Craniocervical Flexion Training for Reducing Migraine Headaches and Disability

NCT06751732 | Completed

• 1 other identifier: Muhammad Husnain
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Migraine, a leading cause of disability globally, necessitates effective interventions beyond pharmacotherapy due to the associated risks. This project addresses the literature gap by focusing on physiotherapy, particularly novel craniocervical flexion training (CCFT), for managing migraine headache. The prevalence of migraines, coupled with their economic burden, underscores the urgency for non-pharmacological alternatives. Current pharmacological treatments pose challenges, making nonpharmacological modalities like exercise physiotherapy and manual therapy promising migraine management. Despite limited research, these interventions show potential benefits in addressing peri-cranial muscle tenderness and cervical dysfunction. This study aims to assess the effects of a comprehensive physiotherapy protocol, including the CCFT, shedding light on its impact on migraine frequency, onset, and intensity. This Randomized Clinical Trial will be conducted at Riphah Rehab Training and Research Center, spans 8 months. The sample size of 38 individuals will undergo a comprehensive physiotherapy protocol, either with or without the CCFT. Data collection, occurring at baseline, 2 weeks, and 4 weeks, includes primary outcomes (headache frequency, intensity, HIT-6 scores) and secondary outcomes (MSQ. V2.1). Participants will receive a minimum of 2 sessions per week, maintaining confidentiality. Randomization, conducted by computer-generated stratified randomization, ensures unbiased allocation to the two groups. The single-blind study incorporates rigorous statistical analysis, utilizing SPSS software for descriptive statistics, change over time assessments, and intergroup differences via t-tests and f-tests.

Conditions

Episodic Migraine Headache

Keywords

Migraine; Non-Pharmacological Interventions; Physiotherapy; Craniocervical Flexion Training; Craniocervical Flexion Exercises

Outcome Measures

Primary Outcomes (3)

• Numerical Pain Rating Scale

  The Numeric Pain Rating Scale (NPRS) is a pain assessment tool where patients rate their current pain intensity on an 11-point numeric scale, ranging from 0 ("absence of pain") to 10 ("most severe pain imaginable"). While the Minimal Clinically Important Difference (MCID) is established as 1.3 in individuals with mechanical neck pain12, this specific value hasn't been documented for patients with cervical radiculopathy (CR). Recent findings indicate moderate test-retest reliability (ICC = 0.63) in individuals with CR.

  baseline, after 4 weeks, and after 3 months

• The Migraine Disability Assessment Test

  The Migraine Disability Assessment Test (MIDAS) is a widely used, standardized tool designed to measure the impact of migraines on an individual's daily life. It assesses the degree of disability caused by migraines over the previous three months, focusing on areas such as work, household activities, and social or leisure engagements. The test consists of five key questions addressing the number of days migraines affected productivity or routine activities, along with an additional question on headache frequency. Scores are categorized into disability levels, ranging from minimal to severe, to guide clinical decisions and treatment planning.

  baseline, after 4 weeks, and after 3 months

• A headache diary

  A headache diary by the national headache foundation will be used to keep track of the headache episodes, intensity, and other parameters.

  baseline, after 4 weeks, and after 3 months

Secondary Outcomes (1)

• Headache Impact Test questionnaire (HIT-6)

  baseline, after 4 weeks, and after 3 months

Study Arms (2)

Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT)

EXPERIMENTAL

The physiotherapy protocol will consist of the following components: Diaphragm Respiratory Training (15 minutes), Cervical Mobilization and Traction (5 minutes), Digital Compression on Muscle Trigger Points (6 minutes), Passive Stretching of Neck Muscles, Passive Stretching of Neck Muscles, Instruction on Postural Correction and Specialized Craniocervical Flexion Training (CCFT) Protocol.

Other: Craniocervical Flexion Training (CCFT); Other: Diaphragm Respiratory Training; Other: Cervical Mobilization and Traction; Other: Digital Compression on Muscle Trigger Points; Other: Passive Stretching of Neck Muscles; Other: Instruction on Postural Correction

Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT)

ACTIVE COMPARATOR

Participants in Group B will receive the same comprehensive physiotherapy protocol as Group A, excluding the specialized CCFT.

Other: Diaphragm Respiratory Training; Other: Cervical Mobilization and Traction; Other: Digital Compression on Muscle Trigger Points; Other: Passive Stretching of Neck Muscles; Other: Instruction on Postural Correction

Interventions

Craniocervical Flexion Training (CCFT) OTHER

CCFT is a targeted intervention aimed at improving neuromuscular control in the cervicoscapular and craniocervical regions through low-load endurance exercises. A pressure biofeedback unit placed behind the neck sets a baseline at 20 mmHg, ensuring relaxed neck muscles. Participants open the mouth 20 mm to activate deep cervical flexors and minimize superficial muscle use, maintaining head contact with the surface while gazing 45 degrees below the horizontal. Pressure is increased in 5 mmHg steps (20 to 40 mmHg), with each level held for 10 seconds, followed by a 10-second rest. CCFT can also be performed seated, reducing sternocleidomastoid activity and promoting longus colli thickness for functional training.

Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT)

Diaphragm Respiratory Training OTHER

Patients will undergo a 15-minute diaphragmatic respiratory training session, focusing on smooth diaphragmatic breathing with gentle expirations.

Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT); Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT)

Cervical Mobilization and Traction OTHER

A physiotherapist will perform a low-velocity, passive cervical joint mobilization technique (Oscillation technique) based on the regimen described by Maitland.(17) This will be followed by cervical spine traction while patients continue diaphragmatic breathing.

Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT); Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT)

Digital Compression on Muscle Trigger Points OTHER

Digital compression will be applied for 90 seconds on identified trigger points in the craniocervical muscles, not exceeding eight trigger points in each session.

Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT); Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT)

Passive Stretching of Neck Muscles OTHER

Passive stretching will be performed three times for neck flexion and rotation associated with ipsilateral flexion directions, using moderate force within the patient's pain limits, and maintained for 30 seconds.

Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT); Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT)

Instruction on Postural Correction OTHER

Physiotherapists will provide instructions on postural correction, addressing craniocervical extension, cervicothoracic flexion, protraction of shoulders, increased thoracic kyphosis, and flattened lumbar lordosis. Patients will be guided on correcting these postural abnormalities through craniocervical flexion, cervicothoracic extension, shoulder retraction, thoracic spine extension, and normalization of lumbar lordosis.

Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT); Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with episodic Migraine. A diagnosis of episodic migraine will be made by the primary investigator under the guidance of a medical practitioner as per the ICHD-3. An episodic migraine is that which occurs on less than 15 days per month for at least 3 months.(4)

You may not qualify if:

• Headache diagnosis: Other than migraine according to ICHD-3
• Upper cervical spine instability.(21)
• Cervical arterial insufficiency.
• Vertigo or dizziness history.
• Rheumatoid arthritis, ankylosing spondylosis, cervical spine fractures.
• Pregnancy.
• Cognitive compromise.
• Contraindications to manual therapy.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehab Training and Research Center

Lahore, Punjab Province, 54770, Pakistan

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Traction

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Muhammad Husnain Irshad, DPT

  Riphah International University, Lahore

  PRINCIPAL INVESTIGATOR

• Syed Shakil ur Rehman, PhD

  Riphah International University, Lahore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: July 15, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)