Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study. (IBS)

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: Physical Therapy Group

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)

1. Performing direct physical treatment on the diaphragm, using stretching, followed by teaching exercises for re-education of the abdomen and diaphragm. (20 min):

   A) 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.

   B) 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)

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). 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.
3. 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.
4. 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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30003
    • Jose Luis Gil Alcalde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Deep venous thrombosis
• Pregnancy

Elimination criteria:

• Worsening of symptoms after abdominal massage
• Failure to attend sessions of 2 or more days followed by treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Subjects with Irritable bowel syndrome; 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.

Other: Physical Therapy Group; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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.	"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.	"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".	"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.	"up to four weeks"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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.	"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	"up to four weeks"
"Change from baseline of bowel movements at month"	Maximum number of bowel movements in one week	"up to four weeks"

Collaborators and Investigators

• Sponsor: IBS Group, Alcalde

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): June 24, 2020

Study Registration Dates

• First Submitted: July 19, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: IBSGroupAlcalde

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: Are available for 6 months
• IPD Sharing Access Criteria: Those researchers who carry out physiotherapy studies for Irritable Bowel Syndrome
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No