NCT03434899

Brief Summary

The aim is to evaluate a novel treatment routine where contact through a smart phone/computer is used for online support for patients suffering from chronic widespread pain (CWP). The outline is that patients are encouraged to perform physical activity during a period of 12 months with online support from a physical therapist.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

February 6, 2018

Last Update Submit

October 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain during the last week

    The Fibromyalgia Impact Questionnaire (FIQ) subscale for pain.

    Change from Baseline Pain at 6 months

Secondary Outcomes (2)

  • Fatigue

    Change from Baseline Fatigue at 6 months

  • Health

    Change from Baseline Health at 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Health care plan including physical exercise and online support during the entire study

Behavioral: Physical exercise and online support

Control Group

ACTIVE COMPARATOR

Health care plan including physical exercise

Behavioral: Physical exercise

Interventions

Person-centered design of a health care plan including individually adjusted physical exercise. Online support for management of health care plan.

Intervention group

Person-centered design of health care plan individually adjusted physical exercise.

Control Group

Eligibility Criteria

Age20 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • fulfilling the American Colleague of Rheumatology (ACR) 1990 criteria for chronic widespread pain (CWP)
  • access to a smart phone or computer

You may not qualify if:

  • other serious diseases that cause pain or hinder exercise, such as heart disease, neurological disease or severe osteoarthritis
  • unable to speak or read Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alingsas Primary Health Care

Alingsås, Sweden

Location

Göteborg Primary Health Care

Gothenburg, Sweden

Location

Uddevalla Primary Health Care

Uddevalla, Sweden

Location

Related Publications (1)

  • Feldthusen C, Bergenheim A, Barenfeld E, Gjertsson I, Larsson A, Mannerkorpi K. Experience of co-creation of a health plan and support for sustainable physical activity among people with chronic widespread pain: a qualitative interview study in Sweden. BMJ Open. 2022 Apr 8;12(4):e059432. doi: 10.1136/bmjopen-2021-059432.

MeSH Terms

Conditions

Chronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kaisa Mannerkorpi, PhD

    Sahlgren University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 15, 2018

Study Start

February 15, 2018

Primary Completion

April 1, 2019

Study Completion

April 16, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations