search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Taping patients with shoulder problems.


- candidate number8575
- NTR NumberNTR2575
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-okt-2010
- Secondary IDsNL31910.029.10 / 2010/119 ; CCMO / METc VUmc
- Public TitleTaping patients with shoulder problems.
- Scientific TitleRandomized controlled trial of taping patients with a shoulder subacromial impingement syndrome.
- ACRONYM
- hypothesisIs taping patients with the McConnell method for the subacromial impingement syndrome more effective and cost-effective as compared to usual physical therapy alone in the Dutch primary care on the short and long term?
- Healt Condition(s) or Problem(s) studiedComplaints of shoulder, Subacromial impingement syndrome
- Inclusion criteria1. Two or more positive impingement tests;
2. Age between 18 and 65 years;
3. Accepting the consequences of participation at the study.
- Exclusion criteria1. Anatomical abnormalities as dysplasie art. glenohumeralis, total cufftear etc. confirmed with radiography and/or sonography (with exception of minor arthrosis, calcifications and partial cufftears);
2. Operated at the shoulder or cervical spine;
3. Reumatic diseases as polymyalgia rheumatica, artritis rheumatica, lupus erythematosis en fibromyalgia;
4. Severe arthritis of the glenohumeral joint;
5. Three or more injections in the shoulder joint last year;
6. (Suspected) severe diseases as malignities;
7. Severe trauma of the shoulder last 6 months;
8. Neurologic disease with negative consequences for the shoulder (as CVA, MS, Parkinson);
9. Diabetis mellitis with the dependence of insuline;
10. Luxation or fracture of the shoulder in the past;
11. Cervico-radicular syndrome;
12. Pathology of organs with negative consequences for the shoulder;
13. Demented;
14. Psychiatric diseases;
15. Insufficient understanding of the Dutch language;
16. Bad general condition;
17. Bad condition of the skin because of a skindisease;
18. Allergic for tape.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2010
- planned closingdate1-okt-2011
- Target number of participants140
- InterventionsUsual care consists of physical- or manual therapy.
Patients in the intervention group will be treated with McConnell tape at the end of each therapy session for 4 weeks or longer as necessary. Decisions about the frequency and the number of sessions will be left to the discretion of the physical therapist.
- Primary outcome1. Functional status (Simple Shoulder test);
2. Pain intensity (11-point numeral rating scale).
- Secondary outcome1. Global perceived recovery (7-point scale);
2. General health (SF-36);
3. Health care costs (patient and family costs and production losses included);
4. Perceived recovery from primary functional problem (11-point numeral rating scale);
5. Detrimental effects of treating patients with McConnell tape.
- Timepoints1. Baseline;
2. 4 weeks (post-treatment);
3. 26 weeks after randomization.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES A. Apeldoorn
- CONTACT for SCIENTIFIC QUERIES A. Apeldoorn
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
BSN medical
- PublicationsKalter J, Apeldoorn AT, Ostelo RW, Henschke N, Knol DL, van Tulder MW. Taping patients with clinical signs of subacromial impingement syndrome: the design of a randomized controlled trial. BMC Musculoskelet Disord 2011;12:188. Dank en groetjes Adri
- Brief summaryObjective:
To assess the effectiveness and cost-effectiveness of usual physical therapy care in combination with the McConnell method for the subacromial impingement syndrome (SAIS) of the shoulder compared to usual physical therapy care alone.

Participants:
A sample of 140 patients between 18 and 65 years of age with a diagnosis of a SAIS will be recruited from the Dutch primary health care setting between September 2010 and April 2011.

Methods:
An economic evaluation alongside a randomized controlled trial will be conducted. After patients meet the in- and exclusion criteria, they will be randomized to either the intervention group (usual care in combination with McConnell tape) or the control group (usual care only). Usual care consists of physical- or manual therapy. Patients in the intervention group will be treated with McConnell tape at the end of each therapy session for 4 weeks or longer as necessary. Decisions about the frequency and the number of sessions will be left to the discretion of the physical therapist. The primary outcome measures are the Simple shoulder test and the pain intensity measured by an 11-point Visual Analogue Scale. The economic evaluation will be performed using a societal perspective. All relevant costs will be registered using cost diaries. Utilities (Quality Adjusted Life Years) will be measured using the EuroQol. The data will be collected at baseline, and 4 and 26 weeks later.

Analysis:
Estimates of treatment effects, with 95% confidence intervals between baseline and follow-up measurements will be calculated and compared between the two treatment groups. Cost-utility and cost-effectiveness ratios will be estimated using bootstrapping techniques.

Results:
This pragmatic study will provide information about the effectiveness of taping patients with McConnell tape.
- Main changes (audit trail)22-mei-2016:

SECONDARY OUTCOME NEW:
1. Global perceived recovery (7-point scale);
2. General health (EuroQol);
3. Health care costs (patient and family costs and production losses included);
4. Perceived recovery from primary functional problem (11-point numeral rating scale);
5. Detrimental effects of treating patients with McConnell tape.

TIMEPOINTS NEW:
1. Baseline;
2. 4 weeks (post-treatment);
3. 12 weeks after randomization
4. 26 weeks after randomization.

Methods NEW:
An economic evaluation alongside a randomized controlled trial will be conducted. After patients meet the in- and exclusion criteria, they will be randomized to either the intervention group (usual care in combination with McConnell tape) or the control group (usual care only). Usual care consists of physical- or manual therapy. Patients in the intervention group will be treated with McConnell tape at the end of each therapy session for 4 weeks or longer as necessary. Decisions about the frequency and the number of sessions will be left to the discretion of the physical therapist. The primary outcome measures are the Simple shoulder test and the pain intensity measured by an 11-point Visual Analogue Scale. The economic evaluation will be performed using a societal perspective. All relevant costs will be registered using cost diaries. Utilities (Quality Adjusted Life Years) will be measured using the EuroQol. The data will be collected at baseline, and 4, 12 and 26 weeks later.
- RECORD22-okt-2010 - 22-jun-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl