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Trial registered on ANZCTR


Registration number
ACTRN12618000681257
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
26/04/2018
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between abdominal hemodynamic manipulation and manipulation of L4-L5 in patients with Low back pain associated with constipation: controlled randomized study
Scientific title
Comparison between abdominal hemodynamic manipulation and manipulation of L4-L5 in patients with LBP associated with constipation: controlled randomized study
Secondary ID [1] 293929 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back pain 306663 0
Constipation 306763 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305761 305761 0 0
Physiotherapy
Oral and Gastrointestinal 305855 305855 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 305856 305856 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical data and medical history of the patients will be collected to establish whether the patient is suitable for the study.
Patients that meet the criteria for inclusion will then be randomly separated in two different groups A and B.
At the beginning of each session, following the randomization, the initial measurement of the primary outcomes will be performed by the blinded operator for each patient of both groups; each measurement (tenderness of myotome and sclerotome, lumbar mobility, extensibility of the ischiocrural muscles) will be performed three times. The result will be calculated as the average value of the three measurements.
Subsequently, the blinded operator will exit the room and the second operator will perform the treatment, depending on the group to which the patient belongs.
Group A will be treated with global hemodynamic manoeuvre of the abdomen: in this technique, the patient is lying supine on the bed, with a wedge under the knees. The osteopath stands aside the patient, at the level of the patient's thorax, facing the feet of the patient. The technique is carried out as follows:
Contact with the cubital edge of both hands below the abdominal mass. The expiration of the patient is facilitated and during inhalation the osteopath pulls the visceral mass towards the patient's head, vibrating with the hands. 10 repetitions are performed.
Immediately after the execution of the technique the operator will measure the primary outcome again (three times). A Bristol scale will be given to the patient, who will need to fill during the following month and the send it to the researchers. Patents will be instructed to keep a diary of any drugs they will take during the month following the treatment, in order to understand whether these have an effect on their rating of the Bristol scale. Singular treatment that will have a duration of this tecnique (approximately 5minutes). Bristol scale will be completed monthly , one month after the treatment.
Intervention code [1] 300364 0
Rehabilitation
Intervention code [2] 300894 0
Treatment: Other
Comparator / control treatment
Group B will be treated with manipulations of L4-L5 (one on the right and one on the left) according to the indirect lumbar roll technique: the patient is in lateral decubitus position with upper lower limb in triple flexion, with the foot positioned in the popliteal cable of the leg, extended on the bed, with the trunk slightly turned towards the ceiling.
The ostepath stands in front of the patient, at the height of L4, checking the patient's trunk with the cephalic arm inserted under the upper arm of the patient, and the lumbar spine and the pelvis controlled with the caudal arm, which surrounds the upper iliac of the patient posteriorly and touches the lumbar spine with the long fingers.
The osteopath flexes the patient’s lumbar spine until the interspinous space L4-L5 opens, and introduces the parameters of anterior sliding, lateral sliding and compression on the level to be manipulated.
The manipulation is carried out with a brief and explosive contraction of the osteopath's pectorals, associated with a body drop, performed through a flexion of the legs, while the patient's pelvis rotates anteriorly, causing a lumbar rotation.
Immediately after the execution of the technique the blind operator will measure the primary outcome again (three times). A Bristol scale will be given to the patient, who will need to fill during the following month and the send it to the researchers. Patents will be instructed to keep a diary of any drugs they will take during the month following the treatment, in order to understand whether these have an effect on their rating of the Bristol scale.
Singular treatment that will have a duration of this tecnique (approximately 5minutes). Bristol scale will be completed monthly , one month after the treatment.
Control group
Active

Outcomes
Primary outcome [1] 304836 0
the difference between groups A and B in the variation of pain perception on T12 using a pressure algometer
Timepoint [1] 304836 0
Operator will measure the primary outcome immediately post the first treatment
Primary outcome [2] 305631 0
the difference between groups A and B in the variation of pain perception on the adjacent lumbar and paravertebral muscles using a pressure algometer
Timepoint [2] 305631 0
Operator will measure the primary outcome immediately post the first treatment
Secondary outcome [1] 343332 0
the comparison of the pre vs. post-treatment variation between the two groups for Lumbar mobility (with inclinometer)
Timepoint [1] 343332 0
Operator will measure this immediately post the first treatment
Secondary outcome [2] 343914 0
The general flexional mobility, evaluated with a Fingertip-to-Floor (FTF) Test
Timepoint [2] 343914 0
Operator will measure this immediately post the first treatment
Secondary outcome [3] 343915 0
comparison between the quality of the faeces of subjects in groups A and B one month after the pre-treatment, using Bristol scale
Timepoint [3] 343915 0
The patient will fill the Bristol scale after one month of treatment and send it to us

Eligibility
Key inclusion criteria
Subjects with LBP (patients who self-rated their lower back pain with 4 or more, on a 10-points pain scale, within 24 hours from the experiment)
Inclusion criteria:
- Presence of functional constipation, known as chronic idiopathic constipation (CIC), as established by the Congresso di Roma III.
- Patients must be between 18 and 70 years old
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
- Previous lumbar or abdominal surgery
- Presence of any contraindication to the execution of the proposed techniques
- Pregnancy
- Intake of drugs that can interfere in the results (cortisones, opioids, laxatives) during the week of treatments
- Osteopathic treatment received in the last month
- Presence of rheumatic diseases
- The Narrow Lumbar Spinal Canal Syndrome
- Ankylosing spondylitis
- Concomitance of oncological or neurological pathologies
- Impossibility to perform all assessments before and after treatment
- Thoracic and abdominal trauma over the last six months
- Suspected aneurysm of the aorta or use of oral anticoagulants
- Mental illness

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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We assume that the difference between the two groups A and B will be high, with minor variance and an effect size equal to 0.8.
26 participants per group are needed, therefore a population of 52 subject overall, to perform a two-tailed t-test with 99.5% probability (p < 0.05) and 80% statistical power (Cohen's d effect size36)
Primary outcome
The comparison between variations before and after the treatment for the two groups will be performed with an independent sample t-test, after verifying the normality of the sample’s distribution with a Shapiro-Wilks test. Once the normality is verified, a Mann-Whitney test will be performed.
Al the variables will be considered and described by means of descriptive statistics. If the variable is categorical, it will be described in terms of absolute frequencies and percentiles; if the variable is continuous, it will be described in terms of means, medians and standard deviations.
Variables related to secondary endpoints will be analysed mainly as descriptives.
All measures with p-value < 0.05 will be considered statistically significant. All analyses will be performed using the SAS statistical software version 9.4 (SAS Institute Inc., Cary, NC, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2018
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
15/11/2018
Date of last data collection
Anticipated
Actual
17/12/2018
Sample size
Target
52
Accrual to date
Final
52
Recruitment outside Australia
Country [1] 9605 0
Italy
State/province [1] 9605 0
turin

Funding & Sponsors
Funding source category [1] 298556 0
Commercial sector/Industry
Name [1] 298556 0
FisioAlp
Country [1] 298556 0
Italy
Funding source category [2] 298868 0
Commercial sector/Industry
Name [2] 298868 0
Ifor srl
Country [2] 298868 0
Italy
Primary sponsor type
Individual
Name
grisot claudio
Address
FISIOALP , viale vittoria 34 Alpignano (Turin) 10091
Country
Italy
Secondary sponsor category [1] 297704 0
Individual
Name [1] 297704 0
ala giacomo
Address [1] 297704 0
Ala Giacomo, piazza madonna delle grazie 18, volpiano (torino) 10088
Country [1] 297704 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299525 0
S.E.F.O.
Ethics committee address [1] 299525 0
Comité de Ética de la Universidad Camilo José Cela.

Calle Castillo de Alarcón, número 49.

Postal code: 28692

Villanueva de la Cañada, Madrid
Ethics committee country [1] 299525 0
Spain
Date submitted for ethics approval [1] 299525 0
05/02/2018
Approval date [1] 299525 0
21/02/2018
Ethics approval number [1] 299525 0

Summary
Brief summary
Low back pain has recently become one of the most common disorders in developed countries and it is one of the most frequent causes of unemployability. LBP affects mainly people in their working age and it is one of the diseases that more often requires specialist consulting. Several studies have demonstrated that visceral dysfunctions are often referred to in relation with pain in the locomotor system and intestine in particular seems to be related to pain in the lower back. Among gastrointestinal diseases, constipation represents one of the most common reasons for gastroenterology consulting. It affects between 2% and 28% of the population, contributing to the worsening of the quality of life for patients affected by this disease. Spinal manipulation is generally accepted as an effective treatment for LBP; another treatment for LBP is represented by Visceral Manipulation ,A study provided evidence towards an improvement of pressure pain in subjects suffering from constipation and LBP following visceral manipulation. One group of subjects was treated with a specific manoeuvre called ‘modified hemodynamic manipulation’. This was then compared with a control group that had been treated with sham manipulation. Results showed that subjects treated with modified hemodynamic manipulation improved their low back flexibility, their pressure pain on vertebral segments T11-T12 decreased and their extension of the lower limbs increased. A recent study compared the effects of a series of 10 treatments of osteopathic manual therapy with the effects of 10 treatments of osteopathic manual therapy combined with visceral manipulations. Both groups showed a reduction of pain and an improvement of their quality of life but only the group treated with visceral manipulations showed improvements of sub-parameters of energy and physical limitation. Although both are commonly practiced by osteopaths, no study so far has compared the idiosyncratic effects of one specific technique of vertebral manipulation with those of one specific technique of visceral manipulation when applied independently on a population with LBP associated with gastrointestinal disease (constipation). The aim of the present study is to compare the effects of global hemodynamic techniques with High velocity low amplitude (HVLA) thrust techniques on of L4 and L5 in patients suffering from LBP and constipation.
Our primary objective is to evaluate the sensitivity to pain of sclerotome and myotome of the L4 lumbar vertebra (using a pressure algometer) immediately after a single manoeuvre
the secondary objectives are the evaluation of low back mobility evaluate the extensibility of ischiocrural muscles (sit-and-reach test), the evaluation of the improvement of constipation after one month of treatment (Bristol scale).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80722 0
Dr Ala Giacomo
Address 80722 0
Dr Ala Giacomo at IFOR SRL
Via pinelli 60/a Turin
Turin 10144
Country 80722 0
Italy
Phone 80722 0
+39 3493150755
Fax 80722 0
Email 80722 0
[email protected]
Contact person for public queries
Name 80723 0
Ala Giacomo
Address 80723 0
Dr Ala Giacomo at IFOR SRL
Via pinelli 60/a
Turin 10144
Turin Italy
Country 80723 0
Italy
Phone 80723 0
+39 3493150755
Fax 80723 0
Email 80723 0
[email protected]
Contact person for scientific queries
Name 80724 0
grisot claudio
Address 80724 0
Dr Grisot Claudio presso FISIOALP
Viale Vittoria 34
Aplignano (TO)
10091 Italy
Country 80724 0
Italy
Phone 80724 0
+39 3338918229
Fax 80724 0
Email 80724 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication; no end date determined
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2055Ethical approval    374416-(Uploaded-12-05-2019-01-41-12)-Study-related document.pdf



Results publications and other study-related documents

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