NCT07838545

Brief Summary

This study aims to compare the effects of Post Isometric Relaxation (PIR) and Reciprocal Inhibition (RI) in individuals with cervicogenic headache, a secondary headache originating from dysfunction of the cervical spine, particularly the upper cervical segments. Cervicogenic headache is characterized by unilateral head and neck pain, restricted cervical mobility, muscle tightness, and functional limitations that negatively affect daily activities and quality of life. The study will employ a randomized controlled trial involving 46 participants aged 18-45 years who meet the inclusion criteria. Participants will be randomly allocated into two groups: Group A will receive Post Isometric Relaxation, while Group B will receive Reciprocal Inhibition. Both groups will also receive a standard physiotherapy protocol consisting of hot packs, cervical isometric exercises, and C1-C2 Sustained Natural Apophyseal Glides (SNAGs), administered three times per week for four weeks. Pain intensity, functional disability, and cervical range of motion will be assessed before and after the intervention using the Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), and goniometric measurements, respectively. By comparing these two muscle energy techniques, the study seeks to determine which intervention is more effective in reducing pain, improving cervical mobility, and enhancing functional outcomes, thereby providing evidence to support clinical decision-making and optimize physiotherapy management for individuals with cervicogenic headache.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Feb 2026

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 Progress69%
Feb 2026Jan 2027

Study Start

First participant enrolled

February 12, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2027

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

September 18, 2026

Last Update Submit

September 18, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Head Pain

    Pain intensity will be assessed using the Numeric Pain Rating Scale(NPRS).The NPRS is an 11-point self reported scale ranging from 0 to 10,where 0 indicates no pain and 10 reprents the worst pain.

    Baseline and after 4 weeks of intervention

  • Cervical Range of Motion

    Cervical range of motion (ROM) will be assessed as an outcome measure using a goniometer. The assessment will be performed before the intervention and after completion of the treatment protocol to determine changes in cervical mobility. The cervical movements assessed will include flexion, extension, right and left lateral flexion, and right and left rotation. The participant will be positioned appropriately, and the goniometer will be aligned according to the anatomical landmarks for each movement. The available cervical ROM will be measured in degrees and recorded on the data collection form. Goniometry has demonstrated good reliability for assessing cervical ROM, with reported intraclass correlation coefficients (ICC) ranging from 0.79 to 0.98.

    Baseline and after 4 weeks of treatment

  • Neck Disability

    Neck disability will be assessed as an outcome measure using the Neck Disability Index (NDI). The NDI is a valid and reliable self-report questionnaire designed to evaluate the level of disability associated with neck pain and its effects on daily activities. It consists of 10 items covering pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 to 5, with higher scores indicating greater disability. The total score ranges from 0 to 50 and is used to determine the severity of functional disability. A score of 0-4 indicates no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, and 35 or more complete disability.

    Baseline and after 4 weeks of treatment

Study Arms (2)

Group A Post Isometric Relaxation

EXPERIMENTAL
Procedure: Post Isometric Relaxation

Group B Reciprocal Inhibition

EXPERIMENTAL
Procedure: Reciprocal Inhibition

Interventions

Post Isometric Relaxation (PIR) is a muscle energy technique used to reduce pain, decrease muscle tightness, and improve cervical mobility in individuals with cervicogenic headache. The technique is based on the principle that muscle tone temporarily decreases after a gentle isometric contraction, allowing the muscle to be stretched more effectively. During the intervention, the therapist positions the affected muscle at its resistance barrier and asks the patient to perform a 10-second isometric contraction against therapist-applied resistance. After relaxation, a gentle passive stretch is applied to achieve a new range of motion. The procedure is repeated 3-5 times for each targeted muscle, including the upper trapezius, levator scapulae, suboccipital, and sternocleidomastoid muscles.

Group A Post Isometric Relaxation

Reciprocal Inhibition (RI) is a muscle energy technique used to reduce muscle tightness, relieve pain, and improve cervical range of motion by utilizing the neurological principle of reciprocal inhibition. During the technique, the therapist positions the patient appropriately and instructs the patient to perform a gentle 10-second isometric contraction of the antagonist muscle against therapist-applied resistance. This contraction inhibits the activity of the tight agonist muscle, resulting in decreased muscle tone and facilitating relaxation. Following the contraction, the therapist applies a gentle passive stretch to the affected muscle to achieve a new range of motion. The technique is repeated 3-5 times for each targeted muscle to improve flexibility and cervical function.

Group B Reciprocal Inhibition

Eligibility Criteria

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

You may qualify if:

  • Patients are diagnosed according to ICH criteria.
  • Age 18-45 years.
  • Both Genders (Male and Female).
  • Headache \> 3 months.
  • Unilateral neck pain and associated headache.
  • Headache is precipitated by neck movements or sustained positions.
  • Restricted upper cervical segmental mobility.
  • Positive cervical flexion rotation test, restriction greater than 10°.

You may not qualify if:

  • History of head and neck trauma.
  • Neoplasm.
  • Cognitive disability.
  • Inherited disorders such as scoliosis and torticollis.
  • Other chronic pain syndrome (i.e.: fibromyalgia, systematic inflammatory disease).
  • History of recent surgery of cervical spine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, Punjab Province, 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

Kinza Hafeez, DPT

CONTACT

Anam Rehman, MS-OMPT

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

September 18, 2026

First Posted

September 24, 2026

Study Start

February 12, 2026

Primary Completion (Estimated)

December 18, 2026

Study Completion (Estimated)

January 18, 2027

Last Updated

September 24, 2026

Record last verified: 2026-09

Locations