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 patients 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
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