Effect of osteopathic manipulation on neck kinematics using X-Sens motion capture in non-specific neck pain: a protocol for randomised controlled trial

Abstract

Non-specific neck pain (NSNP) is a common musculoskeletal disorder causing functional limitations and reduced quality of life. Conventional physiotherapy provides symptomatic relief but often yields inconsistent improvements in cervical kinematics. Osteopathic manipulation has shown promise in addressing biomechanical dysfunctions and restoring normal neck mobility. This randomised controlled trial aims to evaluate the effect of osteopathic manipulation combined with standard physiotherapy on neck kinematics in individuals with NSNP using X-Sens motion capture analysis. After obtaining written informed consent from the patient, eligible inpatients and outpatients from the Musculoskeletal Physiotherapy and Orthopaedics department will be recruited. Participants who meet the inclusion and exclusion criteria will be randomly assigned (1:1) to either Group A (osteopathic manipulation + standard treatment) or Group B (standard treatment alone) using computer-generated random numbers and sealed opaque envelopes. Both groups will receive 30-minute treatment sessions, 5 days per week for 4 weeks. Follow-ups will be conducted at the second and fourth weeks post-treatment.Baseline neck kinematics and functional outcomes will be assessed using the X-Sens motion capture system. Data will be analysed on an intention-to-treat basis. Descriptive statistics will summarise demographic data. Between-group differences will be analysed using appropriate parametric or non-parametric tests. Repeated measures ANOVA will assess changes over time within and between groups for primary and secondary outcomes.

WHAT IS ALREADY KNOWN ON THIS TOPIC?

WHAT THIS STUDY ADDS?

• Introduces the use of X-Sens motion capture technology to objectively quantify changes in cervical kinematics following OMT in patients with NSNP. Proposes a standardised randomised controlled trial protocol, enhancing reproducibility and scientific rigour in manual therapy research. It aims to identify specific biomechanical changes in neck movement (eg, range of motion, velocity, coordination patterns) that may be influenced by osteopathic intervention.

HOW MIGHT THIS STUDY AFFECT RESEARCH, PRACTICE AND POLICY?

• Research: provides a methodological framework for integrating wearable motion capture into clinical trials of manual therapy, encouraging more objective outcome measures in musculoskeletal studies.

• Practice: could support the clinical value of OMT by providing quantifiable evidence of biomechanical improvements, potentially leading to broader clinical acceptance and integration.

• Policy: this may inform clinical guidelines and reimbursement policies by contributing high-quality evidence regarding the efficacy and mechanisms of OMT in managing NSNP.

Introduction

Non-specific neck pain is described as an unpleasant sensory and emotional experience which begins on the upper nuchal lines with the level of the scapular spinal cord associated either with real or potential tissue injury in the neck region (International Association for the Study of Pain) and is a condition that is frequent in the world and has an aetiology, pathology and symptoms that are all inconsistent.¹

As a result, 3.7% of female workers and 2.8% of male workers were absent due to illness (excluding intervertebral discopathies and spondylosis). Around 15% of all early-pension applications are estimated to be caused by neck pain problems. With a global frequency of 4.9% and a disability score of four, it is highly common in the general population. Several variables can contribute to this.² The following complaints, as well as the main symptom of chronic pain of unknown origin, suggest a serious health problem. The mobility of the cervical spine is mostly affected by age and gender. Non-specific neck discomfort can be caused by incorrect head, neck and upper thorax movement.³

Only a few clinical trials have looked into treatments for non-specific neck pain. Exercise appears to be beneficial in persons with neck pain. Muscle relaxants in the treatment of acute neck discomfort produced by muscular spasms have limited evidence; epidural corticosteroid injections in the therapy of radiculopathy have inconsistent data, and cervical facet joint radiofrequency ablation has poor positive evidence. For most people with radiculopathy or myelopathy, surgery appears to be more effective than nonsurgical therapy in the near term but not in the long run.⁴,⁹ No studies are superior to the range of available therapeutic approaches from the range of therapeutic methods available. Meta-analysis and review reports published before 2010 indicate that mobilisation, manipulation, physiotherapy, medication, acupuncture and active patient education could be effective.¹⁰,¹²

Osteopathy, a system of therapy and medicine initiated by the American doctor Andrew Taylor Still in the late 19th century, relies on the assumption that normal bodies are vital mechanical organisms of equal importance in structural and functional conditions and can remedy infections and adverse environmental conditions in a manner that is beneficial.¹³,¹⁵

It assumes that the normal body is a vital mechanical organism whose structural and functional states are equally important, capable of making its remedies against infections and toxic conditions given favourable environmental conditions and adequate nutrition and shares many characteristics with European naturopathy.^{16 17}

Only a few randomised clinical trials have been published regarding the effectiveness or efficacy of osteopathic treatments. The mechanisms of pain behind the neck are still not fully clarified. The anatomical connection between the tongue and its structures of the mandible, larynx and pharynx muscles suggests a possible clinical relation with the pain in the neck.^{18 19} Given this, it is hypothesised that osteopathic manipulation of non-specific neck pain may improve clinical conditions and neck motion in patients with neck pain.

This study aims to determine whether osteopathic manipulation can result in measurable improvements in the movement patterns and range of motion of the neck, potentially alleviating discomfort and enhancing functional outcomes for individuals with non-specific neck pain. It also aims to assess whether osteopathic manipulation has a measurable impact on neck kinematics in individuals with non-specific neck pain.

Rationale

Manual therapists use a manual treatment technique called osteopathic manipulative therapy (OMT) to identify and treat a variety of musculoskeletal disorders, including generalised neck pain. Restoring normal motion, enhancing blood flow and healing, moderating pain perception, neuromuscular re-education, releasing muscle tension and incorporating placebo and patient interaction, as well as a holistic approach, are some of the principles that underpin the rationale for OMT’s effect on kinematics (movement patterns) in non-specific neck pain. Although there is a theoretical basis for OMT’s effects on kinematics in non-specific neck pain, it is significant to emphasise that the scientific data for these benefits might be conflicting. Diverse outcomes have been found in research studies examining the efficacy of OMT for neck pain, with some studies demonstrating positive outcomes and others showing minimal or no meaningful effects. As a result, individuals contemplating OMT as a therapeutic option should consult with trained medical specialists and base their decisions on their unique needs and medical conditions.

In essence, the primary rationale of this study is to investigate how osteopathic manipulation can potentially enhance neck movement and alleviate discomfort in individuals experiencing specific neck pain. Through a designed, randomised, controlled trial and the use of measures, this research aims to contribute to the existing body of evidence supporting osteopathic manipulation as a viable complementary treatment for this prevalent musculoskeletal issue.

Objectives

The objectives of the present study are:

1. To determine the changes in neck kinematics joint angles in non-specific neck pain individuals.

2. To determine the changes in neck kinematics segment angular velocity in non-specific neck pain individuals.

3. To determine the changes in neck kinematics joint segmental position in non-specific neck pain individuals.

4. To determine the changes in kinematics joint segmental acceleration of the neck in non-specific neck pain individuals.

5. To determine the changes in neck range of motion.

Patient and public involvement statement

Patients and the public were not directly involved in the design, conduct, reporting or dissemination plans of this specific research study. However, all participants will be fully informed about the study procedures, potential benefits and risks, and written informed consent will be obtained prior to participation. Participants will have the opportunity to ask questions at any stage and may withdraw from the study at any time without affecting their standard care. The results of the study will be shared with participants on request, and findings will be disseminated through institutional presentations and peer-reviewed publications for wider community benefit.

Trial design

Single-centre, two-arm parallel randomised controlled trial with concealed ratio 1:1.

This study will be conducted with written informed consent (online supplemental file 1) from all participants. Participants will be chosen from inpatients and outpatients from the musculoskeletal physiotherapy and orthopaedics department at Acharya Vinobhave Rural Hospital, (AVBRH) Sawangi Meghe, Wardha, Maharashtra, following acceptance from the institutional ethics committee of Datta Meghe Institute of Higher Education and Research (DMIHER). Participants in the study will be split into two groups. Group a (standard treatment) and group b (osteopathic manipulation and standard treatment for neck pain) were allotted randomly with 1:1 allocation with intent to treat purpose. All participants, regardless of their background, will be screened for the study according to the established inclusion and exclusion criteria. They will then be selected through simple random sampling, which involves the use of computer-generated random numbers based on the eligibility criteria. Allocation will be made by sequentially numbered, opaque, sealed envelopes. The primary investigator will do allocation and participant enrolment. Selection will be based on the cut-off values for baseline parameters when engaging participants, as determined by the inclusion and exclusion criteria. Throughout the 6-month recruitment phase, a second recruitment source will be used if additional study participants are required. We will ensure that the patients adhere well to the recommended treatment through regular treatment sessions. If needed, patients will be counselled or contacted telephonically for a reminder about the therapy sessions. Group A will receive standard treatment for neck pain (table 1) for 30 min each day, 5 days a week, for 4 weeks. Group B will receive the osteopathic manipulation protocol for 30 min each day, 5 days per week, for 4 weeks, in addition to standard treatment for neck pain. Both groups will receive treatment for four sessions, 5 days per week, over 4 weeks, with a 2-day gap after each session. Baseline and follow-up visits at 6 weeks and 3 weeks after treatment will be carried out, where primary as well as secondary variables will be assessed. The study design is depicted in (figure 1).

Table 1. Standard treatment of neck pain ²³.

	Sessions	Treatment
Standard treatment	Sessions 1 and 3	(1) Sub-occipital distraction/release−7 min, sustained; (2) cervical flexion stretch/traction−7 min, sustained; (3) upper cervical hold/relax technique−left rotation: 3–5 s isometric right cervical rotation contraction, followed by 30 s of passive stretch, 3–5 repetitions
	Sessions 2 and 4	(1) Active craniocervical flexion, supine (chin tuck)−10 s hold, 10 s rest, 30 repetitions; (2) cervical stretching in lateral flexion−10 s hold, 10 s rest, 30 repetitions; (3) cervical stretching in flexion−10 s hold, 10 s rest, 30 repetitions.

Figure 1. Consort diagram of the study procedure.

Inclusion criteria

1. According to common clinical standard guidelines.

2. Both male and female patients.

3. A history of neck pain for more than 4 months; a score of more than 4 out of 10 on the Visual Analogue Scale (VAS) and a score of more than 40% on the Neck Disability Index (NDI).

Exclusion criteria

1. Any neurological conditions.

2. Any recent neck surgeries.

3. Recent trauma.

4. Any recent physical therapy, acupuncture or osteopathy treatment for neck pain within 2 weeks.

5. Psychiatric illness, pregnancy, regular intake of corticosteroid medication, ongoing treatment with anticoagulants.

Participant timeline

All patients enrolled in the study are required to complete the entire 4-week rehabilitation protocol after enrolment. The assessment will be performed at the initial and the end of the session. Figure 1 shows the CONSORT flow chart.

Group A: group A (table 1) will be receiving standard treatment of neck pain consisting of suboccipital distraction/release-7 min, sustained, cervical flexion stretch/traction-7 min, sustained and upper cervical hold/relax technique-left rotation: 3–5 s isometric right cervical rotation contraction, followed by 30 s of passive stretch, 3–5 repetitions for first and third sessions, then active craniocervical flexion, supine (chin tuck)−10 s hold, 10 s rest, 30 repetitions, cervical stretching in lateral flexion-10 s hold, 10 s rest, 30 repetitions, cervical stretching in flexion-10 s hold, 10 s rest, 30 repetitions for second and fourth sessions (the protocol that will be used in the study is following the latest guidelines of American Physical Therapy Association for the treatment of neck pain).

Group B: group B (table 2) will be receiving mandible, tongue and extrinsic muscles of larynx release treatment, which consists of omohyoid with upper trapezius muscle release, digastric muscle release, masseter muscle fascia release and temporal muscle release for first and third sessions, then suprahyoid muscle traction technique, suprahyoid muscle circling movement technique, suprahyoid muscle pressure technique, tongue unwinding technique and cervical fascia release for second and fourth sessions.

Table 2. Mandible, tongue and extrinsic muscles of larynx release treatment protocol.²¹.

Sr. no.	Technique	Description	Intensity
1.	Omohyoid with upper trapezius muscle release	Therapist position: take up a position at the head of the patient. Hand position: place the thumb of one hand at the posterior attachment of the omohyoid muscle to the scapula. Place your other hand on the underside of the mandible. Method: the posterior inferior attachment of the omohyoid muscle cannot be treated directly. With your thumb, first push the trapezius in a posterior direction.	10 reps, 3 sets and hold it for 10 s.
2.	Digastric muscle release	Therapist position: take up a position at the head of the patient. Hand position: extension of the head Method: Posterior belly: finger posterior of the angle of the mandible; slide it in front of the sternocleidomastoid muscle in the direction of the ear while pressing inwards with the finger. Anterior belly: fingers on the tissue beneath the chin tip, on both sides of the midline.	10 reps, 3 sets and hold it for 10 s.
3.	Masseter muscle fascia release	Therapist position: take up a position at the head of the patient. Hand position: position hands one on each masseter muscle in the region between the zygomatic arch of the temporal bones and zygomatic bones and the muscle attachments at the angles of the mandible. Method: (A) for the fascias of the muscle, administer very gentle pressure and follow the fascial tensions of the muscle until the tension is balanced. (B) For the superficial muscle portion, smooth the muscle on one side slowly from the anterior two-thirds of the zygomatic arch obliquely to the angle of the mandible with somewhat greater pressure. While you are doing this, grasp the chin with the other hand while the patient opens the mouth slightly against the gentle resistance (stretching the muscle). (C) For the deep portion of the muscle, smooth the masseter muscle with stronger pressure from the posterior third of the zygomatic arch almost vertically towards the masseteric tuberosity of the ramus. The tensions in the muscle are then released point by point with small rotatory movements.	10 reps, 3 sets and hold it for 10 s.
4.	Temporal muscle release	Therapist position: take up a position at the head of the patient. Hand position: for the posterior muscle fibres, position your hands on the muscles above and posterior to the ears. For the medial muscle fibres, position your hands above the ears. For the anterior muscle fibres, position your hands above and anterior to the ears, approximately 1 cm posterior to the lateral ocular margins. Method: at each position, administer gentle traction in a cranial direction to relax the muscle.	10 reps, 3 sets, and hold it for 10 secs
5.	Suprahyoid muscle traction technique	Therapist position: take up a position at the head of the patient. Hand position: place your hands over both sides of the mandible. From below, direct the tips of the fingers of both hands upward toward the muscles of the floor of the oral cavity. Method: with your fingers, apply cephalad and medial traction. Maintain traction until you sense a release of tension.	10 reps, 3 sets, and hold it for 10 s
6.	Suprahyoid muscle circling movement technique	Therapist position: take up a position beside the patient’s head. Hand position: place the index finger of your cranial hand inside the patient’s mouth at the floor of the oral cavity. Outside the patient’s mouth, position the index finger of your caudal hand at the floor of the oral cavity opposite the location of your other index finger. Method: with the index finger inside the patient’s mouth, perform gentle circling movements on the muscles at the floor of the oral cavity, using the index finger outside as a fulcrum. Stop the procedure if the patient experiences discomfort.	10 reps, 3 sets, and hold it for 10 s
7.	Tongue unwinding technique	Therapist position: take up a position beside the patient’s head. Hand position: take hold of the patient’s tongue between your thumb, index finger and middle finger. Method: follow all the movements of the tongue (unwinding) until we feel the sense of release has occurred.	10 reps, 3 sets, and hold it for 10 s
8.	Cervical fascia release	Therapist position: sit at the head of the table with the patient on their back. Hand position: place your palms at the level of dysfunction under the patient's articular pillar. Method: engage the underlying muscles and fascia by lifting upward (towards the ceiling) into the patient's paravertebral cervical tissues. To identify positions of ease and restriction, evaluate the inferior, superior, left and torsional (twisting) myofascial motion. Gently stack the tissue into the barrier (direct) or the position of ease (indirect) in all three planes of motion.	10 reps, 3 sets and hold for 30–60 s or until you feel a release.

Outcomes

Primary outcome

1. Visual analogue scale (VAS): VAS is subjective or compartmental experience measurement (eg, pain, physical exercise). They are usually presented as a 10 cm line with descriptive anchors at each end, such as ‘completion today of all prescribed activities’ to ‘no activities today completed’. The respondents put a vertical line across the scale that best suits their experience with this structure at the time. To create a discrete variable, the placing of that mark is measured and then used either as a continuous variable or as a line. The latter is often comparable to the Likert scales.^{20 21}

2. Range of motion (ROM): ROM of neck in three movements (flexion, extension, side bending and side rotations).

Secondary outcome

1. Neck joint angles: measurements used to define the positioning and orientation of various joints in the neck are referred to as neck joint angles. Researchers, doctors and biomechanics specialists can gain a deeper understanding of how the neck moves by using these angles, as they offer valuable insights into the intricate movement patterns of the neck. Motion capture techniques, such as X-Sens, which use sensors mounted on specific anatomical landmarks to track movement in real time, are often employed to assess these neck joint angles. Understanding the angles of the neck joints is crucial for identifying typical movement patterns, recognising variations from these patterns and developing interventions to enhance movement effectiveness and prevent neck-related discomfort or injury.

2. Segment angular velocity: Segment angular velocity is the rate at which the angle of a certain body segment changes when that segment moves through space. It measures the rate of rotation or orientation change of a body segment. This concept is crucial to biomechanics and motion analysis because it clarifies the direction and speed of movement for various body parts during different activities. Angular velocity can be divided into many components depending on the axes of rotation (eg, roll, pitch and yaw) and is commonly expressed in degrees per unit of time (eg, degrees per second). Each of these elements sheds light on the rotation of a segment around each of its axes.

3. Joint segmental position: The joint segmental position describes how contiguous body segments are positioned and oriented in space around a particular joint. It entails calculating the angles or locations of several bodily parts in relation to one another at a certain joint. Understanding how joints work and how segments interact during various activities is crucial to biomechanics and the study of human movement.

4. Segmental acceleration: Segmental acceleration is the rate at which the velocity of a particular body segment changes as it moves through space. It measures how quickly a body segment’s speed and direction are changing. Segmental acceleration sheds light on the dynamics of movement in the context of biomechanics and motion analysis, enabling us to understand how separate body segments accelerate and decelerate during various activities. To measure acceleration, it is common to use units of distance per time squared, such as metres per second squared (m/s²). It shows how much a segment’s velocity changes over a given period.

Safety outcomes

Adverse events will be reported at each time. No adverse effects are anticipated.

Sample size calculation

Formula using mean difference,

.$$Z_{\beta }=0.84=Powerat80\%$$

Primary variable=mean value of VAS.

Where, mean±SD value of VAS (pre) = mean ± SD = 6.71±3.54 (as per Young et al correlations among VAS, NDI, shoulder range of motion and muscle strength in young women with forward head posture).²²

Considering a 30% significant margin of improvement for post results ($\delta )$ = 6.71 *30=2.013), minimum sample size required

sample size, N= ${\displaystyle n1=n2=2\frac{{\left(1.96+0.84\right)}^2{\left(3.54\right)}^2}{{\left(2.013\right)}^2}=45pergroup}$,considering a 10% dropout rate, that is, 45+5=50 per group.

Analysis

The assessment and collection of outcomes will be conducted during the preintervention stage after participants have been assigned to the intervention groups. Postintervention data will be collected on the same day. The collection of postintervention data will follow this after the completion of 4 weeks of intervention. The collected information will be summarised using frequency percentages for qualitative data and means and SD for quantitative data. The demographic data (age and gender) will be analysed using descriptive statistics. Descriptive statistics, including mean, SD, n (%), χ² test and independent t-test, were used to check the homogeneity of the descriptive statistics. Inferential statistics for comparing two groups will be analysed using the unpaired t-test. Group comparisons will then be analysed using the t-test, and the analysis will be conducted using SPSS V.21.0. A p value <0.05 is considered significant for the study.

Methods: monitoring

Data monitoring

The data will be monitored by the data monitoring committee of Ravi Nair Physiotherapy College.

Harms

Any episode of the adverse events shall be reported to the ethical committee and the clinician in charge of assessing and managing the solicited and spontaneous adverse events and other unintended effects of trial interventions or trial conduct.

Confidentiality: any information about the subjects participating in the study shall be maintained confidential. Any patient-related information will only be used with the subject’s due permission.

Declaration of interests: there are no financial or competing interests to mention.

Access to data: all the data collected during or after the study shall be stored and maintained by the study’s principal investigator (PI). The PI will have access to the final trial dataset, which will be shared with deidentification after a formal request is received for research and publication purposes only.

Ancillary and post-trial care: care shall be provided to the study subjects in case of events leading to harm from trial participation by the PI following the policy of Ravi Nair, Physiotherapy College and DMIHER.

Dissemination policy: any data collected during or after the study will only be used for academic and research-related purposes culminating in a publication in a reputed journal and presentation in an international or national journal

Discussion

The purpose of the proposed study is to examine how osteopathic therapy affects neck kinematics in people with generalised neck discomfort. X-Sens motion capture technology is used in the randomised controlled trial methodology to detect neck movements precisely and accurately. Either an experimental group receiving osteopathic manipulation or a control group receiving a sham treatment will be randomly assigned to participants. The X-Sens motion capture equipment will be used to measure the range of motion, velocity and neck movements before and after the intervention, serving as the primary outcome measures. Assessments of quality of life, functional impairment and self-reported pain scores will be used as secondary measures. The experiment will adhere to ethical guidelines and ensure the safety of the subjects throughout the investigation. The results of this experiment will provide important new insights into the effects of osteopathic manipulation on neck kinematics and overall health, contributing to the growing body of evidence supporting its effectiveness as a viable treatment for non-specific neck discomfort.

With the use of modern motion capture technology and randomised controlled trial design, this study aims to present solid proof of the efficacy of osteopathic manipulation in treating non-specific neck pain. By using blinding and randomisation techniques, the process seeks to reduce bias and ensure the validity and dependability of the findings. Furthermore, a comprehensive assessment of the intervention’s influence on neck kinematics and related functional and pain parameters will be made possible by examining both objective and subjective outcomes. The study methodology prioritises participant safety and ethical considerations, placing people’s welfare at the forefront throughout the research process. In general, this study could enhance the quality of life for individuals experiencing this common ailment by informing clinical practice and contributing to the development of evidence-based guidelines for the treatment of non-specific neck pain.

Data availability statement

No data are available.