Pain in Chronic Leg- and Foot Ulcers

NCT03086577 | Unknown

• 1 other identifier: 2016/1236 (REK)
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Leg ulcers are a significant cause of impaired functional ability and quality of life for approximately 1-2 percent of the population in western countries. Although pain seems to be one of the most devastating aspects of living with a chronic ulcer, research is limited and there is a lack of knowledge about wound-related pain characteristics. Little is known about prevalence, pain intensity, qualities, location, temporal fluctuations, to witch degree pain impact on physical- and psychosocial functioning, as well as relieving and exacerbating factors. The overall purpose of this study is to investigate the prevalence and characteristics of wound related pain in patients with chronic leg ulcers. More specific research questions are: 1) What is the prevalence and characteristics of wound related pain in patients suffering from various types of persistent ulcers, 2) How do patients with different ulcer diagnoses report the quality of the wound related pain, 3) Is there any differences in wound pain characteristics among patients with different etiology leg ulcers, 4) How is the pain temporal pattern in patients with chronic leg- and foot ulcers, 5) What is the reported quality of life in patients with different ulcer diagnosis, and 6) Is there any association among pain characteristics, sleep and quality of life in patients with chronic leg/foot ulcers? The study has a non-experimental, explorative and descriptive approach. A cross-sectional questionnaire design will be used to explore patient's experience of wound-related pain. The patients will be recruited at the outpatient clinic appointment and home-care nursing in Norway. Participants will fill out self-report questionnaires. The battery of questionnaires will obtain information about demographic data, pain characteristics, quality of life and sleep. Pain characteristics, quality of life and sleep will be assessed by using different questionnaires that has demonstrated high validity and reliability. In addition, the temporal pattern of pain will be assessed by asking the participants to fill out a form stating subjective level of pain (NRS) every hour during a typical day, and to mark times that they rest and sleep. Relevant information about the diagnosis/classification of ulcer, comorbidities, the ulcer management and pain management will be collected in a clinical examination.

Conditions

Leg Ulcer; Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity - Numeric Rating Scale (NRS)

  One-dimensional measure of pain intensity.

  Through study completion, an average of 3 years

Secondary Outcomes (7)

• Sleep assessment - The Insomnia Severity Index (ISI)

  Through study completion, an average of 3 years

• Quality of life - The EuroQol-5D (EQ-5D)

  Through study completion, an average of 3 years

• Quality of pain - The Short Form McGill Pain Questionnaire (SF-MPQ)

  Through study completion, an average of 3 years

• Brief Pain Inventory (BPI)

  Through study completion, an average of 3 years

• Localization of pain, Body map for localization of pain

  Through study completion, an average of 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult persons, with a leg- or foot ulcer that has persisted for more than 6 weeks, and are treated in outpatient clinics and home-care nursing services in Norway.

You may qualify if:

• Leg- or foot ulcer that has persisted for more than 6 weeks

You may not qualify if:

• Psychological and cognitive restrictions that prohibit from providing informed consent, reading or writing disabilities
• Inability to participate due to physical/psychological challenges, and inability to differentiate wound-related pain from other types of pain in the lower extremities.
• The following ulcer-diagnosis will be excluded: Burn-ulcer, cancer-ulcer, radiation-ulcer, immunological ulcers and vasculitis ulcers.

Sponsors & Collaborators

• University College of Southeast Norway: lead
• Vestre Viken Hospital Trust: collaborator

Study Sites (1)

Vestre Viken

Drammen, Buskerud, 3004, Norway

RECRUITING

Related Links

• Oversight authorities presentation of the study

MeSH Terms

Conditions

Leg Ulcer; Pain

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tone M Ljosaa, Phd

  Univerity Collage of Southeast Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Leren, MA

CONTACT

91689936; lena.leren@usn.no

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: March 22, 2017
• Study Start: April 1, 2017
• Primary Completion: February 21, 2018
• Study Completion: June 30, 2020
• Last Updated: May 3, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)