Self-management of Chronic Pain Though E-health

NCT05213468 | Terminated

• 1 other identifier: SUS-S1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to validate if a digital tool for increased self-management of chronic pain can improve the quality of life for patients with chronic pain. The validation is based on the change in pain interference (Quality of life), pain intensity, physical functioning, depression, and anxiety based on self-reported information from baseline to study end.

Conditions

Chronic Pain

Keywords

self management; e-health; health tech; Digital Pain-Management Tool

Outcome Measures

Primary Outcomes (1)

• Pain interference

  Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 4a . Measure of the amount of interference pain causes in life; range 4-20; higher is worse

  6 and 12 weeks from baseline

Secondary Outcomes (7)

• Pain severity

  6 and 12 weeks from baseline

• Physical function

  6 and 12 weeks from baseline

• Depression

  6 and 12 weeks from baseline

• Anxiety

  6 and 12 weeks from baseline

• Fatigue

  6 and 12 weeks from baseline

Study Arms (2)

Self management app as add on to standard care

EXPERIMENTAL

PainDrainerTM App as add on to standard treatment at the physiotherapy program at the clinic PainDrainer software application: PainDrainerTM app (version 1.1.19c). ' The PainDrainer app is an investigational device, intended as a digital aid for the self-management of chronic pain for use by adults without supervision by healthcare professionals in a home setting.

Device: PainDrainerTM

Standard of care

NO INTERVENTION

Treatment as usual, standard treatment of care at the physiotherapy program at the clinic

Interventions

PainDrainerTM DEVICE

Self management digital tool for chronic pain

Self management app as add on to standard care

Eligibility Criteria

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

You may qualify if:

• Have a pain condition that requires analysis and rehabilitation at a specialist clinic
• \>18 years of age
• Be medically investigated, with adequate pharmacological treatment, and do not have any other medical examination or ongoing illness that hinders participation in the physiotherapy program at VO Neurosurgery and Pain rehabilitation, Skåne University Hospital, Lund
• Being included in the physiotherapy program, at VO Neurosurgery and Pain rehabilitation, Skåne University Hospital, Lund
• Have the knowledge and proficiency to use a smart phone, tablet or computer

You may not qualify if:

• Severe or acute psychiatric illness, severe anxiety or depression

Sponsors & Collaborators

• PainDrainer AB: lead
• Skane University Hospital: collaborator
• Lund University: collaborator

Study Sites (1)

VO Neurokirurgi och Smärtrehabilitering Skånes universitetssjukhus

Lund, 21428, Sweden

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Marcelo Rivano Fischer, Clin.Psy.D

  VO Neurosurgery and Pain rehabilitation, Skåne University Hospital, Lund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Parallel study, single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel study, single blinded

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 28, 2022
• Study Start: February 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)