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Development, validation and clinical testing of tension headache assessment tool (THAT) for evaluation of tension type headache

Phase 1
Conditions
Health Condition 1: G892- Chronic pain, not elsewhere classified
Registration Number
CTRI/2024/04/065174
Lead Sponsor
lovely professional university
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Age 35-45

2.both sexes

3.Patient suffering from TTH, stress headache, according to headache diary headache turn into migraine without aura, nausea.

4.limited neck rom

5.neck stiffness, new heavy head,

6.Accurate anamnesis and accurate physical examination will help in diagnosing the etiology of headache

7.Orthopedic disorder that impaired functional neck trunk rom

8.Family history, personal history.

9.The participant has a prior history of headache (s) lasting 6 weeks or longer, when untreated.

10.The participants has episodic headache as define by international headache society international classification with an adequately documented history of headache at least 12 months.

11.The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway (anti-CGRP monoclonal antibodies [mAbs] and gepants)

12.Participants have prolong use of medication, analgesic, etc.

Exclusion Criteria

•1.Temperature elevation, fever, vomiting, migraine with aura etc.

2.CH include severe unilateral orbital, supraorbital and/or temporal pain lasting from 15 minutes to 180 minutes

3.The inclusive criteria were not answering the scales and not signing the informed consent.

4.The History of significant to the head and neck surgery.

5.History of head and cervical region surgery.

6.Subject with another history of neurological problem

7.Vestibular suppressant medication, and condition, dizziness etc.

8. systemic diseases

9.Fibromyalgia

10.Skin rashes

11.meningitis

12.peripheral neuropathies

13.craneomandibular dysfunctions

14.recent trauma

15.chirurgic interventions in neck or facial

16.osteoporotic spine

17.vitamin d deficiency

18.complex regional pain syndrome

19.alcohol intoxication

20.vestibular neuritis

21.bilateral and central vestibular disorder

22.Participants with a lifetime history of psychosis, bipolar mania, or dementia are excluded. Participants with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to Screening Visit 2 are also excluded.

23.The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

24.The participant has a history or diagnosis of hypnic headache, hemicrania continua, new daily persistent headache, chronic migraine or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).

25.The participant is, at Screening Visit 2, at significant risk of suicide.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
THAT ASSESMENT TOOLTimepoint: ASSESMENT FOR 4 WEEK AND FOLLOW UP FOR 6 WEEKS
Secondary Outcome Measures
NameTimeMethod
BLOOD MARKERSTimepoint: 1 week & after 4 week
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