NCT05865808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

May 4, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

cervical spineneurological disorderpost-traumatic disordersecondary headache

Outcome Measures

Primary Outcomes (1)

  • 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.

    8th week

Secondary Outcomes (3)

  • Headache Impact Test-6 SCALE

    8th week

  • Flexion Rotation Test

    8th week

  • Numeric Pain Rating Scale

    8th week

Study Arms (2)

Cervical spine mobilization

EXPERIMENTAL

Subjects in this group will be treated with headache SNAGs

Other: cervical spine mobilization

Rocabado 6x6 exercises

ACTIVE COMPARATOR

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

Interventions

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.

Cervical spine mobilization

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,

Rocabado 6x6 exercises

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zia Hospital

Lahore, Punjab Province, Pakistan

Location

Related Publications (13)

  • 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.

    PMID: 33541242BACKGROUND
  • 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.

    PMID: 34003165BACKGROUND
  • 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.

    PMID: 36045409BACKGROUND
  • 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.

    PMID: 34374330BACKGROUND
  • 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.

    PMID: 30048225BACKGROUND
  • Ghodrati M, Mosallanezhad Z, Shati M, Noroozi M, Moghadam AN, Rostami M, Nourbakhsh MR. Adding Temporomandibular joint treatments to routine physiotherapy for patients with non-specific chronic neck pain: A randomized clinical study. J Bodyw Mov Ther. 2020 Apr;24(2):202-212. doi: 10.1016/j.jbmt.2019.11.004. Epub 2019 Nov 22.

    PMID: 32507146BACKGROUND
  • 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.

    PMID: 32334135BACKGROUND
  • 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.

    PMID: 33482538BACKGROUND
  • 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.

    PMID: 36428529BACKGROUND
  • Pundkar S, Patil D, Naqvi W. A Comparative Study on Effectiveness of Rocabado Approach and Conventional Physiotherapy on Pain, ROM and QOL in Patients with TMJ Dysfunction. 2021.

    BACKGROUND
  • Corum M. Evaluation of Cervical Dysfunctions in Temporomandibular Disorders. Medical Journal of Bakirkoy. 2021;17(1).

    BACKGROUND
  • La Touche R, Martinez Garcia S, Serrano Garcia B, Proy Acosta A, Adraos Juarez D, Fernandez Perez JJ, Angulo-Diaz-Parreno S, Cuenca-Martinez F, Paris-Alemany A, Suso-Marti L. Effect of Manual Therapy and Therapeutic Exercise Applied to the Cervical Region on Pain and Pressure Pain Sensitivity in Patients with Temporomandibular Disorders: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2373-2384. doi: 10.1093/pm/pnaa021.

    PMID: 32181811BACKGROUND
  • Murtza S, Noor R, Bashir MS, Ikram M. Effects of sustained natural apophyseal glides versus rocabado 6 x 6 program in subjects with cervicogenic headache. BMC Musculoskelet Disord. 2024 Feb 22;25(1):169. doi: 10.1186/s12891-024-07290-8.

MeSH Terms

Conditions

Post-Traumatic HeadacheNervous System Diseases

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Rabiya Noor, phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 19, 2023

Study Start

May 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations