NCT06377787

Brief Summary

The aim of our study is to determine the effect of ELDOA in relieving pain, improving ROM and functional disability in patients with cervicogenic headache. This study will add to the growing body of knowledge that if this technique yields comparable outcomes, it would be the alternative therapy. Moreover, it would add to the society as no literature is available on the effect of ELDOA technique in the management of Cervicogenic headache.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

April 18, 2024

Last Update Submit

July 22, 2024

Conditions

Keywords

ELDOACervicogenic HeadacheCervical spine

Outcome Measures

Primary Outcomes (3)

  • (Numeric Pain Rating Scale).

    The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable while the NPRS exhibited moderate reliability (ICC = 0.27-0.84)

    four weeks

  • NDI (U) (Neck Disability Index)

    The neck disability index is a ten-item self-reported questionnaire that assesses pain and associated disability, with a total max score of 50 points . An Urdu version of neck disability index will use in this study. An intra-class correlation coefficient (ICC) revealed excellent test-retest reliability for all items (ICC = 0.86-0.98) and total scores (ICC = 0.99) of the NDI-U.

    four weeks

  • Inclinometer

    Cervical range of motion will be measured using inclinometer. It is a common instrument used to measure joint range of motion.

    four weeks

Study Arms (2)

ELDOA and conventional therapy

EXPERIMENTAL

hot pack and TENS for10 min, cervical PIR (MET) in flexion, extension, side bending and rotation (single set of 4rep with 6 sec hold once a day) and ELDOA method C0-C1-C2, C2 \& C3 positions for cervical spine (2 sets of five repetitions with 45 sec hold and 15sec rest between each set once a day).

Other: ELDOA and conventional therapy

conventional therapy

OTHER

hot pack and TENS for 10 minutes, cervical PIR (MET) in flexion, extension, side bending and rotation (single set of 4 reps with 6 seconds hold once a day).

Other: conventional therapy

Interventions

hot pack and TENS for10 min, cervical PIR (MET) in flexion, extension, side bending and rotation (single set of 4rep with 6 sec hold once a day) and ELDOA method C0-C1-C2, C2 \& C3 positions for cervical spine (2 sets of five repetitions with 45 sec hold and 15sec rest between each set once a day).

ELDOA and conventional therapy

include hot pack and TENS for 10 minutes, cervical PIR (MET) in flexion, extension, side bending and rotation (single set of 4 reps with 6 seconds hold once a day).

conventional therapy

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 30-45 years
  • Both male and female.
  • Onset of pain \> 4 weeks.
  • Flexion rotation test positive with estimated rotation range reduced by more than 10 degrees from the anticipated normal range (44 degrees)
  • Tenderness of upper three cervical joints.
  • Presence of active trigger points in upper trapezius and sub occipital extensors.

You may not qualify if:

  • Hypertension.
  • Recent (\<6 months) whiplash injury and other cervical soft tissue injuries.
  • History of cervical spinal vertebrae fracture.
  • Positive sharp purser test
  • Acute disc protrusion • History of cancer.
  • Previous surgical intervention of head, neck and thoracic spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alkhidmat Raazi Hospital CBR Town

Islamabad, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Asghar Khan

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 22, 2024

Study Start

April 2, 2024

Primary Completion

June 10, 2024

Study Completion

July 1, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations