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

Tension-Type Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452628
• Other study ID #: REC/ RCR & AHS/23/01107
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Imran Amjad, PhD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

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 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.
• 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.

Locations

Country	Name	City	State
Pakistan	DHQ Hospital Toba Tek Singh	Toba Tek Singh	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Robbins MS. Diagnosis and Management of Headache: A Review. JAMA. 2021 May 11;325(18):1874-1885. doi: 10.1001/jama.2021.1640. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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