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PPIVMs for Cervicogenic Headache

J

Jordan University of Science and Technology

Status

Completed

Conditions

Cervicogenic Headache

Treatments

Procedure: Passive Physiological Intervertebral Movements
Procedure: Therapeutic Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT07617051
73/148/2022

Details and patient eligibility

About

Cervicogenic headache is a type of headache that originates from problems in the neck, particularly the upper cervical spine. It may cause headache pain, neck pain, reduced neck movement, disability, emotional distress, and reduced quality of life. Physiotherapy management commonly includes therapeutic exercise and manual therapy techniques.

This randomized clinical trial examined whether adding Passive Physiological Intervertebral Movements to a structured therapeutic exercise program was more effective than therapeutic exercise alone in patients with cervicogenic headache. Participants diagnosed with cervicogenic headache were randomly assigned to one of two groups. The intervention group received Passive Physiological Intervertebral Movements targeting the upper cervical joints, in addition to therapeutic exercises. The control group received the same therapeutic exercise program without Passive Physiological Intervertebral Movements.

Both groups received eight supervised treatment sessions over four weeks, with each session lasting approximately 15 to 20 minutes. The exercise program included cervical flexion exercises, scapular retraction, stretching exercises, and active neck mobility exercises. Participants were also encouraged to perform the exercises at home.

The study was conducted between May 2022 and August 2025 at the outpatient physiotherapy departments of Jordan University of Science and Technology and King Abdullah University Hospital. Outcomes were assessed at baseline, immediately after the four-week intervention, and at three-month follow-up. The outcomes included headache pain intensity, headache frequency, neck pain intensity, neck disability, depression, anxiety, stress, and quality of life. These were measured using validated tools, including the Numeric Pain Rating Scale, Neck Disability Index, Depression Anxiety Stress Scale-21, and Short Form-12 quality of life questionnaire.

The study aimed to determine whether adding Passive Physiological Intervertebral Movements to exercise provides additional benefits for patients with cervicogenic headache compared with exercise alone. The trial included 64 participants.

Full description

This study was designed as a parallel-group randomized clinical trial to evaluate the added effect of Passive Physiological Intervertebral Movements when combined with therapeutic exercise for individuals with cervicogenic headache. The trial compared a combined manual therapy and exercise approach with the same exercise program delivered without Passive Physiological Intervertebral Movements.

Participants were screened using a standardized clinical diagnostic process for cervicogenic headache. The diagnostic process included clinical history, physical examination, assessment of upper cervical dysfunction, and exclusion of headache presentations more consistent with primary headache disorders or other cervical conditions not suitable for mobilization. Screening and baseline assessment procedures were performed using standardized methods to support consistency across participants.

After eligibility confirmation and baseline assessment, participants were randomly allocated to one of two treatment groups. Randomization was performed using a computer-generated random sequence. Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes prepared before recruitment. Group assignment was managed by an independent researcher who was not involved in treatment delivery or outcome assessment.

The experimental intervention consisted of Passive Physiological Intervertebral Movements applied to the upper cervical region in addition to a structured therapeutic exercise program. The manual therapy component was individualized according to the participant's clinical presentation and focused on restoring mobility of the upper cervical segments, particularly the atlanto-occipital, atlantoaxial, and C2-C3 regions. Manual therapy was delivered by a qualified physiotherapist with experience in spinal mobilization.

The comparator intervention consisted of the same structured therapeutic exercise program without Passive Physiological Intervertebral Movements. The exercise program included deep cervical flexor activation, scapular control exercises, cervical stretching, and active cervical mobility exercises. Exercise delivery was standardized through training of the treating students/therapists and use of a consistent intervention protocol. Participants were also encouraged to continue the prescribed exercises at home.

Both groups received eight supervised treatment sessions over four weeks. Treatment sessions were delivered twice weekly and lasted approximately 15 to 20 minutes. The intervention period was followed by post-treatment assessment and longer-term follow-up assessment.

To reduce bias, outcome assessments were conducted by an assessor who was not involved in treatment delivery and was blinded to group allocation. The treating clinicians were not involved in outcome assessment. Baseline demographic and clinical characteristics were collected to describe the sample and examine comparability between groups before treatment.

Data analysis was planned to compare between-group differences across the assessment time points. Baseline characteristics were summarized using descriptive statistics. Continuous variables were described using means and standard deviations, and categorical variables were described using frequencies and percentages. Baseline group comparability was examined using appropriate statistical tests. Multivariate analysis was used to examine between-group differences in clinical outcomes at follow-up time points, followed by individual between-group comparisons where appropriate. Statistical analyses were conducted using IBM SPSS.

The study was approved by the Institutional Review Board at Jordan University of Science and Technology. Written informed consent was obtained from all participants before enrolment. Data were handled confidentially and stored securely according to institutional procedures.

Enrollment

64 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Were diagnosed with cervicogenic headache using a standardized clinical diagnostic protocol based on history and physical examination.

Had a positive Cervical Flexion-Rotation Test, defined as reduced cervical rotation by ≥10° on the symptomatic side compared with the asymptomatic side, or total rotation <32°.

Had referred pain originating from the cervical spine, confirmed by mechanical provocation such as manual palpation or pressure over the C1-C3 zygapophysial joints reproducing typical headache symptoms.

Had pain behavior consistent with cervicogenic headache, such as symptoms worsened by sustained neck posture or specific neck movements.

Had other primary headache disorders excluded based on clinical history and symptom characteristics.

Exclusion criteria

  • Diagnosed with disc herniation and stenosis of the spinal canal.
  • Clinically diagnosed as a case of cervical radiculopathy or myelopathy.
  • Subjects with conditions or diseases that are contraindicated for mobilization treatment: rheumatoid arthritis, ankylosing spondylitis, spondylolistheses, cervical fractures, osteoporosis, osteomyelitis, malignancy, and pregnancy
  • Have received manual therapy or exercise by a physical therapist in the last six months.
  • Patients diagnosed with cognitive dysfunction, psychological disorder, or communication/cognitive deficits.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 2 patient groups

Passive Physiological Intervertebral Movements plus Therapeutic Exercise
Experimental group
Description:
Participants received Passive Physiological Intervertebral Movements targeting the upper cervical joints in addition to a structured therapeutic exercise program.
Treatment:
Procedure: Therapeutic Exercise
Procedure: Passive Physiological Intervertebral Movements
Therapeutic Exercise Alone
Active Comparator group
Description:
Participants received the same structured therapeutic exercise program without Passive Physiological Intervertebral Movements.
Treatment:
Procedure: Therapeutic Exercise

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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