Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000681257
Enrollment
52
Registered
2018-04-26
Start date
2018-06-01
Completion date
2018-11-15
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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, ex

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.

Sponsors

grisot claudio
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026