Plain English Summary
Background and study aims
Chronic pain is one of the most serious quality-of-life impairing and difficult to treat diseases. Usually, affected patients have been through a wide range of treatments with insufficient improvement. For the affected patients, the pain impairs all aspects of daily life. Against this background, the development and evaluation of treatment methods that go beyond conventional pain therapy is urgently required. By modifying the focus of pain perception, music therapy is likely to be an appropriate treatment method. A special receptive music therapy approach has been developed within the MusicMedicine Research Program of the Paracelsus Medical University of Salzburg, containing audio programs composed on the basis of neurophysiological and psychological aspects of music. These programs are applied by listening twice daily for 30 minutes via headphones played from a special audio device. The efficacy of this treatment was demonstrated in a controlled study including outpatients with depression. The aim of this study is to find out about the effectiveness of receptive music therapy during the rehabilitation of patients with chronic low back pain.
Who can participate?
Patients aged 18 65 who have had chronic back pain for over 6 months.
What does the study involve?
Participants will be randomly allocated to be treated with either receptive music therapy in addition to standard treatment, or standard treatment only. The extent of pain reduction will measured by completing a questionnaire before and after treatment and at the 6-month follow-up.
What are the possible benefits and risks of participating?
The possible benefits are relief from pain and depression. There are no risks involved in this study.
When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in October 2011. Participants will be enrolled on the study consecutively for a period of 2 years.
Where is the study run from?
Research Program MusicMedicine, Paracelsus Medical University Salzburg (Austria); Klinik Roseneck, Prien am Chiemsee; Orthopaedie-Zentrum, Bad Fuessing; Schoen Klinik Staffelstein; Schoen Klinik Harthausen; Orthopaedische Klinik Tegernsee.
Who is funding the study?
Deutsche Rentenversicherung Nordbayern (German statutory pension insurance of Northern Bavaria).
Who is the main contact?
Vera Brandes, vera.brandes@pmu.ac.at
Prof. Dr. Dr. Andreas Hillert, ahillert@schoen-kliniken.de
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Media-supported music therapy in the integrative pain therapy of chronic back pain: a randomized controlled trial
Acronym
Study hypothesis
In what way is receptive music therapy effectively applicable in chronic pain patients, particularly in rehab clinic inpatients with chronic low back pain?
We suppose that combination therapy (receptive music therapy and clinical standard treatment) of chronic low back pain patients is more effective than clinical standard therapy alone regarding symptom reduction (measured by the German pain questionnaire) and subjective disability immediately post treatment as well as after 6 months.
Ethics approval
Ethics Commission of Bavarian Chamber of Physicians [Ethik-Kommission der Bayerischen Landesärztekammer (BLAEK)], Germany, 10/17/2011, ref: 11090
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic back pain
Intervention
During their inpatient rehabilitation treatment (3-4 weeks), the intervention group will be treated with receptive music therapy (i.e., specially developed audio programs, 5 to 7 days per week, each day 2 x 30 minutes) in addition to standard clinical pain treatment, whereas the control group will undergo only standard clinical pain treatment.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Short- and long-term (pre-, post-treatment and 6-month follow-up) difference between intervention and control group:
1. Regarding the extent of pain reduction (measured by the German pain questionnaire [Deutscher Schmerzfragebogen])
2. Regarding subjective disability (measured by the Hannover Functional Ability Questionnaire [Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen, FFbH-R]
3. Documentation of sociodemographic data (Bado)
4. German Pain Questionnaire (DSF)
5. Hannover Functional Ability Questionnaire for the diagnosis of near-daily functional impairment by back pain (FFbH-R)
6. Beck Depression - Inventory (BDI-II)
7. Questionnaire for acceptance of receptive music therapy at enrollment MT Primary Questionnaire and to 'hear the inner music' (Brandes and Hillert)
Secondary outcome measures
1. Exploration of mode of action (mediation vs moderation): To what extent will comorbid depression symptoms ameliorate during the intervention (mediation)? Do patients with comorbid depression show more response to the intervention (moderation) than non-depressed patients? Depressive symptom severity will be measured by the Beck Depression Inventory II (BDI II) and the Quick Inventory of Depressive Symptomatology, clinician rating (QIDS-C).
2. To what extent does receptive music therapy affect recreational ability, reaction to stressful situations and subjective life quality?
3. Treatment adherence and compliance will be assessed by a questionnaire (music therapy acceptance questionnaire) as well as an analysis of dates, times and frequencies of listening, which will be automatically recorded by the audio devices.
4. Patients will be asked for their subjective appraisal of the intervention
Overall trial start date
01/10/2011
Overall trial end date
31/03/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Main diagnosis: chronic back pain (highest degree of chronification according to Gerbershagen) of non-specific origin pain symptom duration > 6 months
2. Age: 18 65 years
3. Adequate knowledge of the German language
4. Written consent for study participation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
360
Participant exclusion criteria
1. Pain of specific origin
2. Surgical indication (e.g., radicular deficits, spondylolisthesis)
3. Acute inflammation of the musculoskeletal system
4. Severe acute psychiatric conditions (e.g., psychosis, severe depression)
5. Alcohol or drug addiction
6. Clinically relevant hearing loss
Recruitment start date
01/10/2011
Recruitment end date
31/03/2013
Locations
Countries of recruitment
Germany
Trial participating centre
Waehringer Strasse 115/19
Vienna
1180
Austria
Sponsor information
Organisation
German Statutory Pension Insurance of Northern Bavaria (Deutsche Rentenversicherung Nordbayern) (Germany)
Sponsor details
Wittelsbacherring 11
Bayreuth
95444
Germany
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
German Statutory Pension Insurance of Northern Bavaria (Deutsche Rentenversicherung Nordbayern) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary