- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07617051
PPIVMs for Cervicogenic Headache (PPIVMs)
The Effectiveness of Passive Physiological Intervertebral Movements in Patients With Cervicogenic Headache: A Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Irbid, Jordan, 22110
- Jordan University of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Passive Physiological Intervertebral Movements plus Therapeutic Exercise
Participants received Passive Physiological Intervertebral Movements targeting the upper cervical joints in addition to a structured therapeutic exercise program.
|
Manual therapy technique applied to the upper cervical spine, targeting C0-C1, C1-C2, and C2-C3 mobility.
Structured exercise program including cervical flexion/chin tuck exercises, scapular retraction, stretching, and active neck mobility exercises.
|
|
Active Comparator: Therapeutic Exercise Alone
Participants received the same structured therapeutic exercise program without Passive Physiological Intervertebral Movements.
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Structured exercise program including cervical flexion/chin tuck exercises, scapular retraction, stretching, and active neck mobility exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Headache Pain Intensity Measured by Numeric Pain Rating Scale
Time Frame: Baseline, 4 weeks, and 3 months
|
Headache pain intensity was assessed using the 11-point Numeric Pain Rating Scale.
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores indicate greater headache pain intensity.
|
Baseline, 4 weeks, and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Headache Frequency Per Week
Time Frame: Baseline, 4 weeks, and 3 months
|
Headache frequency was assessed as the number of headache episodes reported per week.
Higher values indicate more frequent headache symptoms.
|
Baseline, 4 weeks, and 3 months
|
|
Neck Pain Intensity Measured by Numeric Pain Rating Scale
Time Frame: Baseline, 4 weeks, and 3 months
|
Neck pain intensity was assessed using the 11-point Numeric Pain Rating Scale.
Scores range from 0 to 10, where higher scores indicate greater neck pain intensity.
|
Baseline, 4 weeks, and 3 months
|
|
Neck Disability Measured by Neck Disability Index
Time Frame: Baseline, 4 weeks, and 3 months
|
Neck-related disability was assessed using the Neck Disability Index.
The scale includes 10 items, each scored from 0 to 5, with a total score ranging from 0 to 50.
Higher scores indicate greater neck-related disability.
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Baseline, 4 weeks, and 3 months
|
|
Stress Symptoms Measured by Depression Anxiety Stress Scale-21
Time Frame: Baseline, 4 weeks, and 3 months
|
Stress symptoms were assessed using the stress subscale of the Depression Anxiety Stress Scale-21.
The score ranges between 0 and 21.
Higher scores indicate greater stress symptoms.
|
Baseline, 4 weeks, and 3 months
|
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Anxiety Symptoms Measured by Depression Anxiety Stress Scale-21
Time Frame: Baseline, 4 weeks, and 3 months
|
Anxiety symptoms were assessed using the anxiety subscale of the Depression Anxiety Stress Scale-21.
The score ranges between 0 and 21.
Higher scores indicate greater anxiety symptoms.
|
Baseline, 4 weeks, and 3 months
|
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Depression Symptoms Measured by Depression Anxiety Stress Scale-21
Time Frame: Baseline, 4 weeks, and 3 months
|
Depression symptoms were assessed using the depression subscale of the Depression Anxiety Stress Scale-21.
The score ranges between 0 and 21.
Higher scores indicate greater depressive symptoms.
|
Baseline, 4 weeks, and 3 months
|
|
Quality of Life Measured by Short Form-12
Time Frame: Baseline, 4 weeks, and 3 months
|
Quality of life was assessed using the Short Form-12 questionnaire.
Higher scores indicate better health-related quality of life.
|
Baseline, 4 weeks, and 3 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
- Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.
- Malo-Urries M, Tricas-Moreno JM, Estebanez-de-Miguel E, Hidalgo-Garcia C, Carrasco-Uribarren A, Cabanillas-Barea S. Immediate Effects of Upper Cervical Translatoric Mobilization on Cervical Mobility and Pressure Pain Threshold in Patients With Cervicogenic Headache: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2017 Nov-Dec;40(9):649-658. doi: 10.1016/j.jmpt.2017.07.007.
- Hall T, Chan HT, Christensen L, Odenthal B, Wells C, Robinson K. Efficacy of a C1-C2 self-sustained natural apophyseal glide (SNAG) in the management of cervicogenic headache. J Orthop Sports Phys Ther. 2007 Mar;37(3):100-7. doi: 10.2519/jospt.2007.2379.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders
- Headache Disorders, Secondary
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Neck Pain
- Post-Traumatic Headache
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise Therapy
Other Study ID Numbers
- 73/148/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared because the participant consent and ethical approval covered confidential use of the data for the final research report and academic publications, not public sharing of individual-level data. In addition, the study sample was relatively small and included clinical and demographic information, which may increase the risk of participant re-identification. Aggregate results will be reported.
This is appropriate because the consent form states that participant information would be treated confidentially and used anonymously in reports/publications, and the thesis ethics section states that data were stored securely and confidentially.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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