None listed
Conditions
Brief summary
Many studies have suggested that psychological factors, including anxiety, depression and somatic symptom disorders (SSDs) are risk factors of LBP and predictors of poor outcomes, thus shaping the concept of a “biopsychosocial pain syndrome”. Notwithstanding, few studies have explored the association between psychological factors and especially SSDs and with pain, disability and quality of life in patients with Chronic Low Back Pain LBP in Greece. Namely, SSDs are one of the most prevalent mental health disorders in medical settings and general populations, and are associated with increased healthcare services use and socioeconomic costs, as a consequence of repeated investigations and treatments. Accordingly, strategies to identify SSD at an earlier stage, such as the use of the newly, standardized and validated questionnaire of Somatic Symptom Scale-8 (SSS-8), are essential both for the provision of an optimal targeted treatment and for minimizing its direct, indirect and overall economic burden. Furthermore, a brief (requires only two minutes to complete and score), easy-to-use, highly accurate diagnostic tool for detecting SSD should be systematically incorporated in routine clinical care, with an emphasis on settings with restricted assessment time, like busy primary care surgeries and hospitals. Consequentially, the aim of this doctoral thesis is to investigate changes in pain, disability and quality of life among patients with Chronic Low Back Pain after the implementation of a physical therapy regimen, and to explore the impact of different psychological factors on the above parameters. Sub-objective of the study is to determine the prevalence of somatic symptom disorders, anxiety and depression in those subjects. The study design is prospective and the participants will be followed for six months after the physical therapy intervention. During this period of time three measurements will take place (baseline measurement before intervention and second at the end of it, and then at six months later) using generic and disease-specific self-administered questionnaires, like the Numerical Pain Scale (NPS) for pain, the Rolland-Morris for disability, the EuroQoL 5-dimension 5-level (EQ-5D-5L) for health status, the Somatic Symptom Scale-8 (SSS-8) for somatic symptom burden, the Hospital Anxiety and Depression Scale (HADS) for anxiety and depression and a questionnaire about sociodemographic characteristics.
Interventions
The conventional intervention was administered to lumbosacral part by a physical therapist (one-on-one), including massage, ultrasound, TENS, low-level laser and exercise program (a sum of 10 sessions with all components of the intervention, 5 consecutive weekdays using a session attendance log). Massage (with deep stroking, wringing, friction, pulling and rolling techniques) and continuous ultrasound (frequency : 1 MHz, intensity : 1.5 W/cm2) lasted for 15 minutes and 5 minutes, respectively. A
The conventional intervention was administered to lumbosacral part by a physical therapist (one-on-one), including massage, ultrasound, TENS, low-level laser and exercise program (a sum of 10 sessions with all components of the intervention, 5 consecutive weekdays using a session attendance log). Massage (with deep stroking, wringing, friction, pulling and rolling techniques) and continuous ultrasound (frequency : 1 MHz, intensity : 1.5 W/cm2) lasted for 15 minutes and 5 minutes, respectively. Additionally, TENS was applied to lumbosacral part with four cutaneous electrodes for 20 minutes. Exercise program consisted of a strengthening part of the back and frontal abdominal muscles performed for 20 minutes with a set of 10 repetitions on each exercise (pelvic tilt, abdominal hollowing, knee to chest, oblique crunch, supine plank, bird and dog, cat and camel, lower abdominal and back extension exercises), as well as a stretching part of the hip flexors, hamstrings and lumbar extensors performed for 30 seconds on each muscle group. Last but not least, continuous low-level laser was applied with a contact method at four points over both sides of the spinal column for 80 seconds (830 nm, 120 m, 0-50000 Hz). During the treatment, patients could select to sit in a chair or lie down on a bed in the prone position in order to control for positional intolerance.
Sponsors
School of Medicine, National and Kapodistrian University of Athens
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with Chronic Low Back Pain
Exclusion criteria
Subjects with previous spinal surgery or cancer, fibromyalgia syndrome, psoriatic arthritis, rheumatoid arthritis, spinal fracture, cauda equina syndrome, spondylolisthesis, scoliosis less than or equal to 20* and ankylosing spondylitis (red flags).
Outcome results
None listed