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

Primary Purpose

Cervicogenic Headache

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
cervical spine mobilization
Rocabado 6x6
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring cervical spine, neurological disorder, post-traumatic disorder, secondary headache

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Zia Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cervical spine mobilization

Rocabado 6x6 exercises

Arm Description

Subjects in this group will be treated with headache SNAGs

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.

Outcomes

Primary Outcome Measures

Neck Disability Index
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
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
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
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.

Full Information

First Posted
May 4, 2023
Last Updated
May 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05865808
Brief Title
Effects of Sustained Natural Appophyseal Glide Versus Rocababo 6x6 Program in Subjects With Cervicogenic Headache.
Official Title
Effects of Sustained Natural Appophyseal Glide Versus Rocababo 6x6 Program in Subjects With Cervicogenic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
cervical spine, neurological disorder, post-traumatic disorder, secondary headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cervical spine mobilization
Arm Type
Experimental
Arm Description
Subjects in this group will be treated with headache SNAGs
Arm Title
Rocabado 6x6 exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
cervical spine mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Rocabado 6x6
Intervention Description
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,
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
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.
Time Frame
8th week
Secondary Outcome Measure Information:
Title
Headache Impact Test-6 SCALE
Description
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.
Time Frame
8th week
Title
Flexion Rotation Test
Description
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.
Time Frame
8th week
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, phd
Phone
03324390125
Email
imran.amjad@.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, phd
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zia Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sadia Murtza, MS-OMPT
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, phd

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33541242
Citation
Paquin JP, Tousignant-Laflamme Y, Dumas JP. Effects of SNAG mobilization combined with a self-SNAG home-exercise for the treatment of cervicogenic headache: a pilot study. J Man Manip Ther. 2021 Aug;29(4):244-254. doi: 10.1080/10669817.2020.1864960. Epub 2021 Feb 5.
Results Reference
background
PubMed Identifier
34003165
Citation
Verma S, Tripathi M, Chandra PS. Cervicogenic Headache: Current Perspectives. Neurol India. 2021 Mar-Apr;69(Supplement):S194-S198. doi: 10.4103/0028-3886.315992.
Results Reference
background
PubMed Identifier
36045409
Citation
Cardoso R, Seixas A, Rodrigues S, Moreira-Silva I, Ventura N, Azevedo J, Monsignori F. The effectiveness of Sustained Natural Apophyseal Glide on Flexion Rotation Test, pain intensity, and functionality in subjects with Cervicogenic Headache: A Systematic Review of Randomized Trials. Arch Physiother. 2022 Sep 1;12(1):20. doi: 10.1186/s40945-022-00144-3.
Results Reference
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PubMed Identifier
34374330
Citation
Rani M, Kaur J. Effectiveness of different physiotherapy interventions in the management of cervicogenic headache: a pilot randomized controlled trial. J Man Manip Ther. 2022 Apr;30(2):96-104. doi: 10.1080/10669817.2021.1962687. Epub 2021 Aug 10.
Results Reference
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PubMed Identifier
30048225
Citation
Coskun Benlidayi I MD, Guzel R MD, Tatli U PhD, Salimov F PhD, Keceli O PhD. The relationship between neck pain and cervical alignment in patients with temporomandibular disorders. Cranio. 2020 May;38(3):174-179. doi: 10.1080/08869634.2018.1498181. Epub 2018 Jul 26.
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Citation
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PubMed Identifier
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Kang JH. Effects on migraine, neck pain, and head and neck posture, of temporomandibular disorder treatment: Study of a retrospective cohort. Arch Oral Biol. 2020 Jun;114:104718. doi: 10.1016/j.archoralbio.2020.104718. Epub 2020 Apr 18.
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Greenbaum T, Dvir Z, Emodi-Perlman A, Reiter S, Rubin P, Winocur E. The association between specific temporomandibular disorders and cervicogenic headache. Musculoskelet Sci Pract. 2021 Apr;52:102321. doi: 10.1016/j.msksp.2021.102321. Epub 2021 Jan 12.
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Craciun MD, Geman O, Leuciuc FV, Holubiac IS, Gheorghita D, Filip F. Effectiveness of Physiotherapy in the Treatment of Temporomandibular Joint Dysfunction and the Relationship with Cervical Spine. Biomedicines. 2022 Nov 17;10(11):2962. doi: 10.3390/biomedicines10112962.
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Effects of Sustained Natural Appophyseal Glide Versus Rocababo 6x6 Program in Subjects With Cervicogenic Headache.

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