Trial to Compare the Effectiveness of Group Versus Indivi... | NCT02833779

Studies
Trial to Compare the Effectiveness of Group Versus Individual Therapy on Alternate Days in Patients With Subacromial Impingement Syndrome

NCT02833779

Sponsor

Basque Health Service

Status

Completed

Last Update Posted

Jul 15, 2016Estimated

Enrollment

89Actual

Phase

Not Applicable

Conditions

Mobility

Interventions

Individual exercises
Group exercises

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Oct 2013Actual

Completion Date

Not provided

First Submitted Date

Jul 5, 2016

First Submission Date that Met QC Criteria

Jul 12, 2016

First Posted Date

Jul 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2016

Last Update Posted Date

Jul 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcos Sanchez Garcia, Registered physiotherapist, Basque Health ServicePrincipal Investigator

Lead Sponsor

Basque Health ServiceOTHER_GOV

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Individual exercises	Other		Individual Manual Therapy Exercises
Group exercises

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The assessment of pain with a visual analogue scale.		Six Months
The mobility (joint range of motion) with a goniometer.		Six Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided