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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05315440
Other study ID # 0002771
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 12, 2020
Est. completion date February 29, 2024

Study information

Verified date May 2023
Source Istituto Ortopedico Rizzoli
Contact Angela Gallo
Phone 3337489277
Email angelagallo87@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date February 29, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
graston tecnique
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.
Conventional rehabilitation
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.

Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna BO

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Passive Range of Motion Recovery of the Shoulder Passive Range of Motion Recovery of the Shoulder in elevation and abduction measured by digital inclinometer after 2 weeks of treatment
Secondary 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"). after 2 weeks of treatment
Secondary 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). after 2 weeks of treatment
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