NCT05962736

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

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

Study Start

First participant enrolled

March 6, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

July 19, 2023

Last Update Submit

August 23, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (3)

  • Height in Meters

    Initial assessment before surgery.

  • Weight in Kilograms

    Initial assessment before surgery.

  • Body Mass Index (BMI) in kg/m^2

    Initial assessment before surgery

Study Arms (2)

Control group

NO INTERVENTION

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.

Study group

EXPERIMENTAL

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.

Device: Mirror therapy

Interventions

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.

Study group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neriman Temel Aksu

Antalya, 07060, Turkey (Türkiye)

Location

Related Publications (1)

  • Aksu NT PhD, Baskurt Z, Keskin H. Effects of Mirror Therapy-Based Upper Extremity Exercises After Thoracotomy: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Aug;26(4):e411-e420. doi: 10.1016/j.pmn.2025.02.003. Epub 2025 Mar 7.

MeSH Terms

Conditions

Shoulder Pain

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Neriman T Aksu

    Akdeniz Üniversitesi Antalya Sağlık Yüksekokulu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant (Expert Physiotherapist)

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 27, 2023

Study Start

March 6, 2022

Primary Completion

April 10, 2023

Study Completion

July 12, 2023

Last Updated

August 26, 2024

Record last verified: 2024-08

Locations