Comparison of Exercise and Massage in Fibromyalgia (FM)

March 7, 2008 updated by: Pamukkale University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
For All measurements aproximately 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

March 14, 2008

Last Update Submitted That Met QC Criteria

March 7, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ekici - 2
  • ISRCTN12345678

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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