HeadacheNCT05990153
Evaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients With Headache
A study testing Myofascial Release (MR), clinical practice drug treatment and Manual therapy (MT) in people with Headache, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
The study aims to evaluate which is the best approach for the non-pharmacological treatment of patients with different types of primary headaches (tension-type headache (TTC), trigeminal autonomic headache (TACs) and migraine) or cervicogenic headache by comparing three methods of intervention to control treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache
- What is being tested?
- Myofascial Release (MR), clinical practice drug treatment and Manual therapy (MT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 5 Apr 2023to Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from primary headache or cervicogenic headache;
- Age > 18 years;
- signature of the informed consent.
Who cannot join
- upper cervical spine instability;
- cervical arterial insufficiency
- cervical spine fractures
- pregnancies
- rheumatoid arthritis
- severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Rehabilitation Department Fondazione Policlinico Universitario Campus Bio-Medico
Roma, RM, 00128
Silvia Sterzi, MD, +390622541624, s.sterzi@policlinicocampus.it
Marco Bravi, PT, +393285357278, m.bravi@policlinicocampus.it
About this study
Official title: Evaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients Suffering From Cervicogenic Headache, or Primary Headache (Tension-type Headache, Migraine, Trigeminal Autonomic Headache)
The study aims to evaluate which is the best approach for the non-pharmacological treatment of patients with different types of primary headaches (tension-type headache (TTC), trigeminal autonomic headache (TACs) and migraine) or cervicogenic headache by comparing three methods of intervention to control treatment (drug therapy): therapeutic exercise (TE), myofascial release + TE, and Mulligan's manual therapy + TE. The efficacy will be evaluated in terms of reduction of headache episodes, pain intensity and its duration.
Read the detailed description
Patients will be evaluated before the start of treatment (T0), at the end of treatment (T1), 3 months after T1 (T2), 6 months after T1 (T3). Results will be stratified by gender, age range, and type of headache diagnosed.
The 3 non-pharmacological treatment groups will carry out 12 treatment sessions, 3 times a week for 4 weeks, with a duration of 45 minutes each. The control group (CTRL) will carry out pharmacological treatment according to clinical practice, the patients of the CTRL group at the end of the last follow-up evaluation (T3 at 6 months) at their request will be randomized into one of the other three intervention groups.
- Conditions
- Headache
- Being tested
- Myofascial Release (MR), clinical practice drug treatment, Manual therapy (MT), Therapeutic exercise (TE)
- Keywords
- headache, rehabilitation, manual therapy, exercise
- Medical subject headings
- Headache, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Release (MR)Other
Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout myofascial tissues.
clinical practice drug treatmentDrug
drug treatment according to the medical indications of clinical practice
Manual therapy (MT)Other
Also called Mulligan Concept
The manual therapy consists of the concurrent application of sustained accessory mobilization applied by a therapist and an active physiological movement to end range applied by the patient. Passive end-of-range overpressure, or stretching, is then delivered without pain as a barrier.
Therapeutic exercise (TE)Other
The ET consists of an initial phase of aerobic exercise (cyclette), subsequently the intervention foresees exercises for the cervical ROM, stretching exercises of the cervical and scapulothoracic muscles and muscle strengthening exercises (isometric, concentric and eccentrics of the cervical musculature).
