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Shoulder PainNCT06702319

Effects of Externally Focused Shoulder Stabilization Exercises on Individuals With Rotator Cuff Tendinopathy

A study testing Exercise in people with Shoulder Pain and Rotator Cuff Tendinitis, run by Izmir Democracy University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the effectiveness of externally focused shoulder stabilization exercises on range of motion, pain, handgrip strength, and proprioception in patients with rotator cuff tendinopathy. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Shoulder Pain, Rotator Cuff Tendinitis
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2025to 15 Oct 2026
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having a diagnosis of rotator cuff tendinopathy,
  • Having sufficient cooperation to perform the exercises.

Who cannot join

  • Having a neurological problem,
  • Having a previous fracture in the shoulder region,
  • Having undergone a relevant surgery in the past,
  • Having any chronic illness that could prevent exercise (e.g., chronic heart failure, pacemaker, etc.),
  • Having a systemic condition that could affect proprioception, such as diabetes, rheumatoid arthritis, ankylosing spondylitis, or advanced osteoarthritis,
  • Having received a physiotherapy program targeting the neck and upper extremity within the last 3 months.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Izmir Democracy University

    Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: İzmir Democracy University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation

This study aims to evaluate the effectiveness of externally focused shoulder stabilization exercises on range of motion, pain, handgrip strength, and proprioception in patients with rotator cuff tendinopathy. For the study, 69 patients will be randomly divided into three groups: Home Program Group (HPG), Internal Focused Exercise Group (IFEG), and External Focused Exercise Group (EFEG). The treatment period for all three groups will be 6 weeks. Shoulder range of motion, pain, handgrip strength, joint position sense, and shoulder function (WORC and QuickDASH) of the three groups will be evaluated at baseline and after intervention. IFEG will do the exercises with a physiotherapist twice a week. During the exercise, the patient will be allowed to focus on the body parts while performing the movement. EFEG will do the exercises with a physiotherapist twice a week. The patient will be allowed to focus on a point outside the body, namely the effect of the movement, during the exercise. In the management of HPG patients will be provided with an exercise brochure. At the conclusion of the study, the three groups will be compared and evaluated using appropriate statistical analyses to assess the outcomes and determine any significant differences between them.

Read the detailed description

Rotator Cuff Tendinopathy Treatment Various strategies are used in the treatment of rotator cuff tendinopathy as conservative, mini-invasive, and surgical treatments. Conservative treatment includes rest, non-steroidal anti-inflammatory drugs, steroid injections, and physiotherapy methods (Chaudhury et al. 2010). The primary goal in physiotherapy applications is the restoration of normal shoulder movement patterns. It focuses on eliminating the loss of flexibility, movement, and strength that cause pain and regaining functions (Kibler, 2003). The response of tendon cells to load depends on both frequency and load. Tendon cells seem to be programmed to perceive a certain level of stress. Adequate doses of mechanical loading provide repair in the tendon. On the other hand, inadequate stimulation can prevent or slow down healing (Arnocky et al. 2007, Camargo et al. 2014).

Focus of attention Focus of attention refers to the place where a person pays attention while performing a certain movement. Wulf et al. (1998) conducted the first study on the focus of attention. When a person focuses on body parts while performing a movement, it is called internal focus, and when a person focuses on something outside the body, that is, the effect of the movement, it is called external focus. Studies show that external focus is effective in balance, performance, and motor learning (Park et al., 2015; Wulf et al., 2016). It has been determined that external focus is effective in improving motor learning and function (Castillo-Vejar et al., 2022). It has been observed that performing exercises with an external focus provides a decrease in the degree of perceived exertion (Lohse et al., 2011). In a study, the effects of internal focus, external focus, and the application without focus conditions on balance performance were evaluated. As a result, a positive effect of external focus on balance was found. Internal focus has been reported to cause a loss of performance on balance compared to the control group (Wulf et al., 2003).

This study aims to determine whether there is a difference between home exercise program, internal focus exercise, and external focus exercise in patients with Rotator Cuff Tendinopathy.

