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

NCT05990153 | Recruiting

• 1 other identifier: 2023.028
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Keywords

headache; rehabilitation; manual therapy; exercise

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (24)

• Headache clinical presentation

  4 weeks (end of treatment)

• Headache clinical presentation

  3 months after the end of the treatment

• Headache clinical presentation

  6 months after the end of the treatment

• Headache related disability

  4 weeks (end of treatment)

• Headache related Disability

  3 months after the end of the treatment

Study Arms (4)

Myofascial Release (MR) + Therapeutic exercise (TE)

EXPERIMENTAL

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); Other: Therapeutic exercise (TE)

Manual therapy (MT) + Therapeutic exercise (TE)

EXPERIMENTAL

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: Manual therapy (MT); Other: Therapeutic exercise (TE)

Therapeutic exercise (TE)

EXPERIMENTAL

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)

Control

ACTIVE COMPARATOR

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

Drug: clinical practice drug treatment

Interventions

Myofascial Release (MR) OTHER

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

Myofascial Release (MR) + Therapeutic exercise (TE)

clinical practice drug treatment DRUG

drug treatment according to the medical indications of clinical practice

Control

Manual therapy (MT) 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.

Also known as: Mulligan Concept

Manual therapy (MT) + Therapeutic exercise (TE)

Therapeutic exercise (TE) 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); Myofascial Release (MR) + Therapeutic exercise (TE); Therapeutic exercise (TE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from primary headache or cervicogenic headache;
• Age \> 18 years;
• signature of the informed consent.

You may not qualify if:

• upper cervical spine instability;
• cervical arterial insufficiency
• cervical spine fractures
• pregnancies
• rheumatoid arthritis
• severe cognitive impairment

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Rehabilitation Department Fondazione Policlinico Universitario Campus Bio-Medico

Roma, RM, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Headache; Motor Activity

Interventions

Myofascial Release Therapy; Musculoskeletal Manipulations; Exercise Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Silvia Sterzi, MD

  Fondazione Policlinico Universitario Campus Bio-Medico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Sterzi, MD

CONTACT

+390622541624; s.sterzi@policlinicocampus.it

Marco Bravi, PT

CONTACT

+393285357278; m.bravi@policlinicocampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the assessor is unaware of the type of treatment the patients have received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Physical Medicine and Rehabilitative Unit

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: August 14, 2023
• Study Start: April 5, 2023
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

IT (1)