Federica Tamburella, Alessandro Antonio Princi, Jacopo Piermaria, Matteo Lorusso, Giorgio Scivoletto, Marcella Masciullo, Giovanni Cardilli, Paola Argentieri, Marco Tramontano | Year 2022

Neurogenic Bowel Dysfunction Changes after Osteopathic Care in Individuals with Spinal Cord Injuries: A Preliminary Randomized Controlled Trial

Pathology:

Traumatology of the spinal cord

Type of study:

Randomized controlled trial

Date of publication of the study’:

2022/Jan/21

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Purpose of the study

  • Objective: to explore the effects of OMT on neurogenic bowel dysfunction in people with spinal cord injury
  • Measured outcomes:
    • primary: assessment of neurogenic bowel dysfunction’s symptoms in case of spinal cord injury and their impact on quality of life using the Neurogenic Bowel Dysfunction Scale (NBDS)
    • secondary: assessment of constipation through Knowles Eccersley Scott Symptom Scale (KESS) and quality of life in case of constipation through Patient Assessment of Constipation Quality Of Life (PAC-QOL)
    • Further outcomes: assessment of abdominal pain,  perception of abdominal swelling and intensity of perceived constipation using the Visual Analog Scale (VAS); evaluation of the number of incontinence events and of the number of daily bowel movements, with related stool consistency using the Bristol Stool Chart (BSC); assessment of the type and dosage of each drug taken

Participants

  • Number: 13 people (2 female and 11 male)
  • Criteria of inclusion: age between 18 and 70 years, patients admitted to the neuro-rehabilitation department, a diagnosis of spinal cord injury of grade A, B, C or D on the American Spinal Injury Association (ASIA) impairment scale, neck or dorsal lesion (up to D10), moderate or severe stable symptoms related to neurogenic bowel dysfunction assessed by NBDS, no changes in their drug treatment plan in the first phase of the study (see below “Interventions and evaluations”).
  • Criteria of exclusion: use of bowel emptying techniques (eg, retrograde trans-anal irrigations), any current or previous inflammatory bowel disease, metabolic or endocrinological dysfunctions, pregnancy, cognitive impairment
  • Groups of study: 2 groups obtained by randomization
    • Group 1: OMT, 7 people (1 female and 6 male, mean age 37.5 years)
    • Group 2: standardized manual treatment 6 people (1 female and 5 male, mean age 52.6 years)

Interventions and evaluations

  • Study divided in 3 phases:
    • phase 1: observation and monitoring for 30 days of the symptoms of neurogenic intestinal dysfunction and of the effects of the drugs taken;
    • phase 2: 4 weekly treatment sessions of 40 minutes with monitoring of the symptoms and of the effects of the drugs taken;
    • phase 3: a 30-days follow-up consisting in the observation and monitoring of the symptoms of neurogenic intestinal dysfunction and of the effect of the drugs taken.
  • Assessments at enrolment, after 30 days (end of phase 1), at the end of the 4 treatment sessions (end of phase 2) and 30 days after the end of treatments (end of phase 3 or follow-up) of neurogenic bowel dysfunction symptoms in case of spinal cord injury and its impact on quality of life using NBDS, constipation using KESS and quality of life in case of constipation using PAC-QOL.
  • Evaluation before and after each treatment session of abdominal pain, perceived abdominal swelling and constipation using VAS.
  • Evaluation of the number of incontinence events and of daily bowel movements (spontaneous or after enema), with annexed evaluation of the consistency of the stools using the Bristol Stool Chart.
  • Evaluation of the type and dosage of each drug taken through a daily intestinal diary recorded by the nursing staff.
    • The drugs were divided into 3 categories: oral laxatives, rectal laxatives and enemas.
  • OMT: assessment in order to detect any somatic dysfunctions throughout the body, using TART parameters and treatment aimed at resolving the dysfunctions found, all recorded via SOAP.
    • Techniques used: myofascial release, balanced ligamentous tension, visceral manipulation, cranial osteopathy, muscle energy, facilitated positional release.
  • Standardized manual treatment: passive mobilizations of the pelvis, upper and lower limbs and of the cervical region; light touch on the abdomen and thoracic regions.
  • OMT and standardized manual treatment performed by healthcare professionals trained in osteopathy.

Results

  • Primary outcomes: the OMT group showed a statistically significant improvement in the symptoms of bowel dysfunction assessed by NBDS both between baseline and follow-up, with a small effect size, and between the first treatment and the follow-up, with a moderate effect size. In contrast, the control group showed no changes.
    Through a specific question on bowel management satisfaction, a positive trend emerged in favor of OMT.
  • Secondary outcomes: while the control group showed no changes, the OMT group showed statistically significant improvements in perceived constipation and abdominal bloating between the start and the end of the treatments, with large effect sizes.

There was no difference between the two groups in terms of daily bowel movements and Bristol Stool Chart assessment. In general, there was a prevalence of evacuations following the administration of an enema; on the other hand, while in the OMT group a decrease in enema use was registered at the follow-up, in the control group there was an increase.

With regard to the incontinence events, a trend emerged in the OMT group towards a reduction both during the treatment period and at the follow-up. In contrast, the control group showed a worsening trend at the follow-up.

In general the pharmacological plan remained the same throughout the all study.

  • Further outcomes: most of the somatic dysfunctions were found in the abdomen, pelvis and thorax. Over time, the number of somatic dysfunctions showed a tendency to decrease, more at the thoracic level than at the abdominal level, bearing in mind that the abdomen was the most treated area in all treatments. The head and ribcage showed an increasing number of somatic dysfunctions over time, while the cervical area showed fewer somatic dysfunctions at the last treatment. The lumbar and sacral areas were the least treated areas and, therefore, with the least somatic dysfunctions.
    Myofascial release, facilitated positional release, and visceral manipulation were the most used techniques, while muscle energy techniques were the least used.
  • Adverse effects: no adverse effect was reported in both groups

Discussion

OMT has been shown to improve symptoms related to neurogenic bowel dysfunction. Given that the group with standardized manual treatment did not seem to have shown any improvement. But most importantly, there was no improvement attributable to the medicinal therapeutic plan in the periods of pharmacological surveillance alone – in these phases the participants showed stable conditions. It is therefore very likely that the improvements observed in the OMT group depended on the OMT itself.

There are, in fact, many examples  in the literature of how the OMT can influence, through touch and manipulation, the central nervous system, the autonomic nervous system, the hemodynamic system and visceral motility. It is therefore conceivable that, in case of spinal cord injury and reduced central control, the OMT may favor a better regulation of the gastrointestinal tract by the enteric nervous system. Not surprisingly, perhaps, the most used techniques were myofascial release, facilitated positional release and visceral manipulation, which can promote revascularization and greater elasticity and motility at the visceral level when applied to the abdomen.

The effectiveness of OMT is also corroborated by the improvement of the PAC-QOL scales’ scores, in relation to concern and satisfaction, an improvement seen at the end of the treatments. Such scores, however, worsened at the follow-up. Given that this effect was also not found in the control group, it can most likely be assumed that the participants perceived the benefit of OMT and began to worry about how they could manage their gut situation after the end of the study.

In this regard, it can be seen that the improvement of symptoms leads to an improvement in quality of life in general: many people with neurogenic intestinal dysfunction, in fact, do not participate in social activities for fear of sudden evacuation events.

It is also interesting to note that two participants in the OMT group stopped taking laxatives at a certain point.

However, due to the low number of people recruited and their heterogeneity the interpretation of data should be carried out with caution, although moderate or even large effect sizes have been highlighted. Future studies will be able to better evaluate the most effective OMT techniques for this situation and to assess their effects through instrumental outcomes such as, for example, the analysis of colonic transit time.

The review of Osteopedia

By Marco Chiera

Strengths: good introduction; sample size based on previous studies; choice of a defined primary outcome; analysis of various outcomes, useful for a better understanding of the impact of the treatments and of the characteristics of the applied OMT; the evaluation of the effect size is useful both from a clinical point of view and for organizing future studies on the subject.

Limits: it was not defined how adverse effects were evaluated, a central element for a pilot study; ratings of daily stools are descriptive trends and have not been evaluated by specific statistical tests; small sample to generalize the results (although normal for a pilot study).

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