Clinical trial NCT05990153: Evaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients With Headache
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Headache
Keywords: headache
rehabilitation
manual therapy
exercise
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Headache frequency
timeFrame: 4 weeks (end of treatment)
measure: Headache frequency
timeFrame: 3 months after the end of the treatment
measure: Headache frequency
timeFrame: 6 months after the end of the treatment
Secondary outcomes:
measure: Headache clinical presentation
timeFrame: 4 weeks (end of treatment)
measure: Headache clinical presentation
timeFrame: 3 months after the end of the treatment
measure: Headache clinical presentation
timeFrame: 6 months after the end of the treatment
measure: Headache related disability
timeFrame: 4 weeks (end of treatment)
measure: Headache related Disability
timeFrame: 3 months after the end of the treatment
measure: Headache related Disability
timeFrame: 6 months after the end of the treatment
measure: Headache related Disability
timeFrame: 4 weeks (end of treatment)
measure: Headache related Disability
timeFrame: 3 months after the end of the treatment;
measure: Headache related Disability
timeFrame: 6 months after the end of the treatment
measure: Perceived Quality of life
timeFrame: 4 weeks (end of treatment)
measure: Perceived Quality of life
timeFrame: 3 months after the end of the treatment
measure: Perceived Quality of life
timeFrame: 6 months after the end of the treatment
measure: Perceived Quality of life
timeFrame: 4 weeks (end of treatment)
measure: Perceived Quality of life
timeFrame: 3 months after the end of the treatment
measure: Perceived Quality of life
timeFrame: 6 months after the end of the treatment
measure: Cervical Range of Motion
timeFrame: 4 weeks (end of treatment)
measure: Cervical Range of Motion
timeFrame: 3 months after the end of the treatment
measure: Cervical Range of Motion
timeFrame: 6 months after the end of the treatment
measure: Cervical muscles Strength
timeFrame: 4 weeks (end of treatment)
measure: Cervical muscles Strength
timeFrame: 3 months after the end of the treatment
measure: Cervical muscles Strength
timeFrame: 6 months after the end of the treatment
measure: Drug intake
timeFrame: 4 weeks (end of treatment)
measure: Drug intake
timeFrame: 3 months after the end of the treatment
measure: Drug intake
timeFrame: 6 months after the end of the treatment
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Rehabilitation Department Fondazione Policlinico Universitario Campus Bio-Medico
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario Campus Bio-Medico
name: Silvia Sterzi, MD
role: PRINCIPAL_INVESTIGATOR
References: