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

NCT06452628 | Not Yet Recruiting

• 1 other identifier: REC/ RCR & AHS/23/01107
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Tension-Type Headache

Keywords

Tension-Type Headache; Mulligan Mobilizations; Active release technique; cervical spine; manual therapy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Stress: Perceived Stress Scale(PSS)

  1st week

Study Arms (3)

Group A

EXPERIMENTAL

This group will receive Mulligan mobilizations.

Other: Mulligan mobilizations

Group B

ACTIVE COMPARATOR

This group will receive the Active release technique.

Other: Active Release Technique

Group C

OTHER

This group will receive both techniques combined.

Other: Mulligan mobilizations with active release technique

Interventions

Mulligan mobilizations 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 A

Active Release Technique 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 B

Mulligan mobilizations with active release technique 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.

Group C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

DHQ Hospital Toba Tek Singh

Toba Tek Singh, Punjab Province, 36050, Pakistan

Location

Related 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.

  PMID: 33767185 BACKGROUND

• 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.

  PMID: 28295304 BACKGROUND

• 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.

  PMID: 26852024 BACKGROUND

• 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.

  PMID: 32527071 BACKGROUND

• 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.

  PMID: 30704678 BACKGROUND

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

  PMID: 33974014 BACKGROUND

• 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.

  PMID: 30425380 BACKGROUND

• 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.

  PMID: 24491791 BACKGROUND

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dr. Hajra

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Imran Amjad, PhD

CONTACT

051-5481826

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding refers to a practice where study participants are prevented from knowing certain information that may somehow influence them-thereby tainting the results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 11, 2024
• Study Start: June 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)