Mulligan Mobilizations Versus Active Release Technique in Tension-type Headache.

Not Applicable

Not yet recruiting

• Conditions: Tension-Type Headache
• Interventions: Other: Mulligan mobilizations; Other: Active Release Technique; Other: Mulligan mobilizations with active release technique

• Registration Number: NCT06452628
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-06
• Last Update Submitted: 2024-06-06
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Primary Completion: 2024-08
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 33

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Mulligan mobilizations	This group will receive Mulligan mobilizations.
Group B	Active Release Technique	This group will receive the Active release technique.
Group C	Mulligan mobilizations with active release technique	This group will receive both techniques combined.

Primary Outcome Measures

Name	Time	Method
Pain: Numeric Pain Rating Scale(NPRS)	4th week	Changes from baseline Numeric pain rating scale is The 11-point scale used to capture the patient's level of pain. The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.'' Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. Numeric pain scales have been shown to be reliable and valid with validity range from 0.86 to 0.95 and high test-retest reliability r=0.96.
Range of motion Cervical(Rotation)	4th week	Changes from the baseline ROM range of motion of cervical rotation will be taken with the help of a universal goniometer.
Disability: Headache Disability Index(HDI)	4th week	Changes from baseline the Headache Disability Index (HDI) is a valid and reliable questionnaire designed to assess the impact of headaches on daily functioning and activities. It is often used to quantify the level of disability associated with headaches. The HDI consists of 25 items, and each item is scored on a scale from 0 to 6.
Range of motion Cervical(Extension)	4th week	Changes from the baseline ROM range of motion of cervical extension will be taken with the help of universal goniometer.
Range of motion Cervical(Side bending)	4th week	Changes from the baseline ROM range of motion of cervical side bending will be taken with the help of a universal goniometer.
Range of motion Cervical(Flexion)	4th week	Changes from the baseline ROM range of motion of cervical flexion will be taken with the help of a universal goniometer.

Trial Locations

Locations (1)

DHQ Hospital Toba Tek Singh; 🇵🇰 Toba Tek Singh, Punjab, Pakistan