Exercise Programs Initially, patients will receive training (30 minutes) to ensure that the exercises are applied correctly and to encourage patient compliance.

Home program group (HPG): In addition to medical treatment, a home exercise program with a brochure will be given to the home exercise group. The exercise program includes; posture exercises, codman exercises, wand exercises, strengthening exercises in all directions of the shoulder, and wall ball rolling exercises. It will be stated that they will do the exercises regularly and follow the given recommendations and come for a check-up at the end of 6 weeks. During this period, individuals will be contacted by phone and interim follow-ups will be made.

Internal Focused Exercise Group (IFEG): A home program will also be given to this group. In addition, participants will do the exercises with a physiotherapist twice a week. The exercises will be applied in the physiotherapy unit of Buca Seyfi Demirsoy Hospital. In this group, internal focus will be used during the exercise. During the exercise, the patient will be allowed to focus on the body parts while performing the movement. For example; while doing the ball rolling exercise on the wall, "While applying pressure to the ball on the wall with your hand, draw a circle clockwise." The exercise program includes; posture exercises, codman exercise, wand exercises, strengthening exercises in all directions of the shoulder, and ball rolling exercises on the wall.

External Focused Exercise Group (EFEG): The home program will also be given to this group. In addition, participants will do the exercises with a physiotherapist twice a week. The exercises will be applied in the physiotherapy unit of Buca Seyfi Demirsoy Hospital. In this group, external focus will be used audibly and visually during the exercise. The patient will be allowed to focus on a point outside the body, namely the effect of the movement, during the exercise. For example; while drawing a circle on the wall and rolling a ball on the wall, giving the command "Draw a circle by applying pressure to the ball on the wall, staying inside the circle." and using audible external focus such as counting the number of movements and giving directions during the exercise. The exercise program includes; posture exercises, codman exercises, wand exercises, strengthening exercises in all directions of the shoulder, and rolling a ball on the wall exercises.

Statistical method(s) The normal distribution of the obtained data will be examined and the method will be determined according to the distribution. The differences before and after the application in one group and after the training between the three groups will be examined. The results will be interpreted and discussed by comparing them with the literature. At the end of the study, statistical analyses will be performed using the SPSS 26.0 program. The conformity of all variables to normal distribution will be investigated using visual (histogram and probability graphs) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Descriptive analyses will be given using the number and percentage (%) values for categorical variables, median and interquartile range (IQR) for variables that are not normally distributed, and mean and standard deviation (x±ss) for variables that are normally distributed. One-way variance analysis and post hoc tukey analysis will be performed in the comparison of variables that are normally distributed. In the comparison of data that are not normally distributed, the Kruskal Wallis test and one-way ANOVA test for post hoc statistics will be performed to determine the groups that create differences. The statistical significance level will be accepted as p < 0.05.

Being tested
Exercise
Medical subject headings
Shoulder Pain, Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Home exercises and home exercises with internal focus exercises or external focus exercises

Study groups in NCT06702319
Study groupRoleWhat they receive
home exercise programNo interventionA total of at least 23 Participants will receive the home exercise program for 6 weeks.
internal focus exercise programExperimentalA total of at least 23 Participants will receive the internal focus exercise program for 6 weeks.
Receives: Other: Exercise
external focus exercise programExperimentalA total of at least 23 Participants will receive the external focus exercise program for 6 weeks.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quick Disabilities of Arm, Shoulder & Hand

    The Quick Disabilities of Arm, Shoulder \& Hand Index is used to measure upper extremity physical function. A Turkish validity and reliability study has been conducted. The scale includes 11 headings extracted from the long version. Each question consists of a 5-point scale. The total score is calculated with the formula [(sum of n responses) /n-1] ×25, where n= indicates the total number of questions answered. The total score varies between 0 (no disability) and 100 (severe disability). The final score is classified as; 0- 15: 'no problem', 16-40: 'problem but able to work', 40 and above: 'unable to work'.

