Trial document




drksid header

  DRKS00003240

Trial Description

start of 1:1-Block title

Title

Manual Therapy of acute low back pain in primary care - a pilot study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ManRück

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Acute low back is a frequent reason for encounter in in primary care. Does additional manual treatment ameliorates the therapy when compared to treatment according to national guidelines. According to the hypothesis that additional manual therapy will ease the pain faster and give back the patients full physical ability earlier, physicians will fist treat a group of patients solely according to national guidelines. After receiving an expert-consent training, they will treat another group with additional manual therapy.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Aim of the study is to compare standard treatment of low back pain according to national guidelines with additional manual therapy. Study physicians will receive a standardized training based on expert consens. Primary outcome is the change in pain-intensity measured by VAS. Secondary outcomes are use of pain-killers, referral-rete and days of sick leave.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003240
  •   2011/10/14
  •   [---]*
  •   yes
  •   Approved
  •   6006, Ethikkommission der Medizinischen Hochschule Hannover
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M54.86 -  [generalization M54.8: Other dorsalgia]
  •   [---]* -  [---]*
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   All Patients in a defined period with acute low back pain. According to national guidelines Patients will be encouraged to keep their normal physical activity and will also receive a short-time treatment with nonsteroidal antirheumatics.
  •   Same primary care patients as in Group 1 after treating physicians received a four hour training which focuses on manual therapy and diagnosis. The Curriculum of the training is based on expert consensus. Patients will be treatet as described in Group 1 and will receive additional manual therapy .
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   [---]*
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Changes in pain intensity measured by VAS on day 0 pre-treatment compared with 3 days post-treatment and after a 6 weeks period. Combined outcome consistent of a one unit reduction in VAS and termination of drug usage.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Use of Drugs in the first 7 days after treatment, Days of sick leave in the first 6 weeks, German back pain questionnaire to measure the physical impairment (Funktionsfragebogen Hannover Rücken) on day 7 and 6 and 12 weeks after treatment.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/03/16
  •   200
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   50   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

All patients with not more than 2 weeks duration of not traumatic acute low back pain.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

known disease of the spine, osteoporosis; spine-surgery in the last 6 months, clinical signs of severe illness of the spine e.g. CES or herniated disc, rheumatic diseases, pregnancy, ongoing treatment including physical therapy / manual therapy

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität Bremen Institut für Public Health und Pflegeforschung Abteilung Versorgungsforschung
    • Mr.  Dr.med.  Guido  Schmiemann 
    • Postfach 330440
    • 28344  Bremen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address primary-sponsor
    • Medizinische Hochschule Hannover Institut für Allgemeinmedizin
    • Ms.  Dr. med.  Heidrun  Lingner 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Medizinische Hochschule Hannover Institut für Allgemeinmedizin
    • Ms.  Dr.med.  Lingner  Heidrun 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Medizinische Hochschule Hannover Institut für Allgemeinmedizin
    • Ms.  Dr.med.  Heidrun  Lingner 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Rut und Klaus Bahlsen Stiftung
    • Berliner Allee 14
    • 30175  Hannover
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/12/30
end of 1:1-Block state
* This entry means the parameter is not applicable or has not been set.