NCT00636623

Brief Summary

The present study was designed to analyse and compare the effects of Pilates exercises and connective tissue massage in terms of pain intensity, pain pressure threshold and tolerance, anxiety, progress, and health related quality of life in females with fibromyalgia (FM)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

November 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
Last Updated

March 14, 2008

Status Verified

March 1, 2008

Enrollment Period

8 months

First QC Date

March 7, 2008

Last Update Submit

March 7, 2008

Conditions

Keywords

Pilates ExercisesConnective Tissue Massage

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale, algometry, State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of the treatments.

    For All measurements aproximately 1 hour

Study Arms (2)

2

OTHER

Pilates exercises

Other: Pilates exercises

1

OTHER

Connective tissue massage

Other: Connective tissue massage

Interventions

15 FM patients participated in the PE programme three times a week during a 4-week period

Also known as: No drug name
2

21 patients received CTM, three times a week during a 4-week period

1

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • being female
  • being over 25 years old
  • meeting the criteria for FM as defined by the American College of Rheumatology
  • having pain in the neck and shoulder region
  • never having been treated for FM.

You may not qualify if:

  • infection
  • fever or an increased tendency to bleed
  • severe physical impairment
  • inflammatory diseases
  • cardiopulmonary disorders
  • uncontrolled endocrine disorders
  • allergic disorders
  • pregnancy
  • malignancy
  • severe psychiatric illnesses
  • factors known to affect autonomic function
  • medication usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Gamze Ekici, PhD

    Pamukkale University

    PRINCIPAL INVESTIGATOR
  • Turkan Akbayrak, Assoc. Prof.

    Hacettepe University

    STUDY DIRECTOR
  • Edibe Yakut, Prof

    Hacettepe University

    STUDY DIRECTOR
  • Naciye Vardar, MsC

    Hacettepe University

    STUDY DIRECTOR
  • Yavuz Yakut, Prof

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

November 1, 2006

Primary Completion

July 1, 2007

Study Completion

August 1, 2007

Last Updated

March 14, 2008

Record last verified: 2008-03

Locations