- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05922007
The Effect of Chronic Pain and Its Treatment on Quality of Life and Physical Activity
The Effect of Chronic Pain and Its Treatment on Quality of Life, Disability, and Physical Activity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic pain is defined as pain whose duration usually exceeds a period of three months and standard treatment is ineffective (exceeds the usual time frame of the duration of an acute illness or the expected time of healing of a pathological condition). This pain is harmful and brings many changes to the individual, it can lead to the devastation of the quality of life. One of the dominant secondary effects of chronic pain is a change in the way one performs activities of daily living. The most common changes in activity are avoidance of activities, overexertion, and modulation of the pace of activities. Determining activity patterns is a condition for subsequent targeted educational activities by the nurse. In the Czech Republic, however, there is no specific tool for evaluating movement activities in patients with chronic pain.
The goal of treatment and nursing care for a patient with chronic pain is to reduce pain intensity, achieve appropriate patterns of physical activity and sleep, and improve quality of life. A key step in treatment is the assessment of pain and its impact on functional status and the level of psychosocial relationships.
The main goal of the research is to determine the impact of pain and treatment on the quality of life and physical activity in patients with chronic pain. Other goals include validating the Patterns of Activity Measures-Pain Scale (POAM-P) questionnaire to assess patterns of daily activities of patients with chronic pain in the Czech Republic, to determine the relationship between chronic pain, quality of life, disability in daily activities, physical activity, BMI and mood disorders, compare differences in quality of life, disability, physical activity, BMI and mood disorders after using different therapeutic approaches and education, compare subjective pain assessment and Analgesia Nociception Index (ANI) assessment.
In the first phase of the study, a transcultural validation of the Czech language version of the POAM-P will be carried out according to published recommendations, followed by the creation of a questionnaire set including demographic characteristics, treatment interventions, assessment of the quality of life, disability, mood disorders, and pain intensity in the second phase. Subsequently, 150 patients with chronic pain will be subjected to a questionnaire survey and BMI measurement repeatedly after a minimum of 3 and 6 months during regular outpatient check-ups. The subjective assessment of pain will be supplemented by the assessment of the Analgesia Nociception Index.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jiří Hynčica
- Phone Number: 2587 0042059737
- Email: jiri.hyncica@fno.cz
Study Locations
-
-
Moravian-Silesian Region
-
Ostrava, Moravian-Silesian Region, Czechia, 70852
- Recruiting
- University Hospital Ostrava
-
Contact:
- Jiří Hynčica
- Phone Number: 2587 0042059737
- Email: jiri.hyncica@fno.cz
-
Principal Investigator:
- Lucie Sikorová, Assoc.Prof.,PhDr.,Ph.D.
-
Sub-Investigator:
- Andrea Polanská, PhDr.,MBA
-
Sub-Investigator:
- Alena Mátlová, MD, MBA
-
Sub-Investigator:
- Jan Divák, MD,Ph.D.,MBA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient with pain lasting at least 3 months
- Age 18-65 years
- Diagnosis of back pain, joint pain in arthrosis, postoperative and post-traumatic pain, and pain in rheumatic diseases
- Czech language competency
- Consent to the research investigation
Exclusion Criteria:
- Severe sight or hearing impairment or other illness that does not allow filling in the questionnaires
- Oncological disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Validation study
A total of 150 patients with chronic pain (18-65 years) will be included in the validation of the Czech version of the Patterns of Activity Measures-Pain scale (POAM-P/CZ).
The reliability and validity study will have a cross-sectional design.
|
Validation of the Czech version of the Patterns of Activity Measures-Pain scale (POAM-P/CZ)
|
Prospective quantitative study
For 150 patients with chronic pain aged 18-65 years, a questionnaire survey will be carried out using the questionnaire set three times, during the first regular check-up at the outpatient clinic and after at least 3 and 6 months, also during a regular check-up.
|
A questionnaire survey will be carried out using the questionnaire set three times
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
World Health Organization Quality of Life - BREF version (WHOQOL-BREF)
Time Frame: 24 months
|
Assessment of the World Health Organization Quality of Life - BREF.
Assessment of the effect of pain and its treatment after 3 and 6 months of therapeutic and educational activities in 4 domains: physical health, experience, social relationships, environment and two separate items assessing overall quality of life and health satisfaction.
A higher score indicates a higher quality of life.
|
24 months
|
Patterns of Activity Measures-Pain scale
Time Frame: 24 months
|
Assessment of the Patterns of Activity Measures-Pain scale (POAM-P) after 3 and 6 months of treatment and educational activities.
Assessment of the effect of pain and its treatment on physical activities (scores in three areas: Avoidance, Overdoing, and Pacing).
Scores for each activity range from 0 to 40 for each behaviour pattern.
A higher score indicates a more active individual.
|
24 months
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 24 months
|
Assessment of the Hospital Anxiety and Depression Scale consists of two subscales.
Each subscale has seven items.
The HADS-A (anxiety) subscale measures anxiety symptoms and the HADS-D (depression) subscale measures depression symptoms.
HADS-T (total) reflects the overall level of distress.
Each item has four answer options, with a possible scoring of 0-3.
The total number of points in each scale is 0-21 points.
