- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05443880
Exercise and Mindfulness in Patients With Non-specific Chronic Low Back Pain: The BACKFIT Project
March 6, 2024 updated by: Víctor Segura Jiménez, IBS Granada
Multidimensional Approach (Exercise and Mindfulness) for Health Improvement in Patients With Non-specific Chronic Low Back Pain: The BackFit Project
Chronic low back pain is among the most common health problems seen in primary care, and is responsible for disability and absenteeism in our country.
In most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (NSCLBP).
Taking into consideration that multidimensional programs usually present more effectiveness reducing pain than unimodal programs, the current research investigates the role of unexplored multidimensional program (exercise and mindfulness) in NSCLBP.
The primary aim of this project is to determine the effectiveness of a supervised exercise program (intervention 1) and a supervised exercise program + mindfulness (intervention 2) on pain, disability, trunk muscle endurance/strength, quality of life and gait parameters in patients with NSCLBP.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Granada, Spain
- iBS.Granada
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Be previously diagnosed with NSCLBP pain by a healthcare professional according to the criteria established by O'Sullivan et al.
- Intend to participate in the intervention and perform all the tests included in the study.
- Able to read and understand informed consent, as well as the objective of the study.
- Able to walk and move without outside help.
- Able to communicate without problems
- Be between 18 and 65 years old.
Exclusion Criteria:
- Having spondylolysis, spondylolisthesis, canal stenosis, degenerative disc disease, and/or disc herniation, tumor, trauma or fracture of the lumbar and lower limbs, Cauda equina syndrome, and radicular leg pain (given that spine degeneration issues are commonly present in asymptomatic individuals and increase with age, only serious lumbar structural disorders were considered).
- Having lumbar surgery as source of pain.
- Having acute or terminal illness.
- Having medical prescription that prevents the performance of the tests.
- Having injury or circumstance that makes it impossible to perform the tests correctly.
- Having other physical or mental illness that prevents participating in the intervention.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
The exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks.
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The exercise intervention will focus on working the core muscles, starting with low-intensity isometric contraction of the core muscles that stabilize the trunk; increasing intensity by performing functional tasks (phase 1: independent isometric contraction of transversus-abdominis and multifidus, phase 2: co-contraction and functional tasks of the deep trunk muscles; phase 3: functional task with load; phase 4: functional task with unstable surface)
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Experimental: Exercise + mindfulness
The exercise + mindfulness intervention will carry out a an exercise intervention together with mindfulness intervention 1 day / week (2.5 hour per session).
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The Mindfulness Based Stress Reduction (MBSR) program will strictly follow the protocol developed by Jon Kabat Zinn.
Each session will include three activities: the presentation of a topic, moments of dialogue and exploration in group (using appreciative inquiry) and a Mindfulness practice.
Participants will be provided with workbooks, audios with guided meditations, and instructions for practice at home.
In addition, the Exercise + mindfulness intervention will include the exercise program described in the exercise intervention.
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Other: Control
The control group will be provided with the usual care received in the Physical Medicine and Rehabilitation Service: stretching, breathing and motor control exercises 2 days / week (45 minutes per session) during a period of 8 weeks
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The control group will be provided with the usual care received in the Physical Medicine and Rehabilitation Service: stretching, breathing and motor control exercises 2 days / week (45 minutes per session) during a period of 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Muscular fitness at 2 months: The trunk muscle strength/endurance
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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It will be measured with the Biering-Sørensen test and the plank test.
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Muscular fitness at 5 months: The trunk muscle strength/endurance
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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It will be measured with the Biering-Sørensen test and the plank test.
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Muscular fitness at 2 months: lower body strength
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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It will be measured by the 30s chair stand test.
Upper body strength (maximal isometric strength) will be measured with the handgrip strength test (TKK dynamometer).
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Muscular fitness at 5 months: lower body strength
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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It will be measured by the 30s chair stand test.
Upper body strength (maximal isometric strength) will be measured with the handgrip strength test (TKK dynamometer).
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Muscular fitness at 2 months: upper body strength
Time Frame: Change from baseline at 2 months (Postest minus Retest)
|
It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer).
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Muscular fitness at 5 months: upper body strength
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
|
It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer).
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Change from baseline at 5 months (Retest minus Pretest)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Pressure pain threshold (PPT) in the lower back at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Pressure pain threshold (PPT) in the lower back at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Disability due to pain at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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It will be assessed with the Oswestry low back pain scale.
The total score will be calculated summing the value of the 10 items and represented as percentage (%), where 0-20% means minimum functional limitation; 20%-40% moderate functional limitation; 40%-60% intense functional limitation; 60%-80% disability and more than 80% maximum functional limitation.
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Disability due to pain at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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It will be assessed with the Oswestry low back pain scale.
The total score will be calculated summing the value of the 10 items and represented as percentage (%), where 0-20% means minimum functional limitation; 20%-40% moderate functional limitation; 40%-60% intense functional limitation; 60%-80% disability and more than 80% maximum functional limitation.
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Pain intensity at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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Patients will be instructed to indicate the intensity of pain they felt on a valid and reliable 10 cm long straight line marked with a score from 0 to 10
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Pain intensity at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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Patients will be instructed to indicate the intensity of pain they felt on a valid and reliable 10 cm long straight line marked with a score from 0 to 10
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Sedentary time and physical activity at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA).
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Sedentary time and physical activity at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA).
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Gait parameters at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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Spatiotemporal parameters (e.g., cadence, stance and support times, step length and stride width) will be calculated using Optogait.
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Gait parameters at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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Spatiotemporal parameters (e.g., cadence, stance and support times, step length and stride width) will be calculated using Optogait.
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Fat percentage at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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will be measured by bioelectrical impedance analysis (InBody R20, Biospace)
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Fat percentage at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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will be measured by bioelectrical impedance analysis (InBody R20, Biospace)
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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they will be measured by bioelectrical impedance analysis (InBody R20, Biospace) and height rod (Seca 22).
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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they will be measured by bioelectrical impedance analysis (InBody R20, Biospace) and height rod (Seca 22).
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Health-related quality of life at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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will be assessed with the Short-Form Health Survey (SF-36).
It contains 36 items grouped into 8 dimensions: physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role, and mental health.
The scores range from 0 to 100 in every dimension, where higher scores indicate better health.
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Health-related quality of life at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
|
will be assessed with the Short-Form Health Survey (SF-36).
It contains 36 items grouped into 8 dimensions: physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role, and mental health.
The scores range from 0 to 100 in every dimension, where higher scores indicate better health.
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Central sensitization at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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The Central Sensitisation Inventory will be used.
It is a self-report questionnaire designed to identify patients who have symptoms that may be related to central sensitisation.
It presents 25 questions and the patient scores each answer on a scale of 0 (never) to 4 (always).
A score of more than 40 indicates the presence of central sensitisation
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Central sensitization at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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The Central Sensitisation Inventory will be used.
It is a self-report questionnaire designed to identify patients who have symptoms that may be related to central sensitisation.
It presents 25 questions and the patient scores each answer on a scale of 0 (never) to 4 (always).
A score of more than 40 indicates the presence of central sensitisation
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Pain Catastrophyzing at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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The Pain Catastrophizing Scale will be used to assess painful experiences and thoughts or feelings about pain.
It contains 13 items on a 5-point scale.
Higher score represents a more negative appraisal of pain.
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Pain Catastrophyzing at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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The Pain Catastrophizing Scale will be used to assess painful experiences and thoughts or feelings about pain.
It contains 13 items on a 5-point scale.
Higher score represents a more negative appraisal of pain.
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Depression severity at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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The Beck Depression Inventory-II will be used.
It contains 21 items and the range of score is 0-63 with higher values indicating greater depression.
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Depression severity at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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The Beck Depression Inventory-II will be used.
It contains 21 items and the range of score is 0-63 with higher values indicating greater depression.
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Anxiety state at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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The State Trait Anxiety Inventory-I will be used to assess anxiety state (i.e., the level of current anxiety).
It is a 20-item self-administered questionnaire and the range of score is 20-80, with higher score indicating a greater anxiety state.
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Change from baseline at 2 months (Postest minus Retest)
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Change from baseline Anxiety state at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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The State Trait Anxiety Inventory-I will be used to assess anxiety state (i.e., the level of current anxiety).
It is a 20-item self-administered questionnaire and the range of score is 20-80, with higher score indicating a greater anxiety state.
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Change from baseline at 5 months (Retest minus Pretest)
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Change from baseline Sleep duration and quality at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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It will be assessed with the Pittsburgh Sleep Quality Index.
It is composed of 19 questions, with four-point Likert scales (0-3), addressing seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction.
The sleep quality global score is the sum of all components.
Higher scores indicate worse sleep quality.
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Change from baseline at 2 months (Postest minus Retest)
|
Change from baseline Sleep duration and quality at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
|
It will be assessed with the Pittsburgh Sleep Quality Index.
It is composed of 19 questions, with four-point Likert scales (0-3), addressing seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction.
The sleep quality global score is the sum of all components.
Higher scores indicate worse sleep quality.
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Change from baseline at 5 months (Retest minus Pretest)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
June 2, 2022
First Submitted That Met QC Criteria
June 29, 2022
First Posted (Actual)
July 5, 2022
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBS.Granada
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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