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Cervicogenic HeadachePPIVMsNCT07617051

PPIVMs for Cervicogenic Headache

A study testing Passive Physiological Intervertebral Movements and Therapeutic Exercise in people with Cervicogenic Headache, run by Jordan University of Science and Technology at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cervicogenic Headache
What is being tested?
Passive Physiological Intervertebral Movements and Therapeutic Exercise
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteJordan
Study dates
2 May 2022to 7 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Jordan1 site
  • Jordan University of Science and Technology

    Irbid, 22110

Other trials in Jordan

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Passive Physiological Intervertebral Movements, Therapeutic Exercise
Keywords
Cervicogenic headache, Neck Pain, Passive physiological intervertebral movements, Therapeutic exercise, Manual therapy
Medical subject headings
Post-Traumatic Headache, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Passive Physiological Intervertebral MovementsProcedure or surgery

    Manual therapy technique applied to the upper cervical spine, targeting C0-C1, C1-C2, and C2-C3 mobility.

  • Therapeutic ExerciseProcedure or surgery

    Structured exercise program including cervical flexion/chin tuck exercises, scapular retraction, stretching, and active neck mobility exercises.

Study groups in NCT07617051
Study groupRoleWhat they receive
Passive Physiological Intervertebral Movements plus Therapeutic ExerciseExperimentalParticipants received Passive Physiological Intervertebral Movements targeting the upper cervical joints in addition to a structured therapeutic exercise program.
Receives: Procedure: Passive Physiological Intervertebral Movements; Procedure: Therapeutic Exercise
Therapeutic Exercise AloneActive comparatorParticipants received the same structured therapeutic exercise program without Passive Physiological Intervertebral Movements.
Receives: Procedure: Therapeutic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache Pain Intensity Measured by Numeric Pain Rating Scale

    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.

    Measured: Baseline, 4 weeks, and 3 months

Secondary outcomes (7)
  1. Headache Frequency Per Week

    Headache frequency was assessed as the number of headache episodes reported per week. Higher values indicate more frequent headache symptoms.

    Measured: Baseline, 4 weeks, and 3 months

  2. Neck Pain Intensity Measured by Numeric Pain Rating Scale

    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.

    Measured: Baseline, 4 weeks, and 3 months

  3. Neck Disability Measured by Neck Disability Index

    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.

    Measured: Baseline, 4 weeks, and 3 months

  4. Stress Symptoms Measured by Depression Anxiety Stress Scale-21

    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.

    Measured: Baseline, 4 weeks, and 3 months

  5. Anxiety Symptoms Measured by Depression Anxiety Stress Scale-21

    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.

    Measured: Baseline, 4 weeks, and 3 months

  6. Depression Symptoms Measured by Depression Anxiety Stress Scale-21

    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.

    Measured: Baseline, 4 weeks, and 3 months

  7. Quality of Life Measured by Short Form-12

    Quality of life was assessed using the Short Form-12 questionnaire. Higher scores indicate better health-related quality of life.

    Measured: Baseline, 4 weeks, and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start2 May 2022
  3. Primary completion7 Aug 2025
  4. Study completion7 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07617051
Sponsor's protocol ID
73/148/2022
Acronym
PPIVMs
Status last verified
May 2026
First submitted
20 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 29229055
  • 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.

    PubMed 17416124
  • 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.

    PubMed 26852024
  • 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.

    PubMed 12221344

Questions about this trial

What is this clinical trial studying?

A study testing Passive Physiological Intervertebral Movements and Therapeutic Exercise in people with Cervicogenic Headache, run by Jordan University of Science and Technology at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache Pain Intensity Measured by Numeric Pain Rating Scale (time frame: Baseline, 4 weeks, and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07617051, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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