|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
German Clinical Trials Register |
|
Last refreshed on:
|
8 April 2024 |
|
Main ID: |
DRKS00007141 |
|
Date of registration:
|
13/11/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The efficacy of a ressource-oriented manual therapy in patients with chronic low back pain compared to massage
|
|
Scientific title:
|
The efficacy of a ressource-oriented manual therapy in patients with chronic low back pain compared to massage |
|
Date of first enrolment:
|
01/11/2014 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Complete |
|
URL:
|
http://drks.de/search/en/trial/DRKS00007141 |
|
Study type:
|
interventional |
|
Study design:
|
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: other
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Martin
Teufel |
|
Address:
|
Osianderstrasse 6
72076
Tübingen
Germany |
|
Telephone:
|
07071/ 29-86719 |
|
Email:
|
martin.teufel@med.uni-tuebingen.de |
|
Affiliation:
|
Medizinische Klinik Tübingen, Abteilung: Psychosomatische Medizin und Psychotherapie |
|
|
Name:
|
Sebastian
Seidel |
|
Address:
|
Osianderstrasse 6
72076
Tübingen
Germany |
|
Telephone:
|
07071/ 29-86719 |
|
Email:
|
sebastian.seidel@med.uni-tuebingen.de |
|
Affiliation:
|
Medizinische Klinik Tübingen, Psychosomatische Medizin und Psychotherapie |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: female; prolonged and recurring chronic low back pain which exist for at least 3 months and appear at least 2 times a week; age: between 18 and 65 years
Exclusion criteria: at least 10 points in PHQ-9; pregnancy inclusive precocious pregnancy; reasons that forbid treatment of the back or the front of the rumps; pronounced systemic and neurologic diseases that influence the musculoskeletal system; grave osteoporosis; infectious and fever diseases; grave disorders of coagulation, cumulative bruises; acute disc prolapse with provocative symptoms; grave sensomotoric disorders of the lower limbs; operation of the backbone which has been realised before less than 6 months; dependance deseases, bipolar disorder, psychosis, schizophrenia, grave depression (current or in the past)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
chronic low back pain
M54
|
|
Dorsalgia
|
|
Intervention(s)
|
Group 1: group 1: treatment with ressource-oriented manual therapy in supine position (5 times, each time 25 minutes); indirect treatment of low back pain considering ventral structures and encouragement of body perception
Group 2: group 2: treatment with massage at the low back in prone position (5 times, each time 25 minutes); treatment at the localization of back pain
|
|
Primary Outcome(s)
|
|
the differ of efficacy of both physiotherapeutic techniques in regard to pain with a questionnaire (german pain questionnaire, before 1st and after 5th treatment)
|
|
Secondary Outcome(s)
|
|
differ of efficacy in regard to body perception, perceived self-efficacy, heat perception, theapeutic relationship and comorbidities. We use questionnaires (Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Short Form Health Survey-12, self efficacy, therapeutic relationship, satisfaction), interview (depression, somatization disorder), caliper and TSA-II thermode (before 1st and after 5th treatment)
|
|
Source(s) of Monetary Support
|
|
Medizinische Klinik Tübingen, Abteilung: Psychosomatische Medizin und Psychotherapie
|
|
Ethics review
|
Status: Approved
Approval date: 02/07/2014
Contact:
|
|