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Trial registered on ANZCTR


Registration number
ACTRN12623000566639
Ethics application status
Approved
Date submitted
13/04/2023
Date registered
25/05/2023
Date last updated
25/05/2023
Date data sharing statement initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Home Therapeutic Exercise Program for patients undergoing Arthroscopic Acromioplasty
Scientific title
Home Therapeutic Exercise Program for patients undergoing Arthroscopic Acromioplasty on Pain, Range of Movement and Funcionality
Secondary ID [1] 309406 0
None
Universal Trial Number (UTN)
U1111-1290-9951
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clavicular Acromioplasty 329639 0
Condition category
Condition code
Physical Medicine / Rehabilitation 326563 326563 0 0
Physiotherapy
Injuries and Accidents 326951 326951 0 0
Other injuries and accidents
Musculoskeletal 326952 326952 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary researcher will visit the patient's room on the day of the surgical intervention to teach and supervise the exercises that the patient will do at home until the date when hospital rehabilitation begins. Patients are immobilized for an estimated 7 days after intervention with a medical sling, which can be removed 48 hours after intervention if there has been rotator cuff tendon repair or 24 hours if there hasn't, during night rest and during the day while the patient is doing the exercises.

Exercises will be done without surpassing pain limits and at least three times a day. The bouts will consist of two series of ten repetitions of each exercise. Patient will rest when pain or muscular fatigue appear and then retake the exercises till they complete the whole bout. Patients were advised to use ice in order to lower inflammation for the first days.

Home exercises consist of:
-Free active exercise of neighboring joints Active movement of the wrist, fingers, hand, and elbow in order to maintain muscular balance and range of motion. Patients will be advised to pay special attention to wrist flexo-extension, hand closing and opening, and lastly, elbow flexo-extension and prono-supination.
-Pendular exercise. Opposite leg to the intervened shoulder: one step forward, trunk flexion of 50. The intervened shoulder is relaxed, and the patient does a pendular flexo-extenstion movement followed up by clockwise and anticlockwise circular movements.
-Self-assisted shoulder exercise Patient in a supine position (when pain remits, this exercise will be done in a seated position). Hands are intertwined with elbows extended. Patient does active shoulder flexion with the healthy upper limb, which will help the movement of the intervened limb. When it reaches the pain limit, both limbs go back to the base position.
-Shoulder rotation exercise with a supported elbow. Patient seated with 90º of hip and knee flexion. Neutral prono-supination with elbow on a stable surface and close to the body. Patient does an active movement sliding the forearm and making internal and external shoulder rotation.
-Finger ladder exercise on the wall. The patient is seated during the first days and then in a standing position when the pain remits. Elbow extended and body parallel to the wall. Patient simulates a ladder on the wall that they climb with their second and third fingers, making a shoulder flexion, and when pain does not allow more movement, patient does the inverse movement without taking the fingers off the wall too harshly.
-Hand-to-back movement exercise. Patient in a standing position. Patient takes the hand of the intervened limb behind their back and to the opposite side to the point where pain allows it. Following that, the patient gently returns to his or her original position.
-Active shoulder abduction. Patient seated with lumbar support with 90º of hip and knee flexion, feet on the ground. Patient does a shoulder abduction till the pain appears, then it goes back to the base position softly, avoiding harsh movements. When the limb reaches 90º, it is indicated to mix the movement with external rotation. The patient can combine the abduction with several degrees of shoulder flexion, and when, at a later stage, they gain more range of movement, they will try to touch their head with their hand.
-Active shoulder extension. Patient standing parallel to the wall with their back facing the wall. Patient does an active shoulder extension with the intervened shoulder trying to touch the wall with the palm of their hand.
-Active shoulder adduction. Patient seated with an elbow flexion of 90º and neutral prono-supination of the intervened upper limb. A towel is placed between the body and the arm. Patient presses the elbow against the towel and body while descending the shoulder down. This contraction should last 5 seconds. The patient will rest between each contraction.

After teaching the exercises to the patient, the main researcher will provide them with a manuscript with general and specific recommendations and reinforce the teaching with a table of the exercise with pictures. In addition, the main researcher wrote their telephone number to clarify any doubts that arise. Finally, each patient was given a follow-up sheet where they record, after the day of the surgery, the number of times they have done the exercises each day and the time of the day when they did it to keep track of their adherence to the exercise program. The patient will do at home until the date when hospital rehabilitation begins, anticipated to be 30-45 days.

The manuscript provided to participants was designed specifically for this study and is not public until the full study is published.
Intervention code [1] 325841 0
Rehabilitation
Comparator / control treatment
Active Control

Combined rehabilitation treatment in hospital service with a frequency of 3-4 sessions per week for 7 weeks,

Treatment Session:
- Previous thermotherapy by application of infrared lamp. Time 15 minutes.
- Codman pendular exercises (clockwise and counterclockwise rotation, flexion-extension, abduction and adduction of the shoulder). Time 15 minutes.
- Self-passive shoulder flexion-extension by means of poleotherapy. Time 15 minutes.
- Finger ladder for upper limb flexion and abduction. Time 15 minutes.
- Self-assisted exercises with the therapeutic stick in flexion-extension and abduction-adduction (supine and seated). Time 15 minutes.
- Isometric exercises in standing position with humeral head recentering. Time 10 minutes.
- Manual Therapy: Analytical mobilization of the scapula in all planes of movement, scar massage, descontracturante massage therapy of pectoralis major, pectoralis minor, subscapularis, teres major, teres minor, deltoid, trapezius, biceps, supraspinatus, infraspinatus, rhomboid, serratus major, serratus minor, levator scapulae. Active-assisted mobilizations in all planes of movement, insisting on recovering the functional gesture (in supine and seated position). 10 minutes.
- Ultrasound: Pulsed application in dynamic mode on acromion and adjacent anatomical structures. Parameters: ERA head 5 cm2, frequency 3Mhz, pulsed at 20%, power 1.2 W/cm2. Application time: 5 minutes.
- Interferential currents: Tetrapolar application with automatic vector, carrier current at 4000 Hz, AMF 90 Hz, spectrum modulation 60 Hz, spectrum modulation program 6/6. Intensity level just below the contraction threshold, slight fasciculations are allowed, without causing pain or discomfort. In case of accommodation, the patient is instructed to increase the intensity.

Passive Interventions will be administered by physiotherapist.

Monitoring of adherence to such audits of medical rehabilitation records
Control group
Active

Outcomes
Primary outcome [1] 334408 0
Constant-Score scale:
The Constant-Score scale (SCS) as it is validated and accepted by the European Society for Shoulder and Elbow Surgery in its publications, being commonly found in publications related to SCS and SCS surgery. The Constant-Score Scale is the most widely accepted shoulder function assessment system in Europe, considering parameters of pain, activities of daily living, mobility and strength. It is scored out of a total of 100. Being excellent when the result is greater than 80 points, good when the result is between 65 and 79 points, average when the result is between 50 and 64 points and bad when the result is less than 50 points.
The 100 points are distributed as follows:
Pain: A question will be asked about the most intense degree of pain suffered during the performance of daily activities. Constant and Murley propose a verbal rating scale in which no pain is 15 points; mild pain is 10 points; moderate pain is 5 points and severe pain is 0 points.
- Current mobility (activities of living): With four sections and can reach up to 20 points.
- Active mobility (joint balance): Four movements are evaluated and each one can reach 10 points. Only the degree of active movement will be taken into account. Rotations are assessed by means of functional gestures. Maximum 40 points.
- Power: 2.27 points per kilogram of weight lifted and with a maximum of 11 kg. Maximum 25 points.
Timepoint [1] 334408 0
Measure 0 (Pre-surgery)
Measure 1 (After home rehabilitation/control time + hospital rehabilitation, anticipated to be 30-45 days post-surgery)
Secondary outcome [1] 420584 0
Joint range of movement.
Measured with the app Smartphone Goniometer. The smartphone (Iphone 6s) was attached to the arm by a smartphone-brazalet (Kalenji).

Patient performed active free movements without help or support till a range of motion where the pain was moderate-intense. Movements measured were: flexion, extension, abduction, internal and external rotation for glenohumeral joint.
Timepoint [1] 420584 0
Measure 0 (Pre-surgery)
Measure 1 (After home rehabilitation/control time + hospital rehabilitation, anticipated to be 30-45 days post-surgery)
Secondary outcome [2] 420585 0
Visual Analogic Scale (VAS)

Devised by Scott and Huskinson in 1976 to make it possible to measure the influence of the applied treatment on the course of pain.treatment applied on the course of pain, i.e. the patient can re-evaluate the perceived pain at different perceived pain on different occasions, as well as the number of sessions to meet therapeutic goals to meet the therapeutic objectives.
Timepoint [2] 420585 0
Measure 0 (Pre-surgery)
Measure 1 (After home rehabilitation/control time + hospital rehabilitation, anticipated to be 30-45 days post-surgery)

Eligibility
Key inclusion criteria
-Patients who have signed the Informed Consent Form.

-Patients who have undergone surgery for SCS by means of arthroscopic acromioplasty at the Hospital de Alta Resolución de Utrera and who undergo physiotherapy treatment at said Hospital.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients undergoing arthroscopic acromioplasty with distal clavicle excision. distal clavicle excision.

- Patients with an absolute contraindication for treatment withPhysiotherapy, such as an infectious process or malignant tumours. Physiotherapy, such as an infectious process or malignant tumours.

- Patients in whom early mobilisation of the affected upper limb is contraindicated. affected upper limb is contraindicated.

- Patients with a bone fracture associated with SCS.

- Patients receiving corticosteroid infiltrations after surgery.

- Patients who have undergone re-intervention of acromioplasty.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence has been hidden from patients and evaluators, and it has been kept in the custody of the administrative staff of the Rehabilitation and Physiotherapy area of the Hospital (external collaborator in the study) in an encrypted file.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We applied a randomised distribution to the participants, using a randomisation sequence obtained from the website. www.randomization.com, a randomisation sequence obtained from the website www.randomization.com. In this way, participants will be distributed into two different study groups, experimental and control randomly.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will estimate the sample size in this study, with type I error values of 5% and type II error values of 20%.

We will carry out a descriptive analysis of the data by means of measures of central tendency and dispersion (mean, standard deviation and confidence intervals), recording the data in tables and graphs. Subsequently, we will carry out an analysis of analysis of the data using the Kolmogorov-Smirnov test, and an intra-group inferential analysis by applying parametric tests (Student's t-test for related samples) or non-parametric (Wilcoxon) depending on the distribution of the data obtained in the normality analysis. In addition, we will carry out an inter-group intergroup analysis using the parametric t Student test for independent samples and the non-parametric non-parametric Mann-Whitney U test. We will use the statistical software SPSS version 22 and we will consider the level of statistical significance at 5%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/06/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25392 0
Spain
State/province [1] 25392 0
Sevilla

Funding & Sponsors
Funding source category [1] 313601 0
University
Name [1] 313601 0
University of Seville
Country [1] 313601 0
Spain
Primary sponsor type
University
Name
Universidad de Sevilla
Address
C/ Avenzoar, 6. 41009 - Sevilla, Andalucía
Country
Spain
Secondary sponsor category [1] 315424 0
None
Name [1] 315424 0
None
Address [1] 315424 0
None
Country [1] 315424 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312777 0
Comité Ético de Investigación de los Hospitales Universitarios Vírgen Macarena-Virgen del Rocío
Ethics committee address [1] 312777 0
Avda de Manuel Siurot s/n, 41013 Seville, Spain
Ethics committee country [1] 312777 0
Spain
Date submitted for ethics approval [1] 312777 0
10/04/2017
Approval date [1] 312777 0
29/05/2017
Ethics approval number [1] 312777 0

Summary
Brief summary
Our principal objetive is know the effectiveness of carrying out a home therapeutic exercise program prior to the start of treatment in the Hospital Physiotherapy Room, in patients undergoing arthroscopic acromioplasty surgery.

Based on this main objective, we propose the following research hypothesis:
“Performing a home therapeutic exercise program in patients undergoing arthroscopic acromioplasty prior to the start of treatment in the Hospital Physiotherapy Room, decreases the number of physiotherapy sessions, increases joint balance, decreases pain and improves functionality. ”
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125878 0
Dr Cleofas Rodriguez-Blanco
Address 125878 0
University of Seville, Faculty of Nursing, Physiotherapy and Podiatry. Calle Avenzoar, 6. 41009 Sevilla.
Country 125878 0
Spain
Phone 125878 0
+34 954 486510
Fax 125878 0
Email 125878 0
cleofas@us.es
Contact person for public queries
Name 125879 0
Dr Cleofas Rodriguez-Blanco
Address 125879 0
University of Seville, Faculty of Nursing, Physiotherapy and Podiatry. Calle Avenzoar, 6. 41009 Sevilla
Country 125879 0
Spain
Phone 125879 0
+34 954 486510
Fax 125879 0
Email 125879 0
cleofas@us.es
Contact person for scientific queries
Name 125880 0
Dr Cleofas Rodriguez-Blanco
Address 125880 0
University of Seville, Faculty of Nursing, Physiotherapy and Podiatry. Calle Avenzoar, 6. 41009 Sevilla
Country 125880 0
Spain
Phone 125880 0
+34 954 486510
Fax 125880 0
Email 125880 0
cleofas@us.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual line-by-line data
When will data be available (start and end dates)?
After publication, no end date determined
Available to whom?
Researchers who provide a solid proposal
Available for what types of analyses?
Meta-analysis or similar studies
How or where can data be obtained?
Contact to the corresponding author via e-mail. cbutrera@us.es


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18848Ethical approval    385705-(Uploaded-12-04-2023-17-49-34)-Study-related document.pdf



Results publications and other study-related documents

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