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Release (MR) + Therapeutic exercise (TE) | Experimental | Patients in the MR+TE group will undergo 12 sessions (3 d/week) of sub-occipital inhibition treatment as a combined muscle and soft tissue inhibition technique. The physiotherapist will apply deep pressure which will be maintained for a total of 10 minutes until the sub-occipital tissues are released. In addition to this technique, the method of pumping and manual treatment (acupressure) of the trigger points on the sub-occipital muscles, on the upper bundles of the trapezius bilaterally, on the sternocleidomastoid bilaterally and on the scalene muscles bilaterally will be applied for a further 10 minutes for a total treatment with myofascial release equal to 20 minutes. At the end of the MR session, the 20-minute TE session will be performed in the same way as described in the TE intervention group. Receives: Other: Myofascial Release (MR); Other: Therapeutic exercise (TE) |
| Manual therapy (MT) + Therapeutic exercise (TE) | Experimental | The MT+TE intervention group will carry out rehabilitation treatment with a structured protocol based on mobilizations according to the Mulligan method. Treatment according to Mulligan will be carried out at the discretion of the therapist on the basis of daily evaluations of cervical dysfunction and the eventual manifestation of headache. 5 different techniques will be performed on the patient in 12 sessions (3 v/week, for 4 weeks) as described in Satpute, K., Bedekar, N. \& Hall, T. Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial. BMC Musculoskelet Disord 22, (2021).. Receives: Other: Manual therapy (MT); Other: Therapeutic exercise (TE) |
| Therapeutic exercise (TE) | Experimental | Patients in the TE intervention group will be asked to perform 12 sessions (3 day/week) of TE supervised by a physiotherapist. Each session will have a total duration of 40 min divided into 20 min of aerobic exercise and 20 min of TE. Aerobic exercise consists of a total of 20 min of activity on a stationary bike using parameters to increase performance (intensity over 20 min) progressively based on fatigue (Borg scale).The TE consists of warm-up and cool-down exercises for the cervical ROM, associated with stretching exercises of the cervical and scapulothoracic muscles. After the warm-up, muscle strengthening exercises will be performed (isometric, concentric and eccentric contractions of the cervical muscles). Receives: Other: Therapeutic exercise (TE) |
| Control | Active comparator | Patients assigned to the control group will follow the pharmacological treatment according to medical doctor indications (clinical practice). Receives: Drug: clinical practice drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency
number of headache attacks in one month
Measured: 4 weeks (end of treatment)
Headache frequency
number of headache attacks in one month
Measured: 3 months after the end of the treatment
Headache frequency
number of headache attacks in one month
Measured: 6 months after the end of the treatment
Secondary outcomes (24)
Headache clinical presentation
the Visual Analogue Scale corresponds to the visual representation of the amplitude of pain felt by the patient at rest and in movement of the headache symptom. The scale consists in a straight horizontal line of100 mm length. The ends are defined as the extreme limits of the pain, and is orientated from the left (no pain) to the right (worst pain)
Measured: 4 weeks (end of treatment)
Headache clinical presentation
the Visual Analogue Scale corresponds to the visual representation of the amplitude of pain felt by the patient at rest and in movement of the headache symptom. The scale consists in a straight horizontal line of100 mm length. The ends are defined as the extreme limits of the pain, and is orientated from the left (no pain) to the right (worst pain)
Measured: 3 months after the end of the treatment
Headache clinical presentation
the Visual Analogue Scale corresponds to the visual representation of the amplitude of pain felt by the patient at rest and in movement of the headache symptom. The scale consists in a straight horizontal line of100 mm length. The ends are defined as the extreme limits of the pain, and is orientated from the left (no pain) to the right (worst pain)
Measured: 6 months after the end of the treatment
Headache related disability
The headache related disability is assessed through the neck disability index
Measured: 4 weeks (end of treatment)
Headache related Disability
The headache related disability is assessed through the neck disability index
Measured: 3 months after the end of the treatment
Headache related Disability
The headache related disability is assessed through the neck disability index
Measured: 6 months after the end of the treatment
Headache related Disability
The headache related disability is assessed through the migraine disability assessment test.
Measured: 4 weeks (end of treatment)
Headache related Disability
The headache related disability is assessed through the migraine disability assessment test.
Measured: 3 months after the end of the treatment;
Headache related Disability
The headache related disability is assessed through the migraine disability assessment test.
Measured: 6 months after the end of the treatment
Perceived Quality of life
The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
Measured: 4 weeks (end of treatment)
Perceived Quality of life
The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
Measured: 3 months after the end of the treatment
Perceived Quality of life
The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
Measured: 6 months after the end of the treatment
Perceived Quality of life
The quality of life is assessed through the Short Form-36 Health Survey
Measured: 4 weeks (end of treatment)
Perceived Quality of life
The quality of life is assessed through the Short Form-36 Health Survey
Measured: 3 months after the end of the treatment
Perceived Quality of life
The quality of life is assessed through the Short Form-36 Health Survey
Measured: 6 months after the end of the treatment
Cervical Range of Motion
Active cervical range of motion recorded through the dynamo vald system
Measured: 4 weeks (end of treatment)
Cervical Range of Motion
Active cervical range of motion recorded through the dynamo vald system
Measured: 3 months after the end of the treatment
Cervical Range of Motion
Active cervical range of motion recorded through the dynamo vald system
Measured: 6 months after the end of the treatment
Cervical muscles Strength
Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
Measured: 4 weeks (end of treatment)
Cervical muscles Strength
Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
Measured: 3 months after the end of the treatment
Cervical muscles Strength
Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
Measured: 6 months after the end of the treatment
Drug intake
Number of drug intake reported in the headache diary
Measured: 4 weeks (end of treatment)
Drug intake
Number of drug intake reported in the headache diary
Measured: 3 months after the end of the treatment
Drug intake
Number of drug intake reported in the headache diary
Measured: 6 months after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start5 Apr 2023
- Primary completionFeb 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- 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
- The allocation sequence will occur by 1:1:1:1 randomization, using the Clinical Trial Randomization tool (web https://ctrandomization.cancer.gov/), stratifying by headache type. The allocation of patients will be hidden, through the use of sealed envelopes in which the randomization will be contained. The enrollment will be carried out by the medical doctors of the Headache and Neurosonology Center clinics of the Campus Bio-Medico University Hospital Foundation, who will communicate the patient's name to a third person external to the study who will assign the patient according to the randomization plan developed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Sterzi, Campus Bio-Medico University
- Investigators
- Silvia Sterzi, MD, Principal investigator, Fondazione Policlinico Universitario Campus Bio-Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990153
- Sponsor's protocol ID
- 2023.028
- Status last verified
- Aug 2023
- First submitted
- 29 May 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients Suffering From Cervicogenic Headache, or Primary Headache (Tension-type Headache, Migraine, Trigeminal Autonomic Headache)
- ClinicalTrials.gov ID
- NCT05990153
- Acronym / sponsor ID
- 2023.028
- Conditions
- Headache
- Keywords
- headache, rehabilitation, manual therapy, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 14 Aug 2023 (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.
The study aims to evaluate which is the best approach for the non-pharmacological treatment of patients with different types of primary headaches (tension-type headache (TTC), trigeminal autonomic headache (TACs) and migraine) or cervicogenic headache by comparing three methods of intervention to control treatment (drug therapy): therapeutic exercise (TE), myofascial release + TE, and Mulligan's manual therapy + TE. The efficacy will be evaluated in terms of reduction of headache episodes, pain intensity and its duration.
Detailed description
Patients will be evaluated before the start of treatment (T0), at the end of treatment (T1), 3 months after T1 (T2), 6 months after T1 (T3). Results will be stratified by gender, age range, and type of headache diagnosed.
The 3 non-pharmacological treatment groups will carry out 12 treatment sessions, 3 times a week for 4 weeks, with a duration of 45 minutes each. The control group (CTRL) will carry out pharmacological treatment according to clinical practice, the patients of the CTRL group at the end of the last follow-up evaluation (T3 at 6 months) at their request will be randomized into one of the other three intervention groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The allocation sequence will occur by 1:1:1:1 randomization, using the Clinical Trial Randomization tool (web https://ctrandomization.cancer.gov/), stratifying by headache type. The allocation of patients will be hidden, through the use of sealed envelopes in which the randomization will be contained. The enrollment will be carried out by the medical doctors of the Headache and Neurosonology Center clinics of the Campus Bio-Medico University Hospital Foundation, who will communicate the patient's name to a third person external to the study who will assign the patient according to the randomization plan developed.
| Arm | Type | Receives |
|---|---|---|
| Myofascial Release (MR) + Therapeutic exercise (TE) | Experimental | Other: Myofascial Release (MR), Other: Therapeutic exercise (TE)Patients in the MR+TE group will undergo 12 sessions (3 d/week) of sub-occipital inhibition treatment as a combined muscle and soft tissue inhibition technique. The physiotherapist will apply deep pressure which will be maintained for a total of 10 minutes until the sub-occipital tissues are released. In addition to this technique, the method of pumping and manual treatment (acupressure) of the trigger points on the sub-occipital muscles, on the upper bundles of the trapezius bilaterally, on the sternocleidomastoid bilaterally and on the scalene muscles bilaterally will be applied for a further 10 minutes for a total treatment with myofascial release equal to 20 minutes. At the end of the MR session, the 20-minute TE session will be performed in the same way as described in the TE intervention group. |
| Manual therapy (MT) + Therapeutic exercise (TE) | Experimental | Other: Manual therapy (MT), Other: Therapeutic exercise (TE)The MT+TE intervention group will carry out rehabilitation treatment with a structured protocol based on mobilizations according to the Mulligan method. Treatment according to Mulligan will be carried out at the discretion of the therapist on the basis of daily evaluations of cervical dysfunction and the eventual manifestation of headache. 5 different techniques will be performed on the patient in 12 sessions (3 v/week, for 4 weeks) as described in Satpute, K., Bedekar, N. \& Hall, T. Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial. BMC Musculoskelet Disord 22, (2021).. |
| Therapeutic exercise (TE) | Experimental | Other: Therapeutic exercise (TE)Patients in the TE intervention group will be asked to perform 12 sessions (3 day/week) of TE supervised by a physiotherapist. Each session will have a total duration of 40 min divided into 20 min of aerobic exercise and 20 min of TE. Aerobic exercise consists of a total of 20 min of activity on a stationary bike using parameters to increase performance (intensity over 20 min) progressively based on fatigue (Borg scale).The TE consists of warm-up and cool-down exercises for the cervical ROM, associated with stretching exercises of the cervical and scapulothoracic muscles. After the warm-up, muscle strengthening exercises will be performed (isometric, concentric and eccentric contractions of the cervical muscles). |
| Control | Active comparator | Drug: clinical practice drug treatmentPatients assigned to the control group will follow the pharmacological treatment according to medical doctor indications (clinical practice). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suffering from primary headache or cervicogenic headache;
- Age > 18 years;
- signature of the informed consent.
Key exclusion criteria (6 listed)
- upper cervical spine instability;
- cervical arterial insufficiency
- cervical spine fractures
- pregnancies
- rheumatoid arthritis
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 |
|---|---|---|
| Myofascial Release (MR)Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout myofascial tissues. | Other | Myofascial Release (MR) + Therapeutic exercise (TE) |
| clinical practice drug treatmentdrug treatment according to the medical indications of clinical practice | Drug | Control |
| Manual therapy (MT)Also: Mulligan ConceptThe manual therapy consists of the concurrent application of sustained accessory mobilization applied by a therapist and an active physiological movement to end range applied by the patient. Passive end-of-range overpressure, or stretching, is then delivered without pain as a barrier. | Other | Manual therapy (MT) + Therapeutic exercise (TE) |
| Therapeutic exercise (TE)The ET consists of an initial phase of aerobic exercise (cyclette), subsequently the intervention foresees exercises for the cervical ROM, stretching exercises of the cervical and scapulothoracic muscles and muscle strengthening exercises (isometric, concentric and eccentrics of the cervical musculature). | Other | Manual therapy (MT) + Therapeutic exercise (TE), Myofascial Release (MR) + Therapeutic exercise (TE), Therapeutic exercise (TE) |
Primary outcome
Headache frequency
Time frame: 4 weeks (end of treatment)
number of headache attacks in one month
Headache frequency
Time frame: 3 months after the end of the treatment
number of headache attacks in one month
Headache frequency
Time frame: 6 months after the end of the treatment
number of headache attacks in one month
24 secondary outcomes
Headache clinical presentation
Time frame: 4 weeks (end of treatment)
Headache clinical presentation
Time frame: 3 months after the end of the treatment
Headache clinical presentation
Time frame: 6 months after the end of the treatment
Headache related disability
Time frame: 4 weeks (end of treatment)
Headache related Disability
Time frame: 3 months after the end of the treatment
Headache related Disability
Time frame: 6 months after the end of the treatment
Headache related Disability
Time frame: 4 weeks (end of treatment)
Headache related Disability
Time frame: 3 months after the end of the treatment;
Headache related Disability
Time frame: 6 months after the end of the treatment
Perceived Quality of life
Time frame: 4 weeks (end of treatment)
Perceived Quality of life
Time frame: 3 months after the end of the treatment
Perceived Quality of life
Time frame: 6 months after the end of the treatment
Perceived Quality of life
Time frame: 4 weeks (end of treatment)
Perceived Quality of life
Time frame: 3 months after the end of the treatment
Perceived Quality of life
Time frame: 6 months after the end of the treatment
Cervical Range of Motion
Time frame: 4 weeks (end of treatment)
Cervical Range of Motion
Time frame: 3 months after the end of the treatment
Cervical Range of Motion
Time frame: 6 months after the end of the treatment
Cervical muscles Strength
Time frame: 4 weeks (end of treatment)
Cervical muscles Strength
Time frame: 3 months after the end of the treatment
Cervical muscles Strength
Time frame: 6 months after the end of the treatment
Drug intake
Time frame: 4 weeks (end of treatment)
Drug intake
Time frame: 3 months after the end of the treatment
Drug intake
Time frame: 6 months after the end of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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.
Silvia Sterzi, MD principal investigator
Fondazione Policlinico Universitario Campus Bio-Medico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Release (MR), clinical practice drug treatment and Manual therapy (MT) in people with Headache, run by Campus Bio-Medico University at 1 site in Italy.
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 3 inclusion and 6 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 14 Aug 2023. 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 Italy. 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 Silvia Sterzi, MD (+390622541624, s.sterzi@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency (time frame: 4 weeks (end of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2023.