Evaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients With Headache
- Conditions
- Headache
- Interventions
- Other: Myofascial Release (MR)Other: Manual therapy (MT)Drug: clinical practice drug treatmentOther: Therapeutic exercise (TE)
- Registration Number
- NCT05990153
- Lead Sponsor
- Campus Bio-Medico University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Patients suffering from primary headache or cervicogenic headache;
- Age > 18 years;
- signature of the informed consent.
- upper cervical spine instability;
- cervical arterial insufficiency
- cervical spine fractures
- pregnancies
- rheumatoid arthritis
- severe cognitive impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Myofascial Release (MR) + Therapeutic exercise (TE) Myofascial Release (MR) 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. Myofascial Release (MR) + Therapeutic exercise (TE) 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) Manual therapy (MT) 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).. Manual therapy (MT) + Therapeutic exercise (TE) 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) 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 clinical practice drug treatment Patients assigned to the control group will follow the pharmacological treatment according to medical doctor indications (clinical practice).
- Primary Outcome Measures
Name Time Method Headache frequency 6 months after the end of the treatment number of headache attacks in one month
- Secondary Outcome Measures
Name Time Method Perceived Quality of life 6 months after the end of the treatment The quality of life is assessed through the Short Form-36 Health Survey
Headache related disability 4 weeks (end of treatment) The headache related disability is assessed through the neck disability index
Cervical Range of Motion 6 months after the end of the treatment Active cervical range of motion recorded through the dynamo vald system
Drug intake 6 months after the end of the treatment Number of drug intake reported in the headache diary
Headache related Disability 6 months after the end of the treatment The headache related disability is assessed through the migraine disability assessment test.
Cervical muscles Strength 6 months after the end of the treatment Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
Headache clinical presentation 6 months after the end of the 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)
Trial Locations
- Locations (1)
Rehabilitation Department Fondazione Policlinico Universitario Campus Bio-Medico
🇮🇹Roma, RM, Italy