    Measured: one day before the intervention and 6 weeks after

Secondary outcomes (5)
  1. Shoulder Joint Range of Motion

    The range of motion of the shoulder joint will be measured in degrees using a standard goniometer. Measurements will be recorded for the shoulder joint in the directions of flexion, extension, abduction, adduction, internal rotation, and external rotation.

    Measured: one day before the intervention and 6 weeks after

  2. Assessment of Shoulder Pain

    The Visual Analog Scale (VAS) will be used to evaluate shoulder pain. Perceived pain ranges from no pain at all to extreme pain. According to the VAS, pain severity is rated as 'no pain' being 0 points and 'worst possible pain' being 10 points (on a 10 cm scale). The individual will be asked to mark the point on a 100-millimeter line that corresponds to their perceived pain level. The unit length from the point representing no pain to the individual's marked point indicates the level of pain. Pain levels are categorized as: <3 mild pain, 3-6 moderate pain, and >6 severe pain. Pain will be assessed in four different conditions: night pain, daytime pain, pain at rest, and pain during activity.

    Measured: one day before the intervention and 6 weeks after

  3. Western Ontario Rotator Cuff (WORC) Index

    The WORC is a self-assessment tool developed by Kirkley and colleagues in 2003 to measure the quality of life in individuals with rotator cuff tendinopathy. This scale consists of five subdomains: physical activities, sports/recreational activities, work, lifestyle, and emotions, and includes a total of 21 questions. The Turkish validity and reliability study has been conducted. The WORC index has been successfully translated and adapted into Turkish. The Turkish version of the WORC index is a reliable and valid tool for use in clinical studies with patients with rotator cuff tendinopathy.

    Measured: one day before the intervention and 6 weeks after

  4. Assessment of Hand Grip Strength:

    Hand grip strength is assessed using a dynamometer. In our study, a Jamar brand dynamometer will be used. The participant sits upright on an armless chair. Necessary precautions are taken to ensure the participant's posture remains stable during the measurement. The participant is instructed to grip the dynamometer as hard as possible while in shoulder adduction, elbow flexed at 90 degrees, and wrist in a mid-prone position. They are then told to release upon verbal command. The measurement is repeated three times separately, and the average value is recorded.

    Measured: one day before the intervention and 6 weeks after

  5. Assessment of Joint Position Sense:

    The joint position sense of the affected shoulder will be measured using a standard goniometer. The assessment will be done through an angle replication test, which evaluates the ability to actively replicate a predetermined angle. The specified angle is taught to the participant, and then they are asked to actively find the taught angle. The deviation between the angle found by the participant and the predetermined angle is recorded. The test will be performed in arm elevation positions including 30, 60, and 90 degrees of shoulder flexion and 30, 60, and 90 degrees of shoulder abduction. Each position will be repeated three times with the participant's eyes open, allowing them to memorize the position. After returning to the starting position, the participant's eyes will be closed, and they will be asked to repeat the same movement three times. After each movement, the goniometer will be positioned at the shoulder joint, and the physiotherapist will measure the angle.

    Measured: one day before the intervention and 6 weeks after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2024
  2. Study start1 May 2025
  3. Primary completion1 Oct 2025
  4. Study completion15 Oct 2026

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06702319
Sponsor's protocol ID
EXTERNALFOCUS
Status last verified
Nov 2026
First submitted
14 Nov 2024
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chaudhury S, Gwilym SE, Moser J, Carr AJ. Surgical options for patients with shoulder pain. Nat Rev Rheumatol. 2010 Apr;6(4):217-26. doi: 10.1038/nrrheum.2010.25.

    PubMed 20357791
  • Kibler WB. Rehabilitation of rotator cuff tendinopathy. Clin Sports Med. 2003 Oct;22(4):837-47. doi: 10.1016/s0278-5919(03)00048-6.

    PubMed 14560550
  • Arnocky SP, Lavagnino M, Egerbacher M. The Response of Tendon Cells to Changing Loads: Implications in the Etiopathogenesis of Tendinopathy. In: Woo L-Y, Renström AFH, Arnoczky SP, editors. Tendinopathy in athletes. Oxford, UK: Wiley online library; 2007. pp. 46-59.

  • Camargo PR, Alburquerque-Sendin F, Salvini TF. Eccentric training as a new approach for rotator cuff tendinopathy: Review and perspectives. World J Orthop. 2014 Nov 18;5(5):634-44. doi: 10.5312/wjo.v5.i5.634. eCollection 2014 Nov 18.

    PubMed 25405092
  • Wulf G, Hoss M, Prinz W. Instructions for motor learning: differential effects of internal versus external focus of attention. J Mot Behav. 1998 Jun;30(2):169-79. doi: 10.1080/00222899809601334.

    PubMed 20037032
  • Wulf G, Lewthwaite R. Optimizing performance through intrinsic motivation and attention for learning: The OPTIMAL theory of motor learning. Psychon Bull Rev. 2016 Oct;23(5):1382-1414. doi: 10.3758/s13423-015-0999-9.

    PubMed 26833314
  • Wulf G, Weigelt M, Poulter D, McNevin N. Attentional focus on suprapostural tasks affects balance learning. Q J Exp Psychol A. 2003 Oct;56(7):1191-211. doi: 10.1080/02724980343000062.

    PubMed 12959910
  • Park SH, Yi CW, Shin JY, Ryu YU. Effects of external focus of attention on balance: a short review. J Phys Ther Sci. 2015 Dec;27(12):3929-31. doi: 10.1589/jpts.27.3929. Epub 2015 Dec 28.

    PubMed 26834382
  • Castillo-Vejar L, Lizama-Fuentes M, Bascour-Sandoval C, Cuyul-Vasquez I. [Attentional focus instructions for therapeutic exercise in people with musculoskeletal disorders. A scoping review]. Rehabilitacion (Madr). 2022 Oct-Dec;56(4):344-352. doi: 10.1016/j.rh.2021.11.006. Epub 2022 Apr 22. Spanish.

    PubMed 35469643
  • Lohse KR, Sherwood DE. Defining the focus of attention: effects of attention on perceived exertion and fatigue. Front Psychol. 2011 Nov 14;2:332. doi: 10.3389/fpsyg.2011.00332. eCollection 2011.

    PubMed 22102843
  • Hayes JR, Sheedy JE, Stelmack JA, Heaney CA. Computer use, symptoms, and quality of life. Optom Vis Sci. 2007 Aug;84(8):738-44. doi: 10.1097/OPX.0b013e31812f7546.

    PubMed 17700327
  • Bertelsen TI. [Visual coordination- and accommodation disturbances and eye diseases as causes of headache]. Nord Med. 1978 Apr;93(3-4):57-8. No abstract available. Norwegian.

    PubMed 643521
  • El O, Bircan C, Gulbahar S, Demiral Y, Sahin E, Baydar M, Kizil R, Griffin S, Akalin E. The reliability and validity of the Turkish version of the Western Ontario Rotator Cuff Index. Rheumatol Int. 2006 Oct;26(12):1101-8. doi: 10.1007/s00296-006-0151-2. Epub 2006 Jun 24.

    PubMed 16799776
  • Kirkley A, Alvarez C, Griffin S. The development and evaluation of a disease-specific quality-of-life questionnaire for disorders of the rotator cuff: The Western Ontario Rotator Cuff Index. Clin J Sport Med. 2003 Mar;13(2):84-92. doi: 10.1097/00042752-200303000-00004.

    PubMed 12629425
  • Koldas Dogan S, Ay S, Evcik D, Baser O. Adaptation of Turkish version of the questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) in patients with carpal tunnel syndrome. Clin Rheumatol. 2011 Feb;30(2):185-91. doi: 10.1007/s10067-010-1470-y. Epub 2010 Apr 22.

    PubMed 20411289

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Shoulder Pain and Rotator Cuff Tendinitis, run by Izmir Democracy University 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 6 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 4 Nov 2026. 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?

Quick Disabilities of Arm, Shoulder & Hand (time frame: one day before the intervention and 6 weeks after). 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 NCT06702319, which also lists 16 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 4 Nov 2026.

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