Effects of Sustained Natural Appophyseal Glide Versus Rocababo 6x6 Program in Subjects With Cervicogenic Headache.

Sponsor

Riphah International University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05865808

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effects of TMJ directed treatment approach using the Rocabado 6x6 program in patients with cervicogenic headache on the intensity of headache, function of the neck, and quality of life and compare its effectiveness with headache SNAGs which have been proven very effective in treatment of cervicogenic headache.

Condition or Disease	Intervention/Treatment	Phase
Cervicogenic Headache	Other: cervical spine mobilization Other: Rocabado 6x6	N/A

Detailed Description

The efectiveness of Sustained Natural Apophyseal Glide on Flexion Rotation Test, pain intensity, and functionality in subjects with Cervicogenic Headache was evaluated. The research was conducted on five computerized databases PubMed/Medline, Web of Science, PEDro, Lilacs, and Cochrane Library (CENTRAL), using the keywords combination: (sustained natural apophyseal glide OR SNAG OR joint mobilization OR Mulligan) AND (cervicogenic headache) according to PRISMA guidelines. The methodological quality of the included studies was analyzed using the Physiotherapy Evidence Database (PEDro) scale. Eight articles fulflled the eligibility criteria and were included in the review. The selected studies had a methodological quality of 6.6/10 on the PEDro scale and included a total of 357 participants. The SNAG signifcantly improved pain, Flexion Rotation Test and reduced functional symptoms. Conclusion: The available evidence suggests that SNAG may be a relevant intervention for CH.

Effectiveness of different physiotherapy interventions in the management of cervicogenic headache was measured. Spinal mobilization, neural mobilization, and postural correction exercises techniques are physiotherapy interventions used for managing CGH symptoms. 80 participants with diagnosed CGH were recruited and divided into 4 groups. The spinal mobilization group received posteroanterior glide at the spinous and transverse process of C2 and C3 vertebra, lateral glide at affected side of the spinous process of C2 and C3 vertebra and translatoric glide at the transverse process of C1 vertebrae and SNAG. The neural mobilization group received neural mobilization of meninges, brachial plexus, and trigeminal nerve. In postural correction exercises group stretching of tight muscles (rectus capitus posterior, suboccipital, upper trapezeius, scalene, levator scapulae, sternocleidomastoid, pectoralis major/minor muscles) were given. Strengthening and endurance exercises for weak muscles (cervical flexors and deep cervical flexor, rhomboidus, and lower trapezeius muscles) were given. The control group was given normal range of motion exercises for the neck and shoulder region. It was concluded by results that applying any of the three modalities randomly in groups of patients with established CGH resulted in improvements of measured outcomes compared to a control group.

Limited literature is available about TMJ treatment in patients with headaches, and few studies has applied direct interventions to the muscles involved in TMJ movement to relieve headache symptoms. Due to the methodological shortcomings, diversity of interventions and inconsistency of findings, there is currently low certainty that there is an effect of physical therapy for TMJ on concomitant headache intensity compared to control interventions. More studies of higher methodological quality are needed so better conclusions could be taken.Further, till now very few studies have done to prove the effect of Rocabado's approach and neither a single study conducted on its effectiveness for headache.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Effects of Sustained Natural Appophyseal Glide Versus Rocababo 6x6 Program in Subjects With Cervicogenic Headache

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cervical spine mobilization Subjects in this group will be treated with headache SNAGs	Other: cervical spine mobilization headache SNAGs, 10 repetitions holding for 10 seconds in each glide with a rest time of 30 seconds in between. Eight weeks of treatment session will be provided and assessment of the improvement in cervicogenic headache will done at baseline, after 04, 06 and at the end of 8 week.
Active Comparator: Rocabado 6x6 exercises Rocabado 6x6 program includes 6 types of exercises which are- rest position of the tongue, TMJ rotation control, upper cervical distraction, axial extension of cervical spine, shoulder girdle retraction, and rhythmic stabilization technique.	Other: Rocabado 6x6 The Rocabado 6x6 program includes 6 types of exercises which are- rest position of the tongue, TMJ rotation control, upper cervical distraction, axial extension of cervical spine, shoulder girdle retraction, and rhythmic stabilization technique, which are to be performed 6 times in a day with 6 repetitions of each exercise in each session,

Arm

Intervention/Treatment

Experimental: Cervical spine mobilization

Subjects in this group will be treated with headache SNAGs

Other: cervical spine mobilization

headache SNAGs, 10 repetitions holding for 10 seconds in each glide with a rest time of 30 seconds in between. Eight weeks of treatment session will be provided and assessment of the improvement in cervicogenic headache will done at baseline, after 04, 06 and at the end of 8 week.

Active Comparator: Rocabado 6x6 exercises

Rocabado 6x6 program includes 6 types of exercises which are- rest position of the tongue, TMJ rotation control, upper cervical distraction, axial extension of cervical spine, shoulder girdle retraction, and rhythmic stabilization technique.

Other: Rocabado 6x6

The Rocabado 6x6 program includes 6 types of exercises which are- rest position of the tongue, TMJ rotation control, upper cervical distraction, axial extension of cervical spine, shoulder girdle retraction, and rhythmic stabilization technique, which are to be performed 6 times in a day with 6 repetitions of each exercise in each session,

Outcome Measures

Primary Outcome Measures

Neck Disability Index [8th week]
Neck Disability Index will be used examine neck pain intensity and cervicogenic headache symptoms.Consists of 10 sections each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Changes from Baseline to 8 weeks.

Secondary Outcome Measures

Headache Impact Test-6 SCALE [8th week]
The 6-item Headache Impact Test scale will be used to examine headache severity and its adverse effects on social life and functions. Consists of 6 sections that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent Changes from Baseline to 8 weeks.
Flexion Rotation Test [8th week]
Flexion-Rotation Test to assess rotation range of motion at the level of C1-C2 and confirmed by a cervical range of motion device/goniometer. The reported normal range of rotation during the FRT is 44° to each side and is positive if mobility is restricted by more than 10° or if symptoms occur during the procedure. Changes from Baseline to 8 weeks.
Numeric Pain Rating Scale [8th week]
The numeric pain rating scale for the intensity of pain ranges from 0-10. Zero represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'. Changes from Baseline to 8 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 20-60 years.
Unilateral headache that do not shift side with ipsilateral neck pain/stiffness.
Headache for past 3 months at least once per week.
Positive flexion rotation test.

Exclusion Criteria:

Subjects with other type of headache.
Specific disorders and congenital conditions of cervical spine.
PT or chiropractic treatment in past 3 months.
Severe pain, traumatic injury, occlusal splints or any surgery in TMJ area

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zia Hospital	Lahore	Punjab	Pakistan

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Rabiya Noor, phd, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05865808

Other Study ID Numbers:

REC/RCR & AHS/23/0121

First Posted:

May 19, 2023

Last Update Posted:

May 19, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

cervical spine

neurological disorder

post-traumatic disorder

secondary headache

Additional relevant MeSH terms:

Post-Traumatic Headache

Headache

Study Results

No Results Posted as of May 19, 2023