Spinal Mobilization Versus Myofacial Release Techniques On Pain And Disability In Patients With Tension Type Headache

April 18, 2023 updated by: Riphah International University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • NUR International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Spinal Mobilizations
  1. Headache SNAG: A posteroanterior mobilization of the second cervical vertebrae is sustained for 10 to 30 s with the aim to reduce headache intensity at the time of application. (6)
  2. Maitland's C1-C7 PA Glide: A posteroanterior (PA) mobilization of the first till seventh cervical vertebra is achieved by applying a force on to a vertebral segment in a posteroanterior direction (Back to front).

The patients will receive Spinal Mobilizations consisting of 1 set of 6 repetitions once daily thrice per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks.
Other: Spinal Mobilizations
  1. Headache SNAG: A posteroanterior mobilization of the second cervical vertebrae is sustained for 10 to 30 s with the aim to reduce headache intensity at the time of application. (6)
  2. Maitland's C1-C7 PA Glide: A posteroanterior (PA) mobilization of the first till seventh cervical vertebra is achieved by applying a force on to a vertebral segment in a posteroanterior direction (Back to front).

The patients will receive Spinal Mobilizations consisting of 1 set of 6 repetitions once daily thrice per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks

Other Names:
  • Headache SNAG, Maitland's C1-C7 PA Glide
Active Comparator: Myofascial Release technique

Suboccipital Inhibition Technique: While the patient will be in the supine position, the physician sitting at the top end of the table will place the fingers of both hands on the patient's suboccipital region. Flexi-perpendicular long fingers exerting an inhibitory pressure on the muscle insertions of the neck extensors in the occiput, perpendicularly to muscle fibers, while the thumbs counterbalance the head against rotation. A deep and progressive pressure would be applied perpendicular to the fibers until a decrease in muscle tone would be detected. This deep and progressive pressure would be maintained for a total of 10 min until release of suboccipital tissues is achieved.

The patients will receive myofascial release with the frequency of 1 set and 10 repetitions once a day three times per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks.
Other: Myofascial Release Technique

Suboccipital Inhibition Technique: While the patient will be in the supine position, the physician sitting at the top end of the table will place the fingers of both hands on the patient's suboccipital region. Flexi-perpendicular long fingers exerting an inhibitory pressure on the muscle insertions of the neck extensors in the occiput, perpendicularly to muscle fibers, while the thumbs counterbalance the head against rotation. A deep and progressive pressure would be applied perpendicular to the fibers until a decrease in muscle tone would be detected. This deep and progressive pressure would be maintained for a total of 10 min until release of suboccipital tissues is achieved.

The patients will receive myofascial release with the frequency of 1 set and 10 repetitions once a day three times per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks.

Other Names:
  • Suboccipital Inhibition Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks
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"
4 weeks
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
4 weeks
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".
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Muhammad Sanaullah, MS, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2022

Primary Completion (Actual)

March 5, 2023

Study Completion (Actual)

March 6, 2023

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AH/22/Faryall Kemall

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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