NCT05444426

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

June 30, 2022

Last Update Submit

October 6, 2022

Conditions

Keywords

shoulder painbalancepostural stability

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (2)

  • Change of Pain Level from baseline to 8 weeks

    8 weeks

  • Change of shoulder joint range baseline to 8 weeks

    8 weeks

Study Arms (2)

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.

Other: Shoulder Rehabilitation

Control Group

NO INTERVENTION

Pain, Active range of motion, balance, and postural stability will be assessed in the first week .

Interventions

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.

Treatment Group

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 34001426BACKGROUND
  • 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.

    PMID: 15769790BACKGROUND
  • 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.

    PMID: 23394717BACKGROUND
  • 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.

    PMID: 25540708BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 5, 2022

Study Start

July 1, 2022

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

October 7, 2022

Record last verified: 2022-10

Locations