Irritable Bowel SyndromeIBSNCT04486469
Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study.
A study testing Physical Therapy Group in people with Irritable Bowel Syndrome, run by IBS Group, Alcalde at 1 site in Spain.
Trial summary
Introduction and State of Question Irritable Bowel Syndrome can be classified as a functional digestive disorder characterized by abdominal pain, bloating, and changes in the frequency and consistency of bowel movements. Recent studies endorse the use of physical therapies for its symptomatic treatment. Read more about this study
- Who is it for?
- Ages 36 to 50 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Physical Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2019to 24 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 36 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Over 18 years
- Collaborating patients
- Patients Diagnosed with IBS from the Digestive System Services of the Virgen de la Arrixaca and Reina Sofía Hospital in Murcia in Outpatient Consultations.
- Accept and sign the informed consent
- Degree of Severity in the IBS-Severity index from Moderate to Serious (greater than 175p.)
- Frequency of abdominal pain in 2 out of 10 days in the IBS-SI
Who cannot join
- Patients with fear or phobia of electricity
- Restrictive diaphragmatic respiratory pathologies in your medical history, either due to neurological or traumatic causes.
- Patients with pacemakers, or diagnosed with heart disease or arrhythmias.
- Presence of developing scars, burns, allergies, wounds or infections in the thigh and lower back application areas.
- undiagnosed pain
- Neoplasms
Show all 11Show fewer
- Deep venous thrombosis
- Pregnancy
- Elimination criteria:
- Worsening of symptoms after abdominal massage
- Failure to attend sessions of 2 or more days followed by treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome
Introduction and State of Question Irritable Bowel Syndrome can be classified as a functional digestive disorder characterized by abdominal pain, bloating, and changes in the frequency and consistency of bowel movements. Recent studies endorse the use of physical therapies for its symptomatic treatment. With the present study investigators wanted to verify the effectiveness of physiotherapy techniques in order to alleviate or eliminate the symptoms of Irritable Bowel Syndrome.
Material and Methods Investigators have carried out an uncontrolled pilot clinical trial in a sample of 24 patients diagnosed with Irritable Bowel Syndrome in two hospitals in the Region of Murcia. Among the measurement tools used, we highlight the use of the IBS-Severity Scale, IBS-QoL, STAI and spirometry tests.
Read the detailed description
Scope of treatment: From the Digestive System Services, patients who meet the criteria described above, will be referred to the Rehabilitation Services of the Virgin of Arrixaca and Reina Sofía University Hospital, and then, to the physiotherapy unit. At the same time, the researcher will contact these patients to manage the appointments proposed in physiotherapy. The physical treatment to be applied individually has a duration of 40 min per session, establishing a maximum of 8 sessions and a minimum of 3 sessions. This treatment is described below: the first three weeks: (3 days / week)
- Performing direct physical treatment on the diaphragm, using stretching, followed by teaching exercises for re-education of the abdomen and diaphragm. (20 min):
- Direct physical treatment on the diaphragm. It refers to the stretching of the xiphoid and costal portions. With the patient in the supine position and the hips flexed 90º, investigator take advantage of the abdominal-diaphragmatic respiration in its expiratory component to stretch these portions, trying to penetrate with fingertips over the xiphoid and costal edge and maintaining the position with each gain, performing a maximum of 3 winnings.
- Abdomino-diaphragmatic reeducation: With the patient in the supine position and the hips flexed 90º, investigator will place the hands in the abdominal area and ask pacient to try to push the hands upwards taking air with the belly. Once the patient have become aware investigator will put up some resistance to the movement. Investigator will avoid possible compensations by controlling the expansion of the rib cage if necessary. Next investigator will ask patient to associate movements of the pelvic scale during breathing. In inspiration, investigator will ask patient to slightly push the sacrum on the stretcher and in ESP, then investigator will ask patient to bring the pelvis back tightening the buttocks as trying to retain defecation. (10min)
- Transcutaneous retrograde electrostimulation: L1-L4 (2hz-10hz) rectangular asymmetric biphasic at the level of the dermatome. From the anterior inferior iliac spine to a pubic symphysis. Second canal from the greater trochanter to the saphenous veins. (30 min). For this, investigator use the TENS STIM-PRO T-800 device. European Certificate of Conformity (CE 2460). The investigator use program of acupuncture TENS according to the Sjound and Erikson theory of endorphin release, with a neuromodulating objective. Parameters of this program: 2 Hz and 180ms, for 30 min. Investigator should increase the intensity measured in Milli-Amps until it produces contraction for a few seconds, then lower it until the contraction is no longer visible. This therapy can be applied during manual therapy treatment, be it diaphragmatic stretching, abdominal massage and diaphragmatic reeducation.
- Connective Tissue Massage or Dicke (10 min): Investigator place the patient sitting on the table and ask that the lumbar area and gluteal and sacral area be discovered. Without the help of oils or creams, investigator have to make three strokes with the help of the ulnar edge of the hand and the 3rd and 5th finger. This therapy may arise that the patient has to go to the bathroom before, during or after treatment due to the activation of the renal system through stimulation of the cuti-visceral reflex.
- Massage with direct maneuvers on the abdomen: It is a massage specially indicated to facilitate intestinal mobility and transit in the large intestine. For its realization investigator can apply creams or oils. The direction of the maneuvers will be clockwise. It is important to apply the not pain rule. Investigator will start with a superficial friction, followed by a spiral massage in the intestinal area. Next, perform 6 very slow strokes adding small pressures on the ascending, transverse and descending colon respectively and repeating this maneuver 3 times. (10min)
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Physical Therapy Group
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy GroupOther
- Performing direct physical treatment on the diaphragm, using stretching, followed by teaching exercises for re-education of the abdomen and diaphragm.
- Transcutaneous retrograde electrostimulation: L1-L4 (2hz-10hz) rectangular asymmetric biphasic at the level of the dermatome. From the anterior inferior iliac spine to a pubic symphysis. Second canal from the greater trochanter to the saphenous veins. (30 min). Parameters of this program: 2 Hz and 180ms.
- Connective Tissue Massage or Dicke
- Massage with direct maneuvers on the abdomen: The direction of the maneuvers will be clockwise. We will perform 6 very slow strokes adding small pressures on the ascending, transverse and descending colon respectively and repeating this maneuver 3 times. (10 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Irritable bowel syndrome | Experimental | Experimental group is formed with 24 patients diagnosed with IBS treated in the digestive system service of the Virgen de la Arrixaca and Reina Sofía General University Hospitals. Receives: Other: Physical Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Change from Baseline IBS-Severity Index at month"-
The severity questionnaire is divided into 3 sections. The first is the main one, and collects information about the severity. It contains 4 questions, each with a maximum score of 100 using visual analog scales, out of a maximum score of 500.
Measured: "up to four weeks"
"Change from Baseline IBS-QoL score at month"-
It is a self-administered questionnaire, which is usually answered in about 10 min. This consists of 34 items with a value of 5 points each, which collect information on the quality of life of patients affected with IBS. This questionnaire is classified into 8 main areas: dysphoria, interference with activity, body image, health concern, avoidance of food, social relationships, sexual scale and relationships.
Measured: "up to four weeks"
"Change from Baseline Trait Anxiety Inventory (STAI) score at month"
It is divided into two subscales (AE and AR). The AE scale consists of 20 sentences that the subject scores from 0 to 3 and defines how he feels in a "specific moment". Trait anxiety (AR) signals an anxious predisposition to perceive situations as threatening. The AR scale consists of 20 sentences, shows how the subject feels in "general".
Measured: "up to four weeks"
"Change from Baseline Simple spirometry parameters at month"
It is a diagnostic test that allows the detection of respiratory pathologies of an obstructive or restrictive nature, as well as making a differential diagnosis in patients at risk. This device allows investigator to measure the following parameters: Forced Vital Capacity (FVC), Forced Expiration Volume in one second (FEV1), calculate the Tifenneau Index of the examinee by means of the ratio between FEV1 and FVC. It also allows to measure the Peak of Maximum Expiratory Flow (PEF), 25% of FVC flow (FEF25), among others possible.The measurement of these parameters will be carried out with the help of the CONTEC SP10W digital spirometer, with a European Conformity certificate (CE-0123). Electromagnetic Compatibility (EMC): Group I, class B. ¾ Class B (Electromagnetic system, which is marketed for use in a residential environment. Its limits are stricter than industrial devices). Medical devices - covered by directive, 93/42 / EEC. Classification of medical device IIa.
Measured: "up to four weeks"
Secondary outcomes (3)
"Change from Baseline Setpoint Abdominal Pain in IBS-Severity Index at month"
Setpoint of the severity scale that measures the subjective sensation of abdominal pain with a visual scale.