A value of 8 is considered as the cut-off point for mild depression/anxiety and a value of 11 for definite depression/anxiety (11 to 14 - moderate; 15 to 21 - high).
The total HADS-T score, which ranges from 0 to 42 points, is also evaluated.
|
24 months
|
Oswestry Disability Index (ODI2.1a)
Time Frame: 24 months
|
Assessment of the Oswestry Disability Index.
Assessment of the effect of pain and its treatment after 3 and 6 months of treatment and educational activities on physical disability (restriction of the ability to sit, stand, lift loads and walk), social handicap (social life, sex life - if relevant, travel, personal care), pain and sleep (10 items).
The rating for each item is 0-5 points, maximum 50 points.
The resulting score is evaluated as minimal disability, moderate disability, severe disability and paralysis.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Physical Activity Questionnaire - Short Form (IPAQ - Short Form)
Time Frame: 24 months
|
Assessment of the International Physical Activity Questionnaire - Short Form.
The International Physical Activity Questionnaire -Short Form measures free-living physical activity levels.
The questionnaire is psychometrically tested and used as an instrument to measure physical activity over the previous seven days of participants.
It includes 7 questions that distinguish individuals with high, medium and low physical activity.
|
24 months
|
Pain intensity rating (NRS 0-10)
Time Frame: 24 months
|
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale 0-10, where 0 is no pain and 10 is the worst pain.
The NRS can be administered verbally or in a written format as needed for the patient.
|
24 months
|
Pain map
Time Frame: 24 months
|
The pain map provides the most accurate information about where the patient is in pain.
It shows the human body from all sides and some of its parts separately.
The patient has the task of marking painful areas.
The size of the ring should correspond to the real one area of pain.
Colored pencils are used for clarification.
|
24 months
|
Analgesia Nociception Index (ANI)
Time Frame: 24 months
|
Analgesia Nociception Index (ANI) is based on ECG data derived from two single-use ANI electrodes applied in V1 and V5 positions to the chest.
The ANI is finally computed from a frequency domain-based analysis of the high frequency component of heart rate variability which also incorporates the respiration rate as a potential confounder.
It is displayed as a score from 0-100 with low values reflecting low and high values high parasympathetic predominance in autonomic cardiac control.
|
24 months
|
Patterns of Activity Measures-Pain scale (POAM-P/CZ)
Time Frame: 24 months
|
Trans-cultural validation Patterns of Activity Measures-Pain scale - Czech version (POAM-P/CZ).
It consists of 30 questions (10 for each activity pattern: Avoidance, Overdoing, and Pacing).
Scores for each activity range from 0 to 40 for each behaviour pattern.
A higher score indicates a more active individual.
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Andrea Polanská, PhDr., MBA, University Hospital Ostrava
- Principal Investigator: Lucie Sikorová, Assoc.Prof.,PhDr.,Ph.D., University Hospital Ostrava
Publications and helpful links
General Publications
- Benaim C, Leger B, Vuistiner P, Luthi F. Validation of the French Version of the "Patterns of Activity Measure" in Patients with Chronic Musculoskeletal Pain. Pain Res Manag. 2017;2017:6570394. doi: 10.1155/2017/6570394. Epub 2017 Feb 1.
- Cane D, Nielson WR, McCarthy M, Mazmanian D. Pain-related activity patterns: measurement, interrelationships, and associations with psychosocial functioning. Clin J Pain. 2013 May;29(5):435-42. doi: 10.1097/AJP.0b013e31825e452f.
- Suygun ET, Celenay ST. Turkish Translation of the Patterns of Activity Measure-Pain in Patients with Chronic Low Back and Neck Pain: Validity and Reliability. Pain Manag Nurs. 2022 Apr;23(2):231-236. doi: 10.1016/j.pmn.2021.01.008. Epub 2021 Feb 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FNO-KARIM-Chronic Pain
- 11/RVO/FNOs/2023 (Other Grant/Funding Number: University Hospital Ostrava)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
Assiut UniversityNot yet recruiting
-
Vastra Gotaland RegionActive, not recruitingPain, Chronic | Widespread Chronic PainSweden
-
Istanbul UniversityCompletedLow Back Pain, Mechanical, Biofeedback, Pain, Chronic
Clinical Trials on Validation of the Questionnaire
-
Central Hospital, Nancy, FranceUniversity of Lorraine; Association François Aupetit, Paris, FranceUnknown
-
Aalborg University HospitalAalborg UniversityCompleted
-
Rennes University HospitalCompletedCrohn's Disease | Ulcerative ColitisFrance
-
Centre Hospitalier Universitaire DijonUnknown
-
Rennes University HospitalCompleted
-
University Rovira i VirgiliCompletedPain | Child Development | Adolescent BehaviorSpain
-
Nicole LindenblattNot yet recruitingTrauma | Limb Injury | Patient Reported Outcome MeasuresSwitzerland
-
University of ZurichSwiss National Science FoundationCompleted
-
University of North Carolina, Chapel HillAmerican Academy of Allergy, Asthma, and ImmunologyCompleted
-
Centre hospitalier de l'Université de Montréal...Canadian Institutes of Health Research (CIHR); Queen Elizabeth II Health Sciences... and other collaboratorsCompletedAortic Aneurysm, AbdominalCanada