Abstract
Abstract
Introduction
Postural neck pain is a prevalent musculoskeletal condition associated with discomfort, disability and impaired quality of life. Osteopathic manipulation has emerged as a potential intervention for managing postural neck pain, but a comprehensive synthesis of the existing evidence is lacking. This systematic review protocol introduces the rationale and objective to evaluate the effectiveness of osteopathic manipulation in alleviating postural neck pain and improving associated outcomes, including pain intensity, disability, range of motion and reposition sense.
Methods
We outline a rigorous methodology for this systematic review. A comprehensive search strategy will be implemented across various databases to identify relevant studies. This systematic review will encompass randomised controlled trials through electronic and manual searches. Electronic searches will be carried out in databases such as PubMed, Medline, Scopus and Web of Science. The search will span articles published from 2004 to December 2024; predefined eligibility criteria involve participants without a history of postural neck pain within the past 6 months. Exposure includes participants diagnosed with postural neck pain, while the comparison group comprises participants without neck pain.
Analysis
Outcome measures focus on pain intensity, range of motion, disability and reposition sense. Two independent reviewers will conduct study selection, data extraction and risk of bias assessment. The primary outcomes encompassing pain intensity, disability, range of motion and reposition sense will be systematically analysed.
Ethics and dissemination
As no primary data will be collected, ethical approval is not required. The findings will be presented at relevant conferences and published in a peer-reviewed journal.
PROSPERO registration number
CRD42023471857.
Keywords: Musculoskeletal disorders, Trauma management, REHABILITATION MEDICINE, Rehabilitation medicine
STRENGTHS AND LIMITATIONS OF THIS STUDY.
Strict methodology guarantees a methodical and open approach to data acquisition, analysis and research selection.
The reliability of results is increased by standardised outcome measures, which improve comparison across investigations.
Relying solely on randomised controlled trials lowers the possibility of bias and improves the quality of the evidence.
Database limits, publishing bias and study heterogeneity are examples of potential limitations that could affect comprehensiveness.
Conclusions on the long-term effects of osteopathic manipulation may be limited by the short-term follow-up data in the included research.
Introduction
Non-specific neck pain (NSNP) is defined as neck pain without an identifiable pathological cause, such as infection, inflammatory disease, fracture or malignancy.1 It is a common musculoskeletal condition that affects individuals of all ages, often linked to poor posture, sedentary behaviour and occupational factors.2 NSNP is typically characterised by localised pain, stiffness and functional limitations, but it does not involve neurological deficits.3 Given its high prevalence and impact on daily activities, effective management strategies are crucial for improving patient outcomes.4
A major health issue that has a big socioeconomic impact is neck pain. Research shows that, excluding diseases such as spondylosis and intervertebral discopathies, 3.7% of female employees and 2.8% of male employees miss work because of illness. Neck pain’s long-term effects are further shown by the fact that it accounts for 15% of all early pension applications. A common ailment that impairs everyday activities and general quality of life, neck discomfort has a global prevalence of 4.9% and ranks fourth in terms of disability burden.5,7 Age, gender and the way the head, neck and upper thorax move are some of the variables that affect its development. Chronic neck discomfort of unclear cause is frequently the main complaint, resulting in decreased cervical spine mobility and functional restrictions.8,12
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 are able to remedy infections and adverse environmental conditions in a manner that is beneficial.13,16 It assumes that the normal body is a vital mechanical organism whose structural and functional states are equally important, capable of making its own remedies against infections and toxic conditions given favourable environmental conditions and adequate nutrition and shares many characteristics with European Naturopathy.17,20
The traditional definition of posture as ‘normal’ or ‘poor’ in connection to neck pain may be changing, according to recent data. Although musculoskeletal strain and discomfort have historically been associated with poor posture, new research questions this direct causal relationship. ‘Normal’ posture is frequently regarded as the best alignment for the head and spine, reducing strain on the joints and muscles. On the other hand, prolonged postures that are believed to exacerbate muscle soreness and tiredness, including forward head posture or slouched sitting, are generally referred to as ‘poor’ posture.21,23 The relationship between posture and neck pain is still complicated though. Movement variety, muscle endurance, psychological stress and activity levels seem to be more important in the development of neck pain than posture alone.24,26 Recent research indicates that extended static postures or a lack of movement, regardless of whether they fall into the ‘normal’ or ‘poor’ category, may be more important in the development of pain than protracted stances, which over time may contribute to discomfort. Therefore, therapies that emphasise movement, strength and ergonomic variability may be more beneficial than those that only address posture correction.
