Trial document




This trial has been registered retrospectively.
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  DRKS00017051

Trial Description

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Title

Assessment of a combined manual therapy and taping method for the treatment of chronic lower back pain: A randomized controlled trial

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Trial Acronym

MEDI-TAPING

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URL of the Trial

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Brief Summary in Lay Language

Chronic lower back pain is the most frequent medical problem and the condition with the most years lived with disability. A pragmatic RCT was performed to assess a new treatment, Medi-Taping, which aims at reducing complaints by treating pelvic obliquity with a combination of manual treatment of trigger points and kinesio taping.

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Brief Summary in Scientific Language

Objectives: Chronic lower back pain is the most frequent medical problem and the condition with the most years lived with disability. A pragmatic RCT was performed to assess a new treatment, Medi-Taping, which aims at reducing complaints by treating pelvic obliquity with a combination of manual treatment of trigger points and kinesio taping.
Methods: 110 patients were randomized at two study centers either to Medi-Taping or to a standard treatment consisting of psychoeducation and physiotherapy as control. Treatment duration was three weeks. Measures were taken at baseline, end of treatment and at follow-up after two months. Main outcome criteria were lower back pain measured with VAS, the Chronic Pain Grade Scale and the Oswestry Low Back Pain Disability Questionnaire.
Results: Patients of both groups benefited from the treatment by medium to large effect sizes. All effects were pointing towards the intended direction with patients receiving Medi-Taping doing better. But at end of treatment and follow-up there were no significant differences for the primary endpoints between groups. Health related quality of life was significantly higher (p=.004) in patients receiving Medi-Taping compared to controls.
Conclusions: Medi-Taping, a purported way of correcting pelvic obliquity and chronic tension resulting from it, is a treatment modality similar in effectiveness as a complex physiotherapy and patient education program.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017051
  •   2019/07/24
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  •   yes
  •   Approved
  •   537/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   CHRONIC LOWER BACK PAIN
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Interventions/Observational Groups

  •   Medi-Taping:
    received three treatments within three weeks on average
  •   Standard Treatment:
    received booklet containing psychoeducative information for patients with lower back pain and standard physiotherapy for CLBP, 6 sessions of 20 minute duration within three weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

changes at t2 for pain (VAS and Korff pain grade), and functional limitations (Oswestry Disability Score)

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Secondary Outcome

changes in quality of life (PLC), spinal mobility (Schober Sign Test and Distance Fingertips to Floor) and leg length difference (as indicator of pelvic obliquity) at t2 and all changes at t3

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/06/09
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

unspecific lower back pain for more than 12 weeks, a rating of at least 4 cm on a 10 cm Visual Analog Scale (VAS) for the back pain, the ability to read and communicate in German

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Exclusion Criteria

neurological malfunction at the lower extremities related to CLBP, a rating larger than 8cm on the VAS for back pain, back pain due to infection, tumor, osteoporosis, stenosis of the cerebrospinal canal, slipped vertebra, vertebral fractures, spinal disc herniation, surgery of vertebra, spinal disc or sacroiliac joint. Furthermore allergy to tape, pregnancy, current cancer diagnosis, addictive disorder, severe psychiatric disorder, significant impairment due to memory problems or brain disorders, artificial hip ankle or knee joint, participations in other RCTs

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Addresses

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    • Dept. for Psychosomatic Medicine and Psychotherapy, Medical Faculty, Medical Center – University of Freiburg, Germany
    • Mr.  Prof. Dr.  Stefan  Schmidt 
    • Hauptstraße 8
    • 79104  Freiburg im Breisgau
    • Germany
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    • Dept. for Psychosomatic Medicine and Psychotherapy, Medical Faculty, Medical Center – University of Freiburg, Germany
    • Mr.  Prof. Dr.  Stefan  Schmidt 
    • Hauptstraße 8
    • 79104  Freiburg im Breisgau
    • Germany
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    • Klinik für Psychosomatische Medizin Universitätsklinikum Freiburg
    • Mr.  Prof Dr  Stefan  Schmidt 
    • Hauptstre. 8
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Schmerz und Tape GmbH
    • Lübecker Str. 95
    • 23843  Bad Oldesloe
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/03/31
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Trial Publications, Results and other Documents

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