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

NCT ID: NCT05990153

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2026-04-30

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.

Conditions

Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Myofascial Release (MR) + 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.

Group Type: EXPERIMENTAL

Myofascial Release (MR)

Intervention Type: OTHER

Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout myofascial tissues.

Therapeutic exercise (TE)

Intervention Type: OTHER

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).

Manual therapy (MT) + 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)..

Group Type: EXPERIMENTAL

Manual therapy (MT)

Intervention Type: OTHER

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.

Therapeutic exercise (TE)

Intervention Type: OTHER

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).

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).

Group Type: EXPERIMENTAL

Therapeutic exercise (TE)

Intervention Type: OTHER

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).

Control

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

Group Type: ACTIVE_COMPARATOR

clinical practice drug treatment

Intervention Type: DRUG

drug treatment according to the medical indications of clinical practice

Interventions

Myofascial Release (MR)

Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout myofascial tissues.

Intervention Type: OTHER

clinical practice drug treatment

drug treatment according to the medical indications of clinical practice

Intervention Type: DRUG

Manual 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.

Intervention Type: OTHER

Therapeutic 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).

Intervention Type: OTHER

Other Intervention Names

Mulligan Concept

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Silvia Sterzi

Director of Physical Medicine and Rehabilitative Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Sterzi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Campus Bio-Medico

Locations

Rehabilitation Department Fondazione Policlinico Universitario Campus Bio-Medico

Roma, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Silvia Sterzi, MD

Role: CONTACT

s.sterzi@policlinicocampus.it

+390622541624

Marco Bravi, PT

Role: CONTACT

m.bravi@policlinicocampus.it

+393285357278

Facility Contacts

Silvia Sterzi, MD

Role: primary

s.sterzi@policlinicocampus.it

+390622541624

Marco Bravi, PT

Role: backup

m.bravi@policlinicocampus.it

+393285357278

Other Identifiers

2023.028

Identifier Type: -

Identifier Source: org_study_id