Effect of dynamic taping on neck pain, disability, and quality of life in patients with chronic non-specific neck pain: a randomized sham-control trial

Study design

A parallel-arm randomized controlled trial was prospectively registered with the Clinical Trial Registry India under the identifier 2022/07/043700. The trial aimed to compare the effects of DT against sham taping, conducted in accordance with the Consort—2010 guidelines (Calvert et al., 2013). All participants provided informed consent, and the trial adhered to the principles outlined in the Declaration of Helsinki (Skierka & Michels, 2018). Ethical approval was obtained from the Departmental Ethics committee of the Physiotherapy Department, NIMS University, affirming adherence to ethical standards and oversight for the research NU/NCPT/JUNE/15. Based on the criteria for inclusion, an independent observer used block procedure with a block size of 6 for the randomization of participants in a 1:1 allocation ratio into the DT or sham group (Kang, Ragan & Park, 2008). Index cards with sequential number were folded and sealed in opaque envelopes. The primary investigator was concealed from this task. The assessors were blinded to the opened envelop and group assignment. This study adhered to the Sex and Gender Equity in Research (SAGER) guidelines for reporting sex and gender information.

Participants and recruitment

Participants with a history of CNSNP were recruited over a 1-year period from the Physical and Rehabilitation Medicine (PMR) department and the outpatient department (OPD) of physiotherapy at the National Institute of Medical Sciences (NIMS) University teaching hospital. Additionally, a targeted advertising campaign, utilizing pamphlets, was implemented to raise awareness about the research within the nearby residential zones, covering an approximate area of 3 square kilometers surrounding the study center. This initiative aimed to enhance recruitment efforts and engage potential participants in the study. NIMS hospital, situated in the densely populated Jaipur city, India, provides free consultation, diagnostics, and treatments, making it a major tertiary care center in the region. Two trained physiotherapists screened all potential participants, and eligible individuals who provided written consent to participate were recruited. Data collection from participants commenced in July and concluded in December 2022.

The inclusion criteria encompassed individuals aged 18 to 60 years with a duration of CNSNP lasting at least three months. Diagnosis was established through a comprehensive assessment of medical history, physical examination, and the exclusion of specific underlying pathologies via imaging studies and laboratory tests. Criteria for inclusion further specified chronic neck pain without a clear structural cause, the absence of identifiable systemic or local pathology, and a minimum duration of three months. Exclusion criteria comprised patients diagnosed with fibromyalgia, those who had undergone taping in the cervical region in the past 6 months, individuals with whiplash injuries, tape-related allergies, cervical myelopathy, a history of cervical and/or thoracic spine fracture, inflammatory conditions, skin conditions involving the cervical region, and pregnant women (see Fig. 1).

Sample size determination

The G*power software, version 3.1.9.4 (University of Kiel, Kiel, Germany) was used to determine the required power-calculated sample for this two tailed trial (Faul et al., 2007). A two-group independent t-test with a significance level of 0.05 and a power of 0.80 was employed. The analysis resulted in an optimal sample size of 140 participants, evenly distributed with 70 in each group (Naseri et al., 2016).

Outcome measures

The primary outcomes of interest included functional disability, measured using the Hindi version of the neck disability index (NDI), and the intensity of neck pain during rest using the visual analogue scale (VAS). Additionally, the quality of life was assessed with the World Health Organization—Five Well-Being Index (WHO-5). The testing of outcome measures was conducted individually in a quiet ambience at the physiotherapy outpatient department (OPD) and lasted for 15 to 20 min. The outcome measures were recorded at baseline (pre-taping), post-intervention (at 4 weeks post-taping), and follow-up (at 4 weeks after the last taping session).

Description of intervention (experimental and standard physiotherapy care protocol)

Six qualified and experienced physical therapists affiliated with NIMS participated in this study. Among them, two therapists (blinded to subject allocation) conducted baseline, post-test, and follow-up outcome measurements. Another two physical therapists (blinded to subject allocation) provided standard physiotherapy care. The remaining two therapists underwent a 3-day training conducted by the principal author (MS) before the study commenced. The principal author (MS) played a crucial role in maintaining consistency throughout the study, ensuring uniformity in standard physiotherapy care, taping application, and pre-post assessments across all six physical therapists. Typically, the taping session lasted 10–15 min, while standard physiotherapy care required 45 min.

Each week, 24–28 patients were managed simultaneously, distributed among six physical therapists. The schedule involved treating 6-7 patients (3-days a week) on Monday, Wednesday, and Saturday, and an additional 6–7 patients on Tuesday, Thursday, and Friday. This arrangement totaled 12–14 patients for each therapist individually and 24–28 for the two therapists working collaboratively. The data collection spanned six months, during which the center successfully collected data for 136 patients with CNSNP, despite encountering 4 dropouts during the study period.

DTC group protocol (experimental group)

After screening for recruitment criteria, a sensitivity test was conducted by applying a small piece of DT to the inner part of the non-dominant arm of the volunteer participant, kept in place for 24 h. The following day, the test area was examined for any allergic reaction. The trial utilized a waterproof tape with a porous texture, adhesive, and a width of five cm, manufactured by Posture Pals Pvt. LTD, Port Vila, Vanuatu.

Before tape application, the treatment area was cleaned with water, and excess hair was trimmed using a trimmer. The skin was kept dry and free from any oils, lotions, or sweat for proper adhesion. The tape was cut to the desired length, rounding the edges to prevent peeling. Patients were informed about the features of DT, such as its four-way stretch materials and strong recoil property. The starting position involved both hands at the side of the body. Patients were instructed to shrug both shoulders while keeping the scapulae in a retracted position. The tape was then applied, running through both shoulders using the cervico-thoracic junction while maintaining C7 as the fulcrum point. Anchor points were created at both ends of the tape with no stretch applied, applying light tension to the skin. Patients were then instructed to shrug their shoulders while retracting both scapulae, and the tape was applied using 20–30% stretch or tension. It was smoothed down from the cervico-thoracic junction to the other side of the shoulder and anchored without any tension. Patients were asked to relax their shoulders, ensuring they felt the weight of the shoulders borne by the tape. The last component of the cervical offload technique involved the box offload technique through the supraclavicular area. Two small strips were cut for both sides of the neck. The anchor points were created around the spine of the scapula, pulling the soft tissue with mild tension, and then stuck around another anchor point anteriorly just below the clavicle, as seen in Fig. 2. Participants were blinded to appropriate tension taping and (sham) no tension taping intervention. The cervical offload technique was employed during the application of dynamic tape. Standard physiotherapy care for both groups was similar, with only the adjunct taping intervention being manipulated. The tape was applied and replaced every 3 days for the next 4 weeks, and the skin under the tape was examined during reapplications. Both groups received nine sessions of taping, and the ninth dynamic tape application was removed on the last day of the 4 weeks’ post-intervention period (see Fig. 2).

Statistical analysis

IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp., Armonk, NY, USA) was utilized for the analysis. Baseline measures and socio-demographic clinical characteristics were analyzed using chi-square test, ANOVA, and independent sample t-test. The scores obtained from the NDI, VAS, and the WHO-5 were approximately normally distributed for both the experimental and sham groups, as indicated by the Shapiro–Wilk test (p > 0.05) and a visual examination of their histograms, normal Q–Q plots, and box plots. A 2 (condition) ×3 (time) mixed model repeated measures ANOVA, with group (dynamic taping and sham taping), and measurement times (baseline, post-intervention, and 4 weeks follow-up) as between and repeated measures respectively, was conducted. Levene’s and Mauchly’s tests were used to check the assumptions of homogeneity and sphericity respectively. In the case of sphericity assumption violations, the Greenhouse-correction method was applied (Mishra et al., 2019). The Bonferroni analysis was conducted to determine the difference within and between groups (Kim, 2015; Haverkamp & Beauducel, 2017). In addition, the effect size was calculated as partial eta squared (ηp²), and the level of significance for the statistical tests was set at p < 0.05 with a 95% confidence interval. The participants completed the questionnaire outcome measures (NDI, VAS, and WHO-5) at baseline, 4 weeks post-intervention, and 4 weeks follow-up. The improvement or changes in scores from baseline to follow-up were expressed as a percentage by calculating the mean difference between the baseline and follow-up scores to the ratio of the baseline score expressed as a percent. The hypothesis of interest was the group*time interaction at a priori alpha (α) level of 0.05. Supplementary data analyses were performed according to the intention-to-treat principle to preserve the original random assignment, using the first observation carried forward method, assuming that the pre-taping data is most representative (important moment of effect) of post-intervention measurements for drop-outs (File S2). According to the recommendation of SAGER guidelines, gender difference and/or similarities were analyzed.

