Comparison of Exercise and Massage in Fibromyalgia (FM)

This study has been completed.
Sponsor:
Collaborator:
Hacettepe University
Information provided by:
Pamukkale University
ClinicalTrials.gov Identifier:
NCT00636623
First received: March 7, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 Intervention
Fibromyalgia
Other: Pilates exercises
Other: Connective tissue massage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Pilates Exercises and Connective Tissue Massage in Females With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Pamukkale University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: November 2006
Study Completion Date: August 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2
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
1
Connective tissue massage
Other: Connective tissue massage
21 patients received CTM, three times a week during a 4-week period

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.

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636623

Locations
Turkey
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
  More Information

No publications provided

Responsible Party: Gamze Ekici, Pamukkale University
ClinicalTrials.gov Identifier: NCT00636623     History of Changes
Other Study ID Numbers: Ekici - 2, ISRCTN12345678
Study First Received: March 7, 2008
Last Updated: March 7, 2008
Health Authority: Turkey: Ethics Committee

Keywords provided by Pamukkale University:
Pilates Exercises
Connective Tissue Massage

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014