Research question
What is the impact of osteopathic manipulation on pain reduction, improvement in disability, changes in range of motion and enhancement of reposition sense in individuals with postural neck pain?
Methods
The study was prospectively registered with the International Prospective Register of Systematic Reviews (PROSPERO) and the registration number is CRD42023471857 and developed the protocol in accordance with the 2015 Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (online supplemental file 1).
Eligibility criteria
The eligibility criteria for this systematic review are based on the Population Intervention Comparison Outcome principle and include the following.
Population
This systematic review investigates the impact of osteopathic manipulation as an intervention for individuals with postural neck pain. Postural neck pain is typically associated with poor neck posture, which can result from factors such as prolonged periods of sitting, incorrect ergonomics or repetitive movements that strain the neck muscles and structures.
Intervention
Osteopathic manipulation encompasses a range of manual techniques used by osteopathic physicians or osteopaths to assess and treat musculoskeletal issues in the neck region. These techniques may include soft tissue manipulation, myofascial release, joint mobilisation and other hands-on approaches.
Comparison (C)
Studies must be non-exposed control group
Placebo
Standard care
No intervention
Outcome Measures (O)
Studies will report at least one of the following outcomes:
Pain intensity using visual analogue scale (VAS) or numerical pain rating scale (NPRS)
Disability using neck disability index (NDI)
Range of motion of the neck
Reposition sense
Study design
The study will be focused on RCT (randomised controlled trial).
Language
Only English-language research or studies with available translations will be deemed eligible for this study due to translation restrictions.
Publication date
Studies published from 2004 to December 2024 will be considered.
Publication type
Databases and sources for grey literature are now specifically mentioned in the approach section. The search will include pertinent grey literature from sources including ClinicalTrials.gov, OpenGrey, ProQuest Dissertations & Theses and WHO (WHO) International Clinical Trials Registry Platform (ICTRP) in addition to published works. This reduces publication bias and guarantees a thorough search method. These additions have been incorporated into the Information Sources section.
Search strategy
We will perform both electronic and manual searches to identify articles relevant to our research question. Clear inclusion criteria are established based on the research question. These criteria include participants (eg, individuals with postural neck pain), interventions (eg, osteopathic manipulation), comparators (if applicable), outcomes (eg, pain, disability, range of motion, reposition sense), study design (eg, RCTs) and language of publication. A comprehensive search strategy is developed to identify relevant studies. Databases such as PubMed, Medline, Scopus and Web of Science are searched using a combination of relevant keywords and Medical Subject Headings (MeSH terms) related to the topic (online supplemental file 2).
The exclusion criteria outline additional forms and causes of neck discomfort that will not be taken into account, including radiculopathy, problems linked to whiplash, headaches and prior surgical procedures. To further assure methodological rigour and preserve the validity of the systematic review, study designs that do not fit the inclusion criteria—such as case series, retrospective studies and non-randomised cohort designs—have been eliminated.
Selection process and data collection process
Identified studies go through a two-stage screening process. In the first stage, titles and abstracts are screened for relevance to the research question and inclusion criteria. In the second stage, full texts of potentially relevant studies are reviewed to determine final inclusion.
Studies will be chosen in two phases by two separate, calibrated reviewers. They will first check abstracts and titles to make sure they fit the study question and inclusion criteria. In order to decide on ultimate inclusion using the same selection criteria, they will examine the complete texts of possibly pertinent research in the second stage. A third reviewer will settle any disputes that may emerge.
Data items and extraction
The standardised data extraction form is created, specifying the data to be collected from each included study. This form is developed based on the review’s objectives and includes fields for study characteristics, participant demographics, intervention details, outcomes and results.
Trained reviewers extract data from the selected studies. Data extraction is performed independently by two reviewers, and any discrepancies are resolved through discussion or by involving a third reviewer when necessary.
Data items: The following data items extracted:
Study characteristics (eg, authors, publication year, study design).
Participant characteristics (eg, sample size, age, gender).
Intervention details (eg, type of osteopathic manipulation, frequency, duration).
Outcome measures and their baseline and postintervention values.
Data entry: Extracted data is entered into a database or spreadsheet in a structured format.
Documentation: The entire process of study selection, data extraction and quality assessment is thoroughly documented to ensure transparency and reproducibility. Any discrepancies, discussions or decisions are recorded.
Outcomes
The review evaluates the effect of osteopathic manipulation on multiple outcomes in individuals with postural neck pain. The VAS and NPRS are used to quantify pain intensity, while the NDI is used to measure disability. Secondary outcomes include reposition sense (proprioception), which is evaluated by certain repositioning tasks, and range of motion, which is measured using instruments like a goniometer or inclinometer for flexion, extension, rotation and side bending. Determining the outcome measures, their evaluation instruments and their importance in assessing the efficacy of osteopathic manipulation are the main objectives of this part.
Assessment of risk of bias in included studies
Two independent reviewers will evaluate the included studies. The Risk of Bias 2 Tool, from the Cochrane Collaboration (RoB 2), will be used to assess the risk of bias in the included studies. A third reviewer will decide on any disputes. To ensure consistent evaluation criteria, the reviewers will discuss the selected instruments prior to conducting the assessment. There will be a calibration procedure to guarantee uniformity among assessors. The findings will be displayed in accordance with each tool’s instructions. A predetermined data extraction form will be used to extract data from the listed studies, including study information, participant demographics, intervention specifics and outcome measurements. Attempts will be undertaken to standardise outcomes evaluated using various scales or units in order to guarantee comparability across investigations. Data will be transformed into a single measure wherever feasible.
The Robvis tool will be used to create figures that illustrate the risk of bias. A funnel plot will be used to evaluate publication bias if there is enough research available, usually more than ten. To assess funnel plot asymmetry, statistical analysis like Egger’s or Begg’s tests will be performed. Statistical measures like Cohen’s kappa will be used to evaluate inter-rater reliability in order to guarantee consistency among reviewers. If there are disagreements, these will be discussed or, if required, a third reviewer will be consulted.
Subgroup analysis
The results from the included studies will be statistically synthesised by a meta-analysis. The type of results will determine the effect sizes, which will provide odds ratios, risk ratios, mean differences, and standardised mean differences (SMD) with 95% CI. In order to compare osteopathic manipulation with control interventions (such as sham therapy, no treatment or other therapeutic approaches), these computations will be carried out. The VAS and NPRS will be used to measure pain intensity, the NDI will be used to measure disability, goniometry or inclinometers will be used to measure the range of motion and proprioceptive assessments will be used to measure reposition sense.
Short-term (immediate postintervention), medium-term (weeks to months postintervention) and long-term (months to years postintervention) analyses will all be carried out at various intervals. To investigate the effects of variables such as participant age, sex, symptom duration, osteopathic manipulation technique and study quality, planned subgroup analyses will be conducted. Means and SD will be used to examine continuous outcomes, taking into account both post-test results and, when available, change scores from baseline. To maintain comparability, SMD will be computed if different measurement scales are employed in various investigations. The I2 statistic will be used to measure heterogeneity, and depending on the degree of heterogeneity, a suitable statistical model (fixed or random effects) will be used.
Confidence in cumulative evidence
The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) method will be used to evaluate the overall quality of the evidence supporting each outcome.27 The five basic categories of risk of bias, inconsistency, indirectness, imprecision and publication bias are used in this method to assess the certainty of the evidence. The RoB 2.0 technique for randomised controlled trials will be used to evaluate the risk of bias. Statistical methods like I2 will be used to evaluate heterogeneity across research in order to assess inconsistency.
By making sure that populations, interventions, comparators and results match the goals of the study, indirectness will be assessed. Sample sizes, confidence intervals and statistical significance will all be taken into consideration when evaluating imprecision. If there are enough papers (usually more than 10) available, statistical tests like Egger’s or Begg’s test and funnel plots will be used to evaluate publication bias. Each meta-analysis will undergo the GRADE assessment, which assigns a total rating of the degree of evidence certainty (high, moderate, low or very low) for the impact of the intervention on each outcome. This assessment will assist in interpreting results and guiding suggestions about how well osteopathic manipulation works for postural neck pain.
Patient and public involvement
The design, conduct, reporting and dissemination strategies of this study did not involve patients or the general public.
Ethics and dissemination
As no primary data will be collected, ethical approval is not required. The findings will be presented at relevant conferences and published in a peer-reviewed journal.
Supplementary material
Footnotes
Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2025-100971).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Patient and public involvement: Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
References
- 1.Kjaer P, Kongsted A, Hartvigsen J, et al. National clinical guidelines for non-surgical treatment of patients with recent onset neck pain or cervical radiculopathy. Eur Spine J. 2017;26:2242–57. doi: 10.1007/s00586-017-5121-8. [DOI] [PubMed] [Google Scholar]
- 2.Hoy DG, Protani M, De R, et al. The epidemiology of neck pain. Best Pract Res Clin Rheumatol. 2010;24:783–92. doi: 10.1016/j.berh.2011.01.019. [DOI] [PubMed] [Google Scholar]
- 3.Côté P, van der Velde G, Cassidy JD, et al. The burden and determinants of neck pain in workers: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976) 2000;33:S60–74. doi: 10.1097/BRS.0b013e3181643ee4. [DOI] [PubMed] [Google Scholar]
- 4.Kazeminasab S, Nejadghaderi SA, Amiri P, et al. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022;23:26. doi: 10.1186/s12891-021-04957-4. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Cappozzo A, Della Croce U, Leardini A, et al. Human movement analysis using stereophotogrammetry. Part 1: theoretical background. Gait Posture. 2005;21:186–96. doi: 10.1016/j.gaitpost.2004.01.010. [DOI] [PubMed] [Google Scholar]
- 6.Ezzatvar Y, Dueñas L, Balasch-Bernat M, et al. Which Portion of Physiotherapy Treatments’ Effect Is Not Attributable to the Specific Effects in People With Musculoskeletal Pain? A Meta-Analysis of Randomized Placebo-Controlled Trials. J Orthop Sports Phys Ther. 2024;54:391–9. doi: 10.2519/jospt.2024.12126. [DOI] [PubMed] [Google Scholar]
- 7.Bouvier B, Duprey S, Claudon L, et al. Upper Limb Kinematics Using Inertial and Magnetic Sensors: Comparison of Sensor-to-Segment Calibrations. Sensors (Basel) 2015;15:18813–33. doi: 10.3390/s150818813. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Rossettini G, Campaci F, Bialosky J, et al. The Biology of Placebo and Nocebo Effects on Experimental and Chronic Pain: State of the Art. J Clin Med. 2023;12:4113. doi: 10.3390/jcm12124113. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Wu G, van der Helm FCT, Veeger HEJD, et al. ISB recommendation on definitions of joint coordinate systems of various joints for the reporting of human joint motion--Part II: shoulder, elbow, wrist and hand. J Biomech. 2005;38:981–92. doi: 10.1016/j.jbiomech.2004.05.042. [DOI] [PubMed] [Google Scholar]
- 10.Cutti AG, Giovanardi A, Rocchi L, et al. Ambulatory measurement of shoulder and elbow kinematics through inertial and magnetic sensors. Med Biol Eng Comput. 2008;46:169–78. doi: 10.1007/s11517-007-0296-5. [DOI] [PubMed] [Google Scholar]
- 11.Picerno P, Cereatti A, Cappozzo A. Joint kinematics estimate using wearable inertial and magnetic sensing modules. Gait Posture. 2008;28:588–95. doi: 10.1016/j.gaitpost.2008.04.003. [DOI] [PubMed] [Google Scholar]
- 12.van den Noort JC, Wiertsema SH, Hekman KMC, et al. Measurement of scapular dyskinesis using wireless inertial and magnetic sensors: Importance of scapula calibration. J Biomech. 2015;48:3460–8. doi: 10.1016/j.jbiomech.2015.05.036. [DOI] [PubMed] [Google Scholar]
- 13.Siciliano B, Sciavicco L, Villani L, et al. Advanced Textbooks in Control and Signal Processing. 2009. [DOI]
- 14.Jara Silva CE, Joseph AM, Khatib M, et al. Osteopathic Manipulative Treatment and the Management of Headaches: A Scoping Review. Cureus. 2022;14:e27830. doi: 10.7759/cureus.27830. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Stovner LJ, Hagen K, Linde M, et al. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022;23:34. doi: 10.1186/s10194-022-01402-2. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16.Vikhe CS, Ramteke SU, Hullumani S. Effect of physiotherapy interventions on pain management, function and quality of life in patellofemoral pain syndrome: A systematic review protocol. PLoS One. 2024;19:e0312279. doi: 10.1371/journal.pone.0312279. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 17.Schwerla F, Bischoff A, Nurnberger A, et al. Osteopathic treatment of patients with chronic non-specific neck pain: a randomised controlled trial of efficacy. Forsch Komplementmed. 2008;15:138–45. doi: 10.1159/000132397. [DOI] [PubMed] [Google Scholar]
- 18.Licciardone JC, Stoll ST, Fulda KG, et al. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1986) 1976;28:1355–62. doi: 10.1097/01.BRS.0000067110.61471.7D. [DOI] [PubMed] [Google Scholar]
- 19.Furlan AD, Malmivaara A, Chou R, et al. 2015 Updated Method Guideline for Systematic Reviews in the Cochrane Back and Neck Group. Spine (Phila Pa 1976) 2015;40:1660–73. doi: 10.1097/BRS.0000000000001061. [DOI] [PubMed] [Google Scholar]
- 20.Bobos P, MacDermid JC, Walton DM, et al. Patient-Reported Outcome Measures Used for Neck Disorders: An Overview of Systematic Reviews. J Orthop Sports Phys Ther. 2018;48:775–88. doi: 10.2519/jospt.2018.8131. [DOI] [PubMed] [Google Scholar]
- 21.Liem T. Cranial osteopathy. Seattle, WA: Eastland Press; 2009. [Google Scholar]
- 22.Berger SE, Baria AT. Assessing Pain Research: A Narrative Review of Emerging Pain Methods, Their Technosocial Implications, and Opportunities for Multidisciplinary Approaches. Front Pain Res (Lausanne) 2022;3:896276. doi: 10.3389/fpain.2022.896276. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Shin YJ, Kim WH, Kim SG. Correlations among visual analogue scale, neck disability index, shoulder joint range of motion, and muscle strength in young women with forward head posture. J Exerc Rehabil. 2017;13:413–7. doi: 10.12965/jer.1734956.478. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24.Sharath HV, Nadipena PT, Qureshi MI, et al. A Review on Osteopathic Manipulation in Patients With Headache. Cureus. 2024;16:e66242. doi: 10.7759/cureus.66242. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25.Roberto G, Raschi E, Piccinni C, et al. Adverse cardiovascular events associated with triptans and ergotamines for treatment of migraine: systematic review of observational studies. Cephalalgia. 2015;35:118–31. doi: 10.1177/0333102414550416. [DOI] [PubMed] [Google Scholar]
- 26.Guillaud A, Darbois N, Monvoisin R, et al. Reliability of diagnosis and clinical efficacy of visceral osteopathy: a systematic review. BMC Complement Altern Med. 2018;18:65. doi: 10.1186/s12906-018-2098-8. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 27.Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336:924–6. doi: 10.1136/bmj.39489.470347.AD. [DOI] [PMC free article] [PubMed] [Google Scholar]