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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Headache
• Intervention / Treatment: Other: Myofascial Release (MR); Other: Therapeutic exercise (TE); Other: Manual therapy (MT); Drug: clinical practice drug treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia Sterzi, MD; Phone Number: +390622541624; Email: s.sterzi@policlinicocampus.it
• Study Contact Backup: Name: Marco Bravi, PT; Phone Number: +393285357278; Email: m.bravi@policlinicocampus.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00128
      • Recruiting
      • Rehabilitation Department Fondazione Policlinico Universitario Campus Bio-Medico
      • Contact: Silvia Sterzi, MD; Phone Number: +390622541624; Email: s.sterzi@policlinicocampus.it
      • Contact: Marco Bravi, PT; Phone Number: +393285357278; Email: m.bravi@policlinicocampus.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Myofascial Release (MR); Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout myofascial tissues.; 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).
Experimental: 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)..	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).; Other: 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.; Other Names: Mulligan Concept
Experimental: 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).	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).
Active Comparator: Control; Patients assigned to the control group will follow the pharmacological treatment according to medical doctor indications (clinical practice).	Drug: clinical practice drug treatment; drug treatment according to the medical indications of clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache frequency	number of headache attacks in one month	4 weeks (end of treatment)
Headache frequency	number of headache attacks in one month	3 months after the end of the treatment
Headache frequency	number of headache attacks in one month	6 months after the end of the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache clinical presentation	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)	4 weeks (end of treatment)
Headache clinical presentation	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)	3 months after the end of the treatment
Headache clinical presentation	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)	6 months after the end of the treatment
Headache related disability	The headache related disability is assessed through the neck disability index	4 weeks (end of treatment)
Headache related Disability	The headache related disability is assessed through the neck disability index	3 months after the end of the treatment
Headache related Disability	The headache related disability is assessed through the neck disability index	6 months after the end of the treatment
Headache related Disability	The headache related disability is assessed through the migraine disability assessment test.	4 weeks (end of treatment)
Headache related Disability	The headache related disability is assessed through the migraine disability assessment test.	3 months after the end of the treatment;
Headache related Disability	The headache related disability is assessed through the migraine disability assessment test.	6 months after the end of the treatment
Perceived Quality of life	The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)	4 weeks (end of treatment)
Perceived Quality of life	The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)	3 months after the end of the treatment
Perceived Quality of life	The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)	6 months after the end of the treatment
Perceived Quality of life	The quality of life is assessed through the Short Form-36 Health Survey	4 weeks (end of treatment)
Perceived Quality of life	The quality of life is assessed through the Short Form-36 Health Survey	3 months after the end of the treatment
Perceived Quality of life	The quality of life is assessed through the Short Form-36 Health Survey	6 months after the end of the treatment
Cervical Range of Motion	Active cervical range of motion recorded through the dynamo vald system	4 weeks (end of treatment)
Cervical Range of Motion	Active cervical range of motion recorded through the dynamo vald system	3 months after the end of the treatment
Cervical Range of Motion	Active cervical range of motion recorded through the dynamo vald system	6 months after the end of the treatment
Cervical muscles Strength	Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)	4 weeks (end of treatment)
Cervical muscles Strength	Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)	3 months after the end of the treatment
Cervical muscles Strength	Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)	6 months after the end of the treatment
Drug intake	Number of drug intake reported in the headache diary	4 weeks (end of treatment)
Drug intake	Number of drug intake reported in the headache diary	3 months after the end of the treatment
Drug intake	Number of drug intake reported in the headache diary	6 months after the end of the treatment

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University
• Investigators: Principal Investigator: Silvia Sterzi, MD, Fondazione Policlinico Universitario Campus Bio-Medico

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; manual therapy; headache
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: 2023.028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No