The efficacy of a ressource-oriented manual therapy in patients with chronic low back pain compared to massage
Organizational Data
- DRKS-ID:
- DRKS00007141
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2014-11-13
- Last update in DRKS:
- 2016-04-22
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
With this study we want to examine if and how the two different physiotherapeutic techniques differ in the efficacy of treatment of chronic low back pain. The ressource oriented technique improves body perception. In this way the subjects can cope better with their afflictions. At that we recruit exclusively female subjects at the university clinic in Tuebingen because females are more often afflicted with chronic low back pain and because we want to examine the aspect of the therapeutical relationship to the therapist. Every subject is treated five times according to group membership and participate in examinations before the first and after the last treatment. We use questionnaires, interview and measurements of two-point-discrimination and heat perception threshold at the low back. Our supposition reads as follows: In the group of the ressource oriented technique the pain can be reduced more successfully than in the group of the massage.
Brief summary in scientific language
The efficacy of a ressource-oriented manual therapy in patients with chronic low back pain compared to massage
Health condition or problem studied
- Free text:
- chronic low back pain
- ICD10:
- M54 - Dorsalgia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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
- Arm 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
Endpoints
- Primary outcome:
- 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:
- 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)
Study Design
- Purpose:
- Other
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Tübingen
Recruitment period and number of participants
- Planned study start date:
- 2014-11-01
- Actual study start date:
- 2014-11-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2016-04-20
- Target Sample Size:
- 30
- Final Sample Size:
- 41
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 Years
- Additional 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)
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Tübingen, Psychosomatische Medizin und PsychotherapieOsianderstrasse 672076 TübingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Medizinische Klinik Tübingen, Abteilung: Psychosomatische Medizin und PsychotherapieDr. med. Martin TeufelOsianderstrasse 672076 TübingenGermany
- Telephone:
- 07071/ 29-86719
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Medizinische Klinik Tübingen, Psychosomatische Medizin und PsychotherapieSebastian SeidelOsianderstrasse 672076 TübingenGermany
- Telephone:
- 07071/ 29-86719
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Medizinische Klinik Tübingen, Abteilung: Psychosomatische Medizin und PsychotherapieDr. med. Martin TeufelOsianderstrasse 672076 TübingenGermany
- Telephone:
- 07071/ 29-86719
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Medizinische Klinik Tübingen, Abteilung: Psychosomatische Medizin und PsychotherapieOsianderstrasse 672076 TübingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-05-28
- Ethics committee number:
- 301/2014B02
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-07-02
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry