- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07403175
Synergistic Impact of Postural Correction Interventions and Sustained Natural Apophyseal Glides in Migraine
Synergistic Impact of Postural Correction Interventions and Sustained Natural Apophyseal Glides on Severity, Disability and Quality of Life in Patients With Migraine
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Sialkot, Punjab Province, Pakistan, 51413
- Abdul Ahaad Hospital, Sialkot
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A diagnosis of episodic migraine made by the primary investigator according to ICHD-2.
- Symptoms must include at least two of the following: Unilateral pain, Pulsating/throbbing pain, Nausea, Vomiting, Photophobia/phonophobia.
- Participants should be full time employees or Desktop users.
- Participants have a history of at least migraine >4 days per month.
- Participants having history of migraine lasting from 4-72 hours
- Age group between 22 and 45 years.
- Both gender male and female.
- Participants who agree to cut-off any pharmacological treatment during study.
- Participants should have an average score between 3-6 on pain intensity scale.
Exclusion Criteria:
- Participants having active migraine and other headache types e.g. Cluster headache.
- Previous neck/head trauma from >2 years.
- Any neck/head surgery >2 years
- Spinal infections/diseases e.g. Tumor, TB spine
- Any history of neurological disorders e.g. stroke, abcess, haemorrhage, haematoma
- Severe Osteoporosis
- Pregnancy
- Upper motor neuron disease, cervical stenosis, and metabolic diseases in bone and joint.
- Ongoing radiotherapy, chemotherapy, steroid therapy, or anticoagulants.
- Psychiatric diseases such as phobia/obsession and depression.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Sustained Natural Apophyseal Glides
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Headache SNAG: A posteroanterior mobilization of the second cervical vertebrae is maintained for 10-30 seconds having the patient comfortably seated on a chair or couch. A maximum of six repetitions were administered. The patient is administered SNAG mobilization by placing the medial border of the thumb's distal phalanx on the spine of one vertebra above while standing behind the patient. The thumb tips were positioned at a 45° angle, and another thumb is used to provide the glides. Glides are performed in 3 sets and 6 times during the session. Reverse Headache SNAG: Anterio-posterior mobilization of the second cervical vertebrae is maintained for 10-30 seconds having the patient comfortably seated on a chair or couch. A maximum of 6 repetitions were administered.
Other Names:
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Experimental: Sustained Natural Apophyseal Glides & Postural Correction Exercises
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Headache SNAG: A posteroanterior mobilization of the second cervical vertebrae is maintained for 10-30 seconds having the patient comfortably seated on a chair or couch. A maximum of six repetitions were administered. The patient is administered SNAG mobilization by placing the medial border of the thumb's distal phalanx on the spine of one vertebra above while standing behind the patient. The thumb tips were positioned at a 45° angle, and another thumb is used to provide the glides. Glides are performed in 3 sets and 6 times during the session. Reverse Headache SNAG: Anterio-posterior mobilization of the second cervical vertebrae is maintained for 10-30 seconds having the patient comfortably seated on a chair or couch. A maximum of 6 repetitions were administered.
Other Names:
The main exercises used in this group are stretching, strengthening, and endurance exercise to maintain a healthy posture and correct the faulty posture due to weakened and tightened muscles Each subject will receive 6 treatment sessions spread over 4 consecutive weeks and each treatment session will not extend beyond 30 min.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numeric Pain Rating Scale (NPRS)
Time Frame: From enrollment to the end of treatment at 4 weeks.
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The NRS is used to gauge the patient's degree of pain.
On a 0-10 scale, where 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, and 7-10 represents severe pain, this tool is frequently used to gauge the intensity of pain.
Patients rate how much pain they are currently experiencing as well as how much pain they have experienced in the past 24 hours.
The patient's level of pain might be represented by the average of three evaluations or by any single value
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From enrollment to the end of treatment at 4 weeks.
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Migraine Specific Quality of Life Questionnaire (MSQ Version 2.1)
Time Frame: From enrollment to the end of treatment at 4 weeks.
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This questionnaire is used to evaluate migraine patient's quality of life.
The 14-item MSQ version 2.1 measures QOL impacts in three domains: Role function-restrictive (RFR), which measures the functional impact of migraine through limitations on daily social and work activities; Role function-preventive (RFP), which measures the impact of migraine through prevention of daily work and social activities; and Emotional function (EF), which measures the emotional impact of migraine through three items.
The raw total score was the sum of all item scores, which were rescaled from 0 to 100, with a higher score denoting better quality of life.
Raw scores in each domain were calculated as the sum of all item scores.
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From enrollment to the end of treatment at 4 weeks.
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Migraine Disability Assessment Scale (MDA)
Time Frame: From enrollment to the end of treatment at 4 weeks.
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The Migraine Disability Assessment Scale (MIDAS) is intended to assist individuals and medical professionals in comprehending how migraines affect day-to-day living.
MIDAS gives a more accurate view of the overall impact of migraines by evaluating how frequently they occur and how they interfere with social activities, employment, and domestic duties.
It is simpler to customize therapy to meet each patient's needs when the information is used to determine treatment choices and monitor progress overtime.
In the end, it's a tool that facilitates improved communication and assistance in migraine management by allowing patients to share their experiences and difficulties.
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From enrollment to the end of treatment at 4 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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ROM Cervical Spine (Flexion)
Time Frame: From enrollment to the end of treatment at 4 weeks.
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Changes in cervical spine flexion ROM at baseline and 4th week of intervention was measured using goniometer.
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From enrollment to the end of treatment at 4 weeks.
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ROM Cervical Spine (Extension)
Time Frame: From enrollment to the end of treatment at 4 weeks.
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Changes in cervical spine extension ROM at baseline and 4th week of intervention was measured using goniometer.
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From enrollment to the end of treatment at 4 weeks.
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ROM Cervical Spine (Lateral Flexion) Left Side
Time Frame: From enrollment to the end of treatment at 4 weeks.
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Changes in cervical spine lateral flexion on left side ROM at baseline and 4th week of intervention was measured using goniometer.
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From enrollment to the end of treatment at 4 weeks.
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ROM Cervical Spine (Lateral Flexion) Right Side
Time Frame: From enrollment to the end of treatment at 4 weeks.
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Changes in cervical spine lateral flexion on right side ROM at baseline and 4th week of intervention was measured using goniometer.
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From enrollment to the end of treatment at 4 weeks.
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ROM Cervical Spine (Rotation) Left Side
Time Frame: From enrollment to the end of treatment at 4 weeks.
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Changes in cervical spine rotation on left side ROM at baseline and 4th week of intervention was measured using goniometer.
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From enrollment to the end of treatment at 4 weeks.
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ROM Cervical Spine (Rotation) Right Side
Time Frame: From enrollment to the end of treatment at 4 weeks.
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Changes in cervical spine rotation on right side ROM at baseline and 4th week of intervention was measured using goniometer.
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From enrollment to the end of treatment at 4 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rafia Mannan, MS-SPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/01104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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