The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05835427
Collaborator
(none)
100
1
2
4.3
23.4

Study Details

Study Description

Brief Summary

Fibromyalgia is a non-articular, chronic rheumatic disease of unknown etiology characterized by widespread musculoskeletal pain, sleep disturbance, fatigue, and the presence of multiple tender points.

Condition or Disease Intervention/Treatment Phase
  • Other: Cervical Extensor Stretch
  • Other: Cervical Extensor Stretch
N/A

Detailed Description

Although the exact etiology cannot be determined in fibromyalgia, it is thought that there are many mechanisms that contribute to the formation of Fibromyalgia. Evidence for some biochemical, neurohormonal, central nervous system, immunological, psychological and environmental factors that may play a role in the disease has been found.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Individuals with fibromyalgia and healthy individuals will be included in the study and the effectiveness of the treatment will be examined. Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.Individuals with fibromyalgia and healthy individuals will be included in the study and the effectiveness of the treatment will be examined. Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.
Masking:
Single (Investigator)
Primary Purpose:
Other
Official Title:
The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia
Actual Study Start Date :
Apr 17, 2023
Anticipated Primary Completion Date :
Jun 21, 2023
Anticipated Study Completion Date :
Aug 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fibromyalgia individual

Cervical Extensor Stretch, cervical flexor stretch, cervical lateral flexion stretch, thoracic stretch, pectoral stretch, lumbar extensor stretch, posterior capsule stretch, knee flexor stretch, gastro-soleus stretch, quadriceps stretch, cat-camel exercise, shoulder circles, neck flip- tilting the neck to the right and left, relaxation of the abdominal and back muscles, posterior pelvic tilt.

Other: Cervical Extensor Stretch
Fibromyalgia individual: Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.

Experimental: Healthy volunteers

Cervical Extensor Stretch, cervical flexor stretch, cervical lateral flexion stretch, thoracic stretch, pectoral stretch, lumbar extensor stretch, posterior capsule stretch, knee flexor stretch, gastro-soleus stretch, quadriceps stretch, cat-camel exercise, shoulder circles, neck flip- tilting the neck to the right and left, relaxation of the abdominal and back muscles, posterior pelvic tilt.

Other: Cervical Extensor Stretch
Healthy volunteers : Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.

Outcome Measures

Primary Outcome Measures

  1. Fibromyalgia Impact Questionnaire [8 weeks]

    In this scale filled by the patient; Physical function, feeling well, not being able to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression were measured. With the exception of the well-being trait, low scores indicate recovery or less affliction. Each subheading was asked to be scored between 0-10. Values of 50 points and below were considered as mildly affected, and values above 50 points were considered as severely affected.

  2. The Pittsburg Sleep Quality Index [8 weeks]

    The Pittsburg Sleep Quality Index is a 19-item self-report scale that assesses sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality".

  3. Beck Anxiety Scale [8 weeks]

    It measures the frequency of anxiety symptoms experienced by the individual. It is a Likert-type self-assessment scale consisting of 21 items and scored between 0-3. The individual is asked to mark only one of the "None", "Mild", "Moderate" and "Severe" options for each item. The total score range is between 0-63. The high score total indicates the high level of anxiety experienced by the individual.

  4. Fibromyalgia ACR Criterion assessed by Composite the Widespread Pain Scale and the Symptom Severity Scale [8 weeks]

    It is obtained by adding the Widespread Pain Scale and the Symptom Severity Scale. The maximum total score here is 19+12=31. Accordingly, scores below a total of 12 do not suggest fibromyalgia. Widespread Pain Scale ≥7 and Symptom Severity Scale ≥5.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria

  • Volunteer

  • Being diagnosed with fibromyalgia Exclusion Criteria

  • Known neurological disorder

  • Serious orthopedic disorders that will prevent him from exercising

  • Cognitive impairment

  • Using regular NSAIDs

  • Being malnourished and malnourished

Contacts and Locations

Locations

Site City State Country Postal Code
1 HAZAL genç Istanbul Turkey 34070

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
hazal genc, Principal Investigator, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT05835427
Other Study ID Numbers:
  • Fibromyalgia
First Posted:
Apr 28, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by hazal genc, Principal Investigator, Istanbul Medipol University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 1, 2023