NCT03319355

Brief Summary

Therapy for fibromyalgia is a well discussed topic in literature, yet not thoroughly evidence-based. Several unicomponent therapies seem to be benificial. Whereas multicomponent and multidisciplinary therapy gains importance and revealing promising results, the investigators aim to combine two well-known therapies in a program for patients with fibromyalgia. From clinical experience, a high drop-out rate has been stated. All data will be explored to analyse explanatory factors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

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

Study Start

First participant enrolled

September 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

October 5, 2017

Last Update Submit

October 23, 2017

Conditions

Fibromyalgia

Keywords

multicomponent therapy

Outcome Measures

Primary Outcomes (8)

  • Fibromyalgia Impact Questionnaire

    impact of fibromyalgia on daily life with a questionnaire

    6weeks

  • Tampa scale for kinesiophobia

    rating the kinesiophobia with a questionnaire

    6weeks

  • Beck Depression Index

    degree of depression with a questionnaire

    6 weeks

  • Pain Coping Inventory

    inventory of the use of pain coping strategies with a questionnaiire

    6 weeks

  • Pain at tenderpoints

    measuring tolerable pain at specified tenderpoints with an algometer

    6 weeks

  • Grip strength

    measuring grip strength of both hands with a dynamometer

    6 weeks

  • Walking

    6 minute walking test on a treadmill

    6 weeks

  • cycling

    10 minutes cycling test on a hometrainer

    6 weeks

Interventions

cognitive behavioral therapyBEHAVIORAL

exercise therapy

Also known as: physical therapy

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • woman with fibromyalgia
  • between the age of 20 and 50
  • agreement with therapy protocol

You may not qualify if:

  • high indication of depression measured with the Beck Depression Index

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibromyalgia

Interventions

Cognitive Behavioral TherapyPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 24, 2017

Study Start

September 1, 2011

Primary Completion

April 1, 2012

Study Completion

January 1, 2013

Last Updated

October 24, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share