Visceral Manipulation in Patients With Chronic Low Back Pain

NCT ID: NCT03101020

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2017-07-28

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.

Detailed Description

Ethical aspects: All volunteers will be informed about the experimental procedures that will be submitted, as well as the fact that these do not affect the participant's health. The participants will also be clarified as to the secrecy of the information collected during the study performance, protecting the identities of the participants. After agreeing to participate in the research, each volunteer will sign the Informed Consent Term, according to resolution 196/96 and update in resolution 466 in 2012 of the National Health Council.

Risks:The interventions offer no harm to the participant's health. There is the possibility of the participant feeling pain and / or tickling during abdominal palpation. If these sensations occur, the procedure will be stopped and tried again. If sensations persist and the participant can not support them the session will be rescheduled or the participant will be disconnected from the study as there is no other way to carry out the proposed therapy.

Benefits:There may be no direct or immediate benefits, however, it is expected that the proposed treatment will improve lumbar pain.

This study does not offer any type of health insurance, and also, it is the responsibility of the participant to get around and bear the costs of transportation to the place of collection of data.

Confidentiality and privacy of research participants will be guaranteed during all phases of the research. At any time the participant can withdraw consent to participate in the research without any kind of penalty.

The research team is committed to making the search results public, whether favorable or not.

It is worth noting that the placebo intervention procedures will always be performed in association with an active treatment, which makes its use of less impact to the patient. In addition, all patients will be informed of the use of this procedure prior to the initiation of the survey.

Criteria for suspending research: This research will be suspended in the event of researchers' deaths, closure of the research site or termination of the Term of Science of the Partner Condition and / or no volunteer to participate in the research.

Financing This study will be funded by the researchers themselves.

Source of Patients: Patients with chronic low back pain will be referred for screening from online surveys, third party indications, and from patients on the waiting list of the Heath Center of the University of Sorocaba. The screening, assessment and evaluation will be performed at the Health Nucleus and in the Integrated Human Movement Laboratory of the University of Sorocaba.

Procedure: The researchers will inform the study objectives and procedures to all patients. If the participants agree to participate, the participants will sign an informed consent form. After that, a therapist will assess them for demographic data and baseline measures, such as pain level (0-10 Numerical Pain Rating Scale), disability associated with low back pain (Roland-Morris Disability Questionnaire), and function (0-10 Patient-Specific Functional Scale)

Random Allocation: One of the researchers will create a randomization code with 1:1 allocation radio using Excel for Windows software. The codes will be the words "E" for experimental or "P" for placebo, then ithe codes will be sealed on opaque envelopes, thus ensuring the concealed allocation of participants to groups. At the first encounter with the treating therapist, patients will choose one of the envelopes on a table and give it to the therapist. The therapist will open it in a different room from the patient and allocate the patient to the group according to the randomization schedule.

Interventions: The volunteers will be allocated in the Experimental group or the Control Group. In the Experimental, the participants will receive the Standard care physiotherapy plus Active visceral manipulation, while the Control will receive Standard care physiotherapy and Placebo visceral manipulation. The standard care physiotherapy lasts 40 minutes and the visceral mobilisation takes around 10 minutes.

Blinding: The assessor and the therapist will be blind to each others work. Therefore the assessor will not have knowledge of the treatment allocation and will perform three assessments, the pre assessment, immediately after the last treatment and 1 week after the treatment. Similarly, the therapist will not know the pre- and post-assessment intervention. In addition, there will be only one assessor and one therapist for the research to decrease bias. To test the blinding, after the last treatment session, the assessor will write on the patient's assessment chart which type of intervention (active or placebo) he thought the participant had received. These codes will be later compared with the randomization codes.

Statistical methods: Statistical analysis will be used SPSS (Statistical Package for Social Sciences) v.19.0. Initially the Kolmogorov-Smirnov test will be performed. If the data are normal, parametric tests will be applied, if the distribution is non-normal, non-parametric tests will be used. It will be calculated from the effect size, by means of the difference between the means of the pre-intervention evaluation and the post-intervention evaluation. In all analyzes, a critical level of 5% (p <0.05) will be set.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

The participants will receive standard care physiotherapy plus active visceral manipulation

Group Type: EXPERIMENTAL

Active Visceral Manipulation

Intervention Type: 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.

Standard care physiotherapy

Intervention Type: 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.

Control Group

The participants will receive standard care physiotherapy plus placebo visceral manipulation

Group Type: PLACEBO_COMPARATOR

Standard care physiotherapy

Intervention Type: 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.

Placebo Visceral Manipulation

Intervention Type: 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

Interventions

Active Visceral Manipulation

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.

Intervention Type: OTHER

Standard care physiotherapy

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.

Intervention Type: OTHER

Placebo Visceral Manipulation

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

Intervention Type: OTHER

Other Intervention Names

Active Visceral Mobilization; Direct Visceral Mobilization; Conventional physiotherapy; Placebo Visceral Mobilization; Indirect Visceral Mobilization

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sorocaba

OTHER

Sponsor Role: lead

Responsible Party

Luciane Cruz Lopes

Director, Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucas V Santos

Role: PRINCIPAL_INVESTIGATOR

University of Sorocaba

Locations

Integrated Laboratory of Human Movement, University of Sorocaba

Sorocaba, São Paulo, Brazil

Health Center, University of Sorocaba

Sorocaba, São Paulo, Brazil

Countries

Brazil

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 22196431 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11076916 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18758050 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26200363 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11175495 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25378096 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26742533 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 22703751 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20961685 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Visceral Mob and LBP

Identifier Type: -

Identifier Source: org_study_id