Trial Outcomes & Findings for Visceral Manipulation in Patients With Chronic Low Back Pain (NCT NCT03101020)
NCT ID: NCT03101020
Last Updated: 2020-08-19
Results Overview
An 11-point Numeric Pain Rating Scale (NPRS) will be used, where 0 is equivalent to "no pain" and 10 to "unbearable pain"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
6 weeks
Results posted on
2020-08-19
Participant Flow
All participants were recruited through third party referral from the Health Center of the University of Queensland. The date of recruitment was from 06/01/2017 to 06/16/2017. The participants usually knew about the study through advertisement on online social media or through folders on the Health Center clinic.
There were no events that occur after participant enrollment, but prior to assignment of participants to a group
Participant milestones
| Measure |
Experimental Group
10 participants received standard care physiotherapy plus active visceral manipulation
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, duodeno-jejunal 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: 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
10 participants received standard care physiotherapy plus placebo visceral manipulation
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.
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Experimental Group
10 participants received standard care physiotherapy plus active visceral manipulation
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, duodeno-jejunal 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: 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
10 participants received standard care physiotherapy plus placebo visceral manipulation
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.
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
|
|---|---|---|
|
Overall Study
Lack of time to participate
|
1
|
0
|
|
Overall Study
Ran over by a car
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group
n=10 Participants
The participants received standard care physiotherapy plus active visceral manipulation
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, duodeno-jejunal 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: 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
n=10 Participants
The participants received standard care physiotherapy plus placebo visceral manipulation
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.
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
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 10.39 • n=10 Participants
|
40.5 years
STANDARD_DEVIATION 12.12 • n=10 Participants
|
40.5 years
STANDARD_DEVIATION 9.55 • n=20 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
|
Visceral dysfunction
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: 20 participants with low back pain and visceral dysfunction
An 11-point Numeric Pain Rating Scale (NPRS) will be used, where 0 is equivalent to "no pain" and 10 to "unbearable pain"
Outcome measures
| Measure |
Experimental Group
n=10 Participants
The participants received standard care physiotherapy plus active visceral manipulation
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, duodeno-jejunal 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: 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
n=10 Participants
The participants received standard care physiotherapy plus placebo visceral manipulation
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.
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
|
|---|---|---|
|
Low Back Pain After 6 Weeks of Intervention
pre-intervention
|
6.50 units on a scale
Standard Deviation 2.33
|
6.00 units on a scale
Standard Deviation 0.92
|
|
Low Back Pain After 6 Weeks of Intervention
post-intervention
|
1.50 units on a scale
Standard Deviation 2.42
|
3.50 units on a scale
Standard Deviation 2.94
|
|
Low Back Pain After 6 Weeks of Intervention
1 week follow-up
|
1.80 units on a scale
Standard Deviation 2.93
|
3.30 units on a scale
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: 20 participants with chronic low back pain and visceral dysfunction
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.
Outcome measures
| Measure |
Experimental Group
n=10 Participants
The participants received standard care physiotherapy plus active visceral manipulation
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, duodeno-jejunal 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: 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
n=10 Participants
The participants received standard care physiotherapy plus placebo visceral manipulation
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.
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
|
|---|---|---|
|
Low Back Mobility Using the Schober Test After 6 Weeks of Intervention
pre-intervention
|
14.75 centimeters
Standard Deviation 0.78
|
15.31 centimeters
Standard Deviation 1.00
|
|
Low Back Mobility Using the Schober Test After 6 Weeks of Intervention
post-intervention
|
15.88 centimeters
Standard Deviation 1.09
|
15.30 centimeters
Standard Deviation 0.63
|
|
Low Back Mobility Using the Schober Test After 6 Weeks of Intervention
1 week follow-up
|
15.71 centimeters
Standard Deviation 1.04
|
15.11 centimeters
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: 20 participants with chronic low back pain and visceral dysfunction
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).
Outcome measures
| Measure |
Experimental Group
n=10 Participants
The participants received standard care physiotherapy plus active visceral manipulation
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, duodeno-jejunal 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: 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
n=10 Participants
The participants received standard care physiotherapy plus placebo visceral manipulation
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.
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
|
|---|---|---|
|
Disability Due to Low Back Pain After 6 Weeks of Intervention
pre-intervention
|
12.00 points
Standard Deviation 4.15
|
9.20 points
Standard Deviation 6.16
|
|
Disability Due to Low Back Pain After 6 Weeks of Intervention
post-interverntion
|
6.60 points
Standard Deviation 6.12
|
5.10 points
Standard Deviation 4.48
|
|
Disability Due to Low Back Pain After 6 Weeks of Intervention
1 week follow-up
|
5.30 points
Standard Deviation 5.06
|
3.80 points
Standard Deviation 4.53
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: 20 participants with chronic low back pain and visceral dysfunction
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.
Outcome measures
| Measure |
Experimental Group
n=10 Participants
The participants received standard care physiotherapy plus active visceral manipulation
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, duodeno-jejunal 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: 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
n=10 Participants
The participants received standard care physiotherapy plus placebo visceral manipulation
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.
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
|
|---|---|---|
|
Functional Activity After 6 Weeks of Intervention
pre-intervention
|
5.90 units on a scale
Standard Deviation 3.05
|
4.10 units on a scale
Standard Deviation 3.08
|
|
Functional Activity After 6 Weeks of Intervention
post-intervention
|
3.20 units on a scale
Standard Deviation 2.71
|
4.50 units on a scale
Standard Deviation 3.29
|
|
Functional Activity After 6 Weeks of Intervention
1 week follow-up
|
3.90 units on a scale
Standard Deviation 3.33
|
3.90 units on a scale
Standard Deviation 2.77
|
Adverse Events
Experimental Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Group
n=10 participants at risk
The participants received standard care physiotherapy plus active visceral manipulation
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, duodeno-jejunal 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: 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
n=10 participants at risk
The participants received standard care physiotherapy plus placebo visceral manipulation
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.
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
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
30.0%
3/10 • The adverse effects were collected before and after each session. A total of 5 weeks.
The patients were asked by the treating physiotherapist about adverse effects such as sore muscles, back pain and abdominal discomfort. The therapist took note on a blank paper corresponding to the participant identification number.
|
20.0%
2/10 • The adverse effects were collected before and after each session. A total of 5 weeks.
The patients were asked by the treating physiotherapist about adverse effects such as sore muscles, back pain and abdominal discomfort. The therapist took note on a blank paper corresponding to the participant identification number.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
1/10 • The adverse effects were collected before and after each session. A total of 5 weeks.
The patients were asked by the treating physiotherapist about adverse effects such as sore muscles, back pain and abdominal discomfort. The therapist took note on a blank paper corresponding to the participant identification number.
|
10.0%
1/10 • The adverse effects were collected before and after each session. A total of 5 weeks.
The patients were asked by the treating physiotherapist about adverse effects such as sore muscles, back pain and abdominal discomfort. The therapist took note on a blank paper corresponding to the participant identification number.
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness
|
100.0%
10/10 • The adverse effects were collected before and after each session. A total of 5 weeks.
The patients were asked by the treating physiotherapist about adverse effects such as sore muscles, back pain and abdominal discomfort. The therapist took note on a blank paper corresponding to the participant identification number.
|
100.0%
10/10 • The adverse effects were collected before and after each session. A total of 5 weeks.
The patients were asked by the treating physiotherapist about adverse effects such as sore muscles, back pain and abdominal discomfort. The therapist took note on a blank paper corresponding to the participant identification number.
|
Additional Information
Lucas Villalta Santos
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Phone: +5515998197899
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60