Cervicogenic HeadacheNCT04625387
Dry Needle In Management of Cervicogenic Headache
A study testing Dry Needle and Exercise in people with Cervicogenic Headache, run by Raj Nursing and Paramedical College at 1 site in India.
Trial summary
Headache is an important health problem. It is the commonest type of all signs of illness in the people worldwide. Cervicogenic Headache is commonest musculoskeletal condition in physiotherapy practice. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Dry Needle and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2020to 25 Jun 2020
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20-50 years.
- Male and female both gender
- Worker in the Office.
- Employed permanently.
- Self-motivated for working continuously for rehab.
- Persistent or regular pain in the neck over a span of at least 6 months.
Who cannot join
- Cervical spine injury or surgery.
- Congenital spinal deformity.
- Participants having age less than 20 or elder than 50 years.
- Cervical radiculopathy,
- The participants had experienced any recent trauma or suffering from dizzy spells, any vascular neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dry Needle With Exercise In Cervicogenic Headache
Headache is an important health problem. It is the commonest type of all signs of illness in the people worldwide. Cervicogenic Headache is commonest musculoskeletal condition in physiotherapy practice. This study's main objective was to evaluate effectiveness of Dry Needle with exercise in decreasing pain and improving function in patients with Cervicogenic Headache.
Read the detailed description
50 patients were included and assigned randomly to group A and B. Group-A received Dry Needle plus exercise and group-B received Dry Needle alone. Baseline assessment was taken before and after treatment; treatment was given for four weeks twice a week. Outcome indicators were measured by Visual analog scale, Neck Disability Index and Cervical Range Of Motion.
The study findings indicate that both groups improve the symptoms of a headache. Clinically better improvement was indicated by Dry Needle plus exercise group than Dry Needle alone group. As per our results, Dry Needle plus exercise should be preferred for the management of cervicogenic headache over Dry Needle alone.
- Conditions
- Cervicogenic Headache
- Being tested
- Dry Needle and Exercise
- Keywords
- Dry Needle, Exercise, Neck pain, Trigger point
- Medical subject headings
- Post-Traumatic Headache, Motor Activity, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Needle and ExerciseOther
Also called Ice pack
A 0.25 X 15 mm acupuncture needle was used for sub occipital muscle and 0.25 X 40 mm needle was used for paraspinal and trapezius muscle. All the necessary precautions were maintained before inserting the needle. Therapists wore hand gloves for all purposes.
The exercise for the muscles of cervical group, for group A was carried out by elevating head from lying in supine position repeating 20 times in three sets and pressing a theraband forward in one set of 15 repetitions, to right side and to left side and back side
| Study group | Role | What they receive |
|---|---|---|
| Dry Needle plus exercise | Experimental | Group A received Dry Needling along with exercise having 25 individuals. Treatment lasted four weeks duration, twice a week. Receives: Other: Dry Needle and Exercise |
| Dry Needling alone | Experimental | Group B received Dry Needling alone having 25 individuals. Treatment lasted four weeks duration, twice a week. Receives: Other: Dry Needle and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Visual analogue scale is a subjective outcome measurement where patients judge the intensity of their pain on a scale of 0-10, which is in the form of a 10cm straight line . On this 0-10 scale, zero denotes no pain and ten denotes severe pain intensity
Measured: four weeks
Neck Disability Index
The Neck Disability index contains 10 items, seven related to activities of daily living, two related to pain, and one item related to concentration. Each item is scored ranging from 0 (no pain or disability) to 5 (severe pain and disability); and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
Measured: four weeks
Secondary outcomes (1)
Cervical Range of Motion
Range of motion of cervical spine is being measured by universal goniometer.
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 posted12 Nov 2020
- Study start15 May 2020
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raj Nursing and Paramedical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharick Shamsi, Raj Nursing and Paramedical College
- Investigators
- Sharick Shamsi, PhD, Principal investigator, Raj Nursing and Paramedical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625387
- Sponsor's protocol ID
- RajNursingParamedical
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dry Needle With Exercise In Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT04625387
- Acronym / sponsor ID
- RajNursingParamedical
- Conditions
- Cervicogenic Headache
- Keywords
- Dry Needle, Exercise, Neck pain, Trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Raj Nursing and Paramedical CollegeUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 12 Nov 2020 (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.
Headache is an important health problem. It is the commonest type of all signs of illness in the people worldwide. Cervicogenic Headache is commonest musculoskeletal condition in physiotherapy practice. This study's main objective was to evaluate effectiveness of Dry Needle with exercise in decreasing pain and improving function in patients with Cervicogenic Headache.
Detailed description
50 patients were included and assigned randomly to group A and B. Group-A received Dry Needle plus exercise and group-B received Dry Needle alone. Baseline assessment was taken before and after treatment; treatment was given for four weeks twice a week. Outcome indicators were measured by Visual analog scale, Neck Disability Index and Cervical Range Of Motion.
The study findings indicate that both groups improve the symptoms of a headache. Clinically better improvement was indicated by Dry Needle plus exercise group than Dry Needle alone group. As per our results, Dry Needle plus exercise should be preferred for the management of cervicogenic headache over Dry Needle alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needle plus exercise | Experimental | Other: Dry Needle and ExerciseGroup A received Dry Needling along with exercise having 25 individuals. Treatment lasted four weeks duration, twice a week. |
| Dry Needling alone | Experimental | Other: Dry Needle and ExerciseGroup B received Dry Needling alone having 25 individuals. Treatment lasted four weeks duration, twice a week. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 20-50 years.
- Male and female both gender
- Worker in the Office.
- Employed permanently.
- Self-motivated for working continuously for rehab.
Key exclusion criteria (5 listed)
- Cervical spine injury or surgery.
- Congenital spinal deformity.
- Participants having age less than 20 or elder than 50 years.
- Cervical radiculopathy,
- The participants had experienced any recent trauma or suffering from dizzy spells, any vascular neurological disorders.
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 |
|---|---|---|
| Dry Needle and ExerciseAlso: Ice packA 0.25 X 15 mm acupuncture needle was used for sub occipital muscle and 0.25 X 40 mm needle was used for paraspinal and trapezius muscle. All the necessary precautions were maintained before inserting the needle. Therapists wore hand gloves for all purposes. The exercise for the muscles of cervical group, for group A was carried out by elevating head from lying in supine position repeating 20 times in three sets and pressing a theraband forward in one set of 15 repetitions, to right side and to left side and back side | Other | Dry Needle plus exercise, Dry Needling alone |
Primary outcome
Visual Analogue Scale
Time frame: four weeks
Visual analogue scale is a subjective outcome measurement where patients judge the intensity of their pain on a scale of 0-10, which is in the form of a 10cm straight line . On this 0-10 scale, zero denotes no pain and ten denotes severe pain intensity
Neck Disability Index
Time frame: four weeks
The Neck Disability index contains 10 items, seven related to activities of daily living, two related to pain, and one item related to concentration. Each item is scored ranging from 0 (no pain or disability) to 5 (severe pain and disability); and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
1 secondary outcome
Cervical Range of Motion
Time frame: four weeks
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 13 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Cervicogenic Headache
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Trigger Point Injection and Myofascial Release for Cervicogenic Headache
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Comparative Effects of Dynamic Cupping and Facilitated Positional Release in Cervicogenic Headache
Cervicogenic Headache
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The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
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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.
Sharick Shamsi, PhD principal investigator
Raj Nursing and Paramedical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needle and Exercise in people with Cervicogenic Headache, run by Raj Nursing and Paramedical College at 1 site in India.
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 5 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 13 Nov 2020. 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 India. 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?
Visual Analogue Scale (time frame: four weeks). The study lists 2 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 13 Nov 2020.