Lucas Villalta Santos, Larissa Lisboa Córdoba, Jamile Benite Palma Lopes, Claudia Santos Oliveira, Luanda André Collange Grecco, Ana Carolina Bovi Nunes Andrade, Hugo Pasin Neto | Year 2019

Active Visceral Manipulation Associated With Conventional Physiotherapy in People With Chronic Low Back Pain and Visceral Dysfunction: A Preliminary, Randomized, Controlled, Double-Blind Clinical Trial

Pathology:

Low back pain

Type of study:

A Preliminary Randomized Controlled Clinical Trial

Date of publication of the study’:

2019/Jun/01

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Purpose of the study

  • Objectives: to evaluate the short-term effects of visceral manipulation combined with conventional physiotherapy in case of low back pain with visceral dysfunction.
  • Measured outcomes:
    • Primary outcomes: assessment of pain intensity by Visual Analog Scale (VAS).
    • Secondary outcomes: assessment of lumbar mobility by Schober Test, general functionality by Roland-Morris Disability Questionnaire and specific functionality by Patient-Specific Functional Scale.

Participants

  • Number: 20 people (19 female and 1 male).
  • Criteria of inclusion: volunteers; adults (age between 18 and 80 years); low back pain for more than 12 weeks; pain ≥ 2 out of 10 by VAS; history of visceral dysfunctions (ie, any alteration in abdominopelvic viscera function occurred in the course of their life, of surgical or nonsurgical origin): in case of dysfunction of surgical origin, the surgery had to be dating back to more than 6 months prior to the study; in case of dysfunction of nonsurgical origin, it had o have begun more than 6 months prior to the study and still be ongoing at the start of the study (assessment of medical history based only on self-report).
  • Criteria of exclusion: suspected severe spinal pathology (eg, metastasis, infection, or inflammatory disease to the spine; cauda equina syndrome; stenosis; spinal fracture); neural compression with at least 2 of the following signs: muscle weakness, diffuse or dermatomeric sensory loss, hyporeflexia or hyperreflexia of the lower extremities; spine, abdomen, or pelvis surgery within the 6 months preceding the study; vascular abnormalities (eg, abdominal aortic aneurysm); ongoing physiotherapy, chiropractic or osteopathic treatment; certain or suspected pregnancy; consumption of drugs that could alter visceral motility; consumption of drugs for an acute inflammatory phase of gastrointestinal or urinary disease (eg, cholecystitis, kidney stones, peritonitis, and appendicitis); consumption of drugs such as oral corticosteroids, which may increase the risk of bowel perforation; presence of gastrointestinal disease with a risk of bowel perforation (eg. Crohn’s disease, diverticulitis and peptic ulcer).
  • Groups of study: 2 groups obtained by randomization
    • Group 1:  conventional physiotherapy with visceral manipulation, 10 people (10 women and 0 men, mean age 41.5 years).
      • 1 person dropped out because they could not attend all sessions, while 1 person fell during the study period.
    • Gruppo 2: Conventional physiotherapy with sham visceral manipulation, 10 people (9 women and 1 man, mean age 40.5 years).
      • 3 people withdrew because they could not attend all sessions.

Interventions and evaluations

  • Assessment  of pain intensity by VAS (0 = no pain; 10 = unbearable pain), lumbar mobility by Schober Test, general function by Roland-Morris Disability Questionnaire, and specific function by Patient-Specific Functional Scale 1 week before the start of treatments, immediately after the last treatment, and 1 week after the end of treatments.
  • Five weekly physiotherapy sessions of 50 minutes: 40 minutes of classical physiotherapy and 10 minutes of visceral manipulation or sham visceral manipulation.
  • Classical physiotherapy: standardized exercise protocol for people with low back pain to mobilize, strengthen, and stabilize the spine, pelvis, and hips.
    • After the first visit, participants received photos and descriptions so they could repeat the exercises at home. They were advised to maintain an active lifestyle and to progress in the exercises only when they felt no pain, fatigue, or fear of performing them.
  • Visceral manipulation: treatment applied in 8 areas of the abdomen by deep pressure to manipulate cardias, pylorus, sphincter of Oddi, duodenodigiunal valve, ileocecal valve, sigmoid colon, liver, and global hemodynamics. Each technique lasted 1 minute, except for the last two, each performed 10 times while having the patient inhale and exhale in association to the manipulation.
  • Visceral sham manipulation: gentle touch on the same areas as visceral manipulation, keeping the same duration and repetitions, without the intention to treat the patient.
  • Visceral manipulation performed by a physical therapist specializing in osteopathy.
  • Whether participants actually did the recommended exercises at home was not checked.

Results

  • Primary outcomes: both groups showed a statistically significant improvement in pain intensity, but there were no statistically significant differences between the two groups.
  • Secondary outcomes: the group with visceral manipulation showed a statistically significant improvement over the group with sham manipulation in lumbar mobility and specific function.
    Regarding general functionality, both groups showed statistically significant improvements, but there were no statistically significant differences between the two groups.
  • Further analyses: the outcome pain was statistically significantly correlated with both general and specific function (in both cases, less pain was associated with better function).
    The sham group showed, at the last session, a statistically significant correlation between pain and function (less pain was associated with better function) and between pain and lumbar mobility (less pain was associated with better mobility).
    With regard to conventional physiotherapy, the exercises induced muscle soreness and fatigue in several participants.

Discussion

Visceral manipulation combined with conventional physiotherapy did not show any different effects on pain compared to conventional physiotherapy combined with sham manipulation.

Instead, it was useful in improving lumbar mobility, a result that was not manifested in the control group. Most likely, as shown by previous studies, visceral manipulation helped to restore connective tissue mobility and motility.

Similarly, visceral manipulation appears to have helped improve specific functionality compared to sham manipulation, although it did not appear to have had any effect on general function. Possible explanations could lie in the fact that participants tend to overestimate their ability to perform specific tasks (as opposed to general function), or that the questionnaires used to assess the two types of function are not comparable to each other.

It would have been interesting if the changes in visceral motility could have been objectively measured with appropriate instrumentation.

The almost exclusive presence of women could result from the fact that, wanting to investigate the effects of visceral manipulation in chronic low back pain with visceral dysfunction, women tend to undergo more abdominopelvic surgeries. Another reason could be the increase in low back pain in women.

the study has several limitations, including: the low number of people recruited; the high dropout rate of participants; a higher number of visceral dysfunctions in the control group; the lack of validation in the literature of visceral sham manipulation; and the lack of evaluation of adverse effects.

The review of Osteopedia

By Marco Chiera

Strengths: one primary outcome; good description of inclusion-exclusion criteria and interventions; good assessment of study limitations.

Limits: as reported by the authors, participants dropping out of the study and one participant falling out reduced the statistical power, and thus the reliability, of the results obtained.
Adverse effects related to visceral manipulation, a central element for a preliminary or pilot study, were not evaluated.
Since the authors wanted to collect data for future studies, they could have performed analyses on effect size (actual magnitude of effect of a treatment).

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