Investigation of the Effect of Conventional Treatment on Postural Stability and Balance in Individuals With Shoulder Pain

October 6, 2022 updated by: Tuğçe Tahmaz, Istanbul University-Cerrahpasa
Shoulder pain is one of the most common musculoskeletal complaints that people need treatment for. Typical signs and symptoms include pain during reaching, muscle weakness, and interrupted sleep. The shoulder is one of the most common areas of pain, ranking third among musculoskeletal pains in the general population. There is a lack of information regarding the impact of shoulder-related problems on the general population, and therefore there is a growing interest in identifying adverse factors associated with shoulder problems. In our study, the postural stability and balance status of individuals with shoulder pain complaints will be evaluated and the effects of conventional treatment of shoulder pain on postural instability and balance parameters will be investigated.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The muscle that is important in lateral flexion of the trunk is the latissimus dorsi. There is a hypothesis that this muscle acts as a force transmitter from the gluteus maximus muscle to the upper extremity via myofascial connections. In the study of Kaur et al., it was reported that the myofascial connection between the hip muscles and the lateral flexors of the trunk increases the serratus anterior muscle activation. Therefore, deterioration in the performance of trunk muscles may affect the activation of the serratus anterior, resulting in decreased scapular upward rotation and posterior tilt, which may contribute to the development of pain and shoulder injury. Decreased core endurance can result in poor transmission of force generated in the lower body to the upper body and may contribute to upper limb incorrect positioning. 40 individuals with shoulder pain symptoms were planned to participate in the study. The individuals included in the study were divided into two groups the treatment group and the control group. A 24-session physiotherapy program will be applied to the patients in the treatment group. Pain, active joint range of motion, balance, and postural stability will be evaluated first week and eighth weeks.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34500
        • Istanbul University Cerrahpasa

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

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having a complaint of shoulder pain for at least 3 months
  • Being between the ages of 19-60

Exclusion Criteria:

  • Having had a surgical operation in the last 6 months,
  • Having cognitive problems that prevent participation in exercises.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group

A 24-session physiotherapy program will be applied to the patients in the treatment group.

The conventional physiotherapy program of the patients in the treatment group; will consist of 20 minutes of the hot pack, 20 minutes of conventional TENS (COMPEX Rehab 400), 1 MHz frequency, 1.5 W/cm² intensity ultrasound (Chattanooga Intelect Ultrasound) on the shoulder joint for 5 minutes. In the exercise program; A combined exercise program including active assistive and active range of motion exercises, stretching exercises for the shoulder muscles at the pain limit and posture exercises will be applied. As the severity of pain decreases, strengthening exercises for the rotator cuff and scapulary muscles will be given.

hot pack, conventional TENS (COMPEX Rehab 400), 1 MHz frequency, 1.5 W/cm² intensity ultrasound (Chattanooga Intelect Ultrasound), active assistive and active range of motion exercises, stretching exercises for the shoulder muscles at the pain limit and posture exercises will be applied.
No Intervention: Control Group
Pain, Active range of motion, balance, and postural stability will be assessed in the first week .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of postural stability from baseline to 8 weeks
Time Frame: 8 weeks

Biodex Balance system will be used to evaluate the postural stability and balance of individuals.

In evaluating the Biodex Balance System, the postural stability test of the participants will be assessed on the dynamic platforms. In the fall risk assessment, it will be evaluated with eyes open and eyes closed on the dynamic platform, which increases its mobility from 12th to 6th Levels. During the test, participants will be asked to look at a fixed point at eye level. The test will be repeated 3 times and the average will be taken. A 15-second rest period will be given between each repetition.

8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Pain Level from baseline to 8 weeks
Time Frame: 8 weeks
A 'Numerical Analog Scale' will be used in the assessment of pain. The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
8 weeks
Change of shoulder joint range baseline to 8 weeks
Time Frame: 8 weeks
A universal goniometer will be used in the assessment of active joint range of motion.
8 weeks

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

July 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Shoulder Pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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