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

Primary Purpose

Tension Type Headache

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Spinal Mobilizations

Myofascial Release Technique

About this trial

This is an interventional treatment trial for Tension Type Headache focused on measuring Tension Type Headache

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

NUR International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Spinal Mobilizations

Myofascial Release technique

Arm Description

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) 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.

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.

Outcomes

Primary Outcome Measures

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

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

Numeric pain rate scale (NPRS)

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"

Headache Disability Index Questionnaire

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

Headache Impact Test (HIT-6)

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".

Secondary Outcome Measures

Full Information

NCT ID

NCT05673330

First Posted

January 4, 2023

Last Updated

April 18, 2023

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT05673330

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

November 6, 2022 (Actual)

Primary Completion Date

March 5, 2023 (Actual)

Study Completion Date

March 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tension Type Headache

Keywords

Tension Type Headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Spinal Mobilizations

Arm Type

Active Comparator

Arm Description

Arm Title

Myofascial Release technique

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Spinal Mobilizations

Other Intervention Name(s)

Headache SNAG, Maitland's C1-C7 PA Glide

Intervention Description

Intervention Type

Other

Intervention Name(s)

Myofascial Release Technique

Other Intervention Name(s)

Suboccipital Inhibition Technique

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4 weeks

Title

Numeric pain rate scale (NPRS)

Description

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"

Time Frame

4 weeks

Title

Headache Disability Index Questionnaire

Description

Time Frame

4 weeks

Title

Headache Impact Test (HIT-6)

Description

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muhammad Sanaullah, MS

Organizational Affiliation

Study Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

NUR International University

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54000

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33517104

Citation

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Results Reference

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PubMed Identifier

25986149

Citation

Zhang Y, Kong Q, Chen J, Li L, Wang D, Zhou J. International Classification of Headache Disorders 3rd edition beta-based field testing of vestibular migraine in China: Demographic, clinical characteristics, audiometric findings and diagnosis statues. Cephalalgia. 2016 Mar;36(3):240-8. doi: 10.1177/0333102415587704. Epub 2015 May 18.

Results Reference

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PubMed Identifier

33423013

Citation

Akbas I, Kocak AO, Akgol Gur ST, Oral Ahiskalioglu E, Dogruyol S, Dolanbay T, Demir M, Cakir Z. Lidocaine versus dexketoprofen in treatment of tension-type headache: A double-blind randomized controlled trial. Am J Emerg Med. 2021 Mar;41:125-129. doi: 10.1016/j.ajem.2020.12.057. Epub 2021 Jan 7. No abstract available.

Results Reference

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PubMed Identifier

30353868

Citation

GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954-976. doi: 10.1016/S1474-4422(18)30322-3. Erratum In: Lancet Neurol. 2021 Dec;20(12):e7.

Results Reference

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PubMed Identifier

33563049

Citation

Schiller J, Karst M, Kellner T, Zheng W, Niederer D, Vogt L, Eckhardt I, Beissner F, Korallus C, Sturm C, Egen C, Gutenbrunner C, Fink MG. Combination of acupuncture and medical training therapy on tension type headache: Results of a randomised controlled pilot study. Cephalalgia. 2021 Jul;41(8):879-893. doi: 10.1177/0333102421989620. Epub 2021 Feb 9.

Results Reference

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PubMed Identifier

33657998

Citation

Satpute K, Bedekar N, Hall T. Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2021 Mar 3;22(1):243. doi: 10.1186/s12891-021-04105-y.

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Citation

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PubMed Identifier

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Citation

Osama M. Effects of autogenic and reciprocal inhibition muscle energy techniques on isometric muscle strength in neck pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2021;34(4):555-564. doi: 10.3233/BMR-200002.

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PubMed Identifier

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Citation

Kwon SH, Chung EJ, Lee J, Kim SW, Lee BH. The Effect of Hamstring Relaxation Program on Headache, Pressure Pain Threshold, and Range of Motion in Patients with Tension Headache: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Sep 27;18(19):10137. doi: 10.3390/ijerph181910137.

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Citation

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

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