Back to resultsThe Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Range of Motion After Arthroscopic Cuff Repair. (GRA-RCR)
Primary Purpose
Cuff Tear Arthropathy
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
graston tecnique
Conventional rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Cuff Tear Arthropathy focused on measuring shoulder rehabilitation, range of motion, rotator cuff repair, instrument assisted soft tissue mobilitation
Eligibility Criteria
Inclusion Criteria:
- arthroscopic rotator cuff repair
- partial lesion due to tendon degeneration (1 or 2 anchors reparation)
Exclusion Criteria:
- traumatic tendon lesions
- associated conditions as arthritis, loss of superficial sensitivity, loss of muscle tone, mental impairment, oncological conditions
- shoulder stiffness before surgery due to calcific tendonitis, adhesive capsulitis
Sites / Locations
- Istituto Ortopedico RizzoliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
experimental group
Arm Description
The treatment of control group will be organized according to the classic protocol currently in use in our Institute which consists of: 30 minutes of passive and active assisted mobilization guided by the therapist, 30 min of Continous passive movement in flexion and abduction and 30 minutes of electrostimulation.
30 minutes of passive and active assisted mobilization guided by the therapist associated with instrument assisted soft tissue mobilization, 30 min of Continous passive movement in flexion and abduction and 30 minutes of electrostimulation.
Outcomes
Primary Outcome Measures
Passive Range of Motion Recovery of the Shoulder
Passive Range of Motion Recovery of the Shoulder in elevation and abduction measured by digital inclinometer
Secondary Outcome Measures
Reduction of pain measured by Visual Analogue Scale (VAS)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain").
Shoulder function improvement measured by Constant Murley and Dash scales
The Constant-Murley score is a 100-points scale composed of a number of individual parameters that define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into 4 subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points). The higher the score, the higher the quality of the function. Since the test is carried out in an acute post-surgery phase, it is not possible to carry out the evaluation of strength, which is assigned a score of zero for all patients. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.The score ranges from 0 (no disability) to 100 (most severe disability).
Full Information
NCT ID
NCT05315440
First Posted
September 14, 2021
Last Updated
May 16, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT05315440
Brief Title
The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Range of Motion After Arthroscopic Cuff Repair.
Acronym
GRA-RCR
Official Title
The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Shoulder Range of Motion After Arthroscopic Cuff Repair.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In shoulder rehabilitation after arthroscopic cuff repair, one of first objectives coincides with improving the range of passive movement: this process often requires considerable time of both patients and physiotherapists. This study aims to verify whether it is useful to add instruments assisted soft-tissue mobilization according to Graston Tecnique to the classic rehabilitation protocol in order to accelerate recovery times of passive range of motion.
Detailed Description
There is conflicting evidence about early versus delayed postoperative rehabilitation after arthroscopic cuff repair: early protocol seems to reduce the risk of stiffness but could increase the risk of rupture of the tendon in long time, especially for large tears; delayed protocol impose a period of shoulder immobilization (from 2 weeks to 40-day) that can promote tendons healing but could determine shoulder stiffness. Our research question is if after the delayed protocol used in our institute (40 -day immobilization period) it migh be useful to add soft-tissue mobilization assisted by instruments according to Graston Tecnique to the classic rehabilitation protocol of the shoulder in order to speed up recovery times of the passive movement range.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cuff Tear Arthropathy
Keywords
shoulder rehabilitation, range of motion, rotator cuff repair, instrument assisted soft tissue mobilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Outcomes Assessor
Masking Description
outcome assessor doesn't know allocation concealment
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The treatment of control group will be organized according to the classic protocol currently in use in our Institute which consists of:
30 minutes of passive and active assisted mobilization guided by the therapist, 30 min of Continous passive movement in flexion and abduction and 30 minutes of electrostimulation.
Arm Title
experimental group
Arm Type
Experimental
Arm Description
30 minutes of passive and active assisted mobilization guided by the therapist associated with instrument assisted soft tissue mobilization, 30 min of Continous passive movement in flexion and abduction and 30 minutes of electrostimulation.
Intervention Type
Other
Intervention Name(s)
graston tecnique
Other Intervention Name(s)
instrument soft tissue mobilization
Intervention Description
Graston technique involves the use of steel tools that are used non-invasively on the skin to identify and treat areas that have stiffness or inflammation. These areas can be located with greater precision than the manual technique precisely because the instruments do not compress in contact with the patient's skin, as is the case with the physiotherapist's fingertips. Thanks to the instruments it is therefore possible to detect the areas of altered consistency and to treat them by pressing a minimum pressure.
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation
Intervention Description
30 minutes of passive and active assisted mobilization guided by the therapist, 30 min of Continous passive movement in flexion and abduction and 30 minutes of electrostimulation.
Primary Outcome Measure Information:
Title
Passive Range of Motion Recovery of the Shoulder
Description
Passive Range of Motion Recovery of the Shoulder in elevation and abduction measured by digital inclinometer
Time Frame
after 2 weeks of treatment
Secondary Outcome Measure Information:
Title
Reduction of pain measured by Visual Analogue Scale (VAS)
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain").
Time Frame
after 2 weeks of treatment
Title
Shoulder function improvement measured by Constant Murley and Dash scales
Description
The Constant-Murley score is a 100-points scale composed of a number of individual parameters that define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into 4 subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points). The higher the score, the higher the quality of the function. Since the test is carried out in an acute post-surgery phase, it is not possible to carry out the evaluation of strength, which is assigned a score of zero for all patients. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.The score ranges from 0 (no disability) to 100 (most severe disability).
Time Frame
after 2 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
arthroscopic rotator cuff repair
partial lesion due to tendon degeneration (1 or 2 anchors reparation)
Exclusion Criteria:
traumatic tendon lesions
associated conditions as arthritis, loss of superficial sensitivity, loss of muscle tone, mental impairment, oncological conditions
shoulder stiffness before surgery due to calcific tendonitis, adhesive capsulitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Gallo
Phone
3337489277
Email
angelagallo87@gmail.com
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
State/Province
BO
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Range of Motion After Arthroscopic Cuff Repair.
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