NCT05404113

Brief Summary

The aim of this randomized controlled trial is to compare the effects of sustained natural apophyseal glide and deep friction massage in patients with cervicogenic headache for reducing pain, enhancing cervical range of motion and improving sleep quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

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

First Submitted

Initial submission to the registry

April 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 14, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

April 21, 2022

Last Update Submit

April 12, 2023

Conditions

Headache Disorders

Keywords

Sustained natural apophyseal glide/SNAGdeep friction massageCervicogenic headache

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index NDI

    This questionnaire gives us the information as to how the neck pain has affected one's ability to manage in everyday life. Questions are scored on a vertical scale of 0-5, Likert type scale. A score of 22% or more is considered a significant ADL disability.

    3 weeks

Secondary Outcomes (2)

  • Visual Analogue Scale VAS

    3 weeks

  • Pitsburg sleep quality index PSQI

    3 weeks

Study Arms (2)

sustained natural apophyseal glide

EXPERIMENTAL

Mulligan's C1-C2 self-SNAG + Conventional PT

Other: sustained natural apophyseal glide

deep friction massage

EXPERIMENTAL

Cyriax deep friction massage+ Conventional PT

Other: deep friction massage

Interventions

sustained natural apophyseal glideOTHER

Mulligan's C1-C2 self-SNAG+ strengthening exercises for anterior and posterior neck muscles (extension, flexion, rotation, lateral flexion) Frequency: 2-3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 20 minutes/session Type: Mobilization with movement SNAG Conventional PT including strengthening exercises neck muscles 10 repetitions, 1 set Resisted neck flexion, extension, lateral flexion, rotation Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 minutes/session Type: Strengthening Exercise

sustained natural apophyseal glide
deep friction massageOTHER

Cyriax deep friction massage+ strengthening exercises for anterior and posterior neck muscles (extension, flexion, rotation, lateral flexion) Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 20 minutes/session Type: Deep soft tissue massage Conventional PT including strengthening exercises neck muscles 10 repetitions, 1 set Resisted neck flexion, extension, lateral flexion, rotation Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 minutes/session Type: Strengthening Exercise

deep friction massage

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Evidence of causation demonstrated by at least two of the following:
  • headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion
  • headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion
  • cervical range of motion is reduced and headache is made significantly worse by provocative maneuvers (Flexion Rotation Test FRT)
  • headache is abolished following diagnostic blockade of a cervical structure or its nerve supply • A headache frequency that is more than 2 months.

You may not qualify if:

  • Bilateral headaches (typifying tension headache) \& features suggestive of migraine.
  • Known cases of Hydrocephalus.
  • Known cases of neurological impairments.
  • Known cases of malignancy.
  • Involvement in physiotherapy or chiropractic treatment for headache in the previous 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest Institute of Health Sciences and Northwest General Hospital Peshawar.

Peshawar, Pakistan

Location

MeSH Terms

Conditions

Headache DisordersPost-Traumatic Headache

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, Secondary

Study Officials

  • KINZA ANWAR, MS-OMPT

    RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 21, 2022

First Posted

June 3, 2022

Study Start

September 14, 2022

Primary Completion

March 30, 2023

Study Completion

April 2, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)