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

Effects of Mulligan Mobilizations Versus Active Release Technique on Pain, Range of Motion and Disability in Patients With Tension-Type Headache.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tension-Type Headache
• Intervention / Treatment: Other: Mulligan mobilizations; Other: Active Release Technique; Other: Mulligan mobilizations with active release technique

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 Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Amjad, PhD; Phone Number: 03324390125; Email: Imran.amjad@riphah.edu.pk
• Study Contact Backup: Name: Imran Amjad, PhD; Phone Number: 051-5481826

Study Locations

• Pakistan
  • Punjab
    • Toba Tek Singh, Punjab, Pakistan, 36050
      • DHQ Hospital Toba Tek Singh
      • Contact: Dr Hajra; Phone Number: +92 334 7052438; Email: hajiraanwer@gmail.com
      • Principal Investigator: Aqsa Fiaz, MS-OM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; This group will receive Mulligan mobilizations.	Other: Mulligan mobilizations; The duration of the intervention will be 4 weeks, 3 sessions a week, a total of 12 sessions will be given to the study participants. Each session will last for 30 minutes. Conventional physical therapy will be given to participants along with Mulligan mobilizations.
Active Comparator: Group B; This group will receive the Active release technique.	Other: Active Release Technique; The duration of the intervention will be 4 weeks, 3 sessions a week, a total of 12 sessions will be given to the study participants. Each session will last for 30 minutes. Conventional physical therapy will be given to participants along with the Active release technique.
Other: Group C; This group will receive both techniques combined.	Other: Mulligan mobilizations with active release technique; The duration of intervention will be 4 weeks, 3 sessions a week, a total of 12 sessions will be given to the study participants. Each session will last for 30 minutes. Conventional physical therapy will be given to participants along with mulligan mobilizations with active release technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain: Numeric Pain Rating Scale(NPRS)	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.	4th week
Disability: Headache Disability Index(HDI)	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.	4th week
Range of motion Cervical(Flexion)	Changes from the baseline ROM range of motion of cervical flexion will be taken with the help of a universal goniometer.	4th week
Range of motion Cervical(Extension)	Changes from the baseline ROM range of motion of cervical extension will be taken with the help of universal goniometer.	4th week
Range of motion Cervical(Rotation)	Changes from the baseline ROM range of motion of cervical rotation will be taken with the help of a universal goniometer.	4th week
Range of motion Cervical(Side bending)	Changes from the baseline ROM range of motion of cervical side bending will be taken with the help of a universal goniometer.	4th week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress: Perceived Stress Scale(PSS)	Changes from the baseline the Perceived Stress Scale (PSS) is a classic stress assessment instrument. The questions in this scale ask about your feelings and thoughts during the last month. In each case, you will be asked to indicate how often you felt or thought a certain way For each question choose from the following alternatives: 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often, 4 - very often	1st week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Dr. Hajra, Riphah International University

Publications and helpful links

General Publications

• Fernandez-de-Las-Penas C, Florencio LL, Plaza-Manzano G, Arias-Buria JL. Clinical Reasoning Behind Non-Pharmacological Interventions for the Management of Headaches: A Narrative Literature Review. Int J Environ Res Public Health. 2020 Jun 9;17(11):4126. doi: 10.3390/ijerph17114126.
• Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
• Jensen RH. Tension-Type Headache - The Normal and Most Prevalent Headache. Headache. 2018 Feb;58(2):339-345. doi: 10.1111/head.13067. Epub 2017 Mar 13.
• McDowell JM, Johnson GM, Hetherington BH. Mulligan Concept manual therapy: standardizing annotation. Man Ther. 2014 Oct;19(5):499-503. doi: 10.1016/j.math.2013.12.006. Epub 2014 Jan 10.
• Ashina S, Mitsikostas DD, Lee MJ, Yamani N, Wang SJ, Messina R, Ashina H, Buse DC, Pozo-Rosich P, Jensen RH, Diener HC, Lipton RB. Tension-type headache. Nat Rev Dis Primers. 2021 Mar 25;7(1):24. doi: 10.1038/s41572-021-00257-2.
• Burch R. Migraine and Tension-Type Headache: Diagnosis and Treatment. Med Clin North Am. 2019 Mar;103(2):215-233. doi: 10.1016/j.mcna.2018.10.003. Epub 2018 Dec 3.
• Robbins MS. Diagnosis and Management of Headache: A Review. JAMA. 2021 May 11;325(18):1874-1885. doi: 10.1001/jama.2021.1640.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: manual therapy; cervical spine; Tension-Type Headache; Active release technique; Mulligan Mobilizations
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: REC/ RCR & AHS/23/01107

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