Condition category
Musculoskeletal Diseases
Date applied
23/04/2004
Date assigned
31/01/2005
Last edited
02/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2004 results on http://www.ncbi.nlm.nih.gov/pubmed/15381516

Publication citations

  1. 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.

Additional files

Editorial Notes