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Clinical Trials/NCT05673330
NCT05673330
Completed
Not Applicable

Effects of Spinal Mobilization Versus Myofacial Release Techniques on Pain And Disability In Patients With Tension Type Headache

Riphah International University1 site in 1 country34 target enrollmentNovember 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tension Type Headache
Sponsor
Riphah International University
Enrollment
34
Locations
1
Primary Endpoint
International Classification of Headache Disorders Criteria (ICHD-3 beta)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The most frequent kind of primary headache is tension headache, often known as stress headache or tension-type headache (TTH). The pain usually affects both sides of the head and might extend from the lower back of the head, the neck, the eyes, or other muscle groups in the body. Nearly 90 percent of all headaches are tension-type headaches causing a debilitating effect on job productibility and overall quality of life. The aim of the study will be to compare the effects of spinal mobilizations comprising Mulligan's headache SNAGs and Maitland's PA glide with the myofascial release technique on pain and disability in patients with tension-type headache.

Detailed Description

A Randomized Clinical Trial will be conducted at FMH Physiotherapy Clinic, NUR International Physical Therapy clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 34 patients which will be allocated using simple random sampling through sealed opaque envelopes into Group A and Group B. Group A will be treated with Spinal Mobilizations comprising Mulligan's headache SNAGs and Maitland's PA glide and Group B will be treated with Myofascial release technique. Outcome measures tools will be conducted through NPRS, Headache disability Index, Headache impact test (HIT-6). Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups

Registry
clinicaltrials.gov
Start Date
November 6, 2022
End Date
March 6, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • • Male and female between ages of 30-60 years
  • Presence of 2 or more of the following: bilateral headache, pressure or squeezing pain, mild or intermediate pain intensity, and headache not elicited by daily physical activities
  • Headache lasting between 30 minutes and 7 days
  • Patients with no increase in pain during physical activity
  • Patients not having any photophobia, phonophobia during headache
  • Headache unaccompanied by vomiting or nausea

Exclusion Criteria

  • Any other primary or secondary headache according to the ICHD-III criteria.
  • A history of neck or head trauma (e.g., whiplash).
  • Any red flags (vertebral tumor, fracture, dislocation and infection, metabolic diseases, rheumatic and connective tissue diseases, systemic neuromuscular diseases, prolonged history of steroid use).
  • Diagnosis of any structural spinal disorders (osteoporosis, disc herniation, myelopathy, spinal stenosis, spondylolisthesis).
  • Prior surgery to the cervical spine.

Outcomes

Primary Outcomes

International Classification of Headache Disorders Criteria (ICHD-3 beta)

Time Frame: 4 weeks

It is used for diagnosis of the tension type headache and has following specifications: The pain should be bilateral, pressing and tightening pain, having a mild-moderate intensity \[≤7.0 on a visual analog scale (VAS)\] and there should be no increase in pain with physical activity. The patients should not have phonophobia, nausea, vomiting or photophobia. Headache should last between 30 minutes and 7 days

Headache Impact Test (HIT-6)

Time Frame: 4 weeks

The HIT-6 is a 6-item screening instrument used to quantify headache. It assesses the effects of headaches on daily life activities. This questionnaire has 6 questions, with a maximum number of points of 6\*13 (78). A total score of 36 means best and 78 means worst in terms of headache. Scores above 50 are "high".

Headache Disability Index Questionnaire

Time Frame: 4 weeks

To quantify the impact of headache on daily living, a 25-item headache disability inventory (HDI) will be used. Each requiring a "yes" (four points), "sometimes" (two points), or "no" (zero points) response based on items derived empirically from case history responses of subjects with headache. Items are sub grouped into functional and emotional subscales

Numeric pain rate scale (NPRS)

Time Frame: 4 weeks

Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain"

Study Sites (1)

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