Clinical trial NCT00636623: Comparison of Exercise and Massage in Fibromyalgia
Official title: Comparison of Pilates Exercises and Connective Tissue Massage in Females With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Pilates Exercises
Connective Tissue Massage
Lead sponsor: Pamukkale University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2008-03-14
Enrollment: 36
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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 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

Primary outcomes:
measure: 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.
timeFrame: For All measurements aproximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Pamukkale University
name: Gamze Ekici, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Turkan Akbayrak, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Edibe Yakut, Prof
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Naciye Vardar, MsC
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Yavuz Yakut, Prof
role: STUDY_DIRECTOR
References: