Clinical trial NCT06702319: Effects of Externally Focused Shoulder Stabilization Exercises on Individuals With Rotator Cuff Tendinopathy
Official title: İzmir Democracy University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Shoulder Pain
Rotator Cuff Tendinitis
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
Collaborators: name: Buca Seyfi Demirsoy State Hospital
First posted: 2024-11-22
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Quick Disabilities of Arm, Shoulder & Hand
timeFrame: one day before the intervention and 6 weeks after
Secondary outcomes:
measure: Shoulder Joint Range of Motion
timeFrame: one day before the intervention and 6 weeks after
measure: Assessment of Shoulder Pain
timeFrame: one day before the intervention and 6 weeks after
measure: Western Ontario Rotator Cuff (WORC) Index
timeFrame: one day before the intervention and 6 weeks after
measure: Assessment of Hand Grip Strength:
timeFrame: one day before the intervention and 6 weeks after
measure: Assessment of Joint Position Sense:
timeFrame: one day before the intervention and 6 weeks after
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Democracy University
Study officials:
affiliation: Izmir Democracy University
name: Onur Engin, Assist Prof
role: PRINCIPAL_INVESTIGATOR
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