N/A
N=20
Visceral Manipulation in Patients With Chronic Low Back Pain
Chronic Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03101020 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Low Back Pain After 6 Weeks of Intervention — 6.50; 6.00; 1.50; 3.50 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Visceral Manipulation (Other); Standard care physiotherapy (Other); Placebo Visceral Manipulation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Sorocaba
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Low Back Pain After 6 Weeks of Intervention |
6.50; 6.00; 1.50; 3.50; 1.80; 3.30 | — |
| SECONDARY Low Back Mobility Using the Schober Test After 6 Weeks of Intervention |
14.75; 15.31; 15.88; 15.30; 15.71; 15.11 | — |
| SECONDARY Disability Due to Low Back Pain After 6 Weeks of Intervention |
12.00; 9.20; 6.60; 5.10; 5.30; 3.80 | — |
| SECONDARY Functional Activity After 6 Weeks of Intervention |
5.90; 4.10; 3.20; 4.50; 3.90; 3.90 | — |
Summary
Non-specific chronic low back pain is a common multifactorial condition common to the world population. It is defined as a pain and discomfort located below the ribs and above the gluteal folds that may or may not have referred pain in the leg for more than 12 weeks. Visceral manipulation is a manual therapy technique that aims to normalize mechanical, vascular and neurological dysfunctions of the viscera with the objective of improving its functioning. Visceral dysfunction may potentially activate or exacerbate the symptoms of low back pain in the presence of compromised movements between the internal organs and its connective tissues. There are two ways in which a change in visceral mobility could interfere with low back pain, referred visceral pain and central hypersensitivity. The first occurs due to neural convergence, since there is no spinocortical tract that only sends visceral or somatic afferences, its afferences are crossed in the dorsal horn of the spinal cord. The second is that the prolonged and continuous activation of nociceptors, due to the alteration in the mobility of the gastrointestinal and urinary system, can generate central hypersensitivity. Therefore, the investigators hypothesized that through the visceral manipulation the fascial adherences would lyse and the visceral spasms would demise, reducing the peripheral input, thus, lessening pain in the low back.
Eligibility Criteria
Inclusion Criteria
- primary complaint of chronic non-specific low back pain (more than 12 weeks);
- pain symptoms in the low back with a score ≥ 2/10 on the 0-10 Numerical Pain Rating Scale (12);
- aged 18-80;
- history of surgery in the abdominopelvic region for more than 6 months;
- history of visceral dysfunction (e.g., constipation and reflux); and
- no known or suspected serious spinal pathology (e.g., metastasis, inflammatory or infective diseases of the spine, causa equine syndrome, canal stenosis, spinal fracture).
Exclusion Criteria
- no nerve root compromise evidenced by at least two of the following: (1) myotomal weakness, (2) dermatomal or widespread sensory loss, (3) hyporeflexia or hyperreflexia of the lower limb reflexes;
- no spinal surgery within the preceding 6 months;
- no vascular abnormality such as abdominal aortic aneurysms;
- not currently receiving chiropractic, osteopathic or other physical therapy;
- not pregnant or suspect being pregnant;
- not currently in an acute inflammatory phase of known gastrointestinal or urinary diseases (such as cholecystitis, renal calculi, peritonitis, appendicitis);
- not currently taking medications that significantly alter gut motility;
- not currently taking medications (such as oral corticosteroids) which are known to increase the risk of intestinal perforation);
- no known gastrointestinal disease that associates with a risk of intestinal perforation (e.g. Chron's disease, diverticular disease, peptic ulcer disease);
- not taking anti-platelet medications such as warfarin.
Data sourced from ClinicalTrials.gov (NCT03101020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.