NCT06415565

Brief Summary

The aim of this study is to investigate the effects of mobilization exercises applied to the thoracic region on pain, anxiety, depression, disease impact questionnaire, sympathetic and parasympathetic activity in patients diagnosed with fibromyalgia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

May 9, 2024

Last Update Submit

July 19, 2024

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (4)

  • Beck Depression Scale

    The Beck Depression Scale is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The 21 questions in the Beck Depression Scale reflect the symptoms, attitudes and intensity of depression; Items receive a score between zero and three. The total score ranges from 0 to 63. Scores from 0 to 9 indicate no or minimal depression; Scores from 10 to 18 indicate mild to moderate depression; Scores from 19 to 29 indicate moderate to severe depression, and scores from 30 to 63 indicate severe depression.

    8 weeks

  • Beck Anxiety Scale

    The Beck Anxiety Scale is a self-report questionnaire that measures 21 common somatic and cognitive symptoms of anxiety. Beck Anxiety Scale has 21 questions, each question scored between 0 and 3. The total score to be obtained from the scale varies between 0-63. Beck Anxiety Scale scores are classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63).

    8 weeks

  • Fibromyalgia Impact Survey

    The Fibromyalgia Impact Questionnaire is an assessment tool developed to measure the condition, progress and outcomes of fibromyalgia patients. It is designed to measure the health status components believed to be most affected in fibromyalgia. Fibromyalgia Impact Questionnaire consists of 10 items. The maximum possible score for each of the 10 items is 10. Therefore the maximum possible score is 100. The average fibromyalgia patient's score is around 50, with severely affected patients often scoring above 70.

    8 weeks

  • Heart rate

    The E-motion Faros device will be used to measure heart rate variability. E-motion Faros is a 3-electrode device that measures heart rate changes. Two of the electrodes in the device are placed under the patient's right and left clavicle, and the other one is placed just above the lowest left rib. Electrocardiogram measurement takes an average of 5 minutes.

    8 weeks

Study Arms (2)

control

ACTIVE COMPARATOR

Conventional physiotherapy practices will be performed.

Other: conventional physiotherapy

mobilization

EXPERIMENTAL

In addition to conventional physiotherapy applications, thoracic mobilization applications will be performed.

Other: conventional physiotherapyOther: thoracic mobilization methods

Interventions

conventional physiotherapyOTHER

Methods applied as conventional physiotherapy methods are: hotpack, Transcutaneous electrical nerve stimulation and ultrasound.

controlmobilization
thoracic mobilization methodsOTHER

Methods applied as conventional physiotherapy methods: hotpack, Transcutaneous electrical nerve stimulation and ultrasound applications will be applied. Also within the scope of thoracic mobilization: thoracic region extension stretching in the kneeling position, thoracic flexion in the crawling position, halo exercise, thoracic rotation exercises in the crawling position, thoracic rotation in the side lying position. , quadruped extension and rotation exercises will be applied. Patients will be informed that these exercises can also be done as home exercises and they will be asked to practice for 8 weeks.

mobilization

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being diagnosed with fibromyalgia by a specialist physician according to the 2013 American Association of Rheumatology diagnostic criteria
  • Being between the ages of 18-45

You may not qualify if:

  • Those with neurological deficit
  • During menopause and postmenstrual period
  • Diagnosed with diabetes
  • Those with neuropathic disease
  • Those with chronic inflammation
  • Have immunodeficiency
  • Those with cardiac disease
  • Patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar Üniversity

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • Larsson A, Palstam A, Lofgren M, Ernberg M, Bjersing J, Bileviciute-Ljungar I, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves muscle strength, health status and pain intensity in fibromyalgia--a randomized controlled trial. Arthritis Res Ther. 2015 Jun 18;17(1):161. doi: 10.1186/s13075-015-0679-1.

    PMID: 26084281BACKGROUND

  • Bronfort G, Haas M, Evans R, Leininger B, Triano J. Effectiveness of manual therapies: the UK evidence report. Chiropr Osteopat. 2010 Feb 25;18:3. doi: 10.1186/1746-1340-18-3.

    PMID: 20184717BACKGROUND

  • Hoogvliet P, Randsdorp MS, Dingemanse R, Koes BW, Huisstede BM. Does effectiveness of exercise therapy and mobilisation techniques offer guidance for the treatment of lateral and medial epicondylitis? A systematic review. Br J Sports Med. 2013 Nov;47(17):1112-9. doi: 10.1136/bjsports-2012-091990. Epub 2013 May 24.

    PMID: 23709519BACKGROUND

  • Assumpcao A, Matsutani LA, Yuan SL, Santo AS, Sauer J, Mango P, Marques AP. Muscle stretching exercises and resistance training in fibromyalgia: which is better? A three-arm randomized controlled trial. Eur J Phys Rehabil Med. 2018 Oct;54(5):663-670. doi: 10.23736/S1973-9087.17.04876-6. Epub 2017 Nov 29.

    PMID: 29185675BACKGROUND

  • Reis MS, Durigan JL, Arena R, Rossi BR, Mendes RG, Borghi-Silva A. Effects of posteroanterior thoracic mobilization on heart rate variability and pain in women with fibromyalgia. Rehabil Res Pract. 2014;2014:898763. doi: 10.1155/2014/898763. Epub 2014 May 29.

    PMID: 24991436BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Cansu ÇİFTÇİ

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 16, 2024

Study Start

May 15, 2024

Primary Completion

July 19, 2024

Study Completion

July 19, 2024

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)