Study Design and participants
The study was a three-arm randomized controlled trial with three, and the procedures were
conducted according to the CONSORT guidelines. Figure 1 presents the flowchart showing
the exact procedures of the trial. A research assistant was assigned to handle the initial
baseline assessment and conduct the randomization for group allocation. The outcome assessor was blinded to the group allocation of the participants.
A total of 90 participants with a history of neck pain for more than 3 months were recruited by convenience sampling among the university staff and student community. As the study progressed, some participants did not complete the intervention for 6 weeks despite repeated reminders. The numbers of drop-outs were 5, 1 and 3 for Muscle Biofeedback Group, Posture Biofeedback Group, and Control Group respectively. Hence the final number of participants who underwent the post-intervention assessment was 81. A flowchart illustrating the study design is presented in Figure 1.
The inclusion criteria for the participants were: 1) daily smartphone user for more than 2 hours per day; 2) current neck pain (at least 2/10); 3) NDI scored > 8/100. The exclusion criteria were: 1) presence of recent trauma or history of cervical or thoracic surgery; 2) severe arthritis or joint disorders; 3) other chronic diseases affecting the musculoskeletal system.
Participants were also asked to declare whether they were currently receiving any medical treatment or any form of therapy prior to the trial. They were instructed to refrain from these other forms of treatment during the trial period.
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Interventions
Muscle Biofeedback Group
Participants in Muscle Biofeedback group were taught how to use the portable EMG electromyographic (EMG) biofeedback device, the Pathway system (Pathway® MR-20 EMG Systems) with 2 channels (see Figure 2). The bilateral cervical erector spinae (CES) were the main muscles for the biofeedback training, as they are the primary muscles for controlling the head-neck flexion posture against gravity. Surface EMG were attached to standardised positions on the neck, and the participants were trained to apply these electrodes correctly. Participants could move around and continue their normal daily activities. They were instructed to use the biofeedback machine for a total of 2 hours (cumulative) daily for 6 weeks.
The researcher would set the threshold amplitude of the muscle biofeedback training in the first session. The baseline threshold amplitude was determined from the average muscle activity of the CES during the 15-min texting task.
Posture Biofeedback Group
In the first session, participants were instructed on how to wear the sensor Upright Go 2 (UpRight Technologies Ltd.) on the headband (see Figure 2) and to activate the “App” saved on their smartphone. Then they were asked to flex the neck slowly to a certain degree of flexion to set the “threshold” angle. Whenever the user’s neck angle exceeded this threshold angle, a vibration would be emitted in the sensor. It would only be turned off when the user reduced the neck flexion angle below the threshold.
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Control Group
Participants in Control Group were instructed to carry out standard home neck and shoulders exercises on a daily basis for 5 days a week for 6 weeks. The participants in the two intervention groups were also instructed to perform the same exercises as the Control group. During the 6-week intervention period, the participants were advised to avoid any co-interventions for their neck pain.
Outcome Measures
The same outcome measures were evaluated at baseline, after the 6-week intervention and at 6 months’ follow-up for all three groups. Subjective pain scores were recorded using the Numeric Pain Rating Scale (NPRS) from 0 to 10.Neck Disability Index (NDI) in the Chinese version was used as the functional outcome measure [20-21]. Both the NPRS and NDI were evaluated before and after the 6-week intervention as well as 6-month follow-up.
For the biomechanical measurements, surface electromyography (EMG) electrodes and 3D motion sensors were placed on the participants’ neck and upper back regions for recording the data during a 15-min texting task using a standard touch-screen smartphone. This specific assessment was conducted before and after the 6-week intervention.
Surface EMG signals were recorded using Noraxon MyoMotion (Noraxon, USA Inc., USA) with a sampling frequency of 1000Hz. Bilateral cervical erector spinae (CES) at C4, upper trapezius (UT) and thoracic erector spinae (TES) at T10 were selected as the muscles for measurement. The EMG signals were recorded with a sampling frequency of 1000Hz, bandwidth of 10–500Hz and common mode rejection ratio of 85db. The EMG signals received from the transmitter had undergone a 12-bit analogue-to-digital (A/D) conversion at a sampling frequency of 1500Hz. Standard procedures in skin preparation and signal processing were performed as in previous research studies.
Maximum voluntary contraction (MVC) was performed to normalise the EMG signals in the smartphone texting tasks. A handheld dynamometer was used to perform the resistance against the muscle contractions and the force produced in each trial was recorded. For each muscle group, three trials of MVC were performed with a 1-min rest in between. The EMG signals recorded during the simulated smartphone texting task were normalised to the respective MVC value of each muscle.
Four inertial motion sensors (IMU) were placed on the occiput, C7, T7 and T12 to record the spinal movements in three planes in the neck, upper thoracic and lower thoracic segments. These measurements were synchronised with the EMG data during the 15-min smartphone texting task.
Data Processing and Statistical Analysis
Baseline demographic data were summarized in descriptive statistics such as means, standard deviations and percentages. The primary dependent variables in the present study consisted of neck pain score (NPRS) and NDI scores. These outcome measures were compared at three time points: pre-, post-intervention, and at 6 months follow-up (T0, T1, T2). Linear mixed model was used to compare these variables with time (x 3 levels), Group (x3 levels), and Groups effects across time (with control group and T0 as reference). All analysis was two-tailed with the alpha-value set at 0.05 for statistical analysis.
Kinematics and muscle activity data collected were synchronized using Noraxon MR3.10 software. For the surface EMG data of the bilateral CES, TES and UT muscles during the smartphone texting task, the data were normalized to the MVC and then processed for the amplitude probability distribution function (APDF). The 50th% APDF of each muscle was considered the median or average muscle activity value. These were compared within each group as the pre-post outcome measure. For the spinal kinematics, the mean flexion angle of the 3 spinal regions during the texting task was also compared at pre-and post-intervention.
All data sets underwent Shapiro–Wilk test to determine if they were normally distributed. Repeated Measure ANOVA and independent sample t-tests were performed for data analysis in the study. Tests were conducted to ensure the residual is normally distributed after model fitted. The significant value of p<0.05 was used for all the statistical analyses.