Headache
Conditions
Keywords
headache, rehabilitation, manual therapy, exercise
Brief 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 (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.
Interventions
OTHERMyofascial Release (MR)
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
OTHERManual therapy (MT)
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.
OTHERTherapeutic 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).
Sponsors
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
the assessor is unaware of the type of treatment the patients have received
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suffering from primary headache or cervicogenic headache; * Age \> 18 years; * signature of the informed consent.
Exclusion criteria
* upper cervical spine instability; * cervical arterial insufficiency * cervical spine fractures * pregnancies * rheumatoid arthritis * severe cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache frequency | 4 weeks (end of treatment) | number of headache attacks in one month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache related disability | 4 weeks (end of treatment) | The headache related disability is assessed through the neck disability index |
| Headache related Disability | 3 months after the end of the treatment | The headache related disability is assessed through the neck disability index |
| Perceived Quality of life | 4 weeks (end of treatment) | The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ) |
| Headache clinical presentation | 4 weeks (end of treatment) | 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) |
| Cervical muscles Strength | 4 weeks (end of treatment) | Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia) |
| Drug intake | 4 weeks (end of treatment) | Number of drug intake reported in the headache diary |
| Cervical Range of Motion | 4 weeks (end of treatment) | Active cervical range of motion recorded through the dynamo vald system |
Countries
Italy
Contacts
Primary ContactSilvia Sterzi, MD
Backup ContactMarco Bravi, PT
Outcome results
None listed