The comparison of Pilates with cognitive functional therapy in adults with chronic neck pain: a protocol for randomized controlled trial

Abstract

Background

Chronic Neck Pain is one of the main musculoskeletal problems in the general population that negatively affects the lives of patients. Its treatment can include various treatment methods, such as Pilates and Cognitive Functional Therapy. The purpose of this research was to investigate the effectiveness of Pilates in relation to Cognitive Functional Therapy in people with Chronic Neck Pain.

Methods

This single-blind randomized controlled study included 60 patients with Chronic Neck Pain who were randomly divided into two groups (Group 1: Pilates, Group 2: Cognitive Functional Therapy). All patients will undergo 16 sessions over 8 weeks. Outcome measures (pain, disability, fear perception, functionality, quality of life, cervical range of motion, and neck muscle isometric strength) will be evaluated at baseline, at the end of the treatment (week 8) and three months after randomization (week 12). Outcome measures will be analyzed via random effects at the three assessment time points, and the interactions of the treatment groups with the assessment points will be included in the results of the fixed model.

Discussion

This is the first Randomized Controlled Trial to compare the effectiveness of Pilates and Cognitive Functional Therapy in patients with chronic neck pain. The results of this research will provide information on the effectiveness of each intervention separately and whether one of the two can outperform the other.

Introduction

Chronic neck pain (CNP) is a pervasive musculoskeletal disorder that affects a large portion of the global population, significantly reducing quality of life due to persistent pain, functional limitations, and psychological consequences [1,2]. It is particularly prevalent among individuals engaged in clerical or sedentary work, where repetitive postures and a lack of movement contribute to its development and chronicity [3]. Defined as a pain persisting for more than three months, CNP can lead to reduced social participation, decreased work productivity, and diminished psychological well-being [4]. Despite its prevalence, there remains no definitive treatment for CNP, and current management strategies largely involve conservative approaches such as physical therapy and exercise [5–8].

Pilates and Cognitive Functional Therapy (CFT) have emerged as promising interventions for the management of CNP. Pilates, a system of exercise focused on core stabilization, breathing, control, and precision, has been shown to improve pain, mobility, and overall functionality in patients with musculoskeletal disorders [9]. It aims to enhance motor control and strengthen muscles around the trunk, which is particularly beneficial for patients with CNP [10]. However, despite some evidence supporting its effectiveness in chronic pain conditions, research on Pilates specifically for CNP is limited [11].

Conversely, CFT is an individualized, biopsychosocial approach aimed at addressing both the physical and cognitive aspects of chronic pain [12]. Initially developed for chronic low back pain, CFT involves cognitive retraining, functional movement exercises, and lifestyle modifications, encouraging patients to manage their pain through behavioral and cognitive strategies [13,14]. Although CFT has shown efficacy in reducing pain and disability in chronic low back pain, research on its application to CNP is sparse but promising [15].

Given the theoretical foundations and mechanisms underlying both interventions, this study aims to directly compare the effectiveness of Pilates and CFT in treating CNP. By focusing on pain reduction, disability, quality of life, and functionality, this randomized controlled trial seeks to determine whether improvements in patients stem from whole-body exercise routines, such as Pilates, or from comprehensive patient-centered behavioral approach, as exemplified by CFT. Currently, no study has compared these two interventions specifically for CNP, and this trial will provide valuable insights into their relative effectiveness. It is hypothesized that both interventions will yield significant improvements in the short- and medium-term outcomes, contributing to a more effective therapeutic approach for individuals with CNP.

Patients and methods

Study design

This single-blind randomized controlled clinical trial will compare two intervention methods (Pilates and CFT) in patients with CNP. The randomization method that will be followed for participants in the two groups is block randomization, which will be performed through the randomization website https://www.randomizer.org/ by an external researcher who has no contact with participants throughout the study [16]. To ensure the sample size balance of groups over time, participants will be randomized into 10 blocks of six participants. The randomization will be sealed in opaque envelopes and delivered to the blinded assessor, who is unaware of any information about the study. The first participant of each block will choose a folder where there will be the allocation for the interventions of the individuals of the blocks, where the letter A will be for Pilates and B for CFT.

Recruitment

Participants will be selected through a clinician or health professional (general practitioner, physiotherapist, orthopedist) or through the community by sending an information form to email addresses and social media. The timing of recruitment was from 01/08/2023, until the required sample number was reached.

Inclusion criteria

The patients who will participate in the research will be people aged 18 to 64 years, who have chronic neck pain for a period of time longer than three months, with a score of 20% or more on the Numerical Pain Rating Scale (NPRS), which will be knowledgeable of the Greek language, regardless of their movement and participation in rehabilitation programs [17–19].

