- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05444426
Investigation of the Effect of Conventional Treatment on Postural Stability and Balance in Individuals With Shoulder Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34500
- Istanbul University Cerrahpasa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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No Intervention: Control Group
Pain, Active range of motion, balance, and postural stability will be assessed in the first week .
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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").
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8 weeks
|
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Change of shoulder joint range baseline to 8 weeks
Time Frame: 8 weeks
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A universal goniometer will be used in the assessment of active joint range of motion.
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8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Rosa DP, Borstad JD, Ferreira JK, Gava V, Santos RV, Camargo PR. Comparison of specific and non-specific treatment approaches for individuals with posterior capsule tightness and shoulder impingement symptoms: A randomized controlled trial. Braz J Phys Ther. 2021 Sep-Oct;25(5):648-658. doi: 10.1016/j.bjpt.2021.04.003. Epub 2021 May 4.
- Ostor AJ, Richards CA, Prevost AT, Speed CA, Hazleman BL. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatology (Oxford). 2005 Jun;44(6):800-5. doi: 10.1093/rheumatology/keh598. Epub 2005 Mar 15.
- Carvalhais VO, Ocarino Jde M, Araujo VL, Souza TR, Silva PL, Fonseca ST. Myofascial force transmission between the latissimus dorsi and gluteus maximus muscles: an in vivo experiment. J Biomech. 2013 Mar 15;46(5):1003-7. doi: 10.1016/j.jbiomech.2012.11.044. Epub 2013 Feb 8.
- Kaur N, Bhanot K, Brody LT, Bridges J, Berry DC, Ode JJ. Effects of lower extremity and trunk muscles recruitment on serratus anterior muscle activation in healthy male adults. Int J Sports Phys Ther. 2014 Dec;9(7):924-37.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Shoulder Pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Shoulder Pain
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Fondazione Policlinico Universitario Campus Bio-MedicoRecruiting
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IRCCS San Camillo, Venezia, ItalyFerRobotics Compliant Robot GmbH, Linz, AustriaCompletedStrokeAustria, Italy
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