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CompletedNCT03041727Updated Feb 15, 2022

Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercises

An interventional study of Fascial Manipulation and Standard exercises protocol in Shoulder Pain and Manual Therapy, sponsored by Azienda Ospedaliera Bolognini di Seriate Bergamo. Completed at 1 site in Italy. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by Azienda Ospedaliera Bolognini di Seriate Bergamo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

The study purpose is to compare the effects of Fascial Manipulation added to standard exercises protocol versus the simple exercises protocol.

Read the detailed description

The shoulder degenerative diseases are recurring in hospital employees. The early approach, as we see in literature, has high probability to reduce the pain and the disfunction in the long term.

In particular stretching and strengthening exercises are the standard protocol applied.

The Fascial Manipulation is a manual therapy that works on the connective tissue, by increasing mobility and reducing pain.

We have added the Fascial Manipulation to prove if it make a faster recovery and a pain reduction in the short and the middle term.

02

Conditions studied

  • Shoulder Pain
  • Manual Therapy

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03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 70 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Azienda Ospedaliera Bolognini di Seriate Bergamo is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • shoulder pain and acute and relapse in six months
  • positive results in two orthopedic testes

Exclusion criteria

Exclusion Criteria:

  • Degenerative diseases and neurological diseases
  • Rheumatological Diseases and cancer
  • fracture of the humerus, scapula and collarbone
  • documented injury of rotator cuff.
  • cortisones therapy in action
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Standard Group

    The subjects will be treated with a standard protocol of stretching and strengthening exercises , we require them to do the exercises by themselves during five weeks, one a day. To make sure that they will do the protocol, we'll give them a diary to sign the daily section.

    Other: Standard exercises protocol

  • Experimental
    Intervention group

    The subjects will be treated with the same protocol of the Standard Group, but in two section, they will receive a Fascial Manipulation approach.

    Other: Fascial Manipulation

Interventions

  • OtherFascial Manipulation

    Fascial Manipulation is a manual therapy that focused on deep muscular fascial.

  • OtherStandard exercises protocol

    Stretching and strengthening exercises

06

What researchers measure

Primary outcomes

  1. Shoulder Pain

    VNS scale in the Apley 'Scratch Test

    Time frame: Before and after the first treatment. A week after the enrollment.

Secondary outcomes

  1. shoulder' function

    Constant Morley Scale

    Time frame: Before and after the first treatment. A week after the enrollment.

  2. shoulder' function

    Constant Morley Scale

    Time frame: Before and after the fifth treatment, after five weeks. This will be the last treatment

  3. shoulder' function

    Constant Morley Scale

    Time frame: A month later the last treatment, as follow up

  4. Range of Movement of the shoulder

    Bubble Inclinometer used in the flexion, abduction and external rotation movement

    Time frame: Before and after the first treatment. A week after the enrollment.

  5. Range of Movement of the shoulder

    Bubble Inclinometer used in the flexion, abduction and external rotation movement

    Time frame: Before and after the fifth treatment, after five weeks.This will be the last treatment

  6. Range of Movement of the shoulder

    Bubble Inclinometer used in the flexion, abduction and external rotation movement

    Time frame: A month later the last treatment, as follow up

  7. The shoulder's muscular strength

    dynamometer survey in flexion and abduction movement

    Time frame: Before and after the first treatment. A week after the enrollment.

  8. The shoulder's muscular strength

    dynamometer survey in flexion and abduction movement

    Time frame: Before and after the fifth treatment, after five weeks. This will be the last treatment

  9. The shoulder's muscular strength

    dynamometer survey in flexion and abduction movement

    Time frame: A month later the last treatment, as follow up

07

Study locations

1 site
  • AO Bolognini
    Seriate, Bergamo 24068, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03041727
Lead sponsor
Azienda Ospedaliera Bolognini di Seriate Bergamo
Responsible party
silvia Bellotti (Physiotherapist, Azienda Ospedaliera Bolognini di Seriate Bergamo) — Principal investigator
First posted
Feb 3, 2017
Start date
Feb 1, 2017
Primary completion
Aug 1, 2021
Completion
Aug 1, 2021
Last update
Feb 15, 2022

Study contacts

Massimo Busato, first level
study director · Azienda Ospedaliera Bolognini di Seriate Bergamo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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