Presentation of the first German SpineMED Study
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1 Presentation of the first German SpineMED Study Doctor Dissertation: Clinical Outcome of Back Pain after SpineMED Therapy by Alexander Dittmar Doctor Thesis Supervisor: PD Dr. med. Manfred Pfahler Ludwig Maximilian University of Munich Duration of Study: Sept Feb. 2013
2 Clinical Relevance Every 5 th male and every 7 th female suffers from chronic cervical and/or lumbar back pain Most common sort of pain in the population Large variety of back pathologies (Discprolaps, Protrusion, Sciatica, Facet syndrome, Stenosis, etc.)
3 Study Design Examination of 100 patients treated with SpineMED Decompression Standardized physical pre- and post outcome measures Standardized and consistent questionnaires (VAS, Oswestry-Disability-Index, Neck-Disability-Index)
4 Study Design Minimum follow-up of 6 months. Maximum follow-up of 1 year. Inclusion criteria: 20 treatment sessions with SpineMED following correct indication/diagnosis Exclusion criteria: patients post surgery.
5 Patient Sample 100 patients enrolled. 47 female, 53 male. 68 patients with Lumbar pathology (32 female, 36 male) 32 patients with cervical pathology (15 female, 17 male) Mean age years
6 Number Age Distribution of Investigations Age at Screening
7 Methods & Materials Average treatment duration (for 20 sessions): 56 days Post Measurements average 8.04 months after last SpineMED session Timeline between pre and post measurements average 10.2 months
8 Prolapse Degenerative Prolapse Protrusion Degenerative Protrusion Non-degenerative changes without bulging Number - Degenerative changes without bulging - Diagnostic Groups
9 Segment Frequency Percent L L L L5-S L L4-S Multisegmental Total Segment Frequency Percent C C C C C Multisegmental Total
10 Investigation Type Entrance Examination Lumbar Check-Up Lumbar Entrance Examination Cervical Inspection Farming Toe-walking Hack Gear Legged Stance Pelvic Obliquity Local Tenderness Scoliosis Cervical Examination Reflex Status Referred Pain Psoas Sign Lasègue Characters Bragard Characters Velleix Pressure Points Check-Up Cervical
11 Results Paired t-test significant (p <0.05) for the following measurements: Lumbar group: Inspection, local tenderness on palpation, physical examination lumbar spine, pain radiation, Psoas-, Lasegue-, and Bragard-Test, Valleix s points. Cervical group: Inspection, local tenderness on palpation, physical examination cervical spine, pain radiation.
12 Number Visual Analogue Scale Pain at Baseline (of 0 10) Durchschnittlicher Wert der VAS vor Therapiebeginn bei 7,49 Punkten. Sehr viele Patienten klagten über heftige Schmerzen (9 Punkte).
13 Results VAS Increase of pain in 2 patients Average reduction of pain from 7.48 to 2.57 (4.91 points) during therapy Post measurements showed a pain of 2.57 in average.
14 Number Visual Analogue Scale Pain Immediately After the Last Session (of 0 10)
15 Number Visual Analogue Scale Pain at Follow-Up Visit (of 0 10)
16 Average Visual Analogue Scale Over Time Before Treatment Immediately After Treatment Follow-Up Visit LWS Group HWS Group
17 Results: Oswestry-Disability-Index Pre Before therapy value of 43.15%. Among all patients, pain was experienced as the most limiting impairment (3 out of 5 possible points) Also, among all patients limitations in weight bearing activities and walking distance (average 1-2 km).
18 Results Oswestry-Disability-Index Post Average value decreased to 15.97% Total decrease of 27.18%
19 Average Oswestry Score Before Oswestry Score Now Female Male Sex
20 Average Pain Intensity Before Pain Intensity After Care Before Care After Before Lifting After Lifting Before Going Go After Sitting Before Sitting Later Have Previously Available After Sleep Before Sleep Afterwards Sex Life Before Sex Life After Social Life Before Social Life After Travel Before Travel After ODI Question Categories in the Pre-Post Comparison
21 Results: Neck-Disability-Index Pre Average value of 32.01%. Pain was experienced as the most limiting impairment (3.05 out of 5 possible points) % of all patients suffered from moderate headache
22 Results Neck-Disability-Index Post Value decreased to 10.69%. Total NDI decrease of 21.32%.
23 Neck Disability Score Preliminary Neck Disability Score Follow-Up Female Sex Male
24 Average Pain Intensity Before Pain Intensity After Care Before Care After Before Lifting After Lifting Work Previously Work Afterwards Headache Before Headache After Concentration Previously Concentration Afterwards Sleep Before Sleep After Driving Before Driving After Reading Before Reading After Leisure Before Leisure After NDI Question Categories in the Pre-Post Comparison
25 ODI NDI Category Previously Afterwards Previously Afterwards ODI Decline of 27.18% NDI Decline of 21.32%
26 Other Influences on Results Type of diagnosis Better outcomes for patients with non-degenerative diseases. Patient Age Younger patients showed better results than older patients.
27 Score Difference Patients Age
28 Other influences on Results Intensity of tension force applied to the patient: Increase in pounds: Tension was increased in average 24 pounds in lumbar patients, and 6 pounds in cervical patients. Optimal increase of tension could be recognized between pounds (lumbar patients).
29 Score Difference Traction Force Difference
30 Other influences on Results: There was no influence on long term results (post measurements) due to the following criteria: BMI Additional medical interventions: NSAR, muscle relaxants, infiltrations Duration of therapy (median 56 days)
31 Limitations No randomization No blinding No control group Sample size
32 Results-Summary: Clear/Considerable improvement in physical examination Significant reduction of pain (VAS) Significant Score-Improvements of ODI and NDI (pre/post)
33 Forecast MRI-Study: 20 Patients (11 lumbar and 10 cervical), with nondegenerative disc prolaps or protrusion, underwent MRI examination pre and post SpineMED treatment. The MRI Images partly showed clear remission of the discus and annulus repair. Results will be published soon!!
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