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Comparison of Exercise and Massage in Fibromyalgia (FM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00636623
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : March 14, 2008
Hacettepe University
Information provided by:
Pamukkale University

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
Fibromyalgia Other: Pilates exercises Other: Connective tissue massage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Pilates exercises
Other: Pilates exercises
15 FM patients participated in the PE programme three times a week during a 4-week period
Other Name: No drug name

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

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. [ Time Frame: For All measurements aproximately 1 hour ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00636623

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Hacettepe University
Ankara, Turkey, 06100
Sponsors and Collaborators
Pamukkale University
Hacettepe University
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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

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Responsible Party: Gamze Ekici, Pamukkale University Identifier: NCT00636623    
Other Study ID Numbers: Ekici - 2
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: March 14, 2008
Last Verified: March 2008
Keywords provided by Pamukkale University:
Pilates Exercises
Connective Tissue Massage
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases