Chronic PainNCT05922007
The Effect of Chronic Pain and Its Treatment on Quality of Life and Physical Activity
An observational study of Chronic Pain, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Validation of the Questionnaire and Prospective quantitative study - questionnaire survey
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Severe sight or hearing impairment or other illness that does not allow filling in the questionnaires
- Oncological disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Lucie Sikorová, Assoc.Prof.,PhDr.,Ph.D.
About this study
Official title: The Effect of Chronic Pain and Its Treatment on Quality of Life, Disability, and Physical Activity
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Validation of the Questionnaire, Prospective quantitative study - questionnaire survey
- Keywords
- Pain, Chronic Pain, Health-Related Quality of Life, Physical Activity, Patterns of Activity, Psychological Status, Lower Back Pain
- Medical subject headings
- Chronic Pain, Pain, Motor Activity, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of the QuestionnaireOther
Validation of the Czech version of the Patterns of Activity Measures-Pain scale (POAM-P/CZ)
Prospective quantitative study - questionnaire surveyOther
A questionnaire survey will be carried out using the questionnaire set three times
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Validation of the Questionnaire | |
| 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. Receives: Other: Prospective quantitative study - questionnaire survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life - BREF version (WHOQOL-BREF)
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.
Measured: 24 months
Oswestry Disability Index (ODI2.1a)
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.
Measured: 24 months
Patterns of Activity Measures-Pain scale
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.
Measured: 24 months
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: 24 months
Secondary outcomes (5)
International Physical Activity Questionnaire - Short Form (IPAQ - Short Form)
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.
Measured: 24 months
Patterns of Activity Measures-Pain scale (POAM-P/CZ)
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.
Measured: 24 months
Pain intensity rating (NRS 0-10)
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.
Measured: 24 months
Pain map
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.
Measured: 24 months
Analgesia Nociception Index (ANI)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Jul 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Polanská, PhDr., MBA, Study chair, University Hospital OstravaLucie Sikorová, Assoc.Prof.,PhDr.,Ph.D., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922007
- Sponsor's protocol ID
- FNO-KARIM-Chronic Pain
- Other IDs
- 11/RVO/FNOs/2023
- Status last verified
- Jul 2023
- First submitted
- 15 Jun 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
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.
PubMed 28255261Cane 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.
PubMed 23247000Suygun 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.
PubMed 33637433
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronic Pain and Its Treatment on Quality of Life, Disability, and Physical Activity
- ClinicalTrials.gov ID
- NCT05922007
- Acronym / sponsor ID
- FNO-KARIM-Chronic Pain
- Conditions
- Chronic Pain
- Keywords
- Pain, Chronic Pain, Health-Related Quality of Life, Physical Activity, Patterns of Activity, Psychological Status, Lower Back Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Validation study | – | Other: Validation of the QuestionnaireA 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. |
| Prospective quantitative study | – | Other: Prospective quantitative study - questionnaire surveyFor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Severe sight or hearing impairment or other illness that does not allow filling in the questionnaires
- Oncological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation of the QuestionnaireValidation of the Czech version of the Patterns of Activity Measures-Pain scale (POAM-P/CZ) | Other | Validation study |
| Prospective quantitative study - questionnaire surveyA questionnaire survey will be carried out using the questionnaire set three times | Other | Prospective quantitative study |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
International Physical Activity Questionnaire - Short Form (IPAQ - Short Form)
Time frame: 24 months
Patterns of Activity Measures-Pain scale (POAM-P/CZ)
Time frame: 24 months
Pain intensity rating (NRS 0-10)
Time frame: 24 months
Pain map
Time frame: 24 months
Analgesia Nociception Index (ANI)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Background: PubMed 28255261Benaim 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.
- Background: PubMed 23247000Cane 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.
- Background: PubMed 33637433Suygun 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.
- The International Physical Activity Questionnaire (IPAQ) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Polanská, PhDr., MBA study chair
University Hospital Ostrava
Lucie Sikorová, Assoc.Prof.,PhDr.,Ph.D. principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Quality of Life - BREF version (WHOQOL-BREF) (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922007, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.