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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | This group will receive Mulligan mobilizations. |
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| Group B | Active Comparator | This group will receive the Active release technique. |
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| Group C | Other | This group will receive both techniques combined. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
All other types of headaches.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imran Amjad, PhD | Contact | 03324390125 | imran.amjad@riphah.edu.pk | |
| Imran Amjad, PhD | Contact | 051-5481826 |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Hajra | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DHQ Hospital Toba Tek Singh | Toba Tek Singh | Punjab Province | 36050 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33767185 | Background | 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. | |
| 28295304 | 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. |
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| ID | Term |
|---|---|
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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Blinding refers to a practice where study participants are prevented from knowing certain information that may somehow influence them-thereby tainting the results.
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| 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. |
|
| 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. |
|
| 4th week |
| 1st week |
| 26852024 | 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. |
| 32527071 | 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. |
| 30704678 | 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. |
| 33974014 | Background | Robbins MS. Diagnosis and Management of Headache: A Review. JAMA. 2021 May 11;325(18):1874-1885. doi: 10.1001/jama.2021.1640. |
| 30425380 | 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. |
| 24491791 | 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. |
| D009422 | Nervous System Diseases |