Comparison of Exercise and Massage in Fibromyalgia

NCT ID: NCT00636623

Last Updated: 2008-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

Pilates exercises

Group Type OTHER

Pilates exercises

Intervention Type OTHER

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

1

Connective tissue massage

Group Type OTHER

Connective tissue massage

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pilates exercises

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

Intervention Type OTHER

Connective tissue massage

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

No drug name

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University

OTHER

Sponsor Role collaborator

Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pamukkale University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gamze Ekici, PhD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Turkan Akbayrak, Assoc. Prof.

Role: STUDY_DIRECTOR

Hacettepe University

Edibe Yakut, Prof

Role: STUDY_DIRECTOR

Hacettepe University

Naciye Vardar, MsC

Role: STUDY_DIRECTOR

Hacettepe University

Yavuz Yakut, Prof

Role: STUDY_DIRECTOR

Hacettepe University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ISRCTN12345678

Identifier Type: -

Identifier Source: secondary_id

Ekici - 2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.