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Completed

NCT Number: NCT05932433

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

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.

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Key information

Conditions

Arthritis Arthritis Rheumatoid Arthritis, Rheumatoid Artrosis of the Knee Autoimmune Diseases Central Sensitisation Chronic Pain Connective Tissue Diseases Exercise Therapy Fibromyalgia Gut Microbiota Immune System Diseases Joint Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

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.

Other names: Therapeutic exercise, physical activity

Primary outcomes

  1. Quantitative Sensory Test (QST), and

    Time frame: From enrollment to the end of the intervention at 6 weeks

    Conditioned Pain Modulation (CPM) and pain threshold will be assesed as measured of QST.

  2. Psychological and PainTest

    Time frame: From enrollment to the end of the intervention at 6 weeks

    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.

  3. Descriptive parameters

    Time frame: From enrollment to the end of the intervention at 6 weeks

    Descriptive parameters of the sample will be explain in a table

Secondary outcomes

  1. Interleukin analysis

    Time frame: From enrollment to the end of the intervention at 6 weeks

    Interleukin-18 and interleukin-1β analysis will be perform in tha baseline in control group and at the end of the intervention in the experimental (exercise) group

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Acronym: MiBioPain

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2023
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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