Clinical trial NCT05922007: The Effect of Chronic Pain and Its Treatment on Quality of Life and Physical Activity
Official title: The Effect of Chronic Pain and Its Treatment on Quality of Life, Disability, and Physical Activity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Keywords: Pain
Chronic Pain
Health-Related Quality of Life
Physical Activity
Patterns of Activity
Psychological Status
Lower Back Pain
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic pain treated at the Centre for Treatment of Chronic Pain at the Department of Anaesthesiology, resuscitation and intensive medicine, University Hospital Ostrava will be selected.

Brief summary: Chronic pain is pain whose duration usually exceeds a period of three months and standard treatment is ineffective. This pain brings many changes in physical and psychological functioning to the individual and can even lead to a reduction in the quality of life. The main goal of the project is to determine the impact of pain and treatment on the quality of life and patterns of physical activity in patients with chronic pain. Furthermore, evaluate specific changes in quality of life, disability, physical activity, BMI, and body composition after the application of therapeutic and educational measures. Another goal is to validate an assessment tool for assessing the activity patterns of patients with chronic pain. In the first phase, the Czech version of the Patterns of Activity Measures-Pain scale (POAM-P/CZ) will be validated to assess the activity patterns of individuals with chronic pain. Subsequently, a prospective observational study will be carried out with the aim of comparing differences in quality of life, disability, activity patterns, BMI (body composition), and psychosocial variables after the application of targeted treatment measures and educational interventions. The subjective assessment of pain will be supplemented by the assessment of the Analgesia Nociception Index. The results of the project can contribute to the development of effective long-term strategies for the optimization of educational programs to support the self-management of chronic pain and the specific focus of health care.

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.

Eligibility criteria: 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

Primary outcomes:
measure: World Health Organization Quality of Life - BREF version (WHOQOL-BREF)
timeFrame: 24 months
measure: Oswestry Disability Index (ODI2.1a)
timeFrame: 24 months
measure: Patterns of Activity Measures-Pain scale
timeFrame: 24 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 24 months
Secondary outcomes:
measure: International Physical Activity Questionnaire - Short Form (IPAQ - Short Form)
timeFrame: 24 months
measure: Patterns of Activity Measures-Pain scale (POAM-P/CZ)
timeFrame: 24 months
measure: Pain intensity rating (NRS 0-10)
timeFrame: 24 months
measure: Pain map
timeFrame: 24 months
measure: Analgesia Nociception Index (ANI)
timeFrame: 24 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Andrea Polanská, PhDr., MBA
role: STUDY_CHAIR
affiliation: University Hospital Ostrava
name: Lucie Sikorová, Assoc.Prof.,PhDr.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.