Cuff Tear ArthropathyGRA-RCRNCT05315440
The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Range of Motion After Arthroscopic Cuff Repair.
A study testing graston tecnique and Conventional rehabilitation in people with Cuff Tear Arthropathy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Cuff Tear Arthropathy
- What is being tested?
- graston tecnique and Conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2020to 21 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- arthroscopic rotator cuff repair
- partial lesion due to tendon degeneration (1 or 2 anchors reparation)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Shoulder Range of Motion After Arthroscopic Cuff Repair.
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.
Read the 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.
- Conditions
- Cuff Tear Arthropathy
- Being tested
- graston tecnique, Conventional rehabilitation
- Keywords
- shoulder rehabilitation, range of motion, rotator cuff repair, instrument assisted soft tissue mobilitation
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
graston tecniqueOther
Also called instrument soft tissue mobilization
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 rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | 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. Receives: Other: Conventional rehabilitation |
| experimental group | Experimental | 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. Receives: Other: graston tecnique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive Range of Motion Recovery of the Shoulder
Passive Range of Motion Recovery of the Shoulder in elevation and abduction measured by digital inclinometer
Measured: after 2 weeks of treatment
Secondary outcomes (2)
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").
Measured: after 2 weeks of treatment
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).
Measured: after 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start12 Nov 2020
- Primary completion31 Jan 2025
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cuff Tear ArthropathyStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315440
- Sponsor's protocol ID
- 0002771
- Acronym
- GRA-RCR
- Status last verified
- Jul 2025
- First submitted
- 14 Sep 2021
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Shoulder Range of Motion After Arthroscopic Cuff Repair.
- ClinicalTrials.gov ID
- NCT05315440
- Acronym / sponsor ID
- GRA-RCR / 0002771
- Conditions
- Cuff Tear Arthropathy
- Keywords
- shoulder rehabilitation, range of motion, rotator cuff repair, instrument assisted soft tissue mobilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Conventional rehabilitationThe 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. |
| experimental group | Experimental | Other: graston tecnique30 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- arthroscopic rotator cuff repair
- partial lesion due to tendon degeneration (1 or 2 anchors reparation)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| graston tecniqueAlso: instrument soft tissue mobilizationGraston 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. | Other | experimental group |
| Conventional rehabilitation30 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. | Other | control group |
Primary outcome
Passive Range of Motion Recovery of the Shoulder
Time frame: after 2 weeks of treatment
Passive Range of Motion Recovery of the Shoulder in elevation and abduction measured by digital inclinometer
2 secondary outcomes
Reduction of pain measured by Visual Analogue Scale (VAS)
Time frame: after 2 weeks of treatment
Shoulder function improvement measured by Constant Murley and Dash scales
Time frame: after 2 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing graston tecnique and Conventional rehabilitation in people with Cuff Tear Arthropathy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive Range of Motion Recovery of the Shoulder (time frame: after 2 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.