Forty-two patients (29 females and 13 males) with CLBP lasting for at least 3 months were included in the study. Patient age (years), body mass index (BMI; kg/m
2), occupation, and duration of symptoms were recorded. All patients were examined thoroughly by the same physicians; routine laboratory test results as well as radiographs were evaluated. Patients were excluded from the study for the following reasons: evidence for acute radiculopathy; the presence of an inflammatory disease, neoplastic disease, spondylolysis, spondylolisthesis or sacroiliitis; lumbar disc herniation requiring surgical treatment; vertebral fractures; pregnancy. The study was approved by the local Ethics Committee and written informed consent was obtained from all patients.
The consecutive patients were randomly allocated into two groups. This was a single-blind study. Patients were treated 5 days a week for 3 weeks. Group 1 patients received hot packs (15 minutes), US, and exercise, and group 2 patients received hot packs (15 minutes), sham US, and exercise.
Therapeutic ultrasound
In group 1, continuous US (Sonopuls 434, Enraf Nonius, Al-Delft, The Netherlands) was applied to the lumbar paravertebral region at a 1 MHz frequency at an intensity of 1 W cm2 for 10 minutes using a probe with an effective radiating area of 5 cm2.
Sham US was applied to the same region for the same duration in group 2 patients. The same US device was used. No current was applied but the device and the indicator lights were kept in the “on” position.
Therapeutic exercise
Both groups performed range of motion, stretching (hamstring, pelvic, and abdominal muscles) and strengthening (cervical, thoracic, and lumbar region muscles) exercises for 15 minutes.
Clinical Assessment
Pain
The severity of pain was assessed using a visual analog scale (VAS). Patients were asked to place a mark along a 100-mm line that best describes the severity of pain they were currently experiencing. Pain was assessed at rest as well as during activity.
Disability
The Modified Oswestry Low Back Pain Disability Questionnaire (m-OSW) consists of 10 items; each item is scored from 0-5. Items include pain intensity, personal care, lifting, walking, sitting, standing, sleeping, employment/homemaking, traveling, and social life 8, 9. The total score ranges from 0-50. The disability level is increased by an increased total score.
The Pain Disability Index (PDI) consists of 7 items, including family/home responsibilities, social activity, recreation, self-care, occupation, sexual behavior, and life-support activity 9, 10. Each item is scored from 0-10, with 0 indicating no disability and 10 indicating worst disability. The total score ranges from 0-70, with 0 indicating no disability and 70 indicating severe disability.
Functional performance
The 6-minute walk test (6MWT) was performed by measuring the distance (in meters) the patient could walk in 6 minutes.
Quality of life
The Short Form-36 (SF-36; the MOS 36-item short-form health survey) is a widely used measure of QOL and consists of 36 items evaluating physical functioning, physical role functioning, emotional role functioning, social role functioning, general health, mental health, bodily pain, and vitality 11. Scores for 8 domains are calculated by summing up the item scores, which are coded in such a way that each domain is scored from 0-100, with 0 indicating the worst health status and 100 indicating the best health status.
Depression
The Beck Depression Inventory (BDI) consists of 21 items 12. Each of the 21 items on the BDI consists of four statements. These statements are placed in an order from a neutral state (0 points) to the worst state (3 points). The statements composing this scale have been taken from the statements of actual patients being treated for depression. The patients are asked to choose one of the four statements which best describes their feelings. The highest score is 63 and scores of 0-13 are rated as no depression, 14-24 as moderate depression, and over 25 as severe depression.
The above-mentioned parameters were measured in all patients before and after treatment.
Statistical Analysis
Statistical analysis was conducted using SPSS for Windows (Version 13.0; SPSS Inc., Chicago, IL, USA). Normality of data distribution was assessed using the Kolmogorov-Smirnov test. Data were presented as mean±standard deviation or median (range). Inter-group comparisons of normally-distributed data were performed using Student's t-test while the Mann Whitney-U test was used for inter-group comparisons of non-normally-distributed data. While a paired-t test was used for intra-group comparisons of normally-distributed data, we performed intra-group comparisons of non-normally distributed data by using the Wilcoxon signed ranks test. The two groups were compared in terms of occupation by a chi-square test. A p value < 0.05 was considered statistically significant.