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

NCT04486469 | Completed

• 1 other identifier: IBSGroupAlcalde
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (4)

• "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 Outcomes (3)

• "Change from Baseline Setpoint Abdominal Pain in IBS-Severity Index at month"

  "up to four weeks"

• "Change from Baseline Setpoint funcional bloating in IBS-Severity Index at month"

  "up to four weeks"

• "Change from baseline of bowel movements at month"

  "up to four weeks"

Study Arms (1)

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.

Other: Physical Therapy Group

Interventions

Physical Therapy Group OTHER

1. 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)

Subjects with Irritable bowel syndrome

Eligibility Criteria

• Age: 36 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IBS Group, Alcalde: lead

Study Sites (1)

Jose Luis Gil Alcalde

Murcia, 30003, Spain

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The patients were cited for individual sessions in a close space so they did not know if they all received the same treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 24 patients diagnosed with Irritable Bowel Syndrome

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 24, 2020
• Study Start: September 30, 2019
• Primary Completion: May 30, 2020
• Study Completion: June 24, 2020
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Are available for 6 months
• Access Criteria: Those researchers who carry out physiotherapy studies for Irritable Bowel Syndrome

Locations

ES (1)