Condition category
Musculoskeletal Diseases
Date applied
13/04/2011
Date assigned
11/05/2011
Last edited
11/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mazda Farshad

ORCID ID

Contact details

Forchstrasse 340
Zürich
8008
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Does subacromial injection influence shoulder strength? A double blind placebo controlled study

Acronym

Study hypothesis

1. Abduction strength is decreased after subacromial injection of a local anaesthetic (LA) with no radiographical guidance
2. Strength of the deltoid muscle and or supraspinate muscle is affected after blind subacromial injection of standard dose of a standard LA

Ethics approval

The study has been approved by the Ethical Committee of Kanton Zürich on 23rd December 2010

Study design

Double blind intra-indivudal placebo controlled single centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Subacromial injection for shoulder pain

Intervention

This study uses a double blind intra-indivudal placebo controlled design, where each shoulder that undergoes the intervention (subacromial injection of the local anesthetic) has an intra-individual control (the contralateral side) where placebo is applied.

For each of the 10 volunteers, the integrity of the supraspintus tendon is evaluated with ultrasonography on both sides. Only if no pathology is found on ultrasonography, the volunteer is included in the study. The abduction strength of both shoulders of the 10 healthy volunteers will be measured three times with Isobex (in 30° and 90° Abduction), while superficial electromyography (EMG) documents the activity of the deltoid muscle. Subsequently, randomly and blinded, 5ml 1% Lidocain in one shoulder and 5ml 0.9% saline solution in the contralateral shoulder will be injected without ultrasonographic guidance aimed to the subacromial space. The injection will be performed blindly because the technique is commonly used in daily clinic and the evidence is not conclusive, although however, might by trend favour the use of ultrasonographic-guided injections. The technique of the injection is based on commonly used aseptic technique with a 21-gauge needle with the covered syringe, into the patient’s subacromial bursa via the anterolateral approach. Subsequently, the bilateral ultrasonography will be repeated to document the location of the injected fluid.

After 20min, again, the abduction strength of both shoulders will be quantified with Isobex (in 30° and 90° Abduction), while superficial EMG documents the activity of the deltoid muscle.

Neither the injecting physician nor the proband, nor who is measuring the abduction strength, will know which substance is injected.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Strength of shoulder abduction - Each volunteer undergoes an ultrasonography of both shoulders to assure full rotator cuff integrity then abduction strengths are measured. Subsequentely, either on the left or the right shoulder a local anaesthetic is injected. The other side serves as control, where sodium chloride (NaCL) is injected. Then we repeat the ultrasonography to document the location of the injected fluid and repeat the abduction strengths.

Secondary outcome measures

Radiographical documentation of location of the aimed subacromial injection

Overall trial start date

30/04/2011

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Past medical history not significant for major disorders
2. No shoulder pain
3. No previous operation or injections on the shoulder
4. No allergy to LA

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

Doe not meet inclusion criteria

Recruitment start date

30/04/2011

Recruitment end date

30/04/2012

Locations

Countries of recruitment

Switzerland

Trial participating centre

Forchstrasse 340
Zürich
8008
Switzerland

Sponsor information

Organisation

Balgrist University Hospital (Switzerland)

Sponsor details

c/o Prof. C. Gerber
Forchstrasse 340
Zürich
8008
Switzerland

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Balgrist Universtiy Hospital (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes