Comparison between abdominal hemodynamic manipulation and manipulation of L4-L5 in patients with Low back pain associated with constipation: controlled randomized study

• Register: ANZCTR
• Last refreshed on: 22 July 2019
• Main ID: ACTRN12618000681257
• Date of registration: 26/04/2018
• Prospective Registration: Yes
• Primary sponsor: grisot claudio
• 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
• Date of first enrolment: 01/06/2018
• Target sample size: 52
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000681257.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;
• Phase: Not Applicable

Countries of recruitment

Italy

Contacts

• Name: Dr Ala Giacomo

• Name: Dr grisot claudio

Key inclusion & exclusion criteria

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

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


Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Low Back pain ;Constipation;
Low Back pain
Constipation

Physical Medicine / Rehabilitation - Physiotherapy

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

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 t

Primary Outcome(s)

the difference between groups A and B in the variation of pain perception on the adjacent lumbar and paravertebral muscles using a pressure algometer[Operator will measure the primary outcome immediately post the first treatment]

the difference between groups A and B in the variation of pain perception on T12 using a pressure algometer[Operator will measure the primary outcome immediately post the first treatment]

Secondary Outcome(s)

comparison between the quality of the faeces of subjects in groups A and B one month after the pre-treatment, using Bristol scale[The patient will fill the Bristol scale after one month of treatment and send it to us]

The general flexional mobility, evaluated with a Fingertip-to-Floor (FTF) Test[Operator will measure this immediately post the first treatment]

the comparison of the pre vs. post-treatment variation between the two groups for Lumbar mobility (with inclinometer) [Operator will measure this immediately post the first treatment]

Secondary ID(s)

None

Source(s) of Monetary Support

FisioAlp

Ifor srl

Secondary Sponsor(s)

ala giacomo

Ethics review

Status: Approved
Approval date:
Contact:

S.E.F.O.

Results

• Results available: Yes
• Date Posted: 09/07/2019
• Date Completed: 17/12/2018