Effect of Scapular Stabilization Exercise Training on Posture and Pain in Fibromyalgia Patients

January 26, 2023 updated by: Hakan Polat, Sanko University

Comparison of the Effect of Scapular Stabilization Exercise Training on Posture and Pain in Fibromyalgia Patients

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pain is usually seen in the scapular region in patients with fibromyalgia. We decided to do this study because we thought that there was no exercise for this area before in our study and that if it was done, improvements in pain and posture could be observed. 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 (wand exercises, codman exercises and stretching exercises) were given to the classical group, and stabilization exercises (push-up exercises on the wall, scapular adduction, scapular elevation, rowing 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: scapular stabilization exercises
scapular stabilization exercises applied to 1st group for 5 days/week for 6 weeks
Other: exercises
Active Comparator: classic shoulder exercises
classic shoulder exercises applied to 1st group for 5 days/week for 6 weeks
Other: exercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
visual analog scale ( VAS)
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanko University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: hakan Polat, Sanko University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HakanPolat

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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