Evaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients With Headache

Campus Bio-Medico University of Rome

Status: Enrolling

Conditions: Headache

Treatments: Drug: clinical practice drug treatment; Other: Myofascial Release (MR); Other: Manual therapy (MT); Other: Therapeutic exercise (TE)

Study type: Interventional

Funder types: Other

Identifiers

NCT05990153

2023.028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Myofascial Release (MR) + Therapeutic exercise (TE)

Experimental group

Description:

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.

Treatment:

Other: Therapeutic exercise (TE)

Other: Myofascial Release (MR)

Manual therapy (MT) + Therapeutic exercise (TE)

Experimental group

Description:

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)..

Treatment:

Other: Therapeutic exercise (TE)

Other: Manual therapy (MT)

Therapeutic exercise (TE)

Experimental group

Description:

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).

Treatment:

Other: Therapeutic exercise (TE)

Control

Active Comparator group

Description:

Patients assigned to the control group will follow the pharmacological treatment according to medical doctor indications (clinical practice).

Treatment:

Drug: clinical practice drug treatment