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Completed

NCT Number: NCT00636623

Comparison of Exercise and Massage in Fibromyalgia

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)

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Key information

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pilates exercises

Other

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

Other names: No drug name

Connective Tissue Massage

Other

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

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.

    Time frame: For All measurements aproximately 1 hour

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Collaborators

  • Hacettepe University

Registry information

Official study title

Comparison of Pilates Exercises and Connective Tissue Massage in Females With Fibromyalgia

Acronym: FM

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 14, 2008
Registry last updated
Mar 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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