Clinical trial NCT06452628: Mulligan Mobilizations Versus Active Release Technique in Tension-type Headache.
Official title: Effects of Mulligan Mobilizations Versus Active Release Technique on Pain, Range of Motion and Disability in Patients With Tension-Type Headache.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tension-Type Headache
Keywords: Tension-Type Headache
Mulligan Mobilizations
Active release technique
cervical spine
manual therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial.
Primary purpose: TREATMENT

Brief summary: Tension-type headaches, characterized by a dull, aching head pain, are one of the most prevalent forms of headache disorders worldwide. Although they are typically not associated with severe disability or neurological symptoms, they can significantly impact an individual's quality of life due to chronic pain and discomfort. Non-pharmacological interventions, such as manual therapy techniques, have gained prominence in headache management, offering potential relief and functional improvements for patients. This study aims to investigate the comparative effectiveness of two widely used manual therapy approaches, Mulligan mobilization and Active Release Technique (ART), in alleviating pain, reducing disability, and enhancing range of motion (ROM) in patients suffering from tension-type headaches. Understanding which technique offers superior outcomes is vital for optimizing headache management strategies.

Detailed description: This randomized controlled trial (RCT) will recruit adult participants diagnosed with tension-type headaches according to standardized criteria. Eligible individuals will be randomly assigned to one of three groups: The Mulligan mobilization group, the ART group, and the control group. Each group will undergo a specific manual therapy intervention protocol administered by trained therapists. The primary outcome measures will include assessments of pain intensity via VAS, disability levels via Headache disability index (HDI), Stress levels will be assessed by PSS (Perceived Stress Scale), and ROM of the cervical spine by using the Flexion rotation test. Secondary outcomes will encompass patient-reported measures of headache frequency, medication usage, and overall quality of life. Data will be collected at baseline, immediately post-intervention, and at follow-up intervals. Statistical analyses will be conducted to assess and compare the effects of the two interventions on the primary and secondary outcomes using ANOVA from SPSS software, thereby addressing the research question regarding their relative efficacy. This study holds the potential to enhance the evidence base for non-pharmacological headache management and guide clinicians and patients toward more effective treatment choices.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 18-35 years.
* Diagnosis of chronic tension-type headache according to the International Classification of --Headache Disorders (ICHD-3) criteria.
* Baseline HDI from 10 and above, and NPRS score 3 and above.
* No prior exposure to any of the two interventions (ART and Mulligan Mobilization).

Exclusion Criteria:

* All other types of headaches.

  * Individuals taking medications for headaches.
  * Serious neurological or medical conditions that could affect the study outcomes.
  * History of psychiatric disorders.
  * Recent head or neck trauma or surgery.
  * Contraindications for any of the two interventions.
  * Participation in other headache management studies during the study period.

Primary outcomes:
measure: Pain: Numeric Pain Rating Scale(NPRS)
timeFrame: 4th week
measure: Disability: Headache Disability Index(HDI)
timeFrame: 4th week
measure: Range of motion Cervical(Flexion)
timeFrame: 4th week
measure: Range of motion Cervical(Extension)
timeFrame: 4th week
measure: Range of motion Cervical(Rotation)
timeFrame: 4th week
measure: Range of motion Cervical(Side bending)
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
measure: Stress: Perceived Stress Scale(PSS)
timeFrame: 1st week
Locations:
city: Toba Tek Singh
country: Pakistan
facility: DHQ Hospital Toba Tek Singh
state: Punjab
Study officials:
affiliation: Riphah International University
name: Dr. Hajra
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Del Blanco Muniz JA, Zaballos Laso A. [Tension-type headache. Narrative review of physiotherapy treatment]. An Sist Sanit Navar. 2018 Dec 26;41(3):371-380. doi: 10.23938/ASSN.0379. Spanish.
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