Tension-Type HeadacheNCT06452628
Mulligan Mobilizations Versus Active Release Technique in Tension-type Headache.
A study testing Mulligan mobilizations, Active Release Technique and Mulligan mobilizations with active release technique in people with Tension-Type Headache, run by Riphah International University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Mulligan mobilizations, Active Release Technique and Mulligan mobilizations with active release technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Imran Amjad, PhD contact
Pakistan1 site
DHQ Hospital Toba Tek Singh
Toba Tek Singh, Punjab Province, 36050
Dr Hajra, +92 334 7052438, hajiraanwer@gmail.com
Aqsa Fiaz, MS-OM
About this study
Official title: 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.
Read the 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
- Being tested
- Mulligan mobilizations, Active Release Technique, Mulligan mobilizations with active release technique
- Keywords
- Tension-Type Headache, Mulligan Mobilizations, Active release technique, cervical spine, manual therapy
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan mobilizationsOther
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 TechniqueOther
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 techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | This group will receive Mulligan mobilizations. Receives: Other: Mulligan mobilizations |
| Group B | Active comparator | This group will receive the Active release technique. Receives: Other: Active Release Technique |
| Group C | Other | This group will receive both techniques combined. Receives: Other: Mulligan mobilizations with active release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Hajra, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452628
- Sponsor's protocol ID
- REC/ RCR & AHS/23/01107
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33767185Jensen 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.
PubMed 28295304Dunning 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.
PubMed 26852024Fernandez-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.
PubMed 32527071Burch 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.
PubMed 30704678Robbins MS. Diagnosis and Management of Headache: A Review. JAMA. 2021 May 11;325(18):1874-1885. doi: 10.1001/jama.2021.1640.
PubMed 33974014Del 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.
PubMed 30425380McDowell 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.
PubMed 24491791
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mulligan Mobilizations Versus Active Release Technique on Pain, Range of Motion and Disability in Patients With Tension-Type Headache.
- ClinicalTrials.gov ID
- NCT06452628
- Acronym / sponsor ID
- REC/ RCR & AHS/23/01107
- Conditions
- Tension-Type Headache
- Keywords
- Tension-Type Headache, Mulligan Mobilizations, Active release technique, cervical spine, manual therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Mulligan mobilizationsThis group will receive Mulligan mobilizations. |
| Group B | Active comparator | Other: Active Release TechniqueThis group will receive the Active release technique. |
| Group C | Other | Other: Mulligan mobilizations with active release techniqueThis group will receive both techniques combined. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- All other types of headaches.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulligan mobilizationsThe 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. | Other | Group A |
| Active Release TechniqueThe 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 B |
| Mulligan mobilizations with active release techniqueThe 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. | Other | Group C |
Primary outcome
Pain: Numeric Pain Rating Scale(NPRS)
Time frame: 4th week
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.
Disability: Headache Disability Index(HDI)
Time frame: 4th week
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.
Range of motion Cervical(Flexion)
Time frame: 4th week
Changes from the baseline ROM range of motion of cervical flexion will be taken with the help of a universal goniometer.
Range of motion Cervical(Extension)
Time frame: 4th week
Changes from the baseline ROM range of motion of cervical extension will be taken with the help of universal goniometer.
Range of motion Cervical(Rotation)
Time frame: 4th week
Changes from the baseline ROM range of motion of cervical rotation will be taken with the help of a universal goniometer.
Range of motion Cervical(Side bending)
Time frame: 4th week
Changes from the baseline ROM range of motion of cervical side bending will be taken with the help of a universal goniometer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Background: PubMed 33767185Ashina 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.
- Background: PubMed 28295304Jensen 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.
- Background: PubMed 26852024Dunning 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.
- Background: PubMed 32527071Fernandez-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.
- Background: PubMed 30704678Burch 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.
- Background: PubMed 33974014Robbins MS. Diagnosis and Management of Headache: A Review. JAMA. 2021 May 11;325(18):1874-1885. doi: 10.1001/jama.2021.1640.
- Background: PubMed 30425380Del 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.
- Background: PubMed 24491791McDowell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Amjad, PhD contact
Dr. Hajra principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan mobilizations, Active Release Technique and Mulligan mobilizations with active release technique in people with Tension-Type Headache, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: Numeric Pain Rating Scale(NPRS) (time frame: 4th week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06452628, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.