CP 28807
Alcala de Henares – Madrid - Spain
Country
Spain
Secondary sponsor category [1] 289161 0
None
Name [1] 289161 0
Address [1] 289161 0
Country [1] 289161 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292132 0
Ethics committee of the Scientific European of Osteopaths
Ethics committee address [1] 292132 0
Saturnino Calleja, number 1, second floor
CP 28002
Madrid - Spain
Ethics committee country [1] 292132 0
Spain
Date submitted for ethics approval [1] 292132 0
18/12/2013
Approval date [1] 292132 0
17/02/2014
Ethics approval number [1] 292132 0

Summary
Brief summary
Primary purpose: To assess the effect of rotation manipulation of atlas on standing stability by a stabilometric study in patients with chronic mechanical neck pain and limited cervical rotation range of motion.
Hypothesis: The rotation manipulation of atlas improves the standing stability and the rotation range of motion in cervical spine in patients with chronic mechanical neck pain and limited cervical rotation range of motion.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 269 269 0 0

Contacts
Principal investigator
Name 53650 0
Dr Roberto Mendez-Sanchez
Address 53650 0
E.U. de Enfermeria y Fisioterapia (University School of Nursing and Physical Therapy)
Donante de Sangre s/n
CP37007 Salamanca - Spain
Country 53650 0
Spain
Phone 53650 0
+34 923294590 ext.3201
Fax 53650 0
+34 923294576
Email 53650 0
ro_mendez@usal.es
Contact person for public queries
Name 53651 0
Dr Roberto Mendez-Sanchez
Address 53651 0
E.U. de Enfermeria y Fisioterapia (University School of Nursing and Physical Therapy)
Donante de Sangre s/n
CP37007 Salamanca - Spain
Country 53651 0
Spain
Phone 53651 0
+34 923294590 ext.3201
Fax 53651 0
+34 923294576
Email 53651 0
ro_mendez@usal.es
Contact person for scientific queries
Name 53652 0
Dr Roberto Mendez-Sanchez
Address 53652 0
E.U. de Enfermeria y Fisioterapia (University School of Nursing and Physical Therapy)
Donante de Sangre s/n
CP37007 Salamanca - Spain
Country 53652 0
Spain
Phone 53652 0
+34 923294590 ext.3164
Fax 53652 0
+34 923294576
Email 53652 0
ro_mendez@usal.es

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary