The Effect of Mirror Therapy After Thoracotomy

Shoulder Pain Clinical Trial

Official title:

The Effect of Mirror Therapy on Shoulder Pain and Function in Patients Undergoing Thoracotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05962736
• Other study ID #: AkdenizUnivesity
• Status: Completed
• Phase: N/A
• Start date: March 6, 2022
• Est. completion date: July 12, 2023

Study information

• Verified date: January 2024
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After thoracotomy, limitation in shoulder functions, ipsilateral shoulder pain, decrease in shoulder muscle strength and deterioration in quality of life occur. The exercise program applied after thoracotomy includes active range of motion exercises, postural correction activities, scapular strengthening exercises, and stretching of the chest and shoulder muscles. Mirror therapy can improve motor functions and reduce unilateral pain. This study aims to evaluate the effects of upper extremity exercises based on mirror therapy after thoracotomy on ipsilateral shoulder pain, shoulder joint range of motion, shoulder muscle strength, shoulder function, quality of life, movement and fear of re-injury. The patients were divided into 2 groups as "mirror therapy group" and "control group", by choosing a simple randomization so that they could not see what was written on their pre-prepared papers. Standard medical treatment, care and pulmonary rehabilitation program were applied to both groups. In addition to the routine rehabilitation program after thoracotomy, the study group received a total of 24 sessions of foal therapy, 3 sessions a week, for 8 weeks. Data were collected using the Personal Information Form including the demographic characteristics of the patients, Tampa Kinesiophobia Scale, Numerical Pain Rating Scale (NPRS), Shoulder Active Range of Motion, Pain Catastrophization Scale, Shoulder Pain and Disability Index, Shoulder muscle strength, SF-12. performed before and after treatment.

Description:

Mirror therapy can improve motor functions and reduce unilateral pain. A Mirror therapy applied to patients with shoulder pain and limited shoulder joint range of motion reduces pain intensity, improves active joint range of motion and shoulder functions, and improves kinesiophobia levels. The exercise program applied after thoracotomy includes active range of motion exercises, postural correction activities, scapular strengthening exercises, and stretching of the chest and shoulder muscles. Verbal and tactile cues may be required to complete these exercises. Therefore, mirror therapy can be a helpful tool that provides visual feedback while performing these exercises. This study aims to evaluate the effects of mirror therapy-based upper extremity exercises on ipsilateral shoulder pain, shoulder joint range of motion, shoulder muscle strength, shoulder function, quality of life, movement and fear of re-injury. This study, which was planned as a prospective randomized controlled study; It was performed on patients aged 25-65 years who were admitted to the Akdeniz University Hospital Thoracic Surgery Clinic underwent lung resection (lobectomy, segmentectomy or wedge resection) with standard posterolateral thoracotomy. PS Power and Sample Size Calculations Version 3.0 program was used for sample size calculation. The study titled "The effect of interscalene block on ipsilateral shoulder pain and pulmonary function in patients undergoing lung lobectomy: A randomized controlled trial" by Woo et al. In this direction, the targeted number of patients in the sample was planned as 70 patients, of which at least 35 were controls. The necessary permissions were obtained and the study was carried out at the Akdeniz University Hospital Thoracic Surgery Clinic. The information form prepared in accordance with the standards of the Akdeniz University Faculty of Medicine Clinical Research Ethics Committee and the voluntary consent form were signed by all cases. Demographic data of the cases were recorded on the "Patient Evaluation Form" created by us. In the preoperative period, the age, gender, weight and height measurements, educational status, type of surgery, whether there was any additional systemic disease, smoking, alcohol habits, medications that they constantly used, and previous operations were recorded in both groups. The patients were divided into 2 groups as "study" and "control group", by choosing a simple randomization so that they could not see what was written on their pre-prepared papers. Standard medical treatment, care and pulmonary rehabilitation program were applied to both groups. Patients were mobilized as early as possible. The control group consisted of patients who underwent thoracotomy and underwent routine rehabilitation in the post-surgical period. routine respiratory rehabilitation program; It consists of a) positioning, b) general body exercises, c) airway clearance techniques, d) breathing exercises, e) incentive spirometry and f) mobilization applications. In this study, the study group consisted of patients who would receive mirror therapy in addition to the routine rehabilitation program described above and applied to the control group in the post-thoracotomy period. In the study group, mirror therapy was started with the permission of the responsible doctor after the patient was extubated during the surgical period, that is, after he was awakened from anesthesia and after he became fully conscious and his hemodynamic status stabilized. To be applied in addition to the standard treatment, the study group was placed in such a way that the mirror was in the midline of the body and it was ensured that the healthy extremity could be seen on the reflected face of the mirror, and the patient's extremity would not be seen by leaving it behind the mirror. In this position, first, symmetrical movements were performed for 1-2 minutes to understand the mirror effect, then active shoulder flexion, abduction, and rotation movements were performed bilaterally, each with 15 repetitions.The patients received treatment for 8 weeks, 3 sessions a week, for a total of 24 sessions. Each treatment session lasts between 60 and 90 minutes. Evaluations were made before and after treatment.

Data, Personal Information Form including demographic characteristics of patients, Numerical Pain Rating Scale (NPRS), Shoulder Active Range of Motion, Shoulder Muscle Strength, Shoulder Pain and Disability Index (SPADI), Short Form 12 (SF-12), Tampa Kinesiophobia Scale, It was collected using the Pain Catastrophe Scale (PCS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 12, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients who were hospitalized in Akdeniz University Hospital Thoracic Surgery Clinic and underwent lung resection with standard posterolateral thoracotomy (lobectomy, segmentectomy or wedge resection),

• Those between the ages of 25-65,

• Hemodynamically stable,

• Those who were extubated at the 2nd or 3rd postoperative hour and who did not develop any complications after extubation,

• No known cerebrovascular disease,

• Not having morbid obesity and heart disease that will prevent working,

• Does not have cognitive and cognitive impairments that will prevent communication,

• No previous paralysis and related effects,

• Individuals who agree to participate in the study.

Exclusion Criteria:

• Those who stayed in the intensive care unit for more than 4 days in the postoperative period,

• Those who have had another surgical procedure within 6 months,

• Those with postoperative cooperation problems such as delirium,

• Those with Rotator Cuff injuries,

• Those with cervical radiculopathy,

• Those with rheumatological diseases,

• Those with neurological disease,

• Those with a history of dislocation, subluxation,

• Those with a history of fracture,

• Those with congenital deformity,

• Those who have a history of surgery related to the shoulder,

• Those who have trouble perceiving tests and exercises

Related Conditions & MeSH terms

• Post-thoracotomy Pain Syndrome
• Shoulder Pain

Intervention

Device:
• Mirror therapy
The patients received a total of 24 sessions of treatment for 8 weeks, 3 sessions a week, starting from the postoperative 1st day after thorakaotomy. Each treatment session lasts between 60 and 90 minutes.

Locations

Country	Name	City	State
Turkey	Neriman Temel Aksu	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pain Score	Numerical Pain Rating Scale (NPRS) was used as a one-dimensional scale for pain	Change from Baseline Pain Score at 8 weeks.
Primary	Change of Active Shoulder Range of Motion	Active shoulder range of motion of the patients will be evaluated with a digital goniometer (Baseline Digital Absolute & Axis Goniometer) using a standard protocol. Total shoulder motion that allows motion of all joints in the shoulder complex will be measured, glenohumeral motion will not be isolated. Flexion, abduction, external and internal rotation of the shoulder will be evaluated. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.	Change from Baseline Active Shoulder Range of Motion at 8 weeks.
Primary	Change of Shoulder Muscle Strength	Shoulder muscle strength will be measured using a dynamometer (MicroFET 2 Manual Muscle Tester). Force measurements will be taken for shoulder flexion, abduction, internal and external rotation. Before starting the test, patients will be informed about how to perform the test. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.	Change from Baseline Shoulder Muscle Strength at 8 weeks.
Primary	Change of Quality of Life Score	The quality of life of our patients will be evaluated using the Short Form-12. Health-related	Change from Baseline Quality of Life Score at 8 weeks.
Primary	Change of Shoulder, Pain and Disability Index Score	Shoulder function will be measured using the Shoulder, Pain and Disability Index , a self-rated questionnaire designed to measure shoulder pain and disability. Shoulder Pain and Disability Index is a reliable questionnaire evaluating shoulder pain and disability. Turkish reliability and validity were performed by Bumin et al. in 2008. There are 2 subscales and 13 items in total in the index. 5 of them evaluate pain and 8 evaluate disability. The items of both subscales are measured with a visual analog scale from 0 to 10. The scores given by the individual are added together and calculated as a percentage. Higher scores indicate more severe pain and higher disability. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated	Change from Baseline Shoulder, Pain and Disability Index Score at 8 weeks.
Primary	Change of Tampa Kinesiophobia Scale	This scale, which is frequently used in the literature, is based on avoidance due to fear, fear in work-related activities, fear of movement or re-injury. Tampa Kinesiophobia Scale is a 17-item scale developed to measure fear of movement and re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. The fact that it is an important outcome parameter for physiotherapists in evaluating the success of the treatment and especially the social participation of the patients, and being a scale that can be used in various patient groups, makes Tampa Kinesiophobia Scale a valuable measurement parameter in the clinic. Tampa Kinesiophobia Scale is a 4-point Likert scale scored as 1-strongly disagree, 2-disagree, 3-agree, 4-strongly agree. The total score is calculated after questions 4, 8, 12 and 16 are reverse scored one by one. The total score is between 17-68. A high value in Tampa Kinesiophobia Scale indicates a high level of kinesiophobia.	Change from Baseline Tampa Kinesiophobia Scale Score at 8 weeks.
Secondary	Height in Meters	The height of all subjects in meters (m) will be noted before the surgery.	Initial assessment before surgery.
Secondary	Weight in Kilograms	The weight of all subjects in kilograms (kg) will be noted before the surgery.	Initial assessment before surgery.
Secondary	Body Mass Index (BMI) in kg/m^2	Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)^2.	Initial assessment before surgery