Visceral Manipulation in Patients With Chronic Low Back Pain

NCT03101020 | Completed Results DMC

• 1 other identifier: Visceral Mob and LBP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Low Back Pain

Keywords

Visceral Manipulation

Outcome Measures

Primary Outcomes (1)

• Low Back Pain After 6 Weeks of Intervention

  An 11-point Numeric Pain Rating Scale (NPRS) will be used, where 0 is equivalent to "no pain" and 10 to "unbearable pain"

  6 weeks

Secondary Outcomes (3)

• Low Back Mobility Using the Schober Test After 6 Weeks of Intervention

  6 weeks

• Disability Due to Low Back Pain After 6 Weeks of Intervention

  6 weeks

• Functional Activity After 6 Weeks of Intervention

  6 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

The participants will receive standard care physiotherapy plus active visceral manipulation

Other: Active Visceral Manipulation; Other: Standard care physiotherapy

Control Group

PLACEBO COMPARATOR

The participants will receive standard care physiotherapy plus placebo visceral manipulation

Other: Standard care physiotherapy; Other: Placebo Visceral Manipulation

Interventions

Active Visceral Manipulation OTHER

Visceral manipulation techniques consists of deep manual pressure in certain points of the abdomen and the amount of pressure will be respected according to the participant discomfort or pain. It will be performed cardia mobilization, pylori mobilization, Oddi's sphincter mobilization, duodenum-jejunum valve mobilization, ileocecal valve mobilization, global technique for the liver, global hemodynamic technique. Each technique will last 1 minutes, with the two last ones repeated 10 times.

Also known as: Active Visceral Mobilization, Direct Visceral Mobilization

Experimental Group

Standard care physiotherapy OTHER

The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes.

Also known as: Conventional physiotherapy

Control Group; Experimental Group

Placebo Visceral Manipulation OTHER

The placebo intervention involves light touch at the same regions of the techniques the active visceral manipulation, and no intention on the part of the therapist to impart any therapeutic technique

Also known as: Placebo Visceral Mobilization, Indirect Visceral Mobilization

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sorocaba: lead

Study Sites (2)

Integrated Laboratory of Human Movement, University of Sorocaba

Sorocaba, São Paulo, 18023000, Brazil

Location

Health Center, University of Sorocaba

Sorocaba, São Paulo, 18110-210, Brazil

Location

Related Publications (12)

• BARRAL, J.-P .; MERCIER, P. Visceral Manipulation. [Sl: sn].

  BACKGROUND

• Bove GM, Chapelle SL. Visceral mobilization can lyse and prevent peritoneal adhesions in a rat model. J Bodyw Mov Ther. 2012 Jan;16(1):76-82. doi: 10.1016/j.jbmt.2011.02.004. Epub 2011 Apr 9.

  PMID: 22196431 BACKGROUND

• Cervero F. Visceral pain-central sensitisation. Gut. 2000 Dec;47 Suppl 4(Suppl 4):iv56-7; discussion iv58. doi: 10.1136/gut.47.suppl_4.iv56. No abstract available.

  PMID: 11076916 BACKGROUND

• Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1.

  PMID: 18758050 BACKGROUND

• Nascimento PR, Costa LO. Low back pain prevalence in Brazil: a systematic review. Cad Saude Publica. 2015 Jun;31(6):1141-56. doi: 10.1590/0102-311X00046114. Epub 2015 Jun 1. English, Portuguese.

  PMID: 26200363 BACKGROUND

• Nusbaum L, Natour J, Ferraz MB, Goldenberg J. Translation, adaptation and validation of the Roland-Morris questionnaire--Brazil Roland-Morris. Braz J Med Biol Res. 2001 Feb;34(2):203-10. doi: 10.1590/s0100-879x2001000200007.

  PMID: 11175495 BACKGROUND

• Panagopoulos J, Hancock MJ, Ferreira P, Hush J, Petocz P. Does the addition of visceral manipulation alter outcomes for patients with low back pain? A randomized placebo controlled trial. Eur J Pain. 2015 Aug;19(7):899-907. doi: 10.1002/ejp.614. Epub 2014 Nov 7.

  PMID: 25378096 BACKGROUND

• REZENDE, RPDB; GABRIEL, A. Relationship between Clinic and Osteopathy. Rev. Soc. Bras. Clin. Avg, v. 6, n. 5, p. 194-196, 2008.

  BACKGROUND

• Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.

  PMID: 26742533 BACKGROUND

• STRATFORD P, GILL C, WESTAWAY M, ET AL. A. DISABILITY AND CHANGE ON INDIVIDUAL PATIENTS: A REPORT OF A PATIENT SPECIFIC. . .Patient-Specific Functional Scale Patient-Specific Functional Scale. Physiother Can 1995; 47: 258-63. , V. 47: 258-63., P. 3, 1995.

  BACKGROUND

• Tozzi P, Bongiorno D, Vitturini C. Low back pain and kidney mobility: local osteopathic fascial manipulation decreases pain perception and improves renal mobility. J Bodyw Mov Ther. 2012 Jul;16(3):381-391. doi: 10.1016/j.jbmt.2012.02.001. Epub 2012 Mar 3.

  PMID: 22703751 BACKGROUND

• Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.

  PMID: 20961685 BACKGROUND

Limitations and Caveats

High dropout rate for the control group compromised statistical power; Unreliability of the placebo technique.

Results Point of Contact

• Title: Lucas Villalta Santos
• Organization: Faculdade de Ciências Médicas da Santa Casa de São Paulo

lucasvillalta.s@gmail.com

+5515998197899

Study Officials

• Lucas V Santos

  University of Sorocaba

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator will be blind as he will not be present during the intervention. As well as the care provider will not be present during the assessor activities.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Model Details: Both experimental and control groups will receive standard care physiotherapy for low back pain according to the evidence presented in the study of Delitto et al. The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform exercise regularly. The therapist will treat the participants once a week for a 5-week period, each session will last 40 minutes. Besides the standard care, the therapist will perform cardia mobilization, pylori mobilization, Oddi's sphincter mobilization,duodenum-jejunum valve mobilization, ileocecal valve mobilization, global technique for the liver, global hemodynamic technique. Each technique will last 1 minutes, with the two last ones repeated 10 times.The placebo intervention involves light touch at the same regions of the techniques as above, and no intention on the part of the therapist to impart any therapeutic technique.

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 4, 2017
• Study Start: June 1, 2017
• Primary Completion: July 6, 2017
• Study Completion: July 28, 2017
• Last Updated: August 19, 2020
• Results First Posted: July 23, 2019

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)