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FM: Comparison of Exercise and Massage in Fibromyalgia

Sponsor
Pamukkale University (Other)
Overall Status
Completed
CT.gov ID
NCT00636623
Collaborator
Hacettepe University (Other)
36
Enrollment
1
Location
2
Arms
9
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Other: Pilates exercises
  • Other: Connective tissue massage
 N/A

Detailed Description

Treatment of FM is difficult. Conventional treatments do not appear to be managing the problem effectively and this has led to other forms of treatment. The aim of treating FM is to decrease pain and increase function by means of a multimodal therapeutic strategy, which, in most cases, includes pharmacological and non-pharmacological interventions. In the literature on non-pharmacological treatment approaches for FM, different managements are described, such as exercise, electrotherapy, patient education, self-management programmes, massage techniques, cryotherapy, and acupuncture. There are a number of reasons why patients choose these complementary and alternative medicine approaches, including dissatisfaction with conventional treatments or concerns over the toxicity of drugs. However, there is no consensus about which treatment approach is the best.The current randomised controlled trial was undertaken as a first pilot study to assess and compare the effectiveness of Pilates exercises, an active-group therapy, and connective tissue massage, a passive-personalised therapy, in the management of FM in females.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Pilates Exercises and Connective Tissue Massage in Females With Fibromyalgia
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Aug 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Other: 2

Pilates exercises

Other: Pilates exercises
15 FM patients participated in the PE programme three times a week during a 4-week period
Other Names:
  • No drug name

    		•
    Other: 1

    Connective tissue massage

    Other: Connective tissue massage
    21 patients received CTM, three times a week during a 4-week period

    Outcome Measures

    Primary Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University Ankara Turkey 06100

    Sponsors and Collaborators

    • Pamukkale University
    • Hacettepe University

    Investigators

    • Principal Investigator: Gamze Ekici, PhD, Pamukkale University
    • Study Director: 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00636623
    Other Study ID Numbers:
    • Ekici - 2
    • ISRCTN12345678
    First Posted:
    Mar 14, 2008
    Last Update Posted:
    Mar 14, 2008
    Last Verified:
    Mar 1, 2008
    Keywords provided by , ,
    Pilates Exercises
    Connective Tissue Massage
    Additional relevant MeSH terms:
    Fibromyalgia
    Myofascial Pain Syndromes

    Study Results

    No Results Posted as of Mar 14, 2008