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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06377787
Other study ID # REC 01732 Aneeqa Zaheer
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2, 2024
Est. completion date July 2024

Study information

Verified date April 2024
Source Riphah International University
Contact maria khalid, MSOMPT
Phone 03315369768
Email maria.khalid@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Cervicogenic Headache (CEH) is mainly caused by neck or paravertebral soft tissue lesions. It is chronic headache that arises from the Atlanto-occipital and upper cervical joints and is perceived in one or more regions of the head or face. One of the known treatment options that create decompression at spinal segment level is called ELDOA it is described as a conditioning method involving a series of movements and body stretches to help correct body posture, rehabilitate people with injuries and prevent injuries


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 45 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ELDOA and conventional therapy
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).
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).

Locations

Country Name City State
Pakistan Alkhidmat Raazi Hospital CBR Town Islamabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary (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
Primary 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
Primary Inclinometer Cervical range of motion will be measured using inclinometer. It is a common instrument used to measure joint range of motion. four weeks
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