12-years Follow-up on 166 Female Patients With Fibromyalgia or Chronic Widespread Pain

Fibromyalgia Clinical Trial

Official title:

12-years Follow-up on 166 Female Patients With Fibromyalgia or Chronic Widespread Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872129
• Other study ID #: GAU1-U
• Status: Completed
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: May 2019
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP) in western Sweden.

The 166 women participated in a Randomised Controlled Trial called GAU in 2004-2005, aiming to investigate the effect of pool exercise and patient education.

The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.

The 166 women will be asked to participate in the present follow-up study. The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.

Description:

A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP).

The 166 women participated in a Randomised Controlled Trial called GAU 2004-2005 in three cities in western Sweden; Göteborg, Alingsås and Uddevalla. The RCT aimed to investigate the effect of pool exercise and patient education.

The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.

The 166 women will be contacted by mail and telephone, and asked to participate in the present follow-up study.

The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria of the present study GAU-U:

• All 166 patients who participated in the study GAU in 2004/2005. (The inclusion criteria of GAU was women with FM or CWP, 18-60 years old. Patients with widespread pain; pain in the right and left side of the body, above and below the waist, as well as axial pain, for at least three months were classified as chronic widespread pain (CWP). Patients who fulfilled the criteria for CWP and who also had pain at palpation of at least 11 of 18 pre-defined tender points were classified as fibromyalgia (FM).

Exclusion criteria for GAU was serious physical or psychological disease)

Exclusion Criteria of the present study GAU-U:

• Patients who has developed serious physical or psychological disease since participating in the GAU 2004/2005

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Widespread Pain
• Fibromyalgia
• Myofascial Pain Syndromes

Locations

Country	Name	City	State
Sweden	Närhälsan, Region Västra Götaland	Alingsås
Sweden	Närhälsan, Region Västra Götaland	Göteborg
Sweden	Närhälsan, Region Västra Götaland	Uddevalla

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sleep	quantity and quality of sleep	2016 (to be compared with previous examination performed in 2004/2005)
Other	alcohol consumption	alcohol consumption assessed with the Balogh questionnaire	2016 (to be compared with previous examination performed in 2004/2005)
Primary	pain intensity	pain intensity assessed with the Fibromyalgia Impact questionnaire subscale for pain	2016 (to be compared with previous examination performed in 2004/2005)
Primary	distribution of pain	Distribution of pain	2016 (to be compared with previous examination performed in 2004/2005)
Secondary	Fatigue	fatigue assessed with the Multidimensional fatigue inventory (MFI-20)	2016 (to be compared with previous examination performed in 2004/2005)
Secondary	Fatigue	fatigue assessed with the Fibromyalgia Impact Questionnaire subscale for global fatigue	2016 (to be compared with previous examination performed in 2004/2005)
Secondary	workability	workability assessed as percentage of full time in work	2016 (to be compared with previous examination performed in 2004/2005)
Secondary	Walking capacity	Walking capacity assessed with 6 min walk test	2016 (to be compared with previous examination performed in 2004/2005)
Secondary	Physical function in lower limbs	physical function in lower limbs assessed with chair-test	2016 (to be compared with previous examination performed in 2004/2005)
Secondary	Hand grip force	Hand grip force assessed with the Grippit	2016 (to be compared with previous examination performed in 2004/2005)
Secondary	Physical activity	physical activity in leisure time assessed with the Leisure Time Physical Activity Instrument	2016 (to be compared with previous examination performed in 2004/2005)
Secondary	Depression and anxiety	depression and anxiety assessed with the Hospital Anxiety and Depression Scale	2016 (to be compared with previous examination performed in 2004/2005)
Secondary	Health related quality of life	Health related quality of life assessed with the Short-Form 36	2016 (to be compared with previous examination performed in 2004/2005)