Study design, participants and sample size
This is a quasi-experimental study. Participants were patients who had referred to Shiraz private chiropractic clinics with chronic LBP who had the first chiropractic visit and had no pathologic abnormalities. Inclusion criteria consisted of being at least eighteen-years-old, mechanical LBP greater than 3 months, and living in Fars province. Exclusion criteria consisted of non-somatic LBP, presence of any comorbidity that could affect the treatment prognosis, pregnancy, chiropractic treatment less than 3 months ago, contraindication of manipulation including coagulation disorders or usage of anticoagulant agents or corticosteroids, inaccessibility to an available phone and drug addiction. Sample size was based on the study by Eklund et al. using the sample size determination formula in quasi-experimental studies, and by considering the type I error of 5% (α = 0.05), and type II error of 20% (β = 0.20) the sample size was determined at 141 patients (19).
Data Collection and Questionnaire
Data were collected in two stages, baseline visit and 8 weeks after treatment. The first stage was at the baseline visit and before the intervention. Data were collected through questionnaires. The first questionnaire included demographic information such as age, gender, weight, height, literacy level, place of residence, marital status, occupation, economic status, duration of LBP, and history of LBP in the family. Economic status was categorized into four groups regarding household income distribution in Shiraz, Iran as follows; 1- lower than intermediate: between 250 and 634 United States Dollars (USD), 2- intermediate: between 634 and 1184 USD, and 3- higher than intermediate: above 1184 USD in 2017 (20).
Moreover, Magnetic Resonance Imaging (MRI) was performed using a 3.0-T unit (Symphony Quantum, Siemens AG Medical Solutions). The patients' lumbosacral spine MRI was evaluated and according to the extent of the intervertebral disc injury, patients were divided into three groups: all subjects were grouped into three categories: mildly degeneration (Grade II), moderately degeneration (Grade III), and severely degeneration (Grade IV and Grade V) (21). The following three questionnaires were used to evaluate the effectiveness of the intervention.
Roland Morris Questionnaire
Assessment of disability due to LBP was performed, using the standard Roland Morris Disability Questionnaire (RMDQ) before and after the intervention. The RMDQ is a patient-administered self-reporting instrument. It is a 24 item questioner with possible scores ranging from 0 level (the less disability) to 24 level (severe disability). Each item includes a sentence in which the qualification of LBP is interpreted. Patients only ticked sentences indicating their LBP during the past 24 hours. This questionnaire has Cronbach's alpha = 0.84 to 0.96 and r = 0.83 to 0.9 (22). The validity and reliability of this questionnaire was obtained by Mousavi et al. in 2006 in Iran (23). The RMDQ was chosen due to its higher sensitivity in detecting changes in disability amongst patients with LBP, which was utilized in clinical trial studies more than other similar questionnaires (24, 25). RMDQ was answered by the patients at baseline visit and eight weeks after the onset of treatment. Based on the previous study a 30 % (7 level) decrease in the RMDQ scale was defined as clinically meaningful effect (26).
Numerical Rating Scale (NRS)
NRS is a patient-administered self-reporting instrument. The participants were asked to rate their average level of LBP within the past week on an ordinal 11-point scale (0 = no LBP, 10 = worst possible LBP) before and 8 weeks after the onset of treatment. Each three scores indicated a level of pain as follows: 0 = no pain, 1 to 3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. The NRS has excellent metric properties and is commonly used in Randomized Clinical Trials (RCTs), and has validated as a reliable measure (27). The sensitivity of the NRS for LBP was evaluated by Childs et al., who confirmed its sensitivity in 2005 (28). This questionnaire was used by Forutani et al., 2018 in Iran and was shown to be valid and reliable (29).
Global Rating of Change (GRC)
The GRC questionnaire was used during the follow-up stage. This is a patient-administered self-reporting instrument, which evaluates the change in LBP after the intervention through a single-question questionnaire that evaluates the global LBP improvement. Participants were asked to rate their perceived LBP improvement 8 weeks after the onset of treatment. The validity and reliability of this questionnaire was confirmed by Foroutani et al., 2018 in Iran (29).
Intervention
The treatment stages include manual techniques that emphasize on the processes of adjustment, manipulation and to some extent, mobilization and soft tissue reflex techniques. It also includes rehabilitation programs, psychosocial aspects of patient’s care, patient’s education on spine health, and proper posture. Our intervention included six sessions, every other day during two weeks. Each treatment session lasted for about twenty minutes, and interventions were selected according to each patient's condition, as follows:
- Activator: A device used to correct spine rotation by asking the patient to perform a specific maneuver for each vertebra, then checking the patient's legs to find any vertebral rotation. If there was any vertebral rotation, the activator would hit the transverse process to adjust all the vertebras.
- Drop table: A table with mobile cervical, lumbar and pelvic parts and is most commonly used to adjust hip rotation.
- Arthrostem: It resembles an activator, but has stronger pulses and is used to align the spine and stimulate the muscles.
- Flexion-destruction bed, creates flexion and extension to reduce muscle spasm and cause rehydration of the intervertebral discs.
- Finally, Manipulation to adjust the spine.
Then patients were advised to avoid activities that could cause LBP relapse. Patients were explained that the best outcome would be achieved six to eight weeks after treatment, when the joints inflammation were relieved. The second stage was followed up via telephone call.
Statistical analysis
The collected data was analyzed by SPSS 24 software (Version 22, IBM Corp, Armonk, NY). Frequencies and percentages were calculated for all variable categories. In this study, in addition to measuring the descriptive statistics such as mean, Standard Deviation (SD), t-test for quantitative variables analysis and Chi-square test for qualitative variables analysis and the effect of gender on the intensity of MRI findings. Linear regression statistical models and logistic analysis were used to examine the factors affecting the effectiveness of the intervention in RMDQ instrument separately. Independent t-test, ANOVA, Paired-T test and Chi-square test were used to compare groups. Differences were considered significant at a two-tailed P < 0.050 for all statistical analyzes.