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

Headache Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990153
• Other study ID #: 2023.028
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: April 2026

Study information

• Verified date: August 2023
• Source: Campus Bio-Medico University
• Contact: Silvia Sterzi, MD
• Phone: +390622541624
• Email: s.sterzi[@]policlinicocampus.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache

Intervention

Other:
• Myofascial Release (MR)
Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout myofascial tissues.

Drug:
• clinical practice drug treatment
drug treatment according to the medical indications of clinical practice

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.
• 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).

Locations

Country	Name	City	State
Italy	Rehabilitation Department Fondazione Policlinico Universitario Campus Bio-Medico	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache frequency	number of headache attacks in one month	4 weeks (end of treatment)
Primary	Headache frequency	number of headache attacks in one month	3 months after the end of the treatment
Primary	Headache frequency	number of headache attacks in one month	6 months after the end of the treatment
Secondary	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)
Secondary	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
Secondary	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
Secondary	Headache related disability	The headache related disability is assessed through the neck disability index	4 weeks (end of treatment)
Secondary	Headache related Disability	The headache related disability is assessed through the neck disability index	3 months after the end of the treatment
Secondary	Headache related Disability	The headache related disability is assessed through the neck disability index	6 months after the end of the treatment
Secondary	Headache related Disability	The headache related disability is assessed through the migraine disability assessment test.	4 weeks (end of treatment)
Secondary	Headache related Disability	The headache related disability is assessed through the migraine disability assessment test.	3 months after the end of the treatment;
Secondary	Headache related Disability	The headache related disability is assessed through the migraine disability assessment test.	6 months after the end of the treatment
Secondary	Perceived Quality of life	The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)	4 weeks (end of treatment)
Secondary	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
Secondary	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
Secondary	Perceived Quality of life	The quality of life is assessed through the Short Form-36 Health Survey	4 weeks (end of treatment)
Secondary	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
Secondary	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
Secondary	Cervical Range of Motion	Active cervical range of motion recorded through the dynamo vald system	4 weeks (end of treatment)
Secondary	Cervical Range of Motion	Active cervical range of motion recorded through the dynamo vald system	3 months after the end of the treatment
Secondary	Cervical Range of Motion	Active cervical range of motion recorded through the dynamo vald system	6 months after the end of the treatment
Secondary	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)
Secondary	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
Secondary	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
Secondary	Drug intake	Number of drug intake reported in the headache diary	4 weeks (end of treatment)
Secondary	Drug intake	Number of drug intake reported in the headache diary	3 months after the end of the treatment
Secondary	Drug intake	Number of drug intake reported in the headache diary	6 months after the end of the treatment