Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Geert JMG van der Heijden


Contact details

University Medical Center Utrecht (Str. 6.131)
Julius Center for Health Sciences and Primary Care
Postbox 85500
3508 GA
+31 (0)30 250 9377

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Shoulder pain and dysfunction


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



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


Overall trial end date


Reason abandoned


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


Age group

Not Specified


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


Recruitment end date



Countries of recruitment


Trial participating centre

University Medical Center Utrecht (Str. 6.131)
3508 GA

Sponsor information


Netherlands Organisation for Scientific Research

Sponsor details

Laan van Nieuw Oost-Indie 300
The Hague
2593 CE
+31 (0)703440640

Sponsor type

Research organisation



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



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

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