Back to resultsEvaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients With Headache
Primary Purpose
Headache
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Myofascial Release (MR)
clinical practice drug treatment
Manual therapy (MT)
Therapeutic exercise (TE)
Sponsored by
About this trial
This is an interventional treatment trial for Headache focused on measuring headache, rehabilitation, manual therapy, exercise
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
Sites / Locations
- Rehabilitation Department Fondazione Policlinico Universitario Campus Bio-MedicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Myofascial Release (MR) + Therapeutic exercise (TE)
Manual therapy (MT) + Therapeutic exercise (TE)
Therapeutic exercise (TE)
Control
Arm 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.
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)..
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).
Patients assigned to the control group will follow the pharmacological treatment according to medical doctor indications (clinical practice).
Outcomes
Primary Outcome Measures
Headache frequency
number of headache attacks in one month
Headache frequency
number of headache attacks in one month
Headache frequency
number of headache attacks in one month
Secondary Outcome Measures
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)
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)
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)
Headache related disability
The headache related disability is assessed through the neck disability index
Headache related Disability
The headache related disability is assessed through the neck disability index
Headache related Disability
The headache related disability is assessed through the neck disability index
Headache related Disability
The headache related disability is assessed through the migraine disability assessment test.
Headache related Disability
The headache related disability is assessed through the migraine disability assessment test.
Headache related Disability
The headache related disability is assessed through the migraine disability assessment test.
Perceived Quality of life
The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
Perceived Quality of life
The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
Perceived Quality of life
The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
Perceived Quality of life
The quality of life is assessed through the Short Form-36 Health Survey
Perceived Quality of life
The quality of life is assessed through the Short Form-36 Health Survey
Perceived Quality of life
The quality of life is assessed through the Short Form-36 Health Survey
Cervical Range of Motion
Active cervical range of motion recorded through the dynamo vald system
Cervical Range of Motion
Active cervical range of motion recorded through the dynamo vald system
Cervical Range of Motion
Active cervical range of motion recorded through the dynamo vald system
Cervical muscles Strength
Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
Cervical muscles Strength
Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
Cervical muscles Strength
Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
Drug intake
Number of drug intake reported in the headache diary
Drug intake
Number of drug intake reported in the headache diary
Drug intake
Number of drug intake reported in the headache diary
Full Information
NCT ID
NCT05990153
First Posted
May 29, 2023
Last Updated
August 10, 2023
Sponsor
Campus Bio-Medico University
1. Study Identification
Unique Protocol Identification Number
NCT05990153
Brief Title
Evaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients With Headache
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
headache, rehabilitation, manual therapy, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The allocation sequence will occur by 1:1:1:1 randomization, using the Clinical Trial Randomization tool (web https://ctrandomization.cancer.gov/), stratifying by headache type. The allocation of patients will be hidden, through the use of sealed envelopes in which the randomization will be contained. The enrollment will be carried out by the medical doctors of the Headache and Neurosonology Center clinics of the Campus Bio-Medico University Hospital Foundation, who will communicate the patient's name to a third person external to the study who will assign the patient according to the randomization plan developed.
Masking
Outcomes Assessor
Masking Description
the assessor is unaware of the type of treatment the patients have received
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myofascial Release (MR) + Therapeutic exercise (TE)
Arm Type
Experimental
Arm 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.
Arm Title
Manual therapy (MT) + Therapeutic exercise (TE)
Arm Type
Experimental
Arm 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)..
Arm Title
Therapeutic exercise (TE)
Arm Type
Experimental
Arm 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).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients assigned to the control group will follow the pharmacological treatment according to medical doctor indications (clinical practice).
Intervention Type
Other
Intervention Name(s)
Myofascial Release (MR)
Intervention Description
Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout myofascial tissues.
Intervention Type
Drug
Intervention Name(s)
clinical practice drug treatment
Intervention Description
drug treatment according to the medical indications of clinical practice
Intervention Type
Other
Intervention Name(s)
Manual therapy (MT)
Other Intervention Name(s)
Mulligan Concept
Intervention Description
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
Intervention Name(s)
Therapeutic exercise (TE)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Headache frequency
Description
number of headache attacks in one month
Time Frame
4 weeks (end of treatment)
Title
Headache frequency
Description
number of headache attacks in one month
Time Frame
3 months after the end of the treatment
Title
Headache frequency
Description
number of headache attacks in one month
Time Frame
6 months after the end of the treatment
Secondary Outcome Measure Information:
Title
Headache clinical presentation
Description
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)
Time Frame
4 weeks (end of treatment)
Title
Headache clinical presentation
Description
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)
Time Frame
3 months after the end of the treatment
Title
Headache clinical presentation
Description
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)
Time Frame
6 months after the end of the treatment
Title
Headache related disability
Description
The headache related disability is assessed through the neck disability index
Time Frame
4 weeks (end of treatment)
Title
Headache related Disability
Description
The headache related disability is assessed through the neck disability index
Time Frame
3 months after the end of the treatment
Title
Headache related Disability
Description
The headache related disability is assessed through the neck disability index
Time Frame
6 months after the end of the treatment
Title
Headache related Disability
Description
The headache related disability is assessed through the migraine disability assessment test.
Time Frame
4 weeks (end of treatment)
Title
Headache related Disability
Description
The headache related disability is assessed through the migraine disability assessment test.
Time Frame
3 months after the end of the treatment;
Title
Headache related Disability
Description
The headache related disability is assessed through the migraine disability assessment test.
Time Frame
6 months after the end of the treatment
Title
Perceived Quality of life
Description
The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
Time Frame
4 weeks (end of treatment)
Title
Perceived Quality of life
Description
The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
Time Frame
3 months after the end of the treatment
Title
Perceived Quality of life
Description
The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
Time Frame
6 months after the end of the treatment
Title
Perceived Quality of life
Description
The quality of life is assessed through the Short Form-36 Health Survey
Time Frame
4 weeks (end of treatment)
Title
Perceived Quality of life
Description
The quality of life is assessed through the Short Form-36 Health Survey
Time Frame
3 months after the end of the treatment
Title
Perceived Quality of life
Description
The quality of life is assessed through the Short Form-36 Health Survey
Time Frame
6 months after the end of the treatment
Title
Cervical Range of Motion
Description
Active cervical range of motion recorded through the dynamo vald system
Time Frame
4 weeks (end of treatment)
Title
Cervical Range of Motion
Description
Active cervical range of motion recorded through the dynamo vald system
Time Frame
3 months after the end of the treatment
Title
Cervical Range of Motion
Description
Active cervical range of motion recorded through the dynamo vald system
Time Frame
6 months after the end of the treatment
Title
Cervical muscles Strength
Description
Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
Time Frame
4 weeks (end of treatment)
Title
Cervical muscles Strength
Description
Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
Time Frame
3 months after the end of the treatment
Title
Cervical muscles Strength
Description
Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
Time Frame
6 months after the end of the treatment
Title
Drug intake
Description
Number of drug intake reported in the headache diary
Time Frame
4 weeks (end of treatment)
Title
Drug intake
Description
Number of drug intake reported in the headache diary
Time Frame
3 months after the end of the treatment
Title
Drug intake
Description
Number of drug intake reported in the headache diary
Time Frame
6 months after the end of the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Sterzi, MD
Phone
+390622541624
Email
s.sterzi@policlinicocampus.it
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Bravi, PT
Phone
+393285357278
Email
m.bravi@policlinicocampus.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Sterzi, MD
Organizational Affiliation
Fondazione Policlinico Universitario Campus Bio-Medico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Department Fondazione Policlinico Universitario Campus Bio-Medico
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Sterzi, MD
Phone
+390622541624
Email
s.sterzi@policlinicocampus.it
First Name & Middle Initial & Last Name & Degree
Marco Bravi, PT
Phone
+393285357278
Email
m.bravi@policlinicocampus.it
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients With Headache
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