Headache DisordersNCT05404113
Sustained Natural Apophyseal Glide and Deep Friction Massage in Patients With Cervicogenic Headache
A study testing sustained natural apophyseal glide and deep friction massage in people with Headache Disorders, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized controlled trial is to compare the effects of sustained natural apophyseal glide and deep friction massage in patients with cervicogenic headache for reducing pain, enhancing cervical range of motion and improving sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Headache Disorders
- What is being tested?
- sustained natural apophyseal glide and deep friction massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Sep 2022to 2 Apr 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Bilateral headaches (typifying tension headache) \& features suggestive of migraine.
- Known cases of Hydrocephalus.
- Known cases of neurological impairments.
- Known cases of malignancy.
- Involvement in physiotherapy or chiropractic treatment for headache in the previous 12 months.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Northwest Institute of Health Sciences and Northwest General Hospital Peshawar.
Peshawar
About this study
Official title: Comparison of Sustained Natural Apophyseal Glide and Deep Friction Massage in Patients With Cervicogenic Headache
The aim of this randomized controlled trial is to compare the effects of sustained natural apophyseal glide and deep friction massage in patients with cervicogenic headache for reducing pain, enhancing cervical range of motion and improving sleep quality.
Read the detailed description
Cervicogenic headache CGH is defined as the headache which arises from lesion occurring in the upper three cervical vertebrae and its associated soft tissue structures. Sleep disturbance has been continuously associated with headaches. CGH is a secondary type of headache as classified by the International Classification of Headache Disorders IHD. Physical and manual modes of therapy are important therapeutic modalities for the acute rehabilitation of cervicogenic headache.
The "mobilization with movement" concept, known as the Mulligan concept, is entirely distinct from other forms of manual therapy. Mulligan described the sustained natural apophyseal glide (SNAG) on the joint with active movement done by the patient in the direction of the symptoms. This glide should be pain-free, with proper force applied by a trained person). Efficacy of SNAG C1-C2 has been proven in patients experiencing acute to subacute CGH for both short and long-term periods. Mulligan recommended that mobilization should be done towards the restricted site or in the direction of symptom reproduction, which is difficult to find in patients experiencing headache and dizziness in only one direction. There is evidence that mobilizing symptomatic and asymptomatic cervical levels result in immediate improvement of pain and segmental mobility at the same level as well as adjacent areas.
James Cyriax proposed a treatment technique, Deep friction massage which has a significant effect in pain relieving. Cyriax friction massage is a widely known and used technique in the field of chronic pain management. It is a type of connective tissue massage applied to the soft tissue structures such as tendon, muscle bellies, musculotendinous junction, ligaments and joint capsules. This approach targets muscles both superficial and deep that can be contributing to headache. Muscles (such as trapezius, sternocleidomastoid, levator scapulae, and deep neck flexors) that contribute in developing CGH can be targeted using this technique.
Mulligan's SNAG is a sustained glide that includes a sustained facet glide and active movement simultaneously; this technique targets the joint as well as muscle's active contraction. This reinforces the cervical lesion thus reducing CGH. Deep friction massage enables the skin, fascia; muscles to be involved in order to improve circulation thus promote healing. These techniques will help relieve cervicogenic headache and a proper comparison will be made which is novel. The effectiveness of these techniques in relieving headache, improving ROM and sleep quality will be investigated.
- Conditions
- Headache Disorders
- Being tested
- sustained natural apophyseal glide, deep friction massage
- Keywords
- Sustained natural apophyseal glide/SNAG, deep friction massage, Cervicogenic headache
- Medical subject headings
- Headache Disorders, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sustained natural apophyseal glideOther
Mulligan's C1-C2 self-SNAG+ strengthening exercises for anterior and posterior neck muscles (extension, flexion, rotation, lateral flexion) Frequency: 2-3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 20 minutes/session Type: Mobilization with movement SNAG Conventional PT including strengthening exercises neck muscles 10 repetitions, 1 set Resisted neck flexion, extension, lateral flexion, rotation Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 minutes/session Type: Strengthening Exercise
deep friction massageOther
Cyriax deep friction massage+ strengthening exercises for anterior and posterior neck muscles (extension, flexion, rotation, lateral flexion) Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 20 minutes/session Type: Deep soft tissue massage Conventional PT including strengthening exercises neck muscles 10 repetitions, 1 set Resisted neck flexion, extension, lateral flexion, rotation Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 minutes/session Type: Strengthening Exercise
| Study group | Role | What they receive |
|---|---|---|
| sustained natural apophyseal glide | Experimental | Mulligan's C1-C2 self-SNAG + Conventional PT Receives: Other: sustained natural apophyseal glide |
| deep friction massage | Experimental | Cyriax deep friction massage+ Conventional PT Receives: Other: deep friction massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index NDI
This questionnaire gives us the information as to how the neck pain has affected one's ability to manage in everyday life. Questions are scored on a vertical scale of 0-5, Likert type scale. A score of 22% or more is considered a significant ADL disability.
Measured: 3 weeks
Secondary outcomes (2)
Visual Analogue Scale VAS
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.
It takes less than a minute to administer. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Based on the distribution of pain VAS scores in post- surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: 3 weeks
Pitsburg sleep quality index PSQI
it contains 19 self-rated questions and 5 self-rated by roommate (if available). The 19 self-rated questions are combined to 7 component scores each of which has 0-3 points. In all cases, a score of 0 indicates no difficulty while a score of 3 indicates severe difficulty. The seven score is then added to form one global score with a range of 0-21, 0 meaning no difficulty while 21 indicates severe difficulties in all areas
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start14 Sep 2022
- Primary completion30 Mar 2023
- Study completion2 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KINZA ANWAR, MS-OMPT, Principal investigator, RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404113
- Sponsor's protocol ID
- REC/01251 Aroosha Akbar
- Status last verified
- Apr 2023
- First submitted
- 21 Apr 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sustained Natural Apophyseal Glide and Deep Friction Massage in Patients With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05404113
- Acronym / sponsor ID
- REC/01251 Aroosha Akbar
- Conditions
- Headache Disorders
- Keywords
- Sustained natural apophyseal glide/SNAG, deep friction massage, Cervicogenic headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 2 Apr 2023 (actual)
- First posted
- 3 Jun 2022 (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.
The aim of this randomized controlled trial is to compare the effects of sustained natural apophyseal glide and deep friction massage in patients with cervicogenic headache for reducing pain, enhancing cervical range of motion and improving sleep quality.
Detailed description
Cervicogenic headache CGH is defined as the headache which arises from lesion occurring in the upper three cervical vertebrae and its associated soft tissue structures. Sleep disturbance has been continuously associated with headaches. CGH is a secondary type of headache as classified by the International Classification of Headache Disorders IHD. Physical and manual modes of therapy are important therapeutic modalities for the acute rehabilitation of cervicogenic headache.
The "mobilization with movement" concept, known as the Mulligan concept, is entirely distinct from other forms of manual therapy. Mulligan described the sustained natural apophyseal glide (SNAG) on the joint with active movement done by the patient in the direction of the symptoms. This glide should be pain-free, with proper force applied by a trained person). Efficacy of SNAG C1-C2 has been proven in patients experiencing acute to subacute CGH for both short and long-term periods. Mulligan recommended that mobilization should be done towards the restricted site or in the direction of symptom reproduction, which is difficult to find in patients experiencing headache and dizziness in only one direction. There is evidence that mobilizing symptomatic and asymptomatic cervical levels result in immediate improvement of pain and segmental mobility at the same level as well as adjacent areas.
James Cyriax proposed a treatment technique, Deep friction massage which has a significant effect in pain relieving. Cyriax friction massage is a widely known and used technique in the field of chronic pain management. It is a type of connective tissue massage applied to the soft tissue structures such as tendon, muscle bellies, musculotendinous junction, ligaments and joint capsules. This approach targets muscles both superficial and deep that can be contributing to headache. Muscles (such as trapezius, sternocleidomastoid, levator scapulae, and deep neck flexors) that contribute in developing CGH can be targeted using this technique.
Mulligan's SNAG is a sustained glide that includes a sustained facet glide and active movement simultaneously; this technique targets the joint as well as muscle's active contraction. This reinforces the cervical lesion thus reducing CGH. Deep friction massage enables the skin, fascia; muscles to be involved in order to improve circulation thus promote healing. These techniques will help relieve cervicogenic headache and a proper comparison will be made which is novel. The effectiveness of these techniques in relieving headache, improving ROM and sleep quality will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sustained natural apophyseal glide | Experimental | Other: sustained natural apophyseal glideMulligan's C1-C2 self-SNAG + Conventional PT |
| deep friction massage | Experimental | Other: deep friction massageCyriax deep friction massage+ Conventional PT |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Bilateral headaches (typifying tension headache) \& features suggestive of migraine.
- Known cases of Hydrocephalus.
- Known cases of neurological impairments.
- Known cases of malignancy.
- Involvement in physiotherapy or chiropractic treatment for headache in the previous 12 months.
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 |
|---|---|---|
| sustained natural apophyseal glideMulligan's C1-C2 self-SNAG+ strengthening exercises for anterior and posterior neck muscles (extension, flexion, rotation, lateral flexion) Frequency: 2-3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 20 minutes/session Type: Mobilization with movement SNAG Conventional PT including strengthening exercises neck muscles 10 repetitions, 1 set Resisted neck flexion, extension, lateral flexion, rotation Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 minutes/session Type: Strengthening Exercise | Other | sustained natural apophyseal glide |
| deep friction massageCyriax deep friction massage+ strengthening exercises for anterior and posterior neck muscles (extension, flexion, rotation, lateral flexion) Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 20 minutes/session Type: Deep soft tissue massage Conventional PT including strengthening exercises neck muscles 10 repetitions, 1 set Resisted neck flexion, extension, lateral flexion, rotation Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 minutes/session Type: Strengthening Exercise | Other | deep friction massage |
Primary outcome
Neck Disability Index NDI
Time frame: 3 weeks
This questionnaire gives us the information as to how the neck pain has affected one's ability to manage in everyday life. Questions are scored on a vertical scale of 0-5, Likert type scale. A score of 22% or more is considered a significant ADL disability.
2 secondary outcomes
Visual Analogue Scale VAS
Time frame: 3 weeks
Pitsburg sleep quality index PSQI
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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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.
KINZA ANWAR, MS-OMPT principal investigator
RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sustained natural apophyseal glide and deep friction massage in people with Headache Disorders, 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 0 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 13 Apr 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?
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?
Neck Disability Index NDI (time frame: 3 weeks). 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 13 Apr 2023.