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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout myofascial tissues.
drug treatment according to the medical indications of clinical practice
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.
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).
Rehabilitation Department Fondazione Policlinico Universitario Campus Bio-Medico
Roma, RM, Italy
RECRUITINGHeadache frequency
number of headache attacks in one month
Time frame: 4 weeks (end of treatment)
Headache frequency
number of headache attacks in one month
Time frame: 3 months after the end of the treatment
Headache frequency
number of headache attacks in one month
Time frame: 6 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months after the end of the treatment
Headache related disability
The headache related disability is assessed through the neck disability index
Time frame: 4 weeks (end of treatment)
Headache related Disability
The headache related disability is assessed through the neck disability index
Time frame: 3 months after the end of the treatment
Headache related Disability
The headache related disability is assessed through the neck disability index
Time frame: 6 months after the end of the treatment
Headache related Disability
The headache related disability is assessed through the migraine disability assessment test.
Time frame: 4 weeks (end of treatment)
Headache related Disability
The headache related disability is assessed through the migraine disability assessment test.
Time frame: 3 months after the end of the treatment;
Headache related Disability
The headache related disability is assessed through the migraine disability assessment test.
Time frame: 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)
Time frame: 4 weeks (end of treatment)
Perceived Quality of life
The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
Time frame: 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)
Time frame: 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
Time frame: 4 weeks (end of treatment)
Perceived Quality of life
The quality of life is assessed through the Short Form-36 Health Survey
Time frame: 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
Time frame: 6 months after the end of the treatment
Cervical Range of Motion
Active cervical range of motion recorded through the dynamo vald system
Time frame: 4 weeks (end of treatment)
Cervical Range of Motion
Active cervical range of motion recorded through the dynamo vald system
Time frame: 3 months after the end of the treatment
Cervical Range of Motion
Active cervical range of motion recorded through the dynamo vald system
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months after the end of the treatment
Drug intake
Number of drug intake reported in the headache diary
Time frame: 4 weeks (end of treatment)
Drug intake
Number of drug intake reported in the headache diary
Time frame: 3 months after the end of the treatment
Drug intake
Number of drug intake reported in the headache diary
Time frame: 6 months after the end of the treatment
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