Primary Objective: Is there reduction in pain using an abduction brace in patients undergoing arthroscopic cuff repair? Secondary Objectives: - Are there differences in function and recovery of the cuff, determined using questionnaires and echo?- Is…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter of this study will be the difference in pain between the
patients receiving an abduction brace and patients receiving a sling. This will
be measured once preoperatively, six times postoperatively in the first 72
hours, two daily in the first week and then weekly up to three months.
Secondary outcome
Secondary parameters:
Constant score, WORC and EQ-5D score.
Intra-operatively the size of the cuff tear will be classified by the operating
Orthopaedic surgeon.
Others:
Patient*s satisfaction
Lenght of stay in hospital, age, BMI, gender, dominant/non-dominant hand, side,
minor/major tear, use of NSAID and interscalene block.
Background summary
Patients undergoing shoulder arthroscopy often complain of postoperative
shoulder pain. There are several techniques in anaesthesia to reduce this pain.
Our hypothesis is that there might be a correlation with the postoperative
treatment and the pain that patients may complain of. In our study we compare
an abduction brace with the currently used sling. We think that by using this
abduction brace there will be less tension on the rotator cuff by preventing
adduction and internal rotation, thereby reducing pain.
Study objective
Primary Objective: Is there reduction in pain using an abduction brace in
patients undergoing arthroscopic cuff repair?
Secondary Objectives:
- Are there differences in function and recovery of the cuff, determined using
questionnaires and echo?
- Is there difference in pain, function and recovery of the cuff between minor
and major cuff lesions?
- Is there difference in satisfactory and comfort between the patients
receiving an abduction brace and patients receiving a sling?
Study design
This will be a randomized controlled trial. Patients included in our study will
be followed-up three months postoperatively. During these three months after
surgery there will be several moment were they are asked to fill in the VAS
score, are contacted by phone, go to the usual planned consult and will finally
get an ultrasound to exclude any cuff tears.
Intervention
Group 1: sling (Procare)
The slings hold the elbow at 90 degrees, and restricts exorotation.
Group 2: abduction brace
The brace holds the arm in 45 degrees of abduction and in neutral rotation.
Study burden and risks
Due to postoperative positioning of the shoulder in abduction and neutral
rotation we expect a reduction in pain. In our view this alternative therapy
doesn*t come together with any risks or harm to the participant.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
Cuff lesion (primary procedure)
Subacromial decompression (optional secondary procedure)
Sufficient understanding of the Dutch language
Competent adults
Willing and able to comply to the study protocol
Exclusion criteria
Age <18, >75
BMI >35
Diabetes mellitus
Chronic pain diseases, fibromyalgia
Current treatment with opiates
Immunocompromized/ HIV+
Labral repair
Lateral clavicle resection
Secondary suturing
Psychiatric patients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL41658.100.12 |
| OMON | NL-OMON22650 |