Does subacromial injection influence shoulder strength?
| ISRCTN | ISRCTN50853594 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50853594 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/04/2011
- Registration date
- 11/05/2011
- Last edited
- 11/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mazda Farshad
Scientific
Scientific
Forchstrasse 340
Zürich
8008
Switzerland
Study information
| Study design | Double blind intra-indivudal placebo controlled single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Does subacromial injection influence shoulder strength? A double blind placebo controlled study |
| Study objectives | 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(s) | The study has been approved by the Ethical Committee of Kanton Zürich on 23rd December 2010 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 30/04/2011 |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Key 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 |
| Key exclusion criteria | Doe not meet inclusion criteria |
| Date of first enrolment | 30/04/2011 |
| Date of final enrolment | 30/04/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Forchstrasse 340
Zürich
8008
Switzerland
8008
Switzerland
Sponsor information
Balgrist University Hospital (Switzerland)
University/education
University/education
c/o Prof. C. Gerber
Forchstrasse 340
Zürich
8008
Switzerland
"ROR" |
https://ror.org/02yzaka98 |
|---|
Funders
Funder type
Hospital/treatment centre
Balgrist Universtiy Hospital (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
