Manual Therapy vs. Multicomponent Exercise in Cervicogenic Headache

NCT07776093 | Not Yet Recruiting

• 1 other identifier: E-60116787-020-796732
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the effects of manual therapy and a multicomponent exercise program on suboccipital muscle thickness, joint position sense, pain, central sensitization, balance, and kinesiophobia in patients diagnosed with cervicogenic headache. Cervicogenic headache is a common secondary headache originating from dysfunction in the upper cervical spine. Dysfunction in the deep neck muscles, impaired neck joint awareness, and heightened pain sensitivity (central sensitization) are frequently observed in these patients. While both manual therapy and targeted exercise are used in physiotherapy practice, evidence regarding their direct comparative effects on suboccipital muscle morphology and somatosensory parameters remains limited. Participants will be randomly assigned to one of two treatment groups for a duration of 4 weeks (12 sessions total):

• Do manual therapy and multicomponent exercise improve suboccipital muscle thickness and cervical joint position sense in patients with cervicogenic headache?
• Is there a significant difference between manual therapy and multicomponent exercise in reducing pain intensity, central sensitization, disability, and fear of movement (kinesiophobia)? It is hypothesized that both intervention protocols will yield significant clinical improvements, with specific synergistic adaptations in muscle structure, somatosensory system processing, and pain-related fear.

Conditions

Cervicogenic Headache; Proprioceptive Disorders; Neck Pain Musculoskeletal

Outcome Measures

Primary Outcomes (5)

• Change from Baseline Pain Intensity

  Evaluated using a 10-cm Visual Analog Scale (VAS) measured in centimeters to assess headache pain intensity.

  Baseline and Post-intervention (Week 4)

• Change from Baseline Central Sensitization Inventory Score

  Assessed using the 25-item Central Sensitization Inventory (CSI) with a total score ranging from 0 to 100 to evaluate the severity of central sensitization.

  Baseline and Post-intervention at 4 Weeks

• Change from Baseline Tampa Scale for Kinesiophobia Score

  Evaluated using the Tampa Scale for Kinesiophobia (TSK) 4-point Likert scale (17-68 score range) to measure fear of movement and re-injury.

  Baseline and Post-intervention at Week 4

• Change from Baseline Migraine Disability Assessment Score

  Assessed using the 5-item Migraine Disability Assessment (MIDAS) questionnaire to evaluate the total number of days with headache-related disability (score range 0 to 21+ for disability severity grades I to IV)

  Baseline and Post-intervention at 4 Weeks.

• Change from Baseline Neck Disability Index Score

  Evaluated using the 10-item Neck Disability Index (NDI) questionnaire to measure neck pain-related functional disability (score range 0 to 50, higher scores indicating higher disability).

  Baseline and Post-intervention at 4 Weeks

Secondary Outcomes (6)

• Change from Baseline Suboccipital Muscle Thickness

  Baseline and Post-intervention at 4 Weeks

• Change from Baseline Cervical Joint Position Sense Error

  Baseline and Post-intervention at 4 Weeks

• Change from Baseline Head-Eye Movement Control Test Score

  Baseline and Post-intervention at Week 4

• Change from Baseline Deep Cervical Flexor Muscle Endurance

  Baseline and Post-intervention (Week 4).

• Change from Baseline Postural Balance Score

  Baseline and Post-intervention at Week 4

Study Arms (2)

Manual Therapy Group

EXPERIMENTAL

Participants in this arm will receive 12 sessions of manual therapy (3 sessions per week for 4 weeks). Interventions include upper cervical joint mobilization, myofascial release, suboccipital distraction, and trigger point therapy targeting the suboccipital and cervical region.

Procedure: Manual Therapy Protocol

Multicomponent Exercise Group

ACTIVE COMPARATOR

Participants in this arm will receive 12 sessions of a multicomponent exercise program (3 sessions per week for 4 weeks). Interventions include deep cervical flexor strengthening, cervical proprioception training, gaze stability/head-eye coordination exercises, and progressive postural balance training.

Other: Multicomponent Exercise Program

Interventions

Manual Therapy Protocol PROCEDURE

Upper cervical joint mobilization, myofascial release, suboccipital distraction, and trigger point therapy targeting the cervical region.

Manual Therapy Group

Multicomponent Exercise Program OTHER

Deep cervical flexor strengthening, cervical proprioception exercises, gaze stability/head-eye coordination training, and progressive balance exercises.

Multicomponent Exercise Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of cervicogenic headache by a specialist physician,
• Aged between 18 and 45 years,
• Ability to read and write (literate),
• Provision of signed informed consent to participate in the study.

You may not qualify if:

• History of head or neck surgery,
• History of spinal surgery,
• History of severe cardiac conditions or cardiac surgery that contraindicates exercise,
• History of ongoing or past malignancy,
• Diagnosis of psychiatric disorders,
• Diagnosis of migraine,
• Diagnosis of fibromyalgia,
• Having received medical (except analgesics), physical therapy, or other interventions (e.g., alternative medicine, massage therapy) for cervicogenic headache within the last 6 months,
• Engaging in regular exercise or attending an exercise facility within the last 6 months,
• Experiencing headaches strictly associated with the menstrual period,
• Communication problems interfering with evaluation and treatment.

Sponsors & Collaborators

• Pamukkale University: lead

MeSH Terms

Conditions

Post-Traumatic Headache; Somatosensory Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study will employ a double-blind design. Participants will be masked regarding their group allocation (manual therapy vs. multicomponent exercise). All baseline and post-intervention outcome assessments will be conducted by an independent outcome assessor who will be fully blinded to the participants' group assignments and intervention protocols. The student physiotherapists administering the treatment protocols will be blinded to all evaluation and assessment results to prevent operator bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share