- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07604935
Comparative Effects of Nerve Flossing and Deep Neck Flexor Muscle Strengthening on Pain, Range of Motion and Functional Disability on Cervical Spinal Stenosis (NF-DNF)
17. mai 2026 oppdatert av: Akasha Khan, Green International University
The goal of this randomized clinical trial is to compare the effectiveness of Nerve Flossing and Deep Neck Flexor strengthening exercises in individuals with cervical spinal stenosis.
The study aims to determine which treatment is more effective in reducing neck pain, improving cervical range of motion, and enhancing the ability to perform daily activities.
Participants will be randomly assigned to receive either Nerve Flossing or Deep Neck Flexor exercises for specified duration.
Both groups will attend physiotherapy sessions 3 times per week as assigned.
Outcomes such as pain intensity, neck disability, and range of motion will be measured before and after the intervention using standard assessment tools.
This study will help identify a more effective physiotherapy approach for managing symptoms of cervical spinal stenosis.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Cervical spinal stenosis is a condition characterized by narrowing of the spinal canal in the cervical region, leading to compression of neural structures.
This often results in neck pain, reduced cervical range of motion, and functional disability that affects daily activities and quality of life.
Conservative management through physiotherapy is the preferred initial approach before considering surgical intervention.
Among conservative techniques, Nerve Flossing and Deep Neck Flexor strengthening are commonly used but their comparative effectiveness remains unclear.
Nerve Flossing involves controlled, low-amplitude movements of the neck and upper limb to mobilize neural tissues and reduce nerve-related pain and sensitivity.
Deep Neck Flexor strengthening uses specific low-load exercises to improve the activation and endurance of the deep cervical flexors that support head and neck posture.
This study is conducted to address the gap in evidence by directly comparing these two interventions in patients with cervical spinal stenosis.
The findings will help physiotherapists and clinicians select the most effective treatment approach for reducing pain and improving function in this population.
Studietype
Intervensjonell
Registrering (Faktiske)
62
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Green International University
-
-
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:
- Adults aged 20-50 years, both male and female.
- Clinical and radiological (MRI) diagnosis of cervical spinal stenosis.
- Cervical pain with or without radiating to the upper limb.
- At least one neurological sign, such as sensory disturbance, muscle weakness or diminished reflexes.
- Symptoms present for more than 4 weeks but less than 6 months.
- Ability to understand and follow exercise instructions.
- VAS pain score ≥ 3/10 at baseline.
Exclusion Criteria:
- History of cervical spine surgery
- Recent trauma, fracture, or cervical instability.
- History of disc herniation involving surgery.
- Other neurological or musculoskeletal conditions, including peripheral neuropathy, thoracic outlet syndrome, and rheumatoid arthritis.
- Pregnancy.
- Recent medication use that may impact nerve function (e.g., systemic steroids).
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: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Nerve Flossing Group
Participants in this arm will receive Nerve Flossing techniques targeting the cervical and upper limb neural tissues.
The intervention involves controlled, low-amplitude movements of the neck and upper limb to improve neural mobility.
Sessions will be conducted as per the study protocol.
|
This intervention involves controlled, low-amplitude movements of the neck and upper limb to mobilize the cervical and upper limb neural tissues.
The technique aims to reduce mechanical sensitivity of the nerves, improve neural mobility, and alleviate nerve-related pain in patients with cervical spinal stenosis.
The specific dosage, frequency, and duration will be applied as per the study protocol.
Andre navn:
|
|
Eksperimentell: Deep Neck Flexor Strengthening Group
Participants in this arm will receive Deep Neck Flexor strengthening exercises using low-load, targeted movements to improve activation and strength of the deep cervical flexor muscles.
The exercises focus on enhancing cervical stability and posture.
Sessions will be conducted as per the study protocol.
|
Low-load, targeted exercises to improve activation and endurance of the deep cervical flexor muscles.
Focuses on enhancing cervical stability and posture.
Frequency, duration, and repetitions will follow the study protocol.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity
Tidsramme: Baseline and 12 weeks post-intervention
|
Pain intensity will be measured using the Visual Analogue Scale (VAS), where participants mark their pain level on 100mm line ranging from "no pain" (0) to "worst imaginable pain (100).
Higher scores indicate greater pain intensity.
|
Baseline and 12 weeks post-intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Neck Disability Index Score
Tidsramme: Baseline and 12 weeks post-intervention
|
Change in neck-related disability from baseline to 6 weeks and post-intervention, measured using the Neck Disability Index (NDI) on a scale of 0-50.
Higher scores indicate greater disability.
|
Baseline and 12 weeks post-intervention
|
|
Change in Cervical Range of Motion
Tidsramme: Baseline and 12 weeks post-intervention
|
Change in cervical flexion, extension, and rotation range of motion from baseline to 6 weeks and 12 weeks, measured by using inclinometer.
|
Baseline and 12 weeks post-intervention
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
6. april 2026
Primær fullføring (Faktiske)
29. april 2026
Studiet fullført (Faktiske)
6. mai 2026
Datoer for studieregistrering
Først innsendt
17. mai 2026
Først innsendt som oppfylte QC-kriteriene
17. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GIU/REC/26-34
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Only IPD used in the results publication will be shared
IPD-delingstidsramme
It will be available after the completion of the study.
Tilgangskriterier for IPD-deling
Through the corresponding author.
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
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