Shoulder PainNCT05444426
Investigation of the Effect of Conventional Treatment on Postural Stability and Balance in Individuals With Shoulder Pain
A study testing Shoulder Rehabilitation in people with Shoulder Pain and Balance; Distorted, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Shoulder Pain, Balance; Distorted
- What is being tested?
- Shoulder Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having a complaint of shoulder pain for at least 3 months
- Being between the ages of 19-60
Who cannot join
- Having had a surgical operation in the last 6 months,
- Having cognitive problems that prevent participation in exercises.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa
Istanbul, 34500
About this study
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.
Read the 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.
- Conditions
- Shoulder Pain, Balance; Distorted
- Being tested
- Shoulder Rehabilitation
- Keywords
- shoulder pain, balance, postural stability
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Other: Shoulder Rehabilitation |
| Control Group | No intervention | Pain, Active range of motion, balance, and postural stability will be assessed in the first week . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of postural stability from baseline to 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.
Measured: 8 weeks
Secondary outcomes (2)
Change of Pain Level from baseline to 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").
Measured: 8 weeks
Change of shoulder joint range baseline to 8 weeks
A universal goniometer will be used in the assessment of active joint range of motion.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Jul 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Tuğçe Tahmaz, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444426
- Sponsor's protocol ID
- Shoulder Pain
- Status last verified
- Oct 2022
- First submitted
- 30 Jun 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34001426Ostor 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.
PubMed 15769790Carvalhais 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.
PubMed 23394717Kaur 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.
PubMed 25540708
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Conventional Treatment on Postural Stability and Balance in Individuals With Shoulder Pain
- ClinicalTrials.gov ID
- NCT05444426
- Acronym / sponsor ID
- Shoulder Pain
- Conditions
- Shoulder Pain, Balance; Distorted
- Keywords
- shoulder pain, balance, postural stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Shoulder RehabilitationA 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. |
| Control Group | No intervention | –Pain, Active range of motion, balance, and postural stability will be assessed in the first week . |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Having a complaint of shoulder pain for at least 3 months
- Being between the ages of 19-60
Key exclusion criteria (2 listed)
- Having had a surgical operation in the last 6 months,
- Having cognitive problems that prevent participation in exercises.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder Rehabilitationhot 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. | Other | Treatment Group |
Primary outcome
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.
2 secondary outcomes
Change of Pain Level from baseline to 8 weeks
Time frame: 8 weeks
Change of shoulder joint range baseline to 8 weeks
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Background: PubMed 34001426Rosa 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.
- Background: PubMed 15769790Ostor 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.
- Background: PubMed 23394717Carvalhais 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.
- Background: PubMed 25540708Kaur 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder Rehabilitation in people with Shoulder Pain and Balance; Distorted, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of postural stability from baseline to 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05444426, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.