NCT06938256

Brief Summary

The purpose of the study is to explore the effectiveness of Suboccipital muscle inhibition technique vs Rocabado exercises on cervicogenic headache. A randomized control trial was conducted at National Institute of Rehabilitation Medicine, Alees Medical Centre Islamabad. The sample size was 40 calculated through G-power 3.1. The participants were divided into two interventional groups each having 20 participants. The study duration was six months. Sampling technique applied was non-probability purposive sampling for recruitment and group randomization using flip coin method. Only 20 to 50 years participants with chronic cervicogenic headache were included in the study. Tools used in this study are Digital Inclinometer, Numeric Pain Rating Scale, Romberg Test and HIT-6 Questionnaire. Data was collected at baseline, and at the end of 2nd week. Data analyzed through SPSS version 27.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 14, 2025

Last Update Submit

April 21, 2025

Conditions

Keywords

Cervicogenic HeadacheSuboccipital Muscle InhibitionRocabado Exercises

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in Numeric Pain Rating Scale

    Change from baseline the NPRS score and 2nd week. NPRS is the ideal to measure pain intensity of pain. It has scale of 0-10 ("0" = no pain and "10" = worst imaginable pain).

    2nd week

Secondary Outcomes (3)

  • Changes from baseline in cervical range of motion

    2nd week

  • Changes from baseline in HIT-6 Questionnaire

    2nd week

  • Changes from baseline in Romerg's Test

    2nd week

Study Arms (2)

Suboccipital Muscle Inhibition

EXPERIMENTAL

Conventional Treatment will be given to this groups, which include heat therapy, cervical muscle stretching, cervical muscle strengthening and manual cervical traction. With the patient in the supine position and the eyes closed, the therapist sits behind the subject's head and place the palms of his/her hands beneath it, resting the pads of his/her fingers on the projection of the posterior arch of the atlas. Pressure is exerted upward and toward the therapist. The pressure is maintained for 2 minutes until tissue relaxation had been achieved. Patients were assessed for baseline measurements against outcome measures. Patients were given a total of 6 sessions such that 3 sessions per week for the duration of 02 weeks. All patients were reassessed at the end of the baseline and 2nd week of treatment for outcome measures.

Other: Suboccipital Muscle Inhibition

Rocabado 6x6 Exercises

EXPERIMENTAL

Conventional Treatment will be given to this groups, which include heat therapy, cervical muscle stretching, cervical muscle strengthening and manual cervical traction. Rocabado created 6X6 program for the management of CGH which includes 6 fundamental components, that are- Rest position of the tongue: The anterior 1/3 of the tongue is placed at the palate with mild pressure, which rests the tongue and jaw musculature and promotes diaphragmatic breathing Control of TMJ rotation: The jaw is repeatedly opened and closed with the anterior 1/3 of tongue on the palate, which decreases initiating jaw movements (eg protrusive movement in opening, talking or chewing) Rhythmic stabilization technique: Gentle isometrics in the resting position are performed for jaw opening, closing and lateral deviation to promote muscular relaxation via reciprocal inhibition, which promotes an improved resting position of the jaw through proprioceptive input Axial extension of the neck: Combined upper cervi

Other: Rocabado 6x6 Exercises

Interventions

With the patient in the supine position and the eyes closed, the therapist sits behind the subject's head and place the palms of his/her hands beneath it, resting the pads of his/her fingers on the projection of the posterior arch of the atlas. Pressure is exerted upward and toward the therapist. The pressure is maintained for 2 minutes until tissue relaxation had been achieved. The physiotherapist progressively increased the pressure exerted during the 10 minutes of treatment.

Suboccipital Muscle Inhibition

Rocabado created 6X6 program for the management of CGH which includes 6 fundamental components, one session under supervision and remaining five sessions by the subject at home. These components are: * Rest position of the tongue * Control of TMJ rotation * Rhythmic stabilization technique * Stabilized head flexion * Axial extension of the neck * Shoulder posture

Rocabado 6x6 Exercises

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants with a history of chronic CGH (\>3 months)
  • CGH pain intensity between 3 and 8 on NPRS
  • Participants who had a unilateral headache that do not shift side (ipsilateral neck pain/stiffness)
  • Pain at least once a week in the previous three months, chronic, episodic, and duration one hour to weeks (non-throbbing pain starts in the neck).
  • CGH due to cervical spine dysfunction
  • Neck pain followed by headache
  • Patients with neck stiffness and movement restriction were included.
  • Flexion Rotation Test results that are positive with a restriction of more than 10 degrees.

You may not qualify if:

  • Participants with other types of headache migraine, sinus, tumor, neural, or temporomandibular joint issues)
  • Cervicogenic headache patients with mixed headache or any diagnosed serious pathology of alar ligament and vertebra basilar artery insufficiency
  • Any contraindications to manual and manipulative therapy (fracture, instability, osteoporosis, arthropathy, or neural symptoms)
  • Using analgesics or corticosteroids
  • Metastasis
  • Cardiac conditions (stroke, hypertension, or syncope)
  • Neurological conditions (radiculopathy, myelopathy, or disc problems)
  • Spinal cord problem
  • Previous brain and spinal cord surgery
  • Occlusal splints or any surgery in Temporomandibular joint area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Rehabilitation and Medicine

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 14, 2025

First Posted

April 22, 2025

Study Start

January 3, 2025

Primary Completion

June 28, 2025

Study Completion

July 15, 2025

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations