Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001035910
Ethics application status
Approved
Date submitted
29/09/2011
Date registered
30/09/2011
Date last updated
6/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
osteopathic techniques effects on hypogastric scars in patients with neck and scapular pain
Scientific title
Toggle Recoil and functional technique effects on hypogastric scars in patients with neck and scapular pain
Secondary ID [1] 273122 0
nil
Universal Trial Number (UTN)
U1111-1124-8945
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypogastric scars 270873 0
neck and scapular pain 270874 0
Condition category
Condition code
Musculoskeletal 279052 279052 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
two groups:
Group I: patients suffering neck and scapular pain with hypogastric scars who receive toggle recoil technique and functional technique
Group II: patients suffering neck ans scapular pain with hypogastric scars who receive placebo maneuver.

Group I:
toggle recoil technique:the subject is supine with arms along the trunk. The therapist is placed standing at the ipsilateral scar' s side. Firstly, he must find where it has more restrictions, as well as the direction of the slide where the skin and deeper layers have more limitations. One thumb is placed in one side of the scar, while the other one is located on the contralateral side facing its homonym, either perpendicular to the scar, parallel to this or other directions (according to the restriction found). Now, therapist is claimed to make fast thrust from biceps and pectoralis major muscles from both sides, followed by a fast contraction from triceps muscles to withdraw abruptly both of thumbs from scar site.
lenght of technique=2minutes


Functional technique: the subject placed in the same position as before and the therapist sitting next to the trunk. The caudal hand is placed in the dorsal part of the region where the scar is. The other one is placed in the ventral region below the scar. Therapist looks at which parameters will best maintain and accumulate, to the right or left sides, after cranial or caudal position, and finally rotation left or right. At this point, he has to wait for the fascia to rebalance and return to the starting position.

Lasting of technique: 2 minutes

both, toggle recoil technique and functional technique occur once only during the same session.

therapist begins with toggle recoil technique, and once it' s over, he will wait 1 minute before beginning with the functional technique.
Intervention code [1] 269464 0
Treatment: Other
Intervention code [2] 269465 0
Rehabilitation
Comparator / control treatment
group 2: placebo maneuver
Articular technique of inferior tibiofibular articulation:

the subject is placed supine with the knee bent. The therapist at the foot of the table standing and looking forward to the subject. With the fingers of one hand takes the edge posterior of lateral malleolus. The thumb and thenar eminence rests in the front edge of the malleolus and talar neck to control the interline talo-fibular and plantar flexion. The other's one lines the lower part of the medial malleolus. The thumb and thenar eminence rests in the anteromedial talar neck and the front of the medial malleolus, controlling dorsal flexion of the anteromedial talus. One Therapist' s hand tractions the fibula towards him, maintaining this position. The other hand pushes the tibia backward and then he relax,and he makes again the same mouvement during two minutes in each foot

lengh of this maneuver= 2 minutes in each feet= 4 minutes

placebo maneuver will be administered once only during the same session.
Control group
Placebo

Outcomes
Primary outcome [1] 279703 0
Check that toggle recoil technique and functional technique on hypogastric scars increase active cervical mobility with an inclinometer CROM in any or all axes of space( Flexion,extension, both lateroflexion left and right, and left and right rotation)
Timepoint [1] 279703 0
baseline.
this outcome is measured before and after both, the intervention/placebo techniques to compare both resultats.
Primary outcome [2] 298540 0
check that toggle recoil technique and functional technique increase the pain threshold to pressure on trigger points (PG) of the levator scapula and trapezius PG1 and PG2. therapist will push with the algometer rubber tip in specific points if trapezius and levator scapulae muscles, and he rises up pression gradually. Subjets are claimed to make a verbal signal to therapist at first time when pain sensation appears
Timepoint [2] 298540 0
baseline. this outcome is measured before and after both, the intervention/placebo techniques to compare both resultats.
Secondary outcome [1] 324519 0
Verify that toggle recoil technique and functional technique on hypogastric scars decrease number of units in a Visual Analogue Scale (VAS) during active cervical motion in any or all axes of space. VAS is a useful and standard tool for subjects pain own-rating. VAS is a bar that measures 10 cm with ranges from 0 to 10, so during each neck mouvement, subjects have to measure their own pain sensation
Timepoint [1] 324519 0
baseline. this outcome is measured before and after both, the intervention/placebo techniques to compare both resultats

Eligibility
Key inclusion criteria
men and women aged between 18 and 60 years
subjects with hypogastric scars such appendicectomies, cesarean section and others.
subjects whose scars are 6 months old minimim
subjects with neck pain during active cervical motion
informed consent signed
do not meet any criteria for exclusion
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with hypogastric scars but no cervical pain
pregnant women
primary tumor or metastasis
subjects with radiotherapy and chemotherapy
not understanding of the study
subjects who do not tolerate manual pressure in abdominal region
subjetcs whose scars are very recents, up to 6 months old

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)
We use an online software application for randomising participants who meet the inclusion criteria into control and experimental group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by a randomisation website method
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We used the program SPSS 15.00

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/10/2011
Actual
7/10/2011
Date of last participant enrolment
Anticipated
19/09/2012
Actual
19/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 3869 0
Spain
State/province [1] 3869 0
Country [2] 3870 0
France
State/province [2] 3870 0

Funding & Sponsors
Funding source category [1] 269948 0
Self funded/Unfunded
Name [1] 269948 0
Ignacio Jimenez de Ory
Country [1] 269948 0
France
Primary sponsor type
Individual
Name
Ignacio JImenez de Ory
Address
11 rue Erard
75012 Paris
Country
France
Secondary sponsor category [1] 268944 0
University
Name [1] 268944 0
Universidad de Sevilla
Address [1] 268944 0
C/ San Fernando, 4
41004 Sevilla
Country [1] 268944 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271917 0
Ethics committee address [1] 271917 0
Ethics committee country [1] 271917 0
Date submitted for ethics approval [1] 271917 0
28/09/2011
Approval date [1] 271917 0
28/02/2012
Ethics approval number [1] 271917 0

Summary
Brief summary
in this clinical trial, we study neck active motion, pain and algometry in some trigger points from any neck muscles in subjects who have neck and scapular pain presenting scars in hypogastrium, before and after toggle recoil technique and functional technique on those scars.

we hipothesize than toggle recoil technique and functional technique on scars improve neck active motion, by decreasing some points in EVA during cervical motion in any/all axes du body and increasev pain threshold to pressure in trigger points from trapezium and levator scapulae muscles.
Trial website
Trial related presentations / publications
Kobesova A, Lewit K. A case of a pathogenic active scar. Australas Chiropr Osteopathy. 2000;9(1):17-9.

Lewit K, Olsanska S. Clinical importance of active scars: abnormal scars as a cause of myofascial pain. J Manipulative Physiol Ther.2004; 27(6):399-402.

Kobesova A, Morris CE, Lewit K, Safarova M. Twenty-year-old pathogenic "active" postsurgical scar: a case study of a patient with persistent right lower quadrant pain. J Manipulative Physiol Ther. 2007;30(3):234-8

Valouchová P, Lewit K. Surface electromyography of abdominal and back muscles in patients with active scars. J Bodyw Mov Ther. 2009;13(3):262-7.
Public notes

Contacts
Principal investigator
Name 33209 0
Mr Ignacio Jimenez de Ory
Address 33209 0
Ignacio Jimenez de Ory, EOM ( escuela de osteopatia de Madrid)
11, rue erard
75012 Paris
France
Country 33209 0
France
Phone 33209 0
+33637562807
Fax 33209 0
Email 33209 0
[email protected]
Contact person for public queries
Name 16456 0
Mr Ignacio Jimenez de Ory
Address 16456 0
11 rue Erard
75012 Paris
Country 16456 0
France
Phone 16456 0
+33637562807
Fax 16456 0
Email 16456 0
[email protected]
Contact person for scientific queries
Name 7384 0
Mr Ignacio Jimenez de Ory
Address 7384 0
11 rue Erard
75012 Paris
Country 7384 0
France
Phone 7384 0
+33637562807
Fax 7384 0
Email 7384 0
[email protected]

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No Supporting Document Provided



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