Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.

Chronic Pain Clinical Trial

— MiBioPain  

Official title:

Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05932433
• Other study ID #: 1601202303523
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 10, 2023

Study information

• Verified date: June 2023
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effect of therapeutic exercise on the gut microbiome in chronic widespread pain patients. Our investigation purpose is to improve the quality of life of participants, reduce their disability and optimize their functionality.

The intervention will last 6 weeks, with 2 face-to-face therapeutic exercise sessions guided by a professional and a 6-week post-intervention follow-up.

The participation will require:

1. Attend the 12 therapeutic exercise sessions

2. Attend the 3 evaluations: at the beginning (A0), post intervention (A1) and +6 weeks after finishing the exercise program (A3).

The items to be evaluated will be the following:

1. The Ronald Morris Disability Questionnaire (RMDQ)

2. Anxiety (State-Trait Anxiety Inventory (STAI))

3. Depression: Beck Depression Inventory (BDI)

4. Quality of Life: SF-12

5. Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI)

6. Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM)

7. Perform a pre blood test on interleukins IL-18 and IL-1β

This study involves the processing of personal data, so the researchers will guarantee confidentiality in their treatment at all times, complying with the personal data protection regulations, in particular, European Regulation 679/2016. , of April 27, general data protection, as well as Organic Law 3/2018, of December 5, Protection of Personal Data and Guarantee of Digital Rights.

In order to maintain your privacy and anonymity during the research, only one person on the research team will know how names were assigned to a participation number.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 10, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be at least 18 years old

• Must be diagnosed with: osteoarthritis, osteoarthritis, Sudeck or fibromyalgia.

Exclusion Criteria:

• Suffering or having suffered from cancer, psychiatric disorders, or another ongoing major illness (irritable bowel syndrome, hepatitis, Lyme disease or diabetes).

• Patients will be excluded if they have more than 6 points on the Beck Depression Inventory, more than 30 points on the "State Trait Anxiety Inventory" or suffer from dementia.

Related Conditions & MeSH terms

• Arthritis
• Arthritis Rheumatoid
• Arthritis, Rheumatoid
• Artrosis of the Knee
• Central Sensitisation
• Chronic Pain
• Exercise Therapy
• Fibromyalgia
• Gut Microbiota

Intervention

Behavioral:
• Exercise
Each session (45 minutes aprox) is made by: mobility, endurance and final exercise to rest. The sesion is going to perform twice a week during 6 weeks.

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Alcorcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative Sensory Test (QST), and	Conditioned Pain Modulation (CPM) and pain threshold will be assesed as measured of QST.	From enrollment to the end of the intervention at 6 weeks
Primary	Psychological and PainTest	Furthermore,Beck Depression Inventory and State-Trait Anxiety Inventory (STAI) will be perform as a psychological test. The Brief Pain Inventory (BPI) and a numerical rate scale will be perform as a pain tests.	From enrollment to the end of the intervention at 6 weeks
Primary	Descriptive parameters	Descriptive parameters of the sample will be explain in a table	From enrollment to the end of the intervention at 6 weeks
Secondary	Interleukin analysis	Interleukin-18 and interleukin-1ß analysis will be perform in tha baseline in control group and at the end of the intervention in the experimental (exercise) group	From enrollment to the end of the intervention at 6 weeks