low back pain, neck pain, headache
Conditions
Interventions
Group 1: Psychosomatic osteopathic treatment using one of the three techniques mentioned above (osteopathic felt sense, heart-focused palpation, or bifocal integration).
Group 2: Shamtreatment
Sponsors
Osteopathie Schule Deutschland
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Pain in the lower back or neck (between linea nuchae superior, Th12 and shoulder-near insertions of the m. trapezius) or tension headache = 2 (measured by NRS) for at least three months duration.
Exclusion criteria
Exclusion criteria: Previous operations in the area of the spine; serious mental/psychiatric or neurological illness (requiring primary treatment by a specialist); ongoing pension proceedings; no command of written or spoken German; manual therapy/physiotherapy interventions in the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary target parameters measured are current self-perceived pain, self-perceived average pain over the last four weeks, self-perceived stress and health-related quality of life. Self-perceived pain is measured using a VAS. The VAS can be considered a valid and reliable measuring instrument (Schomacher 2008; Ferreira-Valente et al. 2011). Health-related quality of life is measured using the SF-36. The SF-36 can be considered a valid and reliable measurement instrument (Brazier et al. 1992). Self-perceived stress is determined using a stress scale (Perceived Stress Scale, PSS-10). The PSS-10 is an established self-report measure based on the psychological concept of stress. (Cohen et al. 1983) The PSS-10 is a reliable, valid and economical instrument for assessing perceived stress (Klein et al. 2016). The quality and quantity of headaches is assessed using the Kiel Headache Questionnaire by Prof. Göbel. The questionnaire records the intensity and pain of headaches and is used to differentiate between migraines and tension-type headaches (see Pioch 2005, Knapp 2016, Sass 2016). All measurements are taken before the first treatment, four to seven days after the last treatment, and 3 months and 6 months after the last treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-specific functionality, the subjectively perceived pressure pain threshold at defined points and heart rate variability (HRV) are defined as secondary target parameters. Functionality is measured for patients with back pain using the Oswestry Disability Index (ODI) and for patients with neck pain using the Neck Pain Disability (NPI). The ODI can be considered a valid and reliable measurement instrument (Mannion et al. 2006; Sheahan et al. 2015). The Polar H10 heart rate sensor is used to measure heart rate variability (HRV), which shows no differences compared to an electrocardiogram (Moya-Ramon et al, 2022) and is therefore a valid and reliable measuring instrument (Schaffarczyk et al., 2022). The data is recorded using the Elite HRV app, exported as a text file and imported into the Kubios analysis software for further evaluation (Schaffarczyk et al., 2022). The following parameters are evaluated: RMSS, SDDN, HF,LF, SD1, SD2, SD2/1. The mobility of the cervical and lumbar spine is defined as a tertiary target parameter. The range of motion of the lumbar spine is measured using the modified Schober-Ott test and an inclinometer. The Schober-Ott test can be considered a valid and reliable measuring instrument (Amjad et al. 2022; Tousignat et al. 2005). With regard to measuring the mobility of the cervical spine, the inclinometer shows good intertester reliability with standardized training of the measuring personnel (Johnson et Mulcahey 2021). All measurements are taken before the first treatment, four to seven days after the last treatment, and 3 months and 6 months after the last treatment. | — |
Countries
Germany, Switzerland
Contacts
Public ContactTobias Schmidt
Osteopathie Schule Deutschland
Outcome results
None listed