Trial document
This trial has been registered retrospectively.
DRKS00017051
Trial Description
Title
Assessment of a combined manual therapy and taping method for the treatment of chronic lower back pain: A randomized controlled trial
Trial Acronym
MEDI-TAPING
URL of the Trial
[---]*
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.
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.
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00017051
- 2019/07/24
- [---]*
- yes
- Approved
- 537/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
- [---]*
Health Condition or Problem studied
- CHRONIC LOWER BACK PAIN
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
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Blinded
- investigator/therapist, assessor, data analyst
- Active control (effective treament of control group)
- Treatment
- Parallel
- II
- N/A
Primary Outcome
changes at t2 for pain (VAS and Korff pain grade), and functional limitations (Oswestry Disability Score)
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
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- Doctor's Practice
Recruitment
- Actual
- 2015/06/09
- 100
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 80 Years
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
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
Addresses
-
start of 1:1-Block address primary-sponsor
- 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
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49 761 270-69280
- [---]*
- stefan.schmidt at uniklinik-freiburg.de
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- 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
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 761 270-69280
- [---]*
- stefan.schmidt at uniklinik-freiburg.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Klinik für Psychosomatische Medizin Universitätsklinikum Freiburg
- Mr. Prof Dr Stefan Schmidt
- Hauptstre. 8
- 79104 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49-761-270-69280
- [---]*
- stefan.schmidt at uniklinik-freiburg.de
- https://www.uniklinik-freiburg.de/psychosomatik/forschung/bereich-systemische-gesundheitsforschung.html
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Schmerz und Tape GmbH
- Lübecker Str. 95
- 23843 Bad Oldesloe
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2016/03/31
Trial Publications, Results and other Documents
- [---]*