Visceral Manipulation in Patients With Chronic Low Back Pain: Randomized Controlled Trial
Phase: NA
Conditions: Chronic Low Back Pain
Sponsor: University of Sorocaba

Study Protocol 
 
Official Title: Visceral Manipulation in Patients With Chronic Low Back Pain 
 
NCT03101020 
 
Document Date: November, 18th 2016 
 

Study Protocol 
All participants received equal treatment during the assessments and conventional 
therapy. They were treated one time per week for five weeks. Each session took 50 
minutes, starting with 40 minutes of conventional physiotherapy and finishing with 10 
minutes of active or placebo visceral manipulation, depending on the participant’s group 
allocation. 
Conventional physiotherapy 
We created a protocol of exercises for individuals with low back pain based on the clinical 
practice guidelines by Delitto et al. (2012). The protocol consisted of general exercises to 
mobilize, strength, and stabilize the spinal column, pelvis and hip, as it is described at 
Figure 1. All participants were oriented to keep an active lifestyle focusing on the 
activities they could perform (Koes et al. 2010; Panagopoulos et al. 2014).  
At the end of the first session, the participants received a list with the description and 
photos of the exercises they performed during that session and that they would need to do 
every other day at home; however, there was no control if the participants performed the 
exercises at home. The criteria to progress the exercises were no pain, no fatigue, and no 
fear on performing it. 
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Figure 2. Exercise protocol. A Erector spinae stretching, in dorsal decubitus pull the 
knee towards the abdomen – 2 sets of 30 seconds. B Knee rolls, roll the knees to one 
side and the other maintaining both shoulders on the floor – 2 sets of 10 seconds per 
side. C Piriformis stretch, in dorsal decubitus cross one ankle over the opposite knee 
and pull this leg towards the abdomen – 2 sets of 30 seconds per side. D Pelvic tilts. 
perform pelvic anteversion and retroversion – 10 to 15 repetitions. E(1) Back 
extensions, in ventral decubitus, extend the back supporting the upper body on flewed 

elbows – 10 to 15 repetitions.  E(2) Back extensions progression, the same position but 
supporting the upper body on the hands with the elbows extended. F(1) Activation of 
abdominal muscles, in dorsal decubitus perform isometric contraction of the profound 
abdominal muscles during breathing – 3 sets of 10 breathings. F(2) Activation of 
abdominal muscles progression 1, the same exercise but lifting a flexed knee in the air 
and maintaining it steady during the set – 2 sets of 10 breathings per side. F(3) 
Activation of abdominal muscles progression 2, the same exercise but lifting an 
extended knee in the air and maintaining it steady during the set – 2 sets of 10 breathings 
per side. G(1) Activation of back and hip muscles, in side lying, perform  isometric 
contraction of unilateral back and hip muscles during breathing – 3 sets of 10 
breathings. G(2) Activation of back and hip muscles progression 1, the same exercise 
but lifting a flexed knee and maintaining the ankle together and the leg steady during 
the set – 2 sets of 10 breathings per side. G(3) Activation of back and hip muscles 
progression 2, the same exercise but lifting an extended knee and maintaining it steady 
during the set – 2 sets of 10 breathings per side. H(1) Bridge exercise – 3 sets of 10 
repetitions. H(2) Bridge progression, perform a single leg brig exercise – 3 sets of 10 
repetitions per side. I(1,2) Quadruped Cat and Camel exercise – 10 to 15 repetitions. 
J(1) Single arm or leg raise, in quadruped position raise all limbs (arms and legs) one 
at a time and maintain the position – 1 set of 30 seconds for each limb. J(2) Quadruped 
opposite arm and leg raise exercise progression – 2 sets of 30 seconds per side.  K(1) 
Plank, perform the plank exercise supporting the lower body on the knees – 2 sets of 
30 to 60 seconds. K(2) Plank progression, perform the plank exercise supporting the 
lower body on the feet – 2 sets of 30 to 60 seconds. L(1) Side plank, perform the side 
plank exercise supporting the lower body on the knees – 2 sets of 30 to 60 seconds. 
L(2) Side plank progression, perform the side plank exercise supporting the lower body 
on the feet – 2 sets of 30 to 60 seconds. 
 
Visceral manipulation 
During all sessions, the participants had to remain in a hook-lying position and the head 
over a pillow to decrease the tension on the abdominal wall. A well-trained 
physiotherapist performed the visceral manipulation over eight spots on the abdomen. 
Each spot has a specific technique name, which are described in Figure 2, and each 
technique took 1 minute, except for the last two techniques that were performed 10 times 
each. For the experimental group (direct visceral manipulation), the therapist performed 
a deep pressure with the lower palm over those spots. The placebo visceral manipulation 
involved a light touch over the same spots, without intending to treat the patient, with the 
same amount of time and repetitions as the experimental group (McSweeney et al. 2012). 
At the end of the last session, the participants were asked to identify if the technique they 
received was the experimental or the placebo one. 
 
 

A 
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H 
 
 
Figure 3. Visceral manipulation protocol. Orientation of the pictures, cranial to the left 
and caudal to the right. A Cardia manipulation – 1 minute. B Pylorus manipulation – 1 
minute. C Oddi sphincter manipulation – 1 minute. D Duodeno-jejunal valve 
manipulation – 1 minute. E Ileocecal valve manipulation - 1 minute. F Sigmoid colon 
manipulation – 1 minute. G Liver global manipulation – 10 repetitions. H Global 
hemodynamic manipulation – 10 repetitions with pressure during expiration and 
another 10 for inspiration. 
 
Outcomes 
All participants were assessed three times, pre-treatment, post-treatment and follow-up. 
Pre-treatment assessment was one week before the first session of treatment, post-
treatment was right after the last session of treatment and the follow-up was one week 
after the last session of treatment. A team member, which was not involved with the 
interventions, was responsible for collecting all the baseline measures and outcomes. 
Primary outcome 

Pain intensity was evaluated through a Visual Analog Pain Scale of 11 points, where the 
participant choose a number from 0 to 10, 0 equals to “no pain at all” and 10 to 
“unbearable pain” (Childs et al., 2005). 
Secondary outcomes 
Lumbar spine mobility was assessed through the original Schober Test. Roland-Morris 
Disability Questionnaire was used for General functionality and Patient Specific 
Functional Scale was used for Specific functionality (Tousignant et al. 2005; Nusbaum et 
al. 2001; Kowalchuk-Horn et al., 2011; Oliveira et al.,  2008; Stratford et al.,  1995).