Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effects of Thoracic Spine and Cervical Spine Mobilization on Pain, Functional Disability, and Quality of Life in Patients With Mechanical Neck Pain.

Mechanical neck pain (MNP) is characterized as neck discomfort mostly originating from musculoskeletal components such as cervical facet joints, intervertebral discs, ligaments, and musculature, in the absence of indications of nerve root compression or severe pathological conditions. Although recent evidence supports the use of both cervical and thoracic mobilization for mechanical neck pain, there remains limited comparative research examining their combined or relative effects on pain, functional disability, and quality of life. A total of 66 Participants with mechanical neck pain (> 4 weeks) will be randomly allocated into two groups: Group A (Cervical spine Maitland mobilization group) will receive cervical spine Maitland mobilization throughout the 8-week intervention period, with sessions conducted twice weekly from pre-treatment to post-treatment assessment, Each session will be lasted approximately 30 minutes, consisting of manual therapy followed by standardized therapeutic exercises, supervised exercises will be performed for approximately 15 minutes. Additionally, participants in both groups will be prescribed a daily home exercise program lasting 10-15 minutes. Group B (Thoracic Plus Cervical Spine Maitland Mobilization) will receive combined thoracic and cervical spine Maitland mobilization, Thoracic mobilization will be applied to the upper thoracic segments (T1-T4) using central PA Technique. Grades III and IV mobilizations for thoracic stiffness and restore extension mobility, while lower grades will be applied in cases of increased pain sensitivity. Thoracic mobilization will be delivered for approximately 6-8 minutes, after that cervical mobilization with same protocol of supervised exercise and home pan for mechanical neck pain will be used. Each treatment session will be lasted approximately 30 minutes. Outcome measures will include: Pain intensity assessed using the Visual Analogue Scale (VAS) Functional disability will be evaluated using the Neck Disability Index (NDI), Health-related quality of life will be measured using the Short Form-36 (SF-36). The primary objective of this study is to evaluate the effects of cervical spine mobilization and thoracic spine mobilization on pain intensity, functional disability, and quality of life in patients with mechanical neck pain.

Studieoversikt

Detaljert beskrivelse

Mechanical neck pain (MNP) is a common musculoskeletal condition characterized by localized or unilateral neck pain arising from cervical musculoskeletal structures, without nerve root involvement. It is frequently associated with restricted cervical and thoracic mobility, muscle stiffness, reduced range of motion, and functional limitations, which can significantly impair daily activities, work performance, and overall quality of life. Due to its high prevalence and recurrent nature, effective conservative physiotherapy management is essential.

Among commonly used physiotherapy interventions, spinal mobilization techniques particularly cervical spine mobilization and thoracic spine mobilization are widely applied to reduce pain, improve joint mobility, and enhance functional outcomes. Cervical mobilization focuses on restoring segmental mobility of the cervical spine and modulating pain through mechanical and neurophysiological mechanisms. In contrast, thoracic spine mobilization targets the upper thoracic region to improve extension mobility and reduce biomechanical stress on the cervical spine through the concept of regional interdependence. Although both techniques are frequently used in clinical practice, there is limited comparative evidence regarding their individual and combined effectiveness in patients with mechanical neck pain.

This study is designed as a two-arm parallel randomized controlled trial. A total of 66 participants diagnosed with mechanical neck pain will be recruited using a convenience sampling technique. Participants will be randomly allocated into two groups using computer-generated randomization with a 1:1 allocation ratio. Allocation concealment will be ensured using sealed opaque envelopes, and outcome assessment will be performed by a blinded assessor.

Participants in Group A will receive cervical spine Maitland mobilization applied to symptomatic cervical segments (C2-C7) using graded oscillatory techniques for pain reduction and mobility improvement. Participants in Group B will receive combined thoracic and cervical spine Maitland mobilization, where thoracic mobilization will be applied to upper thoracic segments (T1-T4) followed by cervical mobilization within the same session.

Both groups will receive standardized physiotherapy care, including patient education on posture and ergonomics, along with a structured home exercise program focusing on cervical mobility and postural control. The intervention will be conducted over a period of 8 weeks, with 2 sessions per week. Each session will last approximately 30 minutes.

Outcome measures will include pain intensity assessed using the Numeric Pain Rating Scale (NPRS), functional disability measured by the Neck Disability Index (NDI), and quality of life evaluated using the Short Form-36 (SF-36). Assessments will be conducted at baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).

Data will be analyzed using SPSS software. Normality of data will be assessed using the Shapiro-Wilk test, and appropriate parametric or non-parametric tests will be applied for within-group and between-group comparisons.

This study aims to provide evidence regarding the effectiveness of cervical spine mobilization alone versus combined thoracic and cervical spine mobilization in improving pain, functional disability, and quality of life in patients with mechanical neck pain, thereby contributing to evidence-based physiotherapy practice.

Studietype

Intervensjonell

Registrering (Antatt)

66

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 53400
        • Rekruttering
        • Lahore University of Biological & Applied Sciences (UBAS)
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

Participants of both genders aged between 20 and 40 years with a clinical diagnosis of mechanical neck pain will be included in the study. Eligible participants must have a history of neck pain lasting more than 4 weeks (subacute to chronic) and demonstrate mild to moderate functional disability, defined by a Neck Disability Index (NDI) score between 10% and 50%.

Exclusion Criteria:

Participants will be excluded if they present with signs or symptoms of cervical radiculopathy or myelopathy, such as a positive Spurling's test accompanied by neurological deficits, dermatomal numbness, or myotome weakness. Individuals with a history of cervical spine fracture, dislocation, or spinal surgery, as well as those with inflammatory, infectious, or neoplastic spinal conditions, will also be excluded. Additional exclusion criteria include diagnosed osteoporosis or prolonged use of systemic corticosteroids, severe cervical spine instability or vertebrobasilar insufficiency, recent trauma to the cervical or thoracic spine within the past 6 months, presence of systemic neurological disorders, pregnancy, and current participation in another physiotherapy or clinical trial for neck pain.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cervical Spine Maitland Mobilization
Participants in this group will receive cervical spine Maitland mobilization along with standardized physiotherapy care, including patient education on posture, ergonomics, and a structured home exercise program. The intervention will be conducted for 8 weeks, with 2 sessions per week, each lasting approximately 30 minutes. Cervical mobilization will be applied to symptomatic segments (C2-C7) using graded oscillatory techniques to reduce pain and improve cervical mobility
Participants in this group will receive cervical spine Maitland mobilization in addition to standard physiotherapy care. The program will be delivered for 8 weeks, with 2 sessions per week, each session lasting approximately 30 minutes. Mobilization will be performed according to the Maitland concept, with Grades I and II techniques applied for pain modulation and Grades III and IV for improving joint mobility, depending on patient tolerance. Each targeted cervical segment (C2-C7) will receive 3 sets of oscillations lasting 30-60 seconds, with short rest intervals between sets. The intervention aims to restore segmental mobility, reduce pain, and improve functional outcomes.
Aktiv komparator: Thoracic plus Cervical Spine Maitland Mobilization
Participants in this group will receive combined thoracic and cervical spine Maitland mobilization along with standardized physiotherapy care, including posture education and a structured home exercise program. The intervention will be conducted for 8 weeks, with 2 sessions per week, each lasting approximately 30 minutes. Thoracic mobilization will be applied to improve thoracic mobility, followed by cervical mobilization to reduce pain and enhance function.
Participants in this group will receive combined thoracic and cervical spine Maitland mobilization in addition to standard physiotherapy care. The program will be conducted for 8 weeks, with 2 sessions per week, each session lasting approximately 30 minutes. Thoracic mobilization will be applied to upper thoracic segments (T1-T4) using central posterior-to-anterior oscillatory techniques, primarily Grades III and IV to improve extension mobility. This will be followed by cervical spine mobilization using the same protocol as Group A. Thoracic mobilization will be performed for approximately 6-8 minutes, followed by cervical mobilization for 8-10 minutes. The combined approach aims to reduce cervical mechanical stress through regional interdependence, improve mobility, and enhance pain relief and functional outcomes.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Numeric Pain Rating Scale, Neck Disability Index, Short Form-36 (SF-36)
Tidsramme: Baseline, 4 weeks, and 8 weeks
Outcome assessment will be conducted at baseline (pre-treatment), at 4 weeks (mid-intervention), and at 8 weeks (post-intervention). Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), functional disability using the Neck Disability Index (NDI), and quality of life using the Short Form-36 (SF-36). Data will be analyzed using appropriate statistical tests to compare within-group and between-group differences.
Baseline, 4 weeks, and 8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Shoaib Waqas, Lahore University of Biological and Applied Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2026

Primær fullføring (Antatt)

30. juli 2026

Studiet fullført (Antatt)

15. september 2026

Datoer for studieregistrering

Først innsendt

20. juli 2026

Først innsendt som oppfylte QC-kriteriene

20. juli 2026

Først lagt ut (Faktiske)

23. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • UBAS/ERB/26/04/021

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

baseline participants

IPD-delingstidsramme

Start Date: De-identified individual participant data (IPD) along with supporting materials will be made available following publication of the main trial findings, anticipated around 12 months after the study concludes.

End Date: The data will be accessible for a period of 5 years from the commencement date to eligible researchers who provide a formal application and consent to the data use agreement.

Tilgangskriterier for IPD-deling

De-identified individual participant data (IPD) along with supporting documents will be available to qualified researchers for academic and non-commercial use only. To access the data, researchers must submit a written application detailing their study objectives and proposed use of the dataset. All requests will be assessed by the principal investigator Irsa and the institutional ethics committee to ensure ethical compliance and protection of participant privacy.

Data Available:

The shared dataset will include anonymized participant information, such as age and sex.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere