NCT00302887

Brief Summary

The aim of this study was to evaluate the short term and one year follow-up results of connective tissue manipulation and combined ultrasound therapy (ultrasound and high voltage pulsed galvanic stimulation) in terms of pain, complaint of non-restorative sleep and impact on the functional activities in patients with fibromyalgia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2006

Enrollment Period

1.3 years

First QC Date

March 14, 2006

Last Update Submit

March 11, 2025

Conditions

Keywords

fibromyalgiaconnective tissue manipulationultrasound therapyhigh voltage pulsed galvanic stimulation

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    The intensity of pain was evaluated by 0-10 cm visual analogue scales (VASs). On the VAS, "0" indicated "no pain" and the "10" indicated "the worst imaginable pain".

    All evaluations were performed before and after 20 sessions of treatment.

Interventions

Eligibility Criteria

Age19 Years - 68 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The sample was derived from a population of 83 FM outpatients of the Hacettepe University School of Physical Therapy and Rehabilitation

You may qualify if:

  • Women with pain depending to FM, with an intensity interfering to activities of daily living for a duration of at least six months, able to participate of 20 physiotherapy sessions within a four week period, volunteer for participating to the study without taking any drugs acting on the nervous system such as antidepressants, myorelaxants, analgesics or hypnotics, in the study period.

You may not qualify if:

  • evidence of neurological, infectious, endocrine and other inflammatory rheumatic diseases, and experience with any kind of manual and/or electrotherapy, within six months before the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, School of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • İlkim Çıtak Karakaya, PT. PhD.

    PT. PhD. Assist. Prof.

    PRINCIPAL INVESTIGATOR
  • Türkan Akbayrak, PT. PhD.

    PT. PhD. Assoc. Prof.

    STUDY DIRECTOR
  • Funda Demirtürk, PT. PhD.

    Research assistant

    STUDY CHAIR
  • Gamze Ekici, PT. MSc.

    Research assistant

    STUDY CHAIR
  • Yeşim Bakar, PT. PhD.

    Assist. Prof.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 15, 2006

Study Start

August 1, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

March 14, 2025

Record last verified: 2006-03

Locations