Acupuncture Randomised Trial in patients with Tension-Type Headache
| ISRCTN | ISRCTN97373659 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97373659 | 
| Secondary identifying numbers | N/A | 
- Submission date
 - 11/10/2004
 - Registration date
 - 11/01/2005
 - Last edited
 - 19/08/2009
 
- Recruitment status
 - No longer recruiting
 - Overall study status
 - Completed
 - Condition category
 - Nervous System 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 Dieter Melchart
Scientific
                                        Scientific
                                                Centre for Complementary Medicine Research
Technische Universitaet Munich
Kaiserstr. 9
Munich
80801
Germany
                                                
| Phone | +49 (0)89 726697 11 | 
|---|---|
| Dieter.Melchart@lrz.tu-muenchen.de | 
Study information
| Study design | Multicentre randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Other | 
| Study type | Treatment | 
| Scientific title | |
| Study acronym | ART-TTH | 
| Study objectives | Added 19/08/09: The aim of this study is to investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. As of 19/08/09 this record has been updated. To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. All updates can be found under the relevant field with the above update date.  | 
| Ethics approval(s) | Added 19/08/09: Received from local medical ethics committies | 
| Health condition(s) or problem(s) studied | Tension-type headache | 
| Intervention | Acupuncture versus minimal acupuncture versus waiting list | 
| Intervention type | Other | 
| Primary outcome measure | Added 19/08/09: Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries.  | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 01/03/2002 | 
| Completion date | 31/08/2004 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Adult | 
| Sex | All | 
| Target number of participants | 296 | 
| Key inclusion criteria | 296 patients with epidosic or chronic tension-type-headache (according to the criteria of the International Headache Society) | 
| Key exclusion criteria | Does not match inclusion criteria | 
| Date of first enrolment | 01/03/2002 | 
| Date of final enrolment | 31/08/2004 | 
Locations
Countries of recruitment
- Germany
 
Study participating centre
                                            Centre for Complementary Medicine Research
                                        
                                        
                                            
                                            Munich
80801
Germany
                                    80801
Germany
Sponsor information
                                            Munich Technical University, Centre for Complementary Medicine Research (Germany)
University/education
                                        University/education
                                                Technische Universitaet Munich
Kaiserstr. 9
Munich
80801
Germany
                                                
| Phone | +49 (0)89 726697 11 | 
|---|---|
| ZnF@lrz.tu-muenchen.de | |
| https://ror.org/02kkvpp62 | 
Funders
Funder type
Government
                                                German statutory sickness funds (Ersatzkassen) (Germany)
                                            
                                            No information available
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 | 13/08/2005 | Yes | No | |
| Protocol article | treatment protocol | 01/12/2005 | Yes | No |