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

NCT ID: NCT06452628

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2024-09-30

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.

Conditions

Tension-Type Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

This group will receive Mulligan mobilizations.

Group Type: EXPERIMENTAL

Mulligan mobilizations

Intervention Type: OTHER

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.

Group B

This group will receive the Active release technique.

Group Type: ACTIVE_COMPARATOR

Active Release Technique

Intervention Type: OTHER

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.

Group C

This group will receive both techniques combined.

Group Type: OTHER

Mulligan mobilizations with active release technique

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Hajra

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

DHQ Hospital Toba Tek Singh

Toba Tek Singh, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Imran Amjad, PhD

Role: CONTACT

imran.amjad@riphah.edu.pk

03324390125

Imran Amjad, PhD

Role: CONTACT

051-5481826

Facility Contacts

Dr Hajra

Role: primary

hajiraanwer@gmail.com

+92 334 7052438

References

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.

Reference Type: BACKGROUND

PMID: 33767185 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28295304 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26852024 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32527071 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30704678 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 33974014 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30425380 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24491791 (View on PubMed)

Other Identifiers

REC/ RCR & AHS/23/01107

Identifier Type: -

Identifier Source: org_study_id