Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001138976
Ethics application status
Not yet submitted
Date submitted
25/10/2011
Date registered
1/11/2011
Date last updated
1/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in the forward head position after the application of osteopathic technique "Thumb-move" at D1 level.
Scientific title
Changes in the value of craniovertebral angle pre-post intervention after the implementation of the bilateral thumb-move technique compared with placebo in cyclists with forward head position.
Secondary ID [1] 273270 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural changes, particularly: forward head position. 279035 0
Condition category
Condition code
Physical Medicine / Rehabilitation 279221 279221 0 0
Other physical medicine / rehabilitation
Musculoskeletal 279234 279234 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Osteopathic manipulative treatment of C7-T1.
Administered only once from each side at the level T1, by a trained physiotherapist with with 11 years of experience and training in osteopathy in accordance with European standards of 1400 hours.

Description of intervention:

Position the patient: prone.
Position of the Therapist: standing, up to the patient's chest on the left side first and then the right.

Contacts:
A hand comes into contact with the thumb on the side of the spinous process of T1, by taking skin fold of the trapezius with the rest of the hand. The forearm is placed perpendicular to the spine.
The other hand on the temporary contact who has his head turned the opposite side to the hand that manipulates.

Parameters: we must put some extent, being careful not to lose double chin to protect the upper cervical. Then you rotate and set the head on the table.

Implementation: realization of thrust, direction from outside to inside, ballistic with short-range, with your thumb on the spine. And repeat on the other side.

Duration of intervention one minute both sides.
Intervention code [1] 269612 0
Treatment: Other
Intervention code [2] 269613 0
Rehabilitation
Comparator / control treatment
Control group subjects received a placebo technique, is to be placed in the same position with the same therapist contacts, the same time that its takes the true technique, but without manipulation, only with slight tension.
Control group
Placebo

Outcomes
Primary outcome [1] 279853 0
Craniovertebral angle. Data was collected via lateral photographs, and was then measured in degrees directly between a horizontal line transecting the spinous process of the seventh cervical vertebra and a line connecting the tragus of the ear with the spinous process of the seventh cervical vertebra.
Timepoint [1] 279853 0
Before, after and fifteen minutes after intervention.
Secondary outcome [1] 294581 0
Strength of the flexors and extensors of the head as assessed using a digital hand dynamometer.
Timepoint [1] 294581 0
Before, after and fifteen minutes after intervention
Secondary outcome [2] 294582 0
Hand strength as assessed using the digital Grip dynamometer.
Timepoint [2] 294582 0
Before, after and fifteen minutes after intervention
Secondary outcome [3] 294583 0
Pain sensitivity changes as assessed using a digital Algometer.
Timepoint [3] 294583 0
Before, after and fifteen minutes after intervention.
Secondary outcome [4] 294584 0
Cervical range of motion as assessed using a digital inclinometer.
Timepoint [4] 294584 0
Before, after and fifteen minutes after intervention.
Secondary outcome [5] 294585 0
Forced Expiratory Volume in the first second of expiration (FEV1), and the Forced Expiratory Volume in the first six seconds of expiration (FEV6) as assessed using an expiratory flow meter.
Timepoint [5] 294585 0
Before, after and fifteen minutes after intervention.

Eligibility
Key inclusion criteria
1 - Patients who give consent in writing.
2 - Male or female aged between 18 and 55.
3 - With forward head position.
4 - Cyclists who practice more than three years of cycling and an activity of at least 4 hours per week.
5 - who had not received osteopathic treatment of the spine, at least two months in advance.
6 - which there is no exclusionary criteria
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 - Orthopedic test Kleyn or Jackson´s positive.
2 - Some type of contraindication to manual therapy and more specifically to techniques for intervention; unresolved cancer process, severe osteoporosis, cervical arthritis, advanced infection or ongoing inflammation, congenital malformations, etc.
3 - Patients with mechanical neck pain secondary to: acute whiplash, rheumatoid arthritis, cervical arthritis advanced cervical myelopathy or other diseases.
4 - radiculalgia cervicobrachial associated with disc herniation or protrusion of the lower cervical spine.
5.- Patients with serious hormonal imbalance diagnosed.

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)
Subjects are recruited to the cycling federation, assigned to the control group or the intervention group tossing a coin at the time of submission of the study, face of the coin is the control group and cross is the intervention group. An investigator performing the technique or placebo intervention and then another researcher who does not know which group the subject, making measurements
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation, assigned to the control group or the intervention group tossing a coin at the time of submission of the study, then, face is the control group and cross is the intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3928 0
Spain
State/province [1] 3928 0
Santa Cruz de Tenerife
Country [2] 3929 0
Spain
State/province [2] 3929 0
Murcia

Funding & Sponsors
Funding source category [1] 284102 0
Self funded/Unfunded
Name [1] 284102 0
Juan Pedro Badt Abad
Country [1] 284102 0
Spain
Primary sponsor type
Individual
Name
Juan Pedro Badt Abad
Address
Calle la Cordillera, 8
Postal code 38330
La Laguna
Santa Cruz de Tenerife
Spain
Country
Spain
Secondary sponsor category [1] 269064 0
None
Name [1] 269064 0
Address [1] 269064 0
Country [1] 269064 0
Other collaborator category [1] 252310 0
Other
Name [1] 252310 0
Escuela de Osteopatia de Madrid
Address [1] 252310 0
Calle San Felix de Alcala, 4
Postal code 28807
Alcala de Henares (Madrid)
Spain
Country [1] 252310 0
Spain

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 272050 0
Comite Etico de Experimentacion de la Universidad de Sevilla.
Ethics committee address [1] 272050 0
Vicerrectorado de Investigacion.
Universidad de Sevilla
Pabellon de Brasil. Paseo de Las Delicias s/n
Postal code 41013
Sevilla

Spain
Ethics committee country [1] 272050 0
Spain
Date submitted for ethics approval [1] 272050 0
01/10/2011
Approval date [1] 272050 0
Ethics approval number [1] 272050 0

Summary
Brief summary
The forward head position is a common posture imbalance that causes a variety of musculoskeletal pathologies. There is evidence of the impact, we have reliable methods, noninvasive, in order to measure the position of the head relative to the cervical spine, there are also studies showing effective techniques to improve this imbalance of posture. But still many other techniques to be evaluated and one of them is studied in this research.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33310 0
Address 33310 0
Country 33310 0
Phone 33310 0
Fax 33310 0
Email 33310 0
Contact person for public queries
Name 16557 0
Juan Pedro Badt Abad
Address 16557 0
Calle la Cordillera,8
Postal code 38330
La Laguna
S/C de Tenerife
Spain
Country 16557 0
Spain
Phone 16557 0
+34 681129977
Fax 16557 0
Email 16557 0
[email protected]
Contact person for scientific queries
Name 7485 0
Juan Pedro Badt Abad
Address 7485 0
Calle la Cordillera, 8
Postal code 38330
La Laguna
S/C de Tenerife
Spain
Country 7485 0
Spain
Phone 7485 0
+34 681129977
Fax 7485 0
Email 7485 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

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