- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07628439
Effects of Mulligan Belt Traction Versus Fisted Traction in Patients With Lower Cervical Spine Radiculopathy
Effects of Mulligan Belt Traction Versus Fisted Traction on Pain, Range of Motion and Disability Level in Patients With Lower Cervical Spine Radiculopathy
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:• Age 25-60 years
- Both Male and Female
- Clinically or radiologically diagnosed lower cervical radiculopathy(C5-C7)
- Neck pain radiating to the arm and hand
- Positive Spurling's Test or Upper Limb Tension test
- Subacute to chronic phase (>4 weeks to 6< weeks)
- Moderate pain (VAS> 4/10)
- Evident by a score on Neck Disability Index (NDI >20%)
- Able and willing to give informed consent and follow the protocol
- Cervical spine active range of motion (CSAROM) Exclusion Criteria:• Cervical Fracture
- Thoracic outlet syndrome or carpal tunnel syndrome
- History of previous cervical surgery
- Osteoporosis of cervical spine
- Sign of myelopathy
- Severe cervical disc herniation with cord compression
- Red flag signs (Rheumatoid arthritis, history of trauma, ankylosing spondylitis, prolonged steroid used and malignancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: conventional group
Conventional physiotherapy which include cervical traction, hot pack and isometric strengthening exercises for lower cervical radiculopathy
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Patient Position:
Therapist Position:
Belt Placement:
Application of Traction:
Duration: • Traction is applied for 10-30 seconds per repetition, repeated 3-5 times per session base Sit upright in a chair with back support. • Keep your spine straight and head in a neutral position. Hand Placement:
Traction Technique:
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Aktiv komparator: conventional therapy
Conventional physiotherapy which include cervical traction, hot pack and isometric strengthening exercises for lower cervical radiculopathy
|
Patient Position:
Therapist Position:
Belt Placement:
Application of Traction:
Duration: • Traction is applied for 10-30 seconds per repetition, repeated 3-5 times per session base Sit upright in a chair with back support. • Keep your spine straight and head in a neutral position. Hand Placement:
Traction Technique:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Neck Disability Index
Tidsramme: baseline to 4 week
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The NDI contains 10 items - 7 relating to activities of daily living, 2 relating to pain and 1 relating to concentration items is scored from 0-5, and the total score is expressed as a percentage (total possible score, 100%), with higher scores corresponding to greater disability.
Scoring the NDI: 0 - 4 = No disability 5 - 14 = Mild disability 15 - 24 = Moderate disability 25 - 34 = Severe disability 35 or over = Complete disability
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baseline to 4 week
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Numeric pain rating scale
Tidsramme: baseline to 4 week
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The NPRS is a reliable and effective tool for measuring pain.
A straight line is drawn on the evaluation sheet, labeled from '0' to '10', where '0' represents no pain and '10' indicates the worst possible pain.
Patients are asked to mark a point on the line that reflects the intensity of pain they are experiencing at the time of assessment
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baseline to 4 week
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Cervical Range of Motion
Tidsramme: baseline to 4 week
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Cervical Flexion (Looking Down) Position: The patient sits upright. Goniometer Axis: Placed at the external auditory meatus (ear). Stationary Arm: Kept perpendicular to the floor. Moving Arm: Aligned with the base of the nose. Normal Range: 0 to 45 degrees 2 Cervical Extension (Looking Up) Position: Patient remains seated upright. Goniometer Axis: Centered at the external auditory meatus. Stationary Arm: Vertical, perpendicular to the floor. Moving Arm: Follows the line of the nose. Normal Range: 0 to 45 degrees 3. Cervical Lateral Flexion (Side Bending) Position: Patient sits straight. Goniometer Axis: Over the C7 spinous process. Stationary Arm: Aligned vertically along the spine. Moving Arm: Follows the midline of the head toward the occipital bone. Normal Range: 0 to 45 degrees 4.Cervical Rotation (Turning Head Side to Side) Position: Patient remains upright. Goniometer Axis: Placed at the top center of the head. Stationary Arm: Imaginary line between both shoulder tips. |
baseline to 4 week
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011 Oct;7(3):265-72. doi: 10.1007/s11420-011-9218-z. Epub 2011 Sep 9.
- Kim HJ, Nemani VM, Piyaskulkaew C, Vargas SR, Riew KD. Cervical Radiculopathy: Incidence and Treatment of 1,420 Consecutive Cases. Asian Spine J. 2016 Apr;10(2):231-7. doi: 10.4184/asj.2016.10.2.231. Epub 2016 Apr 15.
- Peene L, Cohen SP, Brouwer B, James R, Wolff A, Van Boxem K, Van Zundert J. 2. Cervical radicular pain. Pain Pract. 2023 Sep;23(7):800-817. doi: 10.1111/papr.13252. Epub 2023 Jun 4.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REC/RCR&AHS/25/0210
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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