Chronic shoulder pain
Conditions
Interventions
Group 1: Five semi-standardized individual treatments with osteopathic medicine and instruction in movement exercises (self-exercises)
Experimental intervention (group 1): Five semi-standardized indi
Sponsors
Charité - Universitätsmedizin Berlin, Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Important inclusion criteria: - Age from 18 to 65 years, any gender - Clinical diagnosis of CSP (duration of disease at least 12 weeks, including "bursitis sub-acromialis", "tendinosis calcarea", "frozen shoulder") on the most painful shoulder - Subjectively perceived pain intensity at the most painful shoulder within the last seven days of at least 40 mm on a VAS (0-100 mm, 0 = no pain, 100 = worst pain imaginable) - Willingness to forego osteopathic treatment for the next 12 weeks if the study participant is randomized to the control group - Ability to give informed consent - Informed consent (in paper form) is available
Exclusion criteria
Exclusion criteria: Important exclusion criteria: - Pain in the most painful shoulder that requires urgent conventional medical treatment (e.g. muscle disease, recent trauma, SLAP (superior labrum anterior posterior) lesion) - Peripheral and/or central neurological symptoms - Diseases from the rheumatoid arthritis spectrum - Shoulder surgery on the most painful shoulder within the last 6 months - Generalized pain disorder such as fibromyalgia - Treatment of cervical spine complaints with physical medicine currently or within the last 3 months before the start of the study - Obesity with BMI =30 kg/m² - Pregnancy or breastfeeding - Presence of a serious acute and/or chronic organic or mental illness that does not allow participation in the therapy - Lack of time resources to have the OM carried out - Contraindications for non-steroidal anti-inflammatory drugs - Taking centrally acting analgesics - Treatment with OM within the last 6 months before the start of the study - Expected lack of compliance with regard to study participation (e.g. notification that they do not wish to answer any further questions; limitation of general compliance ability in the case of dementia, severe alcohol abuse, drug abuse) - Insufficient knowledge of the German language - Participation in other studies - No e-mail address available - No skills or ability to operate or use tablets or computers independently - Institute staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 12 weeks, the subjectively perceived pain intensity at the most painful shoulder at study inclusion (over the last seven days) measured on a visual analog scale (VAS, 0-100 mm, 0 = no pain, 100 = worst pain imaginable) | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly during the first 12 weeks and after 26 weeks: - Subjectively perceived pain intensity at the most painful shoulder at study inclusion (over the period of the last seven days) on a VAS (0-100 mm) After 6, 12, 26 weeks: - Shoulder function of the most painful shoulder at study inclusion using DASH score - Subjective psychological well-being using the World Health Organization Five Wellbeing Index (WHO-5) - Self-assessed days with routine restrictions due to chronic shoulder pain (CSP) by study participants (last 6 weeks) - Days of incapacity to work due to CSP retrospectively for the period 3 months before the start of the study and the study period - Medication (due to chronic shoulder pain) - Use of additional therapeutic procedures (not permitted are, for example, OM, operations on the shoulders or spine, use of centrally acting analgesics) - Therapy safety through the recording of adverse events in both study groups During the first 12 weeks on a daily basis as a weekly diary: - Intake of on-demand medication (preferably ibuprofen in mg) due to CSP As a mechanistic sub-study, additional electrophysiological measurements are planned for 30-40 study participants (15-20 per group) at baseline after 6 and 12 weeks. To this end, heart rate, blood pressure, respiratory rate, pulse and electrodermal activity (skin conductance as an expression of sympathetic activity) will be recorded simultaneously using multi-channel measurements. | — |
Countries
Germany
Contacts
Public ContactRotter Gabriele
Charité - Universitätsmedizin Berlin, Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie
Outcome results
None listed