Media-supported music therapy in the integrative pain therapy of chronic back pain

ISRCTN ISRCTN76494641
DOI https://doi.org/10.1186/ISRCTN76494641
Secondary identifying numbers N/A
Submission date
11/05/2012
Registration date
08/06/2012
Last edited
29/09/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mrs Vera Brandes
Scientific

Waehringer Strasse 115/19
Vienna
1180
Austria

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMedia-supported music therapy in the integrative pain therapy of chronic back pain: a randomized controlled trial
Study objectivesIn 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(s)Ethics Commission of Bavarian Chamber of Physicians [Ethik-Kommission der Bayerischen Landesärztekammer (BLAEK)], Germany, 10/17/2011, ref: 11090
Health condition(s) or problem(s) studiedChronic back pain
InterventionDuring 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 typeOther
Primary outcome measureShort- 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 measures1. 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 study start date01/10/2011
Completion date31/03/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants360
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2011
Date of final enrolment31/03/2013

Locations

Countries of recruitment

  • Austria
  • Germany

Study participating centre

Waehringer Strasse 115/19
Vienna
1180
Austria

Sponsor information

German Statutory Pension Insurance of Northern Bavaria (Deutsche Rentenversicherung Nordbayern) (Germany)
Government

Wittelsbacherring 11
Bayreuth
95444
Germany

Website http://www.deutsche-rentenversicherung-nordbayern.de
ROR logo "ROR" https://ror.org/05am9gt90

Funders

Funder type

Government

German Statutory Pension Insurance of Northern Bavaria (Deutsche Rentenversicherung Nordbayern) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan