Effects of ELDOA in Patients With Cervicogenic Headache

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.

Study Overview

• Status: Completed
• Conditions: Cervicogenic Headache
• Intervention / Treatment: Other: ELDOA and conventional therapy; Other: conventional therapy

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Islamabad, Punjab, Pakistan, 46000
      • Alkhidmat Raazi Hospital CBR Town

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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).
Other: conventional therapy; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Maria khalid, MSOMPT, Riphah International University; Study Chair: Asghar Khan, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Cervical spine; ELDOA; Cervicogenic Headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache
• Other Study ID Numbers: REC 01732 Aneeqa Zaheer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No