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AzTrials

Cervicogenic HeadacheSCS-PIRNCT07897695

Effects of Strain Counterstrain Versus Post Isometric Relaxation on Pain, Headache Frequency, and Quality of Life in Females With Cervicogenic Headache.

A study testing Post Isometric Relaxation and Strain Counterstrain in people with Cervicogenic Headache, run by Qurat Ul Ain Ashfaq at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cervicogenic headache is a secondary headache disorder associated with dysfunction of the cervical spine and surrounding muscles. It may cause neck pain, muscle tenderness, recurrent headaches, and limitations in daily activities, ultimately affecting quality of life. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Cervicogenic Headache
What is being tested?
Post Isometric Relaxation and Strain Counterstrain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 sitePakistan
Study dates
22 Oct 2025to 17 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females aged 18-45 years.
  • Diagnosed with cervicogenic headache (CGH) per IHS criteria.
  • Presence of palpable tender points in the upper cervical muscles (suboccipital, upper trapezius, and levator scapulae).
  • Headache duration of at least 3 months.

Who cannot join

  • History of cervical fractures, tumors, or infections.
  • Previous cervical spine surgery.
  • Diagnosed migraine or cluster headaches.
  • Evidence of cervical radiculopathy or disc herniation.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Sir Ganga Ram Teaching Hospital

    Lahore, Punjab Province, 34501

Other trials in Pakistan

About this study

Cervicogenic headache is a secondary headache disorder associated with dysfunction of the cervical spine and surrounding muscles. It may cause neck pain, muscle tenderness, recurrent headaches, and limitations in daily activities, ultimately affecting quality of life. The study aimed to determine whether Strain Counterstrain (SCS) or Post-Isometric Relaxation (PIR) produces better outcomes in reducing pain intensity, decreasing headache frequency, and improving headache-related quality of life.

A randomized clinical trial was conducted in the Physiotherapy Department of Sir Ganga Ram Hospital, Lahore, involving 34 female participants who were randomly allocated into two equal groups of 17 participants each. Group A received Strain Counterstrain, while Group B received Post-Isometric Relaxation. Strain Counterstrain is a passive manual therapy technique in which the therapist positions the affected cervical tissues in a comfortable position to reduce tenderness and abnormal muscle activity.

Read more

Participants were assessed using three outcome measures: the Numeric Pain Rating Scale (NPRS) to measure pain intensity, a Headache Frequency Diary to record headache episodes, and the Headache Impact Test (HIT-6) to assess the effect of headaches on daily functioning and quality of life. Assessments were conducted at baseline, after six weeks, and at twelve weeks, as reported in the results section.

The study aimed to determine whether Strain Counterstrain (SCS) or Post-Isometric Relaxation (PIR) produces better outcomes in reducing pain intensity, decreasing headache frequency, and improving headache-related quality of life.

Read the detailed description

Cervicogenic headache (CGH) is a secondary headache disorder associated with dysfunction of the cervical spine and its surrounding musculoskeletal structures. It occurs when a problem involving the neck joints, muscles, ligaments, or upper cervical region contributes to pain that radiates from the neck toward the head. The upper cervical vertebrae, particularly C1, C2, and C3, play an important role in the development of cervicogenic headache because sensory pathways from the upper cervical region converge with pathways associated with the trigeminal nerve. This convergence helps explain why pain originating in the neck may be perceived in the head. Patients commonly experience unilateral headache, neck pain, restricted cervical range of motion, and tenderness in the upper cervical muscles. The headache may be aggravated by neck movements, sustