NCT06875869

Brief Summary

The primary objective of the study is to determine the effects of Jones and Ischemic compression technique on pain, range of motion and disability in patients with cervicogenic headache. Cervicogenic headache is a distinctive type of secondary headache where the pain originates from structures in the neck or cervical spine and radiates to the head. Trigger point release has been associated with decrease in symptoms of patients with cervicogenic headache. This study will be a randomized clinical trial with the sample size of 32 patients. Participants will be randomly allocated into two groups: Group A and Group B. The setting of the study will be Bahawal Victoria Hospital, Bahawalpur. Group A will receive Jones technique of trigger points of the upper trapezius and sternocleidomastoid muscle while Group B will receive ischemic compression of the trigger points of the upper trapezius and sternocleidomastoid muscle. Patients of both groups will receive two treatment sessions per week for 6 weeks. Both groups will receive hot pack for 10 minutes, TENS for 15 minutes and strengthening exercises for deep neck flexors (chin tuck and head raise with ten repetitions of 10-second duration, with a 10-second rest interval between each contraction) as baseline treatment protocol. NPRS, HDI and FRT will be used as outcome measure tools. Data will be analyzed using SPSS version 25.0 with the p-value of \<0.05 taken as significant difference.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 10, 2025

Last Update Submit

March 10, 2025

Conditions

Keywords

Cervicogenic headacheDisability evaluationIschemic compression therapyPain assessmentRange of motionTrigger point

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    It is a standardized self-reporting scale consisting of a horizontal line used to estimate the subjective level of pain intensity. It is a 11 point numerical scale, corresponding to the degree of pain. 0= no pain, 1-2-3 = mild pain, 4-5-6 = moderate pain, 7-8-9-10 = severe pain. The patients will be asked to select from that 11 points numerical continuum the number that corresponds to their perceived pain intensity

    6 weeks

  • Headache Disability index (HDI)

    This scale is intended to help discover impact of headache. It contains 27 questions in total. First two questions are about frequency of headache and remaining 25 regarding impact of headache on daily life of the person. Each question has three possible answers. "yes " will score 4 points, " sometimes" will score 2 and "no" will give 0 score. A total score of 10 - 28 is regarded as an indicator of light disability, the score of 30-48 represents moderate disability, 50-68 expresses severe disability, and 72 or above marks complete disability

    6 weeks

  • Flexion Rotation test (FRT)

    Flexion rotation test is used to measure cervical range of motion employing a goniometer. Impairment in upper cervical spine mobility is associated with cervicogenic headache severity and disability. Measures of such mobility include the flexion-rotation test (FRT), which requires full cervical flexion and may be influenced by lower cervical spine dysfunction.

    6 weeks

Study Arms (2)

Group-A (Jones technique)

EXPERIMENTAL

Patients will receive Jones technique for the Sternocleidomastoid and upper fibers of Trapezius.

Other: Jones technique

Group-B (Ischemic compression therapy)

ACTIVE COMPARATOR

Patients will receive Ischemic compression for the Sternocleidomastoid and upper fibers of Trapezius

Other: Ischemic compression therapy

Interventions

In the Jones technique, pressure will be applied on the tender point and the patient's head will be flexed laterally to the side of the tender point, followed by a shoulder abduction of approximately 90 degrees. This position will be held for 90 s and then patient position will be passively returned to the initial position. This will be repeated three times in each session. Patients will receive two treatment sessions per week for 6 weeks

Group-A (Jones technique)

Patients will receive ischemic compression of the trigger points of the upper trapezius and sternocleidomastoid muscle with hold time varying between 30 seconds to 1 minute repeated 3 to 5 times in each session. Patients will receive two treatment sessions per week for 6 weeks

Group-B (Ischemic compression therapy)

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both males and females
  • years of age
  • Individuals satisfying the Cervicogenic Headache criteria
  • Positive Simon's criteria for trigger points

You may not qualify if:

  • primary headaches (i.e., migraine, tension type headache)
  • bilateral headache
  • Presence of any red flags
  • cervical spinal stenosis
  • evidence of central nervous system involvement
  • prior surgery to the head or neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahaval Victoria Hospital

Bahawalpur, Punjab Province, Pakistan

RECRUITING

Related Publications (5)

  • Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.

    PMID: 22034615BACKGROUND
  • Knackstedt H, Bansevicius D, Aaseth K, Grande RB, Lundqvist C, Russell MB. Cervicogenic headache in the general population: the Akershus study of chronic headache. Cephalalgia. 2010 Dec;30(12):1468-76. doi: 10.1177/0333102410368442. Epub 2010 May 19.

    PMID: 20974607BACKGROUND
  • Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.

    PMID: 19747657BACKGROUND
  • Garcia JD, Arnold S, Tetley K, Voight K, Frank RA. Mobilization and Manipulation of the Cervical Spine in Patients with Cervicogenic Headache: Any Scientific Evidence? Front Neurol. 2016 Mar 21;7:40. doi: 10.3389/fneur.2016.00040. eCollection 2016.

    PMID: 27047446BACKGROUND
  • Olesen J. International Classification of Headache Disorders. Lancet Neurol. 2018 May;17(5):396-397. doi: 10.1016/S1474-4422(18)30085-1. Epub 2018 Mar 14. No abstract available.

    PMID: 29550365BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ghulam Fatima, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PHD*

CONTACT

Imran Amjad, PHD*

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 13, 2025

Study Start

January 2, 2025

Primary Completion

September 2, 2025

Study Completion

September 15, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations