NCT03568006

Brief Summary

From a biomechanical point of view, subacromial syndrome causes an increment in the anterior and superior translation of the humeral head, which increases compression in the adjacent tissues of the subacromial space, aggravating the symptoms of the patients. Conservative treatments are the first option for subacromial syndrome management, despite the fact that there is limited evidence about its effectiveness, due to the lack of experimental studies. The aim of this study is to evaluate the effectiveness of a passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint, within a multimodal approach to reduce pain and improve the range of motion in patients with subacromial syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

June 12, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

June 12, 2018

Last Update Submit

September 17, 2018

Conditions

Subacromial Impingement

Keywords

subacromial impingementpainshoulderpassive mobilization

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    10 centimetres Visual Analogue Scale. 0 is no pain, whilst 10 is maximum intolerable pain

    Change between baseline (immediately before intervention) and post intervention (2 weeks).

Secondary Outcomes (2)

  • Active range of motion

    Change between baseline (immediately before intervention) and post intervention (2 weeks).

  • Constant Score

    Change between baseline (immediately before intervention) and post intervention (2 weeks).

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention will consist of passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint. Besides, participants will receive a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene.

Other: Specific passive mobilizationOther: Standardized treatment (standard protocol)

Control

ACTIVE COMPARATOR

Control treatment will consist of a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene.

Other: Standardized treatment (standard protocol)

Interventions

Specific passive mobilizationOTHER

Specific passive mobilizations for the shoulder

Intervention
Standardized treatment (standard protocol)OTHER

Infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene

ControlIntervention

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of subacromial syndrome
  • Pain at rest, which increases when doing active movements
  • Neer´s impingement test positive
  • Hawkins Kennedy test positive
  • Pain lasting more than one month
  • Anteriorization of humeral head
  • Full capacity (physical and cognitive) to participate in the study and give consent.

You may not qualify if:

  • Infiltrations during the previous six months
  • Traumatic origin of pain
  • Complete tear of any rotator cuff tendon
  • Bilateral pain
  • Previous surgical intervention in the affected shoulder
  • Patients planning to start with other treatments during the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Jorge University

Villanueva de Gállego, Zaragoza, 50830, Spain

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromePain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
It is not possible to mask physiotherapists and patients, so the only masking will be for researchers and evaluators
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Pablo Herrero, PT, PhD. Head of iPhysio Research Group.

Study Record Dates

First Submitted

June 12, 2018

First Posted

June 26, 2018

Study Start

July 1, 2018

Primary Completion

September 17, 2018

Study Completion

September 17, 2018

Last Updated

September 19, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)