Cervicogenic HeadacheNCT05777395
Comparison of Maitland Oscillatory Mobilizations With Kaltenborn Sustained Stretch Mobilizations in Cervicogenic Headache Patients
A study testing Maitland Oscillatory Mobilization, Kaltenborn Sustained Stretch Mobilization and Conventional therapy in people with Cervicogenic Headache, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Cervicogenic headache is a common headache that causes disability and affects everyday activities. Headache related disorders are the second most common reason for years lived with disability all over the world. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Maitland Oscillatory Mobilization, Kaltenborn Sustained Stretch Mobilization and Conventional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 1 Jul 2023
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years
- Both males and females
- Unilateral headache with no shift of side
- C1-C2 dysfunction
- Headache with neck stiffness
- Headache at least once a month in the last 3 months
- Positive flexion rotation test (Rotation restriction is greater than 10 degrees)
- Headache with a score of at least 4 in the Numeric pain rating scale
Who cannot join
- Cervical spondylosis
- Headache of non-cervical origin
- Dizziness or visual disturbance
- Cervical radiculopathy/ nerve root involvement/ disc herniation
- Cervical instability/ fracture
- Vertebrobasilar insufficiency
Show all 15Show fewer
- Thoracic outlet syndrome
- Cervical spine surgery
- Cervical spondylolisthesis
- Spinal infection or tumors
- Osteoporosis
- History of trauma
- Metabolic disorders
- Rheumatoid Arthritis
- Inflammatory Arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Cervicogenic headache is a common headache that causes disability and affects everyday activities. Headache related disorders are the second most common reason for years lived with disability all over the world. According to the latest International Headache Society model, cervicogenicheadache (CGH) is a secondary headache having C1-C2 dysfunction. There is marked limitation in cervical ROM specially rotation. Treatment indicated involves use of electrotherapy and thermal modalities. In addition, use of different manual therapy techniques are advocated to eliminate the root cause i.e. C1-C2 dysfunction. Maitland mobilizations for cervical spine have been found to be effective in treating CGH patients. Maitland mobilizations uses oscillatory mobilizations and has four grades. Kaltenborn, on the other hand, applies sustained stretches and has 3 grades.So, the study will be focusing on comparing the effectiveness of these two mobilizations on cervicogenic headache patients.
- Conditions
- Cervicogenic Headache
- Being tested
- Maitland Oscillatory Mobilization, Kaltenborn Sustained Stretch Mobilization, Conventional therapy
- 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.
Maitland Oscillatory MobilizationProcedure or surgery
Maitland Posteroanterior unilateral vertebral pressure and Maitland cervical rotation technique will be used.3 sets of 15 repetitions. Each set is of 30 seconds and each repetition is given for 2 seconds.
Kaltenborn Sustained Stretch MobilizationProcedure or surgery
Kaltenborn sustained stretch mobilizations. 3 sets of 15 repetitions for 3 seconds.
- Frequency: 3 times a week for 2 weeks. 6 sessions in total.
- Mobilizations will be performed in Grade 1 and then progressed to 2 and 3.
- Kaltenborn technique used will be atlas-axis rotation
Conventional therapyProcedure or surgery
Moist heat, TENS, Neck Muscle Stretching, Neck muscle isometrics
| Study group | Role | What they receive |
|---|---|---|
| Maitland + Conventional PT Group | Experimental | Participants of this group will receive the conventional physical therapy protocol mentioned above. In addition to this, they will receive Maitland oscillatory mobilizations. 3 sets of 15 repetitions. Each set is of 30 seconds and each repetition is given in 2 seconds.
* Frequency: 3 times a week for 2 weeks. 6 sessions in total.
* Mobilizations will be performed in Grade 1 initially and then progressed to Grade 2 and 3.
* Techniques used are postero-anterior unilateral vertebral pressure and Maitland rotation. Receives: Procedure: Maitland Oscillatory Mobilization; Procedure: Conventional therapy |
| Kaltenborn + Conventional PT Group | Experimental | Participants of this Group will receive the conventional physical therapy protocol mentioned above. In addition to this, they will receive Kaltenborn sustained stretch mobilizations. 3 sets of 15 repetitions for 3 seconds.
* Frequency: 3 times a week for 2 weeks. 6 sessions in total.
* Mobilizations will be performed in Grade 1 and then progressed to 2 and 3.
* Kaltenborn technique used will be atlas-axis rotation. Receives: Procedure: Kaltenborn Sustained Stretch Mobilization; Procedure: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain will be measured on the basis of Numeric Pain Rating Scale score.
Measured: 2 weeks
Cervical range of motion
Cervical rotation will be measured through CROM device
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Jan 2023
- Primary completion15 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- This is a randomized controlled trial having two groups. One group will receive conventional physical therapy along with Maitland oscillatory mobilizations and the second will receive Kaltenborn sustained stretch mobilizations with conventional physical therapy. Both groups will be recruited concurrently.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777395
- Sponsor's protocol ID
- FUI/CTR/2023/1
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maitland Oscillatory Mobilizations With Kaltenborn Sustained Stretch Mobilizations in Cervicogenic Headache Patients
- ClinicalTrials.gov ID
- NCT05777395
- Acronym / sponsor ID
- FUI/CTR/2023/1
- Conditions
- Cervicogenic Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervicogenic headache is a common headache that causes disability and affects everyday activities. Headache related disorders are the second most common reason for years lived with disability all over the world. According to the latest International Headache Society model, cervicogenicheadache (CGH) is a secondary headache having C1-C2 dysfunction. There is marked limitation in cervical ROM specially rotation. Treatment indicated involves use of electrotherapy and thermal modalities. In addition, use of different manual therapy techniques are advocated to eliminate the root cause i.e. C1-C2 dysfunction. Maitland mobilizations for cervical spine have been found to be effective in treating CGH patients. Maitland mobilizations uses oscillatory mobilizations and has four grades. Kaltenborn, on the other hand, applies sustained stretches and has 3 grades.So, the study will be focusing on comparing the effectiveness of these two mobilizations on cervicogenic headache patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. One group will receive conventional physical therapy along with Maitland oscillatory mobilizations and the second will receive Kaltenborn sustained stretch mobilizations with conventional physical therapy. Both groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| Maitland + Conventional PT Group | Experimental | Procedure: Maitland Oscillatory Mobilization, Procedure: Conventional therapyParticipants of this group will receive the conventional physical therapy protocol mentioned above. In addition to this, they will receive Maitland oscillatory mobilizations. 3 sets of 15 repetitions. Each set is of 30 seconds and each repetition is given in 2 seconds. * Frequency: 3 times a week for 2 weeks. 6 sessions in total. * Mobilizations will be performed in Grade 1 initially and then progressed to Grade 2 and 3. * Techniques used are postero-anterior unilateral vertebral pressure and Maitland rotation. |
| Kaltenborn + Conventional PT Group | Experimental | Procedure: Kaltenborn Sustained Stretch Mobilization, Procedure: Conventional therapyParticipants of this Group will receive the conventional physical therapy protocol mentioned above. In addition to this, they will receive Kaltenborn sustained stretch mobilizations. 3 sets of 15 repetitions for 3 seconds. * Frequency: 3 times a week for 2 weeks. 6 sessions in total. * Mobilizations will be performed in Grade 1 and then progressed to 2 and 3. * Kaltenborn technique used will be atlas-axis rotation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-45 years
- Both males and females
- Unilateral headache with no shift of side
- C1-C2 dysfunction
- Headache with neck stiffness
Key exclusion criteria (15 listed)
- Cervical spondylosis
- Headache of non-cervical origin
- Dizziness or visual disturbance
- Cervical radiculopathy/ nerve root involvement/ disc herniation
- Cervical instability/ fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maitland Oscillatory MobilizationMaitland Posteroanterior unilateral vertebral pressure and Maitland cervical rotation technique will be used.3 sets of 15 repetitions. Each set is of 30 seconds and each repetition is given for 2 seconds. | Procedure or surgery | Maitland + Conventional PT Group |
| Kaltenborn Sustained Stretch MobilizationKaltenborn sustained stretch mobilizations. 3 sets of 15 repetitions for 3 seconds. * Frequency: 3 times a week for 2 weeks. 6 sessions in total. * Mobilizations will be performed in Grade 1 and then progressed to 2 and 3. * Kaltenborn technique used will be atlas-axis rotation | Procedure or surgery | Kaltenborn + Conventional PT Group |
| Conventional therapyMoist heat, TENS, Neck Muscle Stretching, Neck muscle isometrics | Procedure or surgery | Kaltenborn + Conventional PT Group, Maitland + Conventional PT Group |
Primary outcome
Pain intensity
Time frame: 2 weeks
Pain will be measured on the basis of Numeric Pain Rating Scale score.
Cervical range of motion
Time frame: 2 weeks
Cervical rotation will be measured through CROM device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
Related trials for Cervicogenic Headache
Not yet recruiting
Trigger Point Injection and Myofascial Release for Cervicogenic Headache
Cervicogenic Headache
Not yet recruiting
Comparative Effects of Dynamic Cupping and Facilitated Positional Release in Cervicogenic Headache
Cervicogenic Headache
Active, not recruiting
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
Cervicogenic Headache
Recruiting
Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)
Myofascial Trigger Points, Migraine
Recruiting
Comparative Effects of Post Isometric Relaxation and Reciprocal Inhibition in Individuals With Cervicogenic Headache.
Post Traumatic Headache, Cervicogenic Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maitland Oscillatory Mobilization, Kaltenborn Sustained Stretch Mobilization and Conventional therapy in people with Cervicogenic Headache, run by Foundation University Islamabad 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 15 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: status not confirmed, as of the sponsor's last update on 21 Mar 2023. 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?
Results are not available in the source record.
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?
Pain intensity (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 21 Mar 2023.