2.1. Study Design and Participants
The study was a randomised assessor-blind controlled trial (RCT ID: IRCT20200212046469N1). Patients (age 24.7±2.1 years) with chronic neck pain were recruited by orthopaedic physicians via flyers displayed at the hospitals over 3-months from April to June 2020.
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Inclusion criteria were males and females who using a smartphone for more than 4 hours a day who rated their ‘worst pain over the last 24-hours’ as moderate using the visual analogue scale (VAS), with neck disability index (NDI) scores between 28% and 45%, and pain lasting longer than 3 months [8-11]. Forward head posture was defined as a cervical angle <50° [12-14]. A lateral-view photograph was taken to identify cervical angle in standing position [12-14].
The exclusion criteria were, previous history of neck or back surgery, neurological signs, rheumatoid arthritis, and currently using muscle relaxation medication. The local ethics committee at Kharazmi University approved the study protocol. This study complied with the ethical standards of the Declaration of Helsinki and all subjects signed informed consent.
Participants were randomised into two experimental groups and one control group, by drawing a number, from 1 to 63, placed in sealed envelopes in a box prepared in advance by the trainer. The randomisation sequence was not disclosed until participants had completed their baseline assessments. The assessor was blinded to group allocation. Participants were not blinded to exercise study, however they were not aware which treatment was considered to be therapeutic. The same physiotherapist and trainer supervised both active treatment groups.
2.2. Outcome Assessments
The outcomes were measured at baseline and post-treatment two days after the 8-week intervention. The primary outcome measure was pain, and secondary outcome measures were EMG, respiratory pattern, and posture.
All participants completed a baseline questionnaire (Table 1). A physical therapy evaluation was performed by a Ph.D. trained physiotherapist with 25 years of clinical experience who was unaware of the type of treatments given and the group randomisation. All participants were instructed to limit their weekly exercise to the study treatment [3, 15, 16].
2.2.1. Pain intensity
Pain was evaluated using VAS choosing a number from 0 (no pain at all) to 10 (unbearable pain), which was displayed along a horizontal line. This scale is widely used in clinical settings [17, 18] and is a valid and reliable tool [16]. The minimum clinically important difference for within-group on the pain scale has been reported to be 2.5-points in people with chronic neck pain with a baseline score greater than 6.0 [19].
2.2.2. Electromyography
An EMG device with eight channels (made by data Log Biometrics company, Canada) was used to measure the activity of upper trapezius muscles, sternocleidomastoid, scalene, neck erector spine, and diaphragm muscles. Based on the recommendations of SENIAM, the skin surface was shaved of hair and cleaned with alcohol swabs before wireless EMG electrodes were applied. EMG electrodes were placed in five areas as follows: upper trapezius, as positioned from the lateral to the midpoint, as an imaginary line was formed by the posterior aspect of the acromion and the spinous process of C7, and the electrode was placed on the muscle bulk [20]. For the sternocleidomastoid, the electrode was placed at the lower one-third of the line connecting the sternal notch and mastoid process [20]. Forward head posture was defined as a cervical angle<50° [12-14]. A lateral-view photograph was taken to identify cervical angles in a standing position [12-14]. For scalene muscles, the electrode was placed on the posterior triangle of the scalene muscle, above the clavicle, more inclined to the sternocleidomastoid (just posterior to and at a slightly oblique angle relative to the sternocleidomastoid [SCM], just above the clavicle and in the hollow triangle anterior of the upper trapezius) [21]. For neck erector spine, the electrode was attached to the muscles around the C4 vertebra [22]. The diaphragm, lower edge of the rib cage on a vertical line that passes through the nipple centre was selected for electrode placement [23].
The EMG information was collected using an EMG device with a sampling frequency of 1000 hertz, and in this study the EMG signal data were sampled at 1000 hertz. These signals were filtered in the bandpass between 20 and 500 hertz [20]. The full shoulder flexion task was used to obtain data on the activity of the selected muscles. In this regard, each flexion movement and return to the initial state was performed by the subjects at a 5-second time, in 3 consecutive times [20, 21, 24].
Additionally, to estimate a maximum voluntary contraction (MVC) for the upper trapezius, subjects placed their hand at 900 abduction, sitting down on a chair, and were asked to apply pressure against the exposed resistance at the top [25]. To obtain the MVC for sternocleidomastoid and scalene muscles, subjects were placed in the supine position, and their hands were put on their own heads. Then, the head was anterolaterally placed and pressurised against the hand resistance [21]. To obtain the MVC for the erector spinae muscle, the subjects were asked to be in a prone posture and put both hands behind their head as moving the overhand against the resistance in the extension direction [25]. To achieve MVC for the diaphragm muscle in the sitting position subjects took deep breaths [26]. Each position of the maximal voluntary contraction was used two times for 5-second duration to normalise the data [25].
The EMG signal was processed by the Root Mean Square (RMS) algorithm in the MATLAB program. The resulting number represented the average power of a signal that indicated the muscle activity. To compare the subjects and normalise the data, the obtained values from the RMS were divided by those obtained from the MVC of each muscle, and the amount of muscle activity was considered as a percentage of the MVC [20, 21, 24].
2.2.3. Respiratory Pattern Assessment
To assess the breathing pattern using Manual Assessment of Respiratory Motion (MARM), as the subject sitting on the bed, with natural breathing, the tester recorded and interpreted different aspects of respiration, including the number of breaths and the balance of respiration between the upper and lower parts of the rib cage and abdomen, by touching the lower back and lateral rib cage with both hands and without putting pressure on these parts [15].
2.2.4. Forward head posture assessment
The forward head and shoulder angles were measured using photogrammetry of the sagittal plane. This method favoured reliability, and it has been used in various research [3]. To measure the angles, three anatomical signs, including left tragus, acromion, and the spinous process of C7 vertebra were determined and marked. Then, the subjects were asked to stand at the designated area beside a wall (at a 23-cm distance) so that their left side was placed toward the wall. The photographic tripod supporting the digital camera was placed at a distance of 265 cm, and its height was set based on the subject’s right shoulder level. In such circumstances, the subjects were asked to lean forward three times and raise their hand over their head three times. They were then asked to stand in a completely relaxed and natural posture, and to look at an imaginary point on the opposite wall (eyes in line with horizon). The tester took images of the body profile view after a five-second pause. Finally, these images were transferred to a computer, and the angle of the line connecting tragus to C7 vertebrae, and that of the line connecting C7 and the acromion process were respectively measured with the vertical line (forward head and shoulder angles) using Kenova software (Kinova-0.8.27-64-bit, Kinova company, Canada) [27, 28].
2.3. Training Protocol
As intended in this study, training included two parts: therapeutic routine and respiratory exercises. The therapeutic exercises contained resistance and stretching exercises (in the three stretching exercises, we used the static stretching with a 30-second hold for 2 sets) for 45 to 60 minutes per session, specifically one session a day for 3 sessions a week; totally all held in 8 weeks [29, 30]. The rest interval between movements in these exercises was 45 and 30 seconds for resistance and stretching exercises respectively. In the combined group respiratory exercises were added to the therapeutic routine above which consisted of balloon breathing exercises performed in sessions of 4 sets, and as each set had 4 complete breathing breaks, these exercises were conducted for 2 sessions a day and 3 days a week for 8 weeks [31]. All exercise was done under supervision of a physical therapist at the pain clinic. All participants received documentation including information on postural corrections and improving general health.
2.4. Control Group
The control group (n=20) received a pamphlet including information on postural corrections and improving general health during the 8-week study period. No other physical therapy modalities or treatments were performed [32].
2.5. Statistical analysis
The necessary sample size was estimated using G*Power 3.1.7 for Windows (G*Power©, University of Dusseldorf, Germany). The sample size calculation was considered a power calculation to detect between-group differences in the primary outcome measure (neck pain). To obtain 80% statistical power (1-β error probability) with an α error level probability of 0.05, we used repeated-measure analysis of variance (ANOVA), within-between interaction, and a medium effect size of 0.25 to consider two groups and two measurements for the primary outcome, generating a sample size about of 18 participants per group (total sample size of 54 subjects). The sample was increased to 63 (21 in each group) to allow for a 15% dropout rate. A total of 63 subjects met study criteria and participated in the study.
One-way ANOVA was used to compare the group demographics and post hoc independent t-tests were performed in the case of a significant omnibus test. The dependent variables of interest were pain, function, strength, and kinematics. For each variable, the 3-trial mean was calculated for each participant. One-way analysis of covariance (ANCOVA), with a between-factor of the group (control, therapeutic routine, combined exercises) and participants' baseline scores included as a covariate, was used to determine if there were group differences in the dependent variables of interest at post-testing.
This analysis approach (i.e. post-test performance as the outcome with baseline performance as a covariate) allowed us to compare post-testing outcomes while accounting for potential baseline group differences [33]. In the case of a significant omnibus test, pairwise comparisons were performed to examine potential between-group differences. These pairwise comparisons were based on the adjusted group means. In addition, 95% confidence intervals (CI95%) were calculated based on the adjusted group mean differences, and Cohen’s d effect size (ES) statistics were calculated by dividing the adjusted group mean differences by the larger of the group standard deviations. The Bryant-Paulson procedure was used when conducting the pairwise comparisons and calculating the confidence intervals [34]. An alpha of .05 was used for all significance tests. Effect sizes of 0.2, 0.5, and 0.8 were considered ‘small’, ‘moderate’, and ‘large’ respectively [35]. SPSS software was used for statistical analysis (IBM Corp., Armonk, NY, USA).