Contact information
Type
Scientific
Primary contact
Dr Geert JMG van der Heijden
ORCID ID
Contact details
University Medical Center Utrecht (Str. 6.131)
Julius Center for Health Sciences and Primary Care
Postbox 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 9377
g.vanderheijden@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
904-65-901
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Shoulder pain and dysfunction
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2005
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
01/01/2005
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht (Str. 6.131)
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
Netherlands Organisation for Scientific Research
Sponsor details
Laan van Nieuw Oost-Indie 300
The Hague
2593 CE
Netherlands
+31 (0)703440640
nwo@nwo.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Scientific Research
Alternative name(s)
Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation, NWO
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Netherlands
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
Basic results (scientific)
Publication list
2004 results on http://www.ncbi.nlm.nih.gov/pubmed/15381516
Publication citations
-
Results
Bergman GJ, Winters JC, Groenier KH, Pool JJ, Meyboom-de Jong B, Postema K, van der Heijden GJ, Manipulative therapy in addition to usual medical care for patients with shoulder dysfunction and pain: a randomized, controlled trial., Ann. Intern. Med., 2004, 141, 6, 432-439.