Chronic Low Back PainNCT03101020
Visceral Manipulation in Patients With Chronic Low Back Pain
A study testing Active Visceral Manipulation in people with Chronic Low Back Pain, run by University of Sorocaba at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Active Visceral Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Jun 2017to 28 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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);
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Integrated Laboratory of Human Movement, University of Sorocaba
Sorocaba, São Paulo, 18023000
Health Center, University of Sorocaba
Sorocaba, São Paulo, 18110-210
About this study
Official title: Visceral Manipulation in Patients With Chronic Low Back Pain: Randomized Controlled Trial
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.
Read the 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
- Being tested
- Active Visceral Manipulation, Standard care physiotherapy, Placebo Visceral Manipulation
- Keywords
- Visceral Manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Visceral ManipulationOther
Also called Active Visceral Mobilization, Direct Visceral Mobilization
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 physiotherapyOther
Also called Conventional 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.
Placebo Visceral ManipulationOther
Also called Placebo Visceral Mobilization, Indirect Visceral Mobilization
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The participants will receive standard care physiotherapy plus active visceral manipulation Receives: Other: Active Visceral Manipulation; Other: Standard care physiotherapy |
| Control Group | Placebo comparator | The participants will receive standard care physiotherapy plus placebo visceral manipulation Receives: Other: Standard care physiotherapy; Other: Placebo Visceral Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 6 weeks
Secondary outcomes (3)
Low Back Mobility Using the Schober Test After 6 Weeks of Intervention
The Schober test consists of extending a tape measure on the spinal column, between the two posterior superior iliac spines and up to 10 cm above this, with the individual in a neutral position. Then, the patient is asked to do anterior flexion of the trunk, then the therapist will measure the distance of the marked points, in patients without changes of mobility should increase at least 5 cm. Increases smaller than 5 cm indicate that the test is positive, decreased mobility of the lumbar spine.
Measured: 6 weeks
Disability Due to Low Back Pain After 6 Weeks of Intervention
The Roland Morris Disability Questionnaire consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/activity, sleep/rest, psychosocial, household management, eating and pain frequency. It is designed to take approximately 5 minutes to complete, without any assistance from the administrator.
The respondent is presented with each statement and asked if they feel the statement is descriptive of their own circumstance on that day. For example, the first statement is 'I stay at home most of the day because of the pain in my back'. If the respondent feels that this statement applies to them they 'tick' the statement, otherwise they leave it blank. To score the responses, a practitioner need only add up the number of items ticked. There is no weighting applied to the statements, therefore the score can range from 0 (no disability) to 24 (maximal disability).
Measured: 6 weeks
Functional Activity After 6 Weeks of Intervention
he Patient-Specific Functional Scale (PSFS) is a self-reported, patient-specific outcome measure, designed to assess functional change, primarily in patients presenting with musculoskeletal disorders Patients are asked to identify up to five important activities they are unable to perform or are having difficulty with as a result of their problem i.e. putting socks on. In addition to identifying the activities, patients are asked to rate, on an 11-point scale, the current level of difficulty associated with each activity. Following the intervention, patients are asked again to rate the activities previously identified and are given the chance to nominate new problematic activities that might have arisen during that time."0" represents "unable to perform". "10" represents "able to perform at prior level".
Patients select a value that best describes their current level of ability on each activity assessed. Lower scores mean a worse outcome, higher scores mean a better outcome.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jun 2017
- Primary completion6 Jul 2017
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sorocaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciane Cruz Lopes, University of Sorocaba
- Investigators
- Lucas V Santos, Principal investigator, University of Sorocaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101020
- Sponsor's protocol ID
- Visceral Mob and LBP
- Status last verified
- Aug 2020
- First submitted
- 22 Mar 2017
- Last updated
- 19 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
BARRAL, J.-P .; MERCIER, P. Visceral Manipulation. [Sl: sn].
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.
PubMed 22196431Cervero 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.
PubMed 11076916Childs 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.
PubMed 18758050Nascimento 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.
PubMed 26200363Nusbaum 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.
PubMed 11175495Panagopoulos 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.
PubMed 25378096REZENDE, RPDB; GABRIEL, A. Relationship between Clinic and Osteopathy. Rev. Soc. Bras. Clin. Avg, v. 6, n. 5, p. 194-196, 2008.
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.
PubMed 26742533STRATFORD 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.
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.
PubMed 22703751Woolf 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.
PubMed 20961685
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Manipulation in Patients With Chronic Low Back Pain: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03101020
- Acronym / sponsor ID
- Visceral Mob and LBP
- Conditions
- Chronic Low Back Pain
- Keywords
- Visceral Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SorocabaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Active Visceral Manipulation, Other: Standard care physiotherapyThe participants will receive standard care physiotherapy plus active visceral manipulation |
| Control Group | Placebo comparator | Other: Standard care physiotherapy, Other: Placebo Visceral ManipulationThe participants will receive standard care physiotherapy plus placebo visceral manipulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Visceral ManipulationAlso: Active Visceral Mobilization, Direct Visceral MobilizationVisceral 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. | Other | Experimental Group |
| Standard care physiotherapyAlso: Conventional physiotherapyThe 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. | Other | Control Group, Experimental Group |
| Placebo Visceral ManipulationAlso: Placebo Visceral Mobilization, Indirect Visceral MobilizationThe 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 | Other | Control Group |
Primary outcome
Low Back Pain After 6 Weeks of Intervention
Time frame: 6 weeks
An 11-point Numeric Pain Rating Scale (NPRS) will be used, where 0 is equivalent to "no pain" and 10 to "unbearable pain"
3 secondary outcomes
Low Back Mobility Using the Schober Test After 6 Weeks of Intervention
Time frame: 6 weeks
Disability Due to Low Back Pain After 6 Weeks of Intervention
Time frame: 6 weeks
Functional Activity After 6 Weeks of Intervention
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBARRAL, J.-P .; MERCIER, P. Visceral Manipulation. [Sl: sn].
- Background: PubMed 22196431Bove 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.
- Background: PubMed 11076916Cervero 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.
- Background: PubMed 18758050Childs 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.
- Background: PubMed 26200363Nascimento 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.
- Background: PubMed 11175495Nusbaum 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.
- Background: PubMed 25378096Panagopoulos 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.
- BackgroundREZENDE, RPDB; GABRIEL, A. Relationship between Clinic and Osteopathy. Rev. Soc. Bras. Clin. Avg, v. 6, n. 5, p. 194-196, 2008.
- Background: PubMed 26742533Saragiotto 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.
- BackgroundSTRATFORD 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: PubMed 22703751Tozzi 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas V Santos principal investigator
University of Sorocaba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Visceral Manipulation in people with Chronic Low Back Pain, run by University of Sorocaba at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Back Pain After 6 Weeks of Intervention (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03101020, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.