Exclusion criteria

The criteria for excluding people from the research will include a) red flags (i.e. the existence of cancer or infection that causes neck pain, the existence of an unstable heart condition, rheumatological disease or autoimmune disease, the presence of a serious neurological disorder, the presence of stenosis, the existence of a fracture in the last six months), b) a history of shoulder or neck surgery in the last six months, and c) the provision of other treatments in the last three months (treatment based on injectable form) [17–19].

Sample size calculation

The sample size for this study was calculated using G*Power 3.1 software, based on existing evidence from CFT studies for CNP [14,17]. An initial sample size of 26 participants per group was proposed, with an additional 15% added to account for potential dropouts, resulting in a final sample size of 30 participants per group, or 60 participants in total. The calculation was based on an effect size of 0.80, an α error probability of 0.05, and a power (1-β) of 0.80, ensuring that the study would have adequate statistical power to detect meaningful differences between the groups.

Outcome measures

All outcome measures will be assessed at baseline, post-intervention (week 8), and three months after randomization (week 12), which will reflect the follow-up period. To avoid the risk of ‘data collection ascertainment bias’, outcome measures will be assessed by an independent assessor blinded to the interventions. The range of motion of cervical movements and isometric strength of the neck muscles will be assessed using the Activforce 2 Digital Dynamometer device. This device is a handheld device in which a strap is placed to apply and stabilize the device on the examinee’s head. The results of each measurement were presented in the accompanying applications of the device. The remaining outcome measures will be evaluated using weighted questionnaires in the Greek language [20–23]. The primary outcome measures will be pain and disability, assessed using the Numerical Pain Rating Scale (NPRS) (r = 0.86-0.95) [24] and the Neck Disability Index (NDI) (r = 0.93) [23], respectively. The secondary outcome measures included fear perception (Fear Avoidance Beliefs Questionnaire) (FABQ-W: ICC= 0.85-0.95, FABQ-PA: ICC= 0.75-0.90) [25], functionality (Short Form 12) (r = 0.931) [26], quality of life (EuroQuol-5D) (EQ-5D-5L: ICC = 0.73-0.84; EQ VAS: ICC= 0.61-0.68) [27], and range of motion and isometric strength of the cervical spine muscles for flexion, extension, lateral flexion, and rotation of the neck.

Experimental procedure

This research was conducted at the European University of Cyprus. All potential participants were assessed to meet the inclusion criteria of the study. Those who meet the criteria will sign a Consent Form, and then the participants will be randomized into two groups. The complete research process is illustrated in Figure 1. Before the start of the first session for each intervention, age and duration in months of neck pain will be obtained from each participant. In addition, each participant will receive measurements of their body weight and height to calculate their Body Mass Index, which is equal to the ratio of body mass to the square of their height (m2). The outcome measures of the study will then be assessed, where the participants will answer the questionnaires that will be given to them and will be assessed for both the range of motion of the head and isometric strength of the muscles of the cervical spine. For these two measurements, a device (Activforce 2 Digital Dynamometer) was placed at the head of the participant. The participant will be in a sitting position and perform cervical spine movements. However, for isometric strength, the participant will be in the same position as before, and the examiner places his hand to put resistance. Three measurements were obtained for these two assessments it will take 3 measurements and after this the average was calculated. After this process, each participant will receive the intervention groups and the treatments twice a week for a period of eight weeks.

Figure 1.

Schematic diagram of the study.

Pilates group

The participants will be divided into groups of three, and exercises based on Pilates will be performed. In the first session, six basic principles of the technique were learned. All other sessions lasted for 50 min and consisted of warm-up, main program, and cool-down exercises. The degree of difficulty of the exercises in the main part will progress every 2 weeks. The complete schedule for all the sessions is presented in Table 1. All Pilates sessions will be provided by a physiotherapist specializing in Pilates, who has 3 years of experience.

Table 1.

Exercises for Pilates group.

Session	Pilates Program
1st	Inform 6 basic principles and learn how to activate deep muscles of core, glutes and pelvic floor muscles
2nd-4th	Warm-up: pelvis tilt, hip push, arm spheres, spine twist and reach, lift up circles, walking, squat Main program (1 set x 10 repetitions/exercise): double leg stretch level 1, shoulder bridge level 1, hip twist level 1, side lift-adduction level 1, clam level 1, arm openings level 1, side blank-circles level 1, dart level 1, swan dive level 1, swimming level 1 side roll up level 1, spine twist level 1, hip circles level 1 Cool-down: mermaid, spine twist lunge, body circles
5th-8th	Warm-up: pelvis tilt, hip push, arm spheres, spine twist and reach, lift up circles, walking, squat Main program (1 set x 10 repetitions/exercise): double leg stretch level 1, shoulder bridge level 1, hip twist level 2, side lift-adduction level 1, clam level 2, arm openings level 1, side blank-circles level 1, dart level 2, swan dive level 1, swimming level 2, side roll up level 1, spine twist level 1, hip circles level 1 Cool-down: mermaid, spine twist lunge, body circles
9th-12th	Warm-up: pelvis tilt, hip push, arm spheres, spine twist and reach, lift up circles, walking, squat Main program (1 set x 10 repetitions/exercise): double leg stretch level 2, shoulder bridge level 2, hip twist level 3, side lift-adduction level 2, clam level 2, arm openings level 2, side blank-circles level 2, dart level 3, swan dive level 2, swimming level 3, side roll up level 2, spine twist level 2, hip circles level 2 Cool-down: mermaid, spine twist lunge, body circles
13th-16th	Warm-up: pelvis tilt, hip push, arm spheres, spine twist and reach, lift up circles, walking, squat Main program (1 set x 10 repetitions/exercise): double leg stretch level 2, shoulder bridge level 2, hip twist level 4, side lift adduction level 2, side kick-lift up/down level 1, arm openings level 2, side blank-circles level 2, dart level 4, swan dive level 3, swimming level 4, side roll up level 2, spine twist level 2, hip circles level 2 Cool-down: mermaid, spine twist lunge, body circles

CFT group

In this group, the participants will receive personalized treatment; therefore, the sessions will be performed individually for each session. In the first session, the therapist obtained a complete history from the patients, including information about the medical history, the possible medication, the quality, the area where the pain occurred, the behavior of the pain during the day, the movements that relieved or worsened symptoms, perception, and beliefs about pain. In addition, information will be obtained about the psychological perception that the patients have of the ongoing problems, that is, if it itself causes phobia, if there is an activity that bothers them, or if the specific problem affects them at work or in their social life. At the end of the interview, the patients stated their treatment goals so that there was little discussion about achieving them. All other interventions will include a) cognitive components, b) specific functional training, and c) lifestyle changes. The modes of intervention according to the CFT are presented in Table 2. All CFT sessions will be provided by a physiotherapist specializing in CFT who has more than two years of experience.

Table 2.

Interventions for the CFT group.

Intervention	Explanation of Intervention
Cognitive component	Educating patients about their perceptions of pain, explaining diagnosis and diagnostic findings, answering questions about their problem and symptoms, progressively challenge their customers in a non-judgmental way, education for multifactorial and biopsychosocial spectrum of pain, encouraging participants to movement and for active participation in daily activities, if receiving a self-management plan that will include postural relaxation, disorders, self-massage, breathing exercises, participation in activities with a degree of difficulty 2-3/10, tips for more effective sleep
Specific functional training	Understanding pain modification through relaxation exercises, awareness and body control, modified body positions for better control of the cervical spine with parallel relaxation of the thoracic spine to participate in fearful or painful activities, engaging in movements of daily activities such as sitting, sitting, and rolling in a chair, standing up from sitting, lifting, bending, walking
Lifestyle changes	Gradual increase in physical activity based on patient preferences, stress management and social interaction

Statistical analysis

Data analysis will be conducted using SPSS 25.0, with the significance level set at p < 0.05. A blinded statistician will perform the analysis to minimize bias. Descriptive statistics (median, mean, standard deviation, and 95% Confidence Interval) will summarize the data, followed by a Normality Test to determine whether parametric or non-parametric tests are appropriate. The primary outcome measure will be pain reduction (NPRS) and disability (NDI), while secondary outcomes will include fear-avoidance beliefs (FABQ), functionality (SF-12), quality of life (EQ-5D), range of motion, and isometric strength.

Baseline differences in age and Body Mass Index (BMI) between the groups will be assessed using the Independent Samples t-test (parametric) or Mann-Whitney U test (non-parametric). These tests will also compare the primary and secondary outcomes at baseline, post-intervention, and one month post-intervention to evaluate the effectiveness of the interventions. If significant group differences are found, post-hoc tests will be conducted to further explore these relationships.

Within-group comparisons across time points (baseline to post-intervention, baseline to one month post-intervention, and post-intervention to one month post-intervention) will be conducted using the Paired t-test or Wilcoxon signed-rank test, depending on data distribution. These statistical methods will provide a comprehensive evaluation of both between-group and within-group changes over time. Post-hoc analyses will be employed to assess the detailed nature of significant findings. This approach ensures robust analysis and allows for thorough examination of intervention effects on both primary and secondary outcomes.

Ethics and dissemination

Individuals interested in participating in the survey will initially be given an information form to inform them about the research. The people who will be selected to participate in the research will be given a Consent Form so that they can give their written consent to be informed and participate in the research. None of the two intervention methods induced any side effects in the study participants. In addition, the participants, if they wished, would be able to withdraw from the research at any time, without declaring the reason for their withdrawal. However, if participants are not compliant with their sessions, they should withdraw from the study, as non-compliance with scheduled sessions may lead to distortion of the study. The institute to which authors are affiliated do not have Bioethics Committee, so the approval statement for this trial was taken by the Cyprus National Bioethics Committee (ΕΕBΚ/ΕΡ/2023/20) and is registered in ClinicalTrials.gov (Registration Number: NCT06225063).

Discussion

CNP is a prevalent musculoskeletal condition that specifically impacts individuals’ quality of life, with many experiencing chronic pain, disability, and reduced functionality [28]. Physiotherapists commonly employ exercise-based interventions as a core component of CNP management, targeting both the physical and psychological aspects of the condition. However, the effectiveness of specific interventions, such as Pilates and CFT, in addressing CNP has not extensively studied, particularly in direct comparison [14,29].

CFT, initially developed to address chronic low back pain [30], has demonstrated efficacy in reducing pain and disability by addressing cognitive and behavioral factors related to chronic pain [15]. Despite the growing body of evidence supporting CFT for low back pain, limited research exists on its effectiveness for CNP. Nevertheless, the available studies suggest that CFT can yield positive outcomes in terms of pain reduction, improved functionality, and increased patient self-efficacy [14]. This protocol aims to fill this research gap by comparing CFT to Pilates, another intervention that focuses on improving motor control, flexibility, and strength, specifically targeting the core muscles involved in posture and neck movement.

Pilates, while extensively studied for its benefits in chronic low back pain [11], has been less frequently examined in the context of CNP. Research has indicated that Pilates may improve pain, muscle strength, and mobility in patients with CNP [10,31], but the statistical significance and clinical relevance of these findings have not been robustly established [32]. Given the mechanical nature of CNP and the emphasis of Pilates on motor control and functional movement, this intervention may offer significant benefits in terms of enhancing cervical range of motion and muscle strength. However, more research is required to determine its comparative effectiveness against other interventions like CFT.

This protocol also seeks to explore whether the improvements observed in CNP through both interventions are predominantly a result of exercise ore the modification of cognitive-behavioral factors, a central feature of CFT. Both interventions share some similarities, particularly in promoting body awareness, proper breathing techniques, and self-management strategies [9], yet their theoretical foundations and mechanisms of action differ. Pilates primarily focuses on physical exercises to improve motor control and alignment, while CFT incorporates a biopsychological components of chronic pain [12].

The expected outcomes of this study included reductions in pain and disability, as well as improvements in cervical range of motion, muscle strength, and quality of life. Both interventions are also likely to decrease kinesiophobia, a common psychological barrier in patients with chronic pain that leads to avoidance of movement due to fear of exacerbating symptoms [33]. By encouraging patients to participate in controlled exercises and pain education components, particularly in CFT, patients may develop greater confidence in their ability to manage pain and engage in everyday activities without fear of injury.

In conclusion, this study will provide valuable insights into the comparative effectiveness of Pilates and CFT in treating CNP. While both interventions are expected to yield positive results, the distinction between physical and cognitive-behavioral contributions to patient outcomes will help inform clinical decision-making. If both interventions demonstrate similar efficacy, it may suggest that both physical and behavioral components play equally significant roles in managing CNP, highlighting the importance of a holistic, patient-centered approach. The findings of this study will contribute to the growing body of evidence on conservative management strategies for CNP and potentially guide future therapeutic interventions.

Limitations

The main limitation of the present study was that we did not monitor the blinding of our participants because of the intervention procedure. The research did not include a control group and whether the improvement was due to the interventions or the passage of time.

Funding Statement

This study did not receive external funding.

Authors contributions

Conceptualization: E.L., C.S. and G.P.; Data curation: E.L. and G.P.; Formal Analysis: E.L., C.S., G.P., C.K., C.P., I.C., P.R.; Methodology: E.L. and G.P.; Project administration: C.S, C.K., and R.P.; Supervision: C.S., C.K., and R.P.; Writing—original draft preparation: E.L.; Writing—review and editing: C.S., C.K., and C.P. All authors have read and agreed to the published version of the manuscript.

Administrative information

This trial was approved by the Cyprus National Bioethics Committee (ΕΕBΚ/ΕΡ/2023/20) and is registered in ClinicalTrials.gov (Registration Number: NCT06225063). The funder played no role in the design, conduct, or reporting of this study.

Disclosure statement

All authors declare that they have no conflicts of interest.

Data availability statement

Due to the nature of the research, due to Cyprus Bioethics Committee supporting data is not available. In addition, the participants of this study did not give the written consent for their data to be shared publicity, so due to the sensitive nature of the research supporting data is not available.