Clinical trial NCT05673330: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tension Type Headache
Keywords: Tension Type Headache
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: International Classification of Headache Disorders Criteria (ICHD-3 beta)
timeFrame: 4 weeks
measure: Numeric pain rate scale (NPRS)
timeFrame: 4 weeks
measure: Headache Disability Index Questionnaire
timeFrame: 4 weeks
measure: Headache Impact Test (HIT-6)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: NUR International University
state: Punjab
Study officials:
affiliation: Study Principal Investigator
name: Muhammad Sanaullah, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corum M, Aydin T, Medin Ceylan C, Kesiktas FN. The comparative effects of spinal manipulation, myofascial release and exercise in tension-type headache patients with neck pain: A randomized controlled trial. Complement Ther Clin Pract. 2021 May;43:101319. doi: 10.1016/j.ctcp.2021.101319. Epub 2021 Jan 24.
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.
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.
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.
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.
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.
citation: Pourahmadi M, Dommerholt J, Fernandez-de-Las-Penas C, Koes BW, Mohseni-Bandpei MA, Mansournia MA, Delavari S, Keshtkar A, Bahramian M. Dry Needling for the Treatment of Tension-Type, Cervicogenic, or Migraine Headaches: A Systematic Review and Meta-Analysis. Phys Ther. 2021 May 4;101(5):pzab068. doi: 10.1093/ptj/pzab068.
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.
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.
citation: Choi W. Effect of 4 Weeks of Cervical Deep Muscle Flexion Exercise on Headache and Sleep Disorder in Patients with Tension Headache and Forward Head Posture. Int J Environ Res Public Health. 2021 Mar 25;18(7):3410. doi: 10.3390/ijerph18073410.