Measured: "up to four weeks"
"Change from Baseline Setpoint funcional bloating in IBS-Severity Index at month"
Setpoint of the severity scale that measures the subjective sensation of bloating
Measured: "up to four weeks"
"Change from baseline of bowel movements at month"
Maximum number of bowel movements in one week
Measured: "up to four weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start30 Sep 2019
- Primary completion30 May 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 24 patients diagnosed with Irritable Bowel Syndrome
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBS Group, Alcalde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486469
- Sponsor's protocol ID
- IBSGroupAlcalde
- Acronym
- IBS
- Status last verified
- Jul 2020
- First submitted
- 19 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04486469
- Acronym / sponsor ID
- IBS / IBSGroupAlcalde
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- IBS Group, AlcaldeUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction and State of Question Irritable Bowel Syndrome can be classified as a functional digestive disorder characterized by abdominal pain, bloating, and changes in the frequency and consistency of bowel movements. Recent studies endorse the use of physical therapies for its symptomatic treatment. With the present study investigators wanted to verify the effectiveness of physiotherapy techniques in order to alleviate or eliminate the symptoms of Irritable Bowel Syndrome.
Material and Methods Investigators have carried out an uncontrolled pilot clinical trial in a sample of 24 patients diagnosed with Irritable Bowel Syndrome in two hospitals in the Region of Murcia. Among the measurement tools used, we highlight the use of the IBS-Severity Scale, IBS-QoL, STAI and spirometry tests.
Detailed description
Scope of treatment: From the Digestive System Services, patients who meet the criteria described above, will be referred to the Rehabilitation Services of the Virgin of Arrixaca and Reina Sofía University Hospital, and then, to the physiotherapy unit. At the same time, the researcher will contact these patients to manage the appointments proposed in physiotherapy. The physical treatment to be applied individually has a duration of 40 min per session, establishing a maximum of 8 sessions and a minimum of 3 sessions. This treatment is described below: the first three weeks: (3 days / week)
- Performing direct physical treatment on the diaphragm, using stretching, followed by teaching exercises for re-education of the abdomen and diaphragm. (20 min):
- Direct physical treatment on the diaphragm. It refers to the stretching of the xiphoid and costal portions. With the patient in the supine position and the hips flexed 90º, investigator take advantage of the abdominal-diaphragmatic respiration in its expiratory component to stretch these portions, trying to penetrate with fingertips over the xiphoid and costal edge and maintaining the position with each gain, performing a maximum of 3 winnings.
- Abdomino-diaphragmatic reeducation: With the patient in the supine position and the hips flexed 90º, investigator will place the hands in the abdominal area and ask pacient to try to push the hands upwards taking air with the belly. Once the patient have become aware investigator will put up some resistance to the movement. Investigator will avoid possible compensations by controlling the expansion of the rib cage if necessary. Next investigator will ask patient to associate movements of the pelvic scale during breathing. In inspiration, investigator will ask patient to slightly push the sacrum on the stretcher and in ESP, then investigator will ask patient to bring the pelvis back tightening the buttocks as trying to retain defecation. (10min)
- Transcutaneous retrograde electrostimulation: L1-L4 (2hz-10hz) rectangular asymmetric biphasic at the level of the dermatome. From the anterior inferior iliac spine to a pubic symphysis. Second canal from the greater trochanter to the saphenous veins. (30 min). For this, investigator use the TENS STIM-PRO T-800 device. European Certificate of Conformity (CE 2460). The investigator use program of acupuncture TENS according to the Sjound and Erikson theory of endorphin release, with a neuromodulating objective. Parameters of this program: 2 Hz and 180ms, for 30 min. Investigator should increase the intensity measured in Milli-Amps until it produces contraction for a few seconds, then lower it until the contraction is no longer visible. This therapy can be applied during manual therapy treatment, be it diaphragmatic stretching, abdominal massage and diaphragmatic reeducation.
- Connective Tissue Massage or Dicke (10 min): Investigator place the patient sitting on the table and ask that the lumbar area and gluteal and sacral area be discovered. Without the help of oils or creams, investigator have to make three strokes with the help of the ulnar edge of the hand and the 3rd and 5th finger. This therapy may arise that the patient has to go to the bathroom before, during or after treatment due to the activation of the renal system through stimulation of the cuti-visceral reflex.
- Massage with direct maneuvers on the abdomen: It is a massage specially indicated to facilitate intestinal mobility and transit in the large intestine. For its realization investigator can apply creams or oils. The direction of the maneuvers will be clockwise. It is important to apply the not pain rule. Investigator will start with a superficial friction, followed by a spiral massage in the intestinal area. Next, perform 6 very slow strokes adding small pressures on the ascending, transverse and descending colon respectively and repeating this maneuver 3 times. (10min)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 24 patients diagnosed with Irritable Bowel Syndrome
| Arm | Type | Receives |
|---|---|---|
| Subjects with Irritable bowel syndrome | Experimental | Other: Physical Therapy GroupExperimental group is formed with 24 patients diagnosed with IBS treated in the digestive system service of the Virgen de la Arrixaca and Reina Sofía General University Hospitals. |
Who may qualify
- Ages
- 36 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Over 18 years
- Collaborating patients
- Patients Diagnosed with IBS from the Digestive System Services of the Virgen de la Arrixaca and Reina Sofía Hospital in Murcia in Outpatient Consultations.
- Accept and sign the informed consent
- Degree of Severity in the IBS-Severity index from Moderate to Serious (greater than 175p.)
Key exclusion criteria (11 listed)
- Patients with fear or phobia of electricity
- Restrictive diaphragmatic respiratory pathologies in your medical history, either due to neurological or traumatic causes.
- Patients with pacemakers, or diagnosed with heart disease or arrhythmias.
- Presence of developing scars, burns, allergies, wounds or infections in the thigh and lower back application areas.
- undiagnosed pain
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 |
|---|---|---|
| Physical Therapy Group1. Performing direct physical treatment on the diaphragm, using stretching, followed by teaching exercises for re-education of the abdomen and diaphragm. 2. Transcutaneous retrograde electrostimulation: L1-L4 (2hz-10hz) rectangular asymmetric biphasic at the level of the dermatome. From the anterior inferior iliac spine to a pubic symphysis. Second canal from the greater trochanter to the saphenous veins. (30 min). Parameters of this program: 2 Hz and 180ms. 3. Connective Tissue Massage or Dicke 4. Massage with direct maneuvers on the abdomen: The direction of the maneuvers will be clockwise. We will perform 6 very slow strokes adding small pressures on the ascending, transverse and descending colon respectively and repeating this maneuver 3 times. (10 minutes) | Other | Subjects with Irritable bowel syndrome |
Primary outcome
"Change from Baseline IBS-Severity Index at month"-
Time frame: "up to four weeks"
The severity questionnaire is divided into 3 sections. The first is the main one, and collects information about the severity. It contains 4 questions, each with a maximum score of 100 using visual analog scales, out of a maximum score of 500.
"Change from Baseline IBS-QoL score at month"-
Time frame: "up to four weeks"
It is a self-administered questionnaire, which is usually answered in about 10 min. This consists of 34 items with a value of 5 points each, which collect information on the quality of life of patients affected with IBS. This questionnaire is classified into 8 main areas: dysphoria, interference with activity, body image, health concern, avoidance of food, social relationships, sexual scale and relationships.
"Change from Baseline Trait Anxiety Inventory (STAI) score at month"
Time frame: "up to four weeks"
It is divided into two subscales (AE and AR). The AE scale consists of 20 sentences that the subject scores from 0 to 3 and defines how he feels in a "specific moment". Trait anxiety (AR) signals an anxious predisposition to perceive situations as threatening. The AR scale consists of 20 sentences, shows how the subject feels in "general".
"Change from Baseline Simple spirometry parameters at month"
Time frame: "up to four weeks"
It is a diagnostic test that allows the detection of respiratory pathologies of an obstructive or restrictive nature, as well as making a differential diagnosis in patients at risk. This device allows investigator to measure the following parameters: Forced Vital Capacity (FVC), Forced Expiration Volume in one second (FEV1), calculate the Tifenneau Index of the examinee by means of the ratio between FEV1 and FVC. It also allows to measure the Peak of Maximum Expiratory Flow (PEF), 25% of FVC flow (FEF25), among others possible.The measurement of these parameters will be carried out with the help of the CONTEC SP10W digital spirometer, with a European Conformity certificate (CE-0123). Electromagnetic Compatibility (EMC): Group I, class B. ¾ Class B (Electromagnetic system, which is marketed for use in a residential environment. Its limits are stricter than industrial devices). Medical devices - covered by directive, 93/42 / EEC. Classification of medical device IIa.
3 secondary outcomes
"Change from Baseline Setpoint Abdominal Pain in IBS-Severity Index at month"
Time frame: "up to four weeks"
"Change from Baseline Setpoint funcional bloating in IBS-Severity Index at month"
Time frame: "up to four weeks"
"Change from baseline of bowel movements at month"
Time frame: "up to four weeks"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy Group in people with Irritable Bowel Syndrome, run by IBS Group, Alcalde at 1 site in Spain.
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 11 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 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
"Change from Baseline IBS-Severity Index at month"- (time frame: "up to four weeks"). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2020.