NCT05315440

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

4.2 years

First QC Date

September 14, 2021

Last Update Submit

July 17, 2025

Conditions

Keywords

shoulder rehabilitationrange of motionrotator cuff repairinstrument assisted soft tissue mobilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Reduction of pain measured by Visual Analogue Scale (VAS)

    after 2 weeks of treatment

  • Shoulder function improvement measured by Constant Murley and Dash scales

    after 2 weeks of treatment

Study Arms (2)

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.

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.

Other: graston tecnique

Interventions

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.

Also known as: instrument soft tissue mobilization
experimental group

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.

control group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • arthroscopic rotator cuff repair
  • partial lesion due to tendon degeneration (1 or 2 anchors reparation)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

ChondrocalcinosisArthritisJoint DiseasesMusculoskeletal DiseasesCrystal Arthropathies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome assessor doesn't know allocation concealment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

April 7, 2022

Study Start

November 12, 2020

Primary Completion

January 31, 2025

Study Completion

February 21, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations