NCT02833779

Brief Summary

Pathology of the rotator cuff and subacromial bursa is considered to be the principal cause of pain and symptoms arising from the shoulder. Physiotherapy specialists often disagree about which type of exercise is most appropriate. Manual Physiotherapy combined with guided exercise is a commonly applied clinical treatment, but no proof of its effectiveness has been shown. Clinical trials comparing results of treating subacromial syndrome of the shoulder with guided self-treatment and conventional physiotherapy yielded a slightly higher improvement, basically because patients suffered from chronic tendinitis and the treatment period lasted only two weeks. That is the reason why the investigators propose a long-term follow-up study and a more complete assessment of effectiveness of the exercise prescribed to improved this pathology. Objectives:

  • Assessment of effectiveness of two different types of treatment of subacromial syndrome of the shoulder.
  • Comparison of effectiveness of both treatments in order to select that one yielding better results as the one to be applied as a routine practice. Patients will be assigned one of the following treatments:
  • Group 1: patients will be taught exercises in groups of six people, on a daily basis for twelve sessions.
  • Group 2: patients will be taught the same exercise as Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering. A modified version of the Constant scale will be used to assess mobility and pain shoulder.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

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

April 1, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

3.5 years

First QC Date

July 5, 2016

Last Update Submit

July 14, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • The assessment of pain with a visual analogue scale.

    Six Months

  • The mobility (joint range of motion) with a goniometer.

    Six Months

Study Arms (2)

Group Therapy Exercises

ACTIVE COMPARATOR

Patients will be taught exercises in groups of six persons, on a daily basis for twelve sessions.

Other: Group exercises

Individual Manual Therapy Exercises

ACTIVE COMPARATOR

Patients will be taught the same exercises as in a Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering

Other: Individual exercises

Interventions

Individual Manual Therapy Exercises
Group Therapy Exercises

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • History of shoulder pain defined as at least 2 positive results in subacromial impingement tests.
  • Self-perceived pain reported by the patient under clinical examination of the shoulder.
  • A minimum of 90º mobility in flexion.

You may not qualify if:

  • Luxation, a history of surgery, or evidence the current shoulder pain or other symptoms under cervical examination or other shoulder bone disease, except for acromioclavicular joint arthrosis.
  • Patients were receiving other physiotherapy or rehabilitation treatments.
  • Patients had been treated for SIS (subacromial impingement syndrome) with injection of anti-inflammatory or analgesic drugs in the last month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered physiotherapist

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 14, 2016

Study Start

April 1, 2010

Primary Completion

October 1, 2013

Last Updated

July 15, 2016

Record last verified: 2016-07