NCT05710939

Brief Summary

Our study was conducted to investigate the effect of scapular stabilization exercise training on cervical posture and pain in fibromyalgia. 59 patients aged 18-60 years were included in the study. The patients included in the study were diagnosed with fibromyalgia from the physical therapy outpatient clinic and individuals who did not have any other disease were included. The included individuals were divided into 2 groups by randomization method. Individuals were divided into scapula exercise therapy group (n=29) and classical exercise therapy group (n=30). Hotpack, tens and ultrasound applications were applied to both groups as conventional treatment before exercise. This protocol was applied to both groups for 6 weeks, 5 days a week. Following this protocol, classical shoulder exercises were given to the classical group and stabilization exercises were given to the scapular stabilization group. While the study designer applied the treatment, another designer applied the evaluation. The patients were evaluated for pain, cervical posture, functional status, and quality of life. pain was evaluated with a visual analog scale (vas), cervical posture was evaluated by tragus-wall distance, functional status was evaluated with fibromyalgia impact questionnaire and quality of life was evaluated with nottingam quality of life questionnaire. All evaluations were performed twice before and at the end of the treatment (6 weeks).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

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

Study Start

First participant enrolled

November 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 18, 2023

Last Update Submit

January 26, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • visual analog scale ( VAS)

    pain, This scale evaluates pain verbally. It questions the level of pain to the patients. It is between 0 and 10 points. O No pain, 10 means severe pain.

    6 weeks

  • tragus-to-wall distance

    cervical posture, This scale measures the cervical posture, the distance between the wall and the tragus in cm. The results vary from person to person, and increasing distance indicates that cervical posture has a poor prognosis.

    6 weeks

  • fibromyalgia impact scale

    functional status, This scale evaluates functional status. verbally questioned. scale type is survey. The questions asked are asked to give points between 0 and 3. 0 points always means 1 point often, 2 points sometimes, and 3 points never. activity, doing business, and well-being. It is stated that a high score does not affect the functional state of the disease, while a low score indicates that the disease affects the functional state. The total score range is between 0 points and 80 points.

    6 weeks

  • Nottingham Health Profile

    life quality,This scale evaluates quality of life. questions patients' problems with pain, social isolation, emotional reaction, physical activity, energy, and sleep. scale type is survey. Patients are asked and their answers are recorded. answers are yes or no. The total score scale is in 2 parts. The 1 section score range is between 0 and 600 points, and the 2nd section is between 0 and 7 points. A high score indicates that the quality of life is badly affected, while a low score indicates that the quality of life is not affected.

    6 weeks

Study Arms (2)

scapular stabilization exercises

ACTIVE COMPARATOR

scapular stabilization exercises applied to 1st group for 5 days/week for 6 weeks

Other: exercises

classic shoulder exercises

ACTIVE COMPARATOR

classic shoulder exercises applied to 1st group for 5 days/week for 6 weeks

Other: exercises

Interventions

classic shoulder exercisesscapular stabilization exercises

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • between the ages of 18-60,
  • Have not received any physical therapy and exercise therapy in the last 6 months,
  • No musculoskeletal problems,
  • Having no barriers to exercise therapy
  • individuals were included in the study.

You may not qualify if:

  • Individuals with psychological, cardiovascular and neurological problems,
  • Female individuals with pregnancy status,
  • Individuals who do not want to participate in physical therapy and exercise practices excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FibromyalgiaCompulsive ExercisePain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • hakan Polat

    Sanko University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants' personal information is hidden
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 18, 2023

First Posted

February 2, 2023

Study Start

November 1, 2016

Primary Completion

February 1, 2017

Study Completion

June 1, 2018

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share