Cervicogenic HeadacheNCT06377787
Effects of ELDOA in Patients With Cervicogenic Headache
A study testing ELDOA and conventional therapy and conventional therapy in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- ELDOA and conventional therapy and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Apr 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Alkhidmat Raazi Hospital CBR Town
Islamabad, Punjab Province, 46000
About this study
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.
Read the 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
- Conditions
- Cervicogenic Headache
- Being tested
- ELDOA and conventional therapy, conventional therapy
- Keywords
- ELDOA, Cervicogenic Headache, Cervical spine
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELDOA and conventional therapyOther
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 therapyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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)
Measured: 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.
Measured: four weeks
Inclinometer
Cervical range of motion will be measured using inclinometer. It is a common instrument used to measure joint range of motion.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start2 Apr 2024
- Primary completion10 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maria Khalid, MSOMPT, Principal investigator, Riphah International UniversityAsghar Khan, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377787
- Sponsor's protocol ID
- REC 01732 Aneeqa Zaheer
- Status last verified
- Jul 2024
- First submitted
- 18 Apr 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ELDOA in Patients With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT06377787
- Acronym / sponsor ID
- REC 01732 Aneeqa Zaheer
- Conditions
- Cervicogenic Headache
- Keywords
- ELDOA, Cervicogenic Headache, Cervical spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELDOA and conventional therapy | Experimental | Other: ELDOA and conventional therapyhot 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 | Other | Other: conventional therapyhot 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). |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELDOA and conventional therapyhot 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 therapyinclude 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 |
Primary outcome
(Numeric Pain Rating Scale).
Time frame: four weeks
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)
NDI (U) (Neck Disability Index)
Time frame: four weeks
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.
Inclinometer
Time frame: four weeks
Cervical range of motion will be measured using inclinometer. It is a common instrument used to measure joint range of motion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Cervicogenic Headache
Not yet recruiting
Trigger Point Injection and Myofascial Release for Cervicogenic Headache
Cervicogenic Headache
Not yet recruiting
Comparative Effects of Dynamic Cupping and Facilitated Positional Release in Cervicogenic Headache
Cervicogenic Headache
Active, not recruiting
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
Cervicogenic Headache
Recruiting
Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)
Myofascial Trigger Points, Migraine
Recruiting
Comparative Effects of Post Isometric Relaxation and Reciprocal Inhibition in Individuals With Cervicogenic Headache.
Post Traumatic Headache, Cervicogenic Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
maria Khalid, MSOMPT principal investigator
Riphah International University
Asghar Khan study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELDOA and conventional therapy and conventional therapy in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Numeric Pain Rating Scale). (time frame: four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.