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Trial registered on ANZCTR


Registration number
ACTRN12618000873224p
Ethics application status
Not yet submitted
Date submitted
16/05/2018
Date registered
22/05/2018
Date last updated
22/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate effects of lift off manipulation in subjects with non-specific acute and subacute low back pain
Scientific title
Immediate effects of lift off manipulation in subjects with non-specific acute and subacute low back pain, a pilot study.
Secondary ID [1] 294881 0
Nil known
Universal Trial Number (UTN)
U1111-1213-3943
Trial acronym
LIM.ON.LBP - LIft off Manipulation ON Low Back Pain
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific acute low back pain 307837 0
Non-specific subacute low back pain 307906 0
Condition category
Condition code
Musculoskeletal 306881 306881 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
From TIDieR:
1. Lift off thrust on T12-L1;
2. T12-L1 crucial sensation and movement area in subject affected by low back pain. The target is to stimulate this area and to improve lumbar ROM and pain;
3. an electric cot for therapies (height adjustable) maximum width 65 cm; digital algometer to assess PPT
4. test and treatment: m-Scober test, fingertip-to-floor distance (FDD), NRS are given to subjects; after which each subject sits on the end of the cot with legs on the sides. The therapist stands behind him. The subject puts his open hands on the T12 area. The therapist's thorax makes contact with the subject's palms, his arms pass through patients arms, and his palms make contact with subject's thorax. The patient flexes forward his head and trunk, and at the end the therapist applies posterior-anterior impulse in a high velocity and low amplitude way; then the subject is reassessed with m-Scober test, fingertip-to-floor distance (FDD), NRS.
5. therapist: always a Physical Therapist with an upgrade in Osteopathy and at least 10 years experience
6. the valuator is blind concerning subject group and while he performs the assessment, he doesn't know the aim of the study. The therapist obviously is not blind and waits in other room during the assessment, he performs the manipulation one subject at a time.
7. each session is carried out in a Physical Therapist's private practice in Udine, Italy
8. the intervention is delivered only once if the manipulation is successful, a maximum of three times if the manipulation was not successful at the first or second attempt. The assessment is always carried out three times and an average of the three is calculated
Intervention code [1] 301196 0
Treatment: Other
Comparator / control treatment
From TIDieR:
1. Lift off thrust on T12-L1;
2. T12-L1 crucial sensation and movement area in subject affected by low back pain. The target is to stimulate this area and to improve lumbar ROM and pain;
3. an electric cot for therapies (height adjustable) maximum width 65 cm; digital algometer to assess PPT
4. test and treatment: m-Scober test, fingertip-to-floor distance (FDD), NRS are given to subjects; after which each subject sits on the end of the cot with legs on the sides. The therapist stands behind him. The subject puts his open hands on the T12 area. The therapist's thorax makes contact with the subject's palms, his arms pass through patients arms, and his palms make contact with subject's thorax. The patient flexes forward his head and trunk, and at the end the therapist applies sham technique (without any impulse); then the subject is reassessed with m-Scober test, fingertip-to-floor distance (FDD), NRS.
5. therapist: always a Physical Therapist with an upgrade in Osteopathy and at least 10 years experience
6. the valuator is blind concerning subject group and while he performs the assessment, he doesn't know the aim of the study. The therapist obviously is not blind and waits in other room during the assessment, he performs the sham technique (same position without impulse) one subject at a time.
7. each session is carried out in a Physical Therapist's private practice in Udine, Italy
8. the intervention is delivered only once, while the assessment is always carried out three time and an average of the three is calculated
Control group
Active

Outcomes
Primary outcome [1] 305874 0
Lumbar ROM change assessed with m-Schober test
Timepoint [1] 305874 0
Timepoint: baseline (before intervention/control) and immediate after manipulation/sham technique
Secondary outcome [1] 346862 0
Lumbar ROM change assessed with finger-to-floor distance (FDD)
Timepoint [1] 346862 0
Timepoint: baseline (before intervention/control) and immediate after manipulation/sham technique
Secondary outcome [2] 346863 0
Pain change assessed with NRS
Timepoint [2] 346863 0
Timepoint: baseline (before intervention/control) and immediate after manipulation/sham technique
Secondary outcome [3] 346864 0
Pain Pressure Threshold change assessed with algometer
Timepoint [3] 346864 0
Timepoint: baseline (before intervention/control) and immediate after manipulation/sham technique

Eligibility
Key inclusion criteria
non-specific acute and subacute low back pain
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- lumbar stabilization surgery
- inflammatory/metabolic diseases (diabetes, ankylosing spondylitis, Paget's disease, sarcoidosis, arachnoiditis)
- direct or indirect trauma that foresees risk of injury to the structural integrity
- suspected tumors or suspected weight losses
- disc herniations and irradiation (lasegue and braggard positives)
- osteopathic treatment in the last 3 months

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)
Sequence of randomization will be concealed until interventions will be assigned. A third-party (EOM Research Department) will be contacted by phone for the group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Sample size: this is a pilot study and we engage 10 people for each group.
The primary objective will be study with Mann-Whitney test (difference pre/post manipulation between groups about m-Schober Test ), and also secondary one (difference between pre and post manipulation between groups about NRS, FFD and PPT).
Group features will be describe:
continuous variables with median, range, mean and standard deviation and categorical variables with absolute frequencies and percentages. Treatment effect will also be described by the Cohen coefficient d (greater than 0.8 large improvement, around 0.5 moderate and less than 0.2 small).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 10405 0
Italy
State/province [1] 10405 0
Friuli Venezia Giulia/Udine

Funding & Sponsors
Funding source category [1] 299466 0
Self funded/Unfunded
Name [1] 299466 0
Simone Milocco
Country [1] 299466 0
Italy
Primary sponsor type
Individual
Name
Simone Milocco
Address
Private practice STUDIO MILOCCO Via Molin Nascosto 14, 33100 Udine - Italy
Country
Italy
Secondary sponsor category [1] 298766 0
Other Collaborative groups
Name [1] 298766 0
EOM Italia Srl
Address [1] 298766 0
EOM Italia Srl (Clizia Cazzarolli PT) Via Caterina Bon Brenzoni, 9, 37060 Mozzecane VR - Italy
Country [1] 298766 0
Italy
Other collaborator category [1] 280107 0
Individual
Name [1] 280107 0
Cazzarolli Clizia
Address [1] 280107 0
EOM Italia Srl (Clizia Cazzarolli PT) Via Caterina Bon Brenzoni, 9, 37060 Mozzecane VR - Italy
Country [1] 280107 0
Italy

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300373 0
Comitato Etico Unico Regionale (C.E.U.R.)
Ethics committee address [1] 300373 0
Registered office: Via Pozzuolo, 330 - 33100 Udine - Italy
Ethics committee country [1] 300373 0
Italy
Date submitted for ethics approval [1] 300373 0
31/05/2018
Approval date [1] 300373 0
Ethics approval number [1] 300373 0

Summary
Brief summary
Pilot study about effectiveness of LIFT OFF manipulation applied to T12-L1 for lumbar ROM and pain in subject with non-specific acute and subacute low back pain.
Low back pain is painful manifestation with high incidence and prevalence mainly in the western world. Some guidelines suggest that the majority of patients have spontaneous recovery in the first months of onset but according to Itz CJ et al (review 2012) there is a large proportion of subjects who still experience pain after a year. It is therefore necessary to focus the research by targeting these patients in order to avoid the chronicity of low back disorders.
There are several examples of studies that have compared rehabilitative and manipulative interventions, but so far we have not yet identified the most effective intervention. There are no more in-depth literature regarding the immediate effect of manipulation in LIFT OFF of the dorsolumbar hinge often involved in the painful manifestations of these subjects. The high-velocity low-amplitude (HVLA) manipulation on the dorsolumbar spine hinge, also called LIFT-OFF, consists of a mechanical stimulation at the facet joints T12-L1 in anteroposterior direction.
This technique is often used by physical therapists and osteopaths but needs support to indicate it as an elective treatment for subjects with non-specific acute and subacute low back pain.
A clinical case study described a patient with thoraco-lumbar hinge syndrome with low back and posterior iliac crests pain, confirming the possible implication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83446 0
Mr Simone Milocco
Address 83446 0
Private practice STUDIO MILOCCO Via Molin Nascosto 14, 33100 Udine - Italy
Country 83446 0
Italy
Phone 83446 0
+393492341948
Fax 83446 0
Email 83446 0
[email protected]
Contact person for public queries
Name 83447 0
Simone Milocco
Address 83447 0
Simone Milocco (PT), Via Molin Nascosto 14, 33100 Udine - Italy
Country 83447 0
Italy
Phone 83447 0
+393492341948
Fax 83447 0
Email 83447 0
[email protected]
Contact person for scientific queries
Name 83448 0
Simone Milocco
Address 83448 0
Simone Milocco (PT), Via Molin Nascosto 14, 33100 Udine - Italy
Country 83448 0
Italy
Phone 83448 0
+393492341948
Fax 83448 0
Email 83448 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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