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Cervicogenic HeadacheNCT06938256

Suboccipital Muscle Inhibition Technique vs Rocabado Exercises on Cervicogenic Headache

A study testing Suboccipital Muscle Inhibition and Rocabado 6x6 Exercises in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.

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

The purpose of the study is to explore the effectiveness of Suboccipital muscle inhibition technique vs Rocabado exercises on cervicogenic headache. A randomized control trial was conducted at National Institute of Rehabilitation Medicine, Alees Medical Centre Islamabad. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Cervicogenic Headache
What is being tested?
Suboccipital Muscle Inhibition and Rocabado 6x6 Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
3 Jan 2025to 15 Jul 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 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants with a history of chronic CGH (>3 months)
  • CGH pain intensity between 3 and 8 on NPRS
  • Participants who had a unilateral headache that do not shift side (ipsilateral neck pain/stiffness)
  • Pain at least once a week in the previous three months, chronic, episodic, and duration one hour to weeks (non-throbbing pain starts in the neck).
  • CGH due to cervical spine dysfunction
  • Neck pain followed by headache
  • Patients with neck stiffness and movement restriction were included.
  • Flexion Rotation Test results that are positive with a restriction of more than 10 degrees.

Who cannot join

  • Participants with other types of headache migraine, sinus, tumor, neural, or temporomandibular joint issues)
  • Cervicogenic headache patients with mixed headache or any diagnosed serious pathology of alar ligament and vertebra basilar artery insufficiency
  • Any contraindications to manual and manipulative therapy (fracture, instability, osteoporosis, arthropathy, or neural symptoms)
  • Using analgesics or corticosteroids
  • Metastasis
  • Cardiac conditions (stroke, hypertension, or syncope)
Show all 10Show fewer
  • Neurological conditions (radiculopathy, myelopathy, or disc problems)
  • Spinal cord problem
  • Previous brain and spinal cord surgery
  • Occlusal splints or any surgery in Temporomandibular joint area.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • National Institute of Rehabilitation and Medicine

    Islamabad, 44000

Other trials in Pakistan

About this study

Official title: Comparison of Suboccipital Muscle Inhibition Technique vs Rocabado Exercises on Cervicogenic Headache

The purpose of the study is to explore the effectiveness of Suboccipital muscle inhibition technique vs Rocabado exercises on cervicogenic headache. A randomized control trial was conducted at National Institute of Rehabilitation Medicine, Alees Medical Centre Islamabad. The sample size was 40 calculated through G-power 3.1. The participants were divided into two interventional groups each having 20 participants. The study duration was six months. Sampling technique applied was non-probability purposive sampling for recruitment and group randomization using flip coin method. Only 20 to 50 years participants with chronic cervicogenic headache were included in the study. Tools used in this study are Digital Inclinometer, Numeric Pain Rating Scale, Romberg Test and HIT-6 Questionnaire. Data was collected at baseline, and at the end of 2nd week. Data analyzed through SPSS version 27.

Read the detailed description

Cervicogenic headache is a type of secondary headache that originates from cervical spine dysfunction, particularly involving the upper cervical segments. It is frequently unilateral and is often accompanied by neck stiffness and reduced cervical range of motion. The pain typically radiates from the occipital or suboccipital region to the frontotemporal or retro-orbital areas. It is commonly described as dull and non-throbbing. Cervicogenic Headache constitutes about 14-18% of all chronic headaches, making it a significant concern in musculoskeletal and neurologic clinical practice. The condition often leads to impaired quality of life and mild to moderate disability. Manual therapy and therapeutic exercises are widely used in physiotherapy for management.

The suboccipital region plays a crucial role in postural stability and dural tension regulation due to the presence of myodural bridges between the suboccipital muscles and the dura mater. Dysfunction in these structures can contribute to pain and sensorimotor disturbances in Cervicogenic headache. Suboccipital Muscle Inhibition is a manual technique aimed at relieving tension in these muscles and restoring balance. The technique involves sustained pressure applied to the suboccipital area, helping reduce nociceptive input and improving cerebral spinal fluid flow. Studies have found Suboccipital Muscle Inhibition effective for headache relief and postural improvement. It is recognized for promoting muscular relaxation and decreasing headache intensity. However, more comparative evidence is needed.

Cervical postural alignment plays a significant role in managing musculoskeletal conditions such as cervicogenic headaches. Poor posture, particularly forward head posture, can place excessive strain on the upper cervical spine, contributing to headache symptoms and muscular imbalance. To address these postural deficits, Dr. Mariano Rocabado developed the 6×6 exercise protocol, a structured program aimed at restoring proper cranio-cervical alignment. The protocol includes six exercises performed six times per session, repeated six times daily. These exercises target key elements such as tongue posture, cervical spine control, axial extension, and scapular stabilization. By promoting postural awareness and neuromuscular coordination, the protocol supports improved cervical mechanics. It has been shown to be effective in reducing tension, enhancing movement control, and optimizing cervical posture in individuals with postural dysfunctions.

This study aims to compare the effectiveness of the Suboccipital Muscle Inhibition technique and Rocabado 6×6 exercises in managing cervicogenic headaches. It hypothesizes that both interventions will produce improvements, but one may yield superior outcomes in terms of pain reduction, cervical range of motion, and balance. A randomized clinical trial will be conducted involving 40 participants divided equally into two groups. One group will receive SMI with conventional therapy, and the other will perform Rocabado exercises alongside conventional treatment. The treatment duration will consist of six sessions over two weeks. Both subjective and objective outcome measures will be employed to assess changes.

Participants will be assessed using tools like the Numeric Pain Rating Scale for pain intensity, the Flexion Rotation Test for cervical rotation dysfunction, and the HIT-6 for headache-related disability. Balance will be evaluated using the Romberg test, and cervical Range of motion will be measured with a digital inclinometer. Participants eligible for the study will include adults aged 24-50 years with a history of Cervicogenic headache for over three months. Strict inclusion and exclusion criteria will be followed to ensure sample validity. Patients using pain medication or having contraindications to manual therapy will be excluded. The outcome will be measured before and after the intervention.

Both groups will receive the same conventional treatments such as moist heat, cervical stretching, strengthening exercises, and manual traction. Group A will additionally receive the Suboccipital Muscle Inhibition technique applied for 10 minutes in each session. Group B will perform the Rocabado 6×6 protocol, with one supervised session and five sessions conducted independently each day. All treatments are expected to alleviate pain and restore cervical biomechanics. The hypothesis is that direct dural and postural modulation through Suboccipital Muscle Inhibition may show faster effects, while Rocabado's protocol may offer long-term neuromuscular control benefits. Comparative effectiveness will be analyzed using SPSS software with appropriate statistical tests.

The research is expected to fill the gap in literature regarding the comparative effectiveness of these two distinct but relevant approaches in treating Cervicogenic headache. A clearer understanding of their benefits can guide clinicians in personalizing care for patients with Cervicogenic headache, potentially combining the strengths of both methods. The study also aims to provide cost-effective, non-pharmacological management options that reduce headache recurrence, enhance cervical function, and improve patient quality of life. By establishing evidence-based guidelines, this research may influence future physical therapy protocols and headache rehabilitation strategies, ensuring optimized outcomes for Cervicogenic headache sufferers.

Being tested
Suboccipital Muscle Inhibition, Rocabado 6x6 Exercises
Keywords
Cervicogenic Headache, Suboccipital Muscle Inhibition, Rocabado Exercises
Medical subject headings
Post-Traumatic Headache

What participants receive

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

  • Suboccipital Muscle InhibitionOther

    With the patient in the supine position and the eyes closed, the therapist sits behind the subject's head and place the palms of his/her hands beneath it, resting the pads of his/her fingers on the projection of the posterior arch of the atlas. Pressure is exerted upward and toward the therapist. The pressure is maintained for 2 minutes until tissue relaxation had been achieved. The physiotherapist progressively increased the pressure exerted during the 10 minutes of treatment.

  • Rocabado 6x6 ExercisesOther

    Rocabado created 6X6 program for the management of CGH which includes 6 fundamental components, one session under supervision and remaining five sessions by the subject at home.

    These components are:

    • Rest position of the tongue
    • Control of TMJ rotation
    • Rhythmic stabilization technique
    • Stabilized head flexion
    • Axial extension of the neck
    • Shoulder posture
Study groups in NCT06938256
Study groupRoleWhat they receive
Suboccipital Muscle InhibitionExperimentalConventional Treatment will be given to this groups, which include heat therapy, cervical muscle stretching, cervical muscle strengthening and manual cervical traction. With the patient in the supine position and the eyes closed, the therapist sits behind the subject's head and place the palms of his/her hands beneath it, resting the pads of his/her fingers on the projection of the posterior arch of the atlas. Pressure is exerted upward and toward the therapist. The pressure is maintained for 2 minutes until tissue relaxation had been achieved. Patients were assessed for baseline measurements against outcome measures. Patients were given a total of 6 sessions such that 3 sessions per week for the duration of 02 weeks. All patients were reassessed at the end of the baseline and 2nd week of treatment for outcome measures.
Receives: Other: Suboccipital Muscle Inhibition
Rocabado 6x6 ExercisesExperimentalConventional Treatment will be given to this groups, which include heat therapy, cervical muscle stretching, cervical muscle strengthening and manual cervical traction. Rocabado created 6X6 program for the management of CGH which includes 6 fundamental components, that are- Rest position of the tongue: The anterior 1/3 of the tongue is placed at the palate with mild pressure, which rests the tongue and jaw musculature and promotes diaphragmatic breathing Control of TMJ rotation: The jaw is repeatedly opened and closed with the anterior 1/3 of tongue on the palate, which decreases initiating jaw movements (eg protrusive movement in opening, talking or chewing) Rhythmic stabilization technique: Gentle isometrics in the resting position are performed for jaw opening, closing and lateral deviation to promote muscular relaxation via reciprocal inhibition, which promotes an improved resting position of the jaw through proprioceptive input Axial extension of the neck: Combined upper cervi
Receives: Other: Rocabado 6x6 Exercises

What is being measured

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

  1. Changes from baseline in Numeric Pain Rating Scale

    Change from baseline the Numeric Pain Rating Scale score and 2nd week. Numeric Pain Rating Scale is the ideal to measure pain intensity of pain. It has scale of 0-10 ("0" = no pain and "10" = worst imaginable pain).

    Measured: 2nd week

Secondary outcomes (3)
  1. Changes from baseline in cervical range of motion

    ROM Cervical Spine (Flexion) Changes from the Baseline range of motion of Cervical spine flexion was taken with the Help of Digital Inclinometer ROM Cervical Spine (extension) Changes from the Baseline range of motion of Cervical spine extension was taken with the Help of Digital Inclinometer ROM Cervical Spine (Right side flexion) Changes from the Baseline range of motion of Cervical spine right side flexion was taken with the Help of Digital Inclinometer ROM Cervical Spine (left side Flexion) Changes from the Baseline range of motion of Cervical spine left side flexion was taken with the Help of Digital Inclinometer ROM Cervical Spine (right rotation) Changes from the Baseline range of motion of Cervical spine right rotation was taken with the Help of Digital Inclinometer ROM Cervical Spine (left rotation) Changes from the Baseline range of motion of Cervical spine left rotation was taken with the help of Digital Inclinometer.

    Measured: 2nd week

  2. Changes from baseline in HIT-6 Questionnaire

    Changes from baseline in HIT-6 Questionnaire were taken.The HIT-6, a 6-item questionnaire, designed to measure patient's severity and frequency of headache and impact on daily life.

    Measured: 2nd week

  3. Changes from baseline in Romerg's Test

    The changes from baseline were taken with the help of Romberg test which is a simple clinical assessment used to evaluate a person's balance and proprioception. The patient stands with feet together, arms at the sides, first with eyes open, then closed. A positive test-marked by increased swaying or loss of balance with eyes closed-indicates impaired proprioceptive or vestibular function.

    Measured: 2nd week

Timeline

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

  1. First posted22 Apr 2025
  2. Study start3 Jan 2025
  3. Primary completion28 Jun 2025
  4. Study completion15 Jul 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
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06938256
Sponsor's protocol ID
RCRAHS-ISB/REC/MS-PT/02015
Status last verified
Jul 2026
First submitted
14 Apr 2025
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Suboccipital Muscle Inhibition and Rocabado 6x6 Exercises in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.

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 8 inclusion and 10 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 20 Jul 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 Pakistan. 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?

Changes from baseline in Numeric Pain Rating Scale (time frame: 2nd week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Jul 2026.

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