Investigation of the Effectiveness of Thoracic Mobilization Exercise in Fibromyalgia Patients

NCT ID: NCT06415565

Last Updated: 2024-07-22

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2024-07-19

Brief Summary

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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.

Detailed Description

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The patients included in the study were randomly divided into two as Thoracic Mobilization Group and Control Group and will be included in the treatment programs after the initial evaluations. Patients in both groups will receive a treatment of 11 sessions in total, 5 sessions per week. Participants will be evaluated twice before and after treatment with the Fibromyalgia impact questionnaire, Beck anxiety and Beck depression questionnaires. In addition, the E-motion Faros device will be used to measure heart rate variability. Measurements of heart rate variables will be made before and after the first day of treatment, before and after the 11th session, and on the 45th day.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

Conventional physiotherapy practices will be performed.

Group Type ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type OTHER

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

mobilization

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

Group Type EXPERIMENTAL

conventional physiotherapy

Intervention Type OTHER

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

thoracic mobilization methods

Intervention Type OTHER

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.

Interventions

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conventional physiotherapy

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

Intervention Type OTHER

thoracic mobilization methods

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Öğr. Üyesi Ömer Şevgin

Asst. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cansu ÇİFTÇİ

Role: STUDY_CHAIR

Uskudar University

Locations

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Uskudar Üniversity

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26084281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20184717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23709519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29185675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24991436 (View on PubMed)

Other Identifiers

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Uskudar11

Identifier Type: -

Identifier Source: org_study_id

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