Manipulative Therapy added on Usual Medical Care in patients with shoulder pain and dysfunction: a randomized controlled trial
| ISRCTN | ISRCTN86183481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86183481 |
| Secondary identifying numbers | 904-65-901 |
- Submission date
- 23/04/2004
- Registration date
- 31/01/2005
- Last edited
- 02/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Geert JMG van der Heijden
Scientific
Scientific
University Medical Center Utrecht (Str. 6.131)
Julius Center for Health Sciences and Primary Care
Postbox 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 250 9377 |
|---|---|
| g.vanderheijden@umcutrecht.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2005 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht (Str. 6.131)
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
Netherlands Organisation for Scientific Research
Research organisation
Research organisation
Laan van Nieuw Oost-Indie 300
The Hague
2593 CE
Netherlands
| Phone | +31 (0)703440640 |
|---|---|
| nwo@nwo.nl | |
"ROR" |
https://ror.org/01bnjb948 |
Funders
Funder type
Research organisation
Netherlands Organisation for Scientific Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation, Dutch Research Council (Nederlandse Organisatie voor Wetenschappelijk Onderzoek), NWO:Nederlandse Organisatie voor Wetenschappelijk Onderzoek, Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO), Dutch Research Council, Dutch Research Council, Netherlands, NWO
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/09/2004 | Yes | No |
