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

December 26, 2023 updated by: Riphah International University

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

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.

Study Overview

Status

Completed

Conditions

Cervicogenic Headache

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Pakistan
- Punjab
  - Lahore, Punjab, Pakistan
    - Zia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index Time Frame: 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.	8th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Impact Test-6 SCALE Time Frame: 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.	8th week
Flexion Rotation Test Time Frame: 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.	8th week
Numeric Pain Rating Scale Time Frame: 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.	8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

Principal Investigator: Rabiya Noor, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

REC/RCR & AHS/23/0121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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