Participants

Table 1 presents the descriptive statistics of the participants who completed the baseline questionnaire in this trial. Initially, 140 patients with CNSNP volunteered to participate. After 1:1 allocation and baseline assessment, four patients dropped out (DTC group n = 1 and STC group n = 3) after one taping session. The flow chart (Fig. 1) describes the reasons for dropout and exclusion (n = 16) from the study. The participants had a mean age of 43.76 ± 8.15, with a majority being female (n = 84) 61.8%, DTC group (n = 46) 66.7% versus STC group (n = 38) 56.7%, p < 0.01 as shown in Table 1. The Chi-square test indicated significant differences between the groups at baseline for variables such as gender, type of occupation, self-reported level of physical activity, and smoking habits . However, the independent sample t-tests revealed no differences between the groups on any of the baseline outcome measures. Adverse effects or events reported during the taping sessions included a feeling of restriction in neck movements (n = 2), redness of the skin under the tape (n = 3), which resolved in 2 days. Importantly, none of the adverse events resulted in the discontinuation of the intervention.

Effect of treatment

To assess the impact of the intervention on functional disability related to neck pain, a 2 (intervention groups) × 3 (time points) repeated measures ANOVA was conducted. Differences between STC and DTC were explored using Bonferroni-corrected post hoc tests to determine the variations between taping interventions. The results of the NDI demonstrated a significant main effect for time (F = 219.24, p < 0.001, ηp² = 0.62). Although the interaction effect was significant (F = 35.67, p < 0.001, ηp² = 0.21), the effect size considerably reduced, indicating a smaller effect of NDI scores between groups. The mean NDI scores in percentage over time for both the groups are presented in Fig. 3.

The post-hoc analysis (Bonferroni correction) revealed significant differences between baseline NDI scores and post-intervention NDI scores (mean difference = 10.24 (8.81–11.67), p < 0.001). However, the NDI scores between post-intervention and the follow-up period were not significant (mean difference = 0.285 (−0.79–1.36), p = 0.91), suggesting that the improvement in neck function occurred until the taping intervention but did not improve further. Within the DTC group, a significant reduction in functional disability scores (NDI) was observed between baseline and post-intervention (mean difference = −13.76, t = 14.3, p < 0.001), but not between post-intervention and follow-up (mean difference = 1.4, t = 2.46, p = 0.16). Standard physiotherapy care with sham taping resulted in a 13.4% improvement compared to DT with tension, which resulted in a 35.4% improvement (Table 2).

A repeated measures ANOVA was conducted for pain intensity (VAS) and WHO-5, for each measures 2 (intervention group) × 3 (time points) was tested with the Bonferroni post-hoc tests. The 2 × 3 mixed ANOVA of VAS score demonstrated a significant main effect of intervention for time (F = 305.2, ηp² = 0.69, p < 0.001) with a large effect size, and a significant interaction between intervention and time (F = 26.6, ηp² = 0.166, p < 0.001) with a small effect size. Bonferroni comparison analysis indicated significant differences between baseline pain and post-intervention pain VAS scores (mean difference = 1.99 [1.76–2.23], p < 0.001), as well as post-intervention pain and follow-up pain scores (mean difference = 0.377 [0.17–0.59], p < 0.001) (see Fig. 4). The DTC and the STC exhibited a substantial difference in the percentage of improvement between baseline and follow-up measures (47.26% versus 28.4%). The mental wellbeing measures (WHO-5) showed a significant main effect of intervention (F = 7.32, ηp² = 0.05, p = 0.008) but did not demonstrate significant interaction between intervention and time effect (F = 3.38, ηp² = 0.0525, p = 0.078). Further, both groups showed a nearly similar improvement percentage in WHO-5 scores between baseline and follow up (23.4% versus 19.9% respectively). A supplementary analysis for gender difference for the main effect and interaction effect (time*gender) showed no significant differences for the outcome measures NDI, VAS, and WHO-55 (F = 3.13, p = 0.80, ηp² = 0.023, F = 0.339, p = 0.67, ηp² = 0.03, F = 0.64, p = 0.46, ηp² = 0.04 respectively) (see Fig. 5).

Effect of DT on pain (VAS)

Our study revealed a statistically significant decrease in VAS scores from baseline to follow-up, demonstrating a reduction of 47.26% and 28.4% in the DTC and STC groups, respectively. Notably, both groups surpassed the Minimal Clinically Important Difference (MCID) for VAS, which is reported for CNSNP at −21% (Lauche et al., 2013). Consistent with our findings, a clinical trial comparing KT to DT in 30 patients with non-specific low back pain reported a 47.9% improvement in VAS scores for the DT group (Mean = 5.80 to 3.71), while the KT group exhibited a 28.0% improvement (Mean = 5.7 to 4.5) from baseline to the 3rd day post-treatment (Jain, 2022). Similarly, a study conducted in Korea involving 40 participants with chronic neck pain for 4 weeks (three times a week) reported a 50% reduction in VAS scores compared to 46.5% in the sham group (Yoon & Kim, 2022).

Effect on disability (NDI)

Our study reported a 13.7% reduction in neck disability from baseline to post-test scores, indicating a total improvement of 37%, while studies suggest that the MCID for NDI is approximately −10% (Lauche et al., 2013). Similarly, a study reported a 45.6% reduction in disability after 4 weeks (three times a week) in the DT group and 34.6% in the Sham group (Yoon & Kim, 2022). These changes in NDI scores may be attributed to improved cervical muscle activity, potentially leading to a further reduction in muscle fatigue (Zulfikri & Justine, 2017), and the superior mechanical properties of DT fostering favorable postural habits among participants with CNSNP (McNeill & Pedersen, 2016). Additionally, research indicates that DT outperforms KT in enhancing muscle endurance (Alahmari et al., 2020). Remarkably, our study also demonstrated improvement in the sham group without tension. These results align with research suggesting that taping without tension can provide additional afferent inputs and enhance positional sense (Alahmari et al., 2017; Reddy, Maiya & Rao, 2012; Kilinç, Harput & Baltaci, 2015; Vanti et al., 2015; Öztürk et al., 2016; Alahmari et al., 2017; Ay et al., 2017). However, contrasting were reported by De Jesus et al. (2017) and Pinheiro et al. (2021), indicating no change in muscle function with different tape tensions.

A comprehensive review of studies conducted on DT has revealed heterogeneous outcomes. For instance, Esen et al. (2022) reported a significant reduction in navicular drop distance following DT application in adolescent female volleyball players. Conversely, Rengaramanujam (2021) found no significant immediate or short-term differences between DT and KT in individuals with chronic non-specific low back pain regarding pain, disability, mobility, and kinesiophobia. DT has proven to be effective in addressing other musculoskeletal conditions, as evidenced by a study that investigated its role in managing greater trochanteric pain syndrome (GTPS). The study analyzed the impact of DT on specific gait-related parameters and pain reduction (Robinson et al., 2019). Fifty women with GTPS underwent three-dimensional gait analysis with active and sham tape applications. The results indicated a significant reduction in hip adduction moment, adduction angle, internal rotation, and pelvic obliquity, with meaningful pain reduction observed for both active and sham taping applications (Robinson et al., 2019). This implies that the effectiveness of DT in addressing disability is context-dependent, and its impact varies across different musculoskeletal conditions.

Effect on well-being (WHO-5)

The WHO-5 Index, a measure of psychological well-being, exhibits a progressive increase from baseline (53.4) to post-intervention (57.6) and extends to follow-up (65.8). The improvement percentage indicates a substantial 23.2% positive change in DTC and 19.9% in STC group from baseline to follow-up. This finding suggests that the intervention involving DT positively influenced the mental and emotional states of the participants, implying that DT, as part of a comprehensive treatment approach, may be effective in addressing psychological well-being among patients with CNSNP. Further discussions and analyses could explore the specific elements of psychological well-being that were influenced and the potential mechanisms through which DT may have contributed to this improvement. Additionally, considering the broader clinical implications of these findings could be beneficial for healthcare practitioners and researchers working in the field.

Immediate and long term effect of DT

The body of literature on taping techniques has significantly expanded in recent years (Thelen, Dauber & Stoneman, 2008). Studies tend to emphasize immediate gains (Tudini et al., 2023) more prominently than short or long-term effects of tape application. However, it is noteworthy that the majority of research is focused on KT rather than DT. Our study showed a statistically significant short-term effect of DT after a 4-week intervention period. Likewise, a single-blind randomized clinical trial involving 30 patients with myofascial pain syndrome reported significant improvements in pain, range of motion (except for neck extension), and neck disability in the treatment group compared to the control group, both in the short and long term with KT (Rasti & Shamsoddini, 2018).