Dry Needle In Management of Cervicogenic Headache
Primary Purpose
Cervicogenic Headache
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Dry Needle and Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Cervicogenic Headache focused on measuring Dry Needle, Exercise, Neck pain, Trigger point
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Sharick Shamsi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dry Needle plus exercise
Dry Needling alone
Arm Description
Group A received Dry Needling along with exercise having 25 individuals. Treatment lasted four weeks duration, twice a week.
Group B received Dry Needling alone having 25 individuals. Treatment lasted four weeks duration, twice a week.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Cervical Range of Motion
Range of motion of cervical spine is being measured by universal goniometer.
Full Information
NCT ID
NCT04625387
First Posted
November 6, 2020
Last Updated
November 10, 2020
Sponsor
Raj Nursing and Paramedical College
1. Study Identification
Unique Protocol Identification Number
NCT04625387
Brief Title
Dry Needle In Management of Cervicogenic Headache
Official Title
Efficacy of Dry Needle With Exercise In Cervicogenic Headache
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
June 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Raj Nursing and Paramedical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Dry Needle, Exercise, Neck pain, Trigger point
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry Needle plus exercise
Arm Type
Experimental
Arm Description
Group A received Dry Needling along with exercise having 25 individuals. Treatment lasted four weeks duration, twice a week.
Arm Title
Dry Needling alone
Arm Type
Experimental
Arm Description
Group B received Dry Needling alone having 25 individuals. Treatment lasted four weeks duration, twice a week.
Intervention Type
Other
Intervention Name(s)
Dry Needle and Exercise
Other Intervention Name(s)
Ice pack
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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
Time Frame
four weeks
Title
Neck Disability Index
Description
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.
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
Cervical Range of Motion
Description
Range of motion of cervical spine is being measured by universal goniometer.
Time Frame
four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharick Shamsi, PhD
Organizational Affiliation
Raj Nursing and Paramedical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharick Shamsi
City
Gorakhpur
State/Province
Uttar Pradesh
ZIP/Postal Code
273001
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
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Dry Needle In Management of Cervicogenic Headache
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