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Comparison of Exercise and Massage in Fibromyalgia (FM)

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Pilates exercises

Connective tissue massage

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Pilates Exercises, Connective Tissue Massage

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm Description

Pilates exercises

Connective tissue massage

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00636623

First Posted

March 7, 2008

Last Updated

March 7, 2008

Sponsor

Pamukkale University

Collaborators

Hacettepe University

1. Study Identification

Unique Protocol Identification Number

NCT00636623

Brief Title

Comparison of Exercise and Massage in Fibromyalgia

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pamukkale University

Collaborators

Hacettepe University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Pilates Exercises, Connective Tissue Massage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Pilates exercises

Arm Title

Arm Type

Other

Arm Description

Connective tissue massage

Intervention Type

Other

Intervention Name(s)

Pilates exercises

Other Intervention Name(s)

No drug name

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Connective tissue massage

Intervention Description

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials: