The Effect of Chronic Pain and Its Treatment on Quality of Life and Physical Activity

NCT05922007 | Recruiting

• 2 other identifiers: FNO-KARIM-Chronic Pain11/RVO/FNOs/2023
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Pain; Chronic Pain; Health-Related Quality of Life; Physical Activity; Patterns of Activity; Psychological Status; Lower Back Pain

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  24 months

Secondary Outcomes (5)

• International Physical Activity Questionnaire - Short Form (IPAQ - Short Form)

  24 months

• Patterns of Activity Measures-Pain scale (POAM-P/CZ)

  24 months

• Pain intensity rating (NRS 0-10)

  24 months

• Pain map

  24 months

• Analgesia Nociception Index (ANI)

  24 months

Study Arms (2)

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.

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.

Other: Prospective quantitative study - questionnaire survey

Interventions

Validation of the Questionnaire OTHER

Validation of the Czech version of the Patterns of Activity Measures-Pain scale (POAM-P/CZ)

Validation study

Prospective quantitative study - questionnaire survey OTHER

A questionnaire survey will be carried out using the questionnaire set three times

Prospective quantitative study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Severe sight or hearing impairment or other illness that does not allow filling in the questionnaires
• Oncological disease

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (3)

• 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.

  PMID: 28255261 BACKGROUND

• 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.

  PMID: 23247000 BACKGROUND

• 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.

  PMID: 33637433 BACKGROUND

Related Links

• The International Physical Activity Questionnaire (IPAQ) website

MeSH Terms

Conditions

Chronic Pain; Pain; Motor Activity; Low Back Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Back Pain

Study Officials

• Andrea Polanská, PhDr., MBA

  University Hospital Ostrava

  STUDY CHAIR

• Lucie Sikorová, Assoc.Prof.,PhDr.,Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 28, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)