|
ISRCTN
|
ISRCTN86183481
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Manipulative Therapy added on Usual Medical Care in patients with shoulder pain and dysfunction: a randomized controlled trial
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
904-65-901
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Netherlands
|
|
Disease/condition/study domain
|
Shoulder pain and dysfunction
|
|
Participants - inclusion criteria
|
1. Patients with shoulder pain and dysfunction and a dysfunction of the cervicothoracic spine and adjacent ribs with a new episode of shoulder complaints.
2. Participants had to be at least 18 years of age.
|
|
Participants - exclusion criteria
|
1. Acute severe trauma, such as fractures, ruptures or dislocation in the shoulder-region
2. Previous (orthopedic) surgery
3. Clear treatment preference deviating from study treatments
4. Contraindications for manipulative therapy (e.g. hyper-mobility, instability or severe arthrosis of the cervicothoracic spine)
5. Signs of cervical nerve root compression
6. Presence of specific rheumatic disorders
7. Presence of dementia or other severe psychiatric, emotional or behavioral disorders
8. Shoulder disorders due to general internal pathology of thoracic and abdominal organs
9. Inability to complete Dutch written questionnaires
|
|
Anticipated start date
|
01/01/2005
|
|
Anticipated end date
|
31/12/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
Manipulative Therapy added on Usual Medical Care versus Usual Medical Care only
Manipulative therapy:
Included specific manipulations (low-amplitude, high-velocity thrust techniques) and specific mobilizations (high-amplitude, low-velocity thrust techniques) to improve overall joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine and upper thoracic spine and adjacent ribs. The choice of the applied techniques was determined by the manual therapist, based on location of the dysfunction and technique preferences.
Usual Medical Care:
All patients received usual care from their general practitioner. The treatment by the general practitioner was similar to the practice guidelines for shoulder disorders issued by the Dutch College of General Practitioners, including information, advice and therapy. During the first two weeks information regarding the nature and the course of shoulder complaints was given, together with advice on how to use the affected shoulder in daily living, supplemented with oral analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) if necessary. If there was any improvement, treatment could be prolonged by 1-2 weeks. If this approach lacked sufficient effect, up to three corticosteroid injections (in subacromial space or glenohumeral joint) could be given. If there was insufficient improvement after 2 weeks, the injection could be repeated. If there was no improvement after the second injection, further treatment with corticosteroid injections was not advisable. Physiotherapy was considered in complaints persisting for 6 weeks or more and consisted of treatment of the shoulder with exercises, massage and physical applications.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Netherlands Organisation for Scientific Research
|
|
Trial website
|
|
|
Publications
|
2004 results on http://www.ncbi.nlm.nih.gov/pubmed/15381516
|
|
Contact name
|
Dr
Geert JMG
van der Heijden
|
|
Address
|
University Medical Center Utrecht (Str. 6.131)
Julius Center for Health Sciences and Primary Care
Postbox 85500
|
|
City/town
|
Utrecht
|
|
Zip/Postcode
|
3508 GA
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)30 250 9377
|
|
Fax
|
+31 (0)30 2505485
|
|
Email
|
g.vanderheijden@umcutrecht.nl
|
|
Sponsor
|
Netherlands Organisation for Scientific Research
|
|
Address
|
Laan van Nieuw Oost-Indie 300
|
|
City/town
|
The Hague
|
|
Zip/Postcode
|
2593 CE
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)703440640
|
|
Fax
|
+31 (0)703850971
|
|
Email
|
nwo@nwo.nl
|
|
Date applied
|
23/04/2004
|
|
Last edited
|
02/10/2008
|
|
Date ISRCTN assigned
|
31/01/2005
|
