NCT06731114

Brief Summary

This study is a randomised control trial and the purpose of this study is to determine the "Additional effects of sternocleidomastoid release along with suboccipital muscle release in management of cervicogenic headache".

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

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

July 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 9, 2024

Last Update Submit

December 9, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity

    Pain will be measured on the basis of Numeric Pain Rating Scale score.

    2 weeks

  • ROM

    Cervical rotation will be measured through CROM device

    2 weeks

Study Arms (2)

Group A

EXPERIMENTAL

On group A we will perform suboccipital muscle release (3 repititions 3 mins)9 minutes along with conventional physical therapy including TENS and hot pack for 10 mins 6 days a week for consective 2 weeks.

Procedure: Suboccipital muscle releaseProcedure: Conventional physical therapy

Group B

EXPERIMENTAL

On group B we will perform sternocleidomastoid release for 5 mins along with suboccipital muscle release and coventional physical therapy including TENS and hot pack for 10 mins 6 days a week for consective 2 weeks .

Procedure: Suboccipital muscle releaseProcedure: Conventional physical therapyProcedure: Sternocleidomastoid release

Interventions

Suboccipital muscle release.6 consecutive sessions for 2 weeks • Frequency:( 3mins 3 reps) 9 mins .12 sessions in total

Group AGroup B

TENS and hot pack for 10 mins 6 days a week for consecutive 2 weeks

Group AGroup B

Frequency: 5 mins of SCM release and 9 mins (3 mins 3 reps )of suboccipital release. 12 sessions in total.

Group B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants will be included according to international classification of headache criteria which includes:
  • Headache with neck stiffness
  • Headache at least once a month in the last 3 months
  • Headache with at least 4 score in Numeric Pain Rating Scale(NPRS)
  • Unilateral headache with no shift of side
  • Positive flexion rotation test (Rotation restriction is greater than 10 degrees)
  • C1-C2 dysfunction
  • Headache precipitated by sustained neck movements,myofacial trigger points palpation in neck
  • Age group 18-45
  • Both male and female

You may not qualify if:

  • Cervical spondylosis
  • Headache of non-cervical origin
  • Dizziness or visual disturbance
  • Cervical radiculopathy/ nerve root involvement/ disc herniation
  • Cervical instability/ fracture
  • Vertebrobasilar insufficiency
  • Thoracic outlet syndrome
  • Cervical spine surgery
  • Cervical spondylolisthesis
  • Spinal infection or tumors
  • Osteoporosis
  • meningitis
  • subarachnoid hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Ayesha Arshad, MS-MSKPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having two groups.one group will recieve conventional physical therapy including hot pack and tens for 10mins and suboccipital muscle release ( 3mins 3 reps) 9 mins .12 sessions in total where as group B will receive Sternocleidomastoid release for 5 mins along with suboccipital muscle release and conventional physical therapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 12, 2024

Study Start

July 15, 2024

Primary Completion

July 15, 2025

Study Completion

July 15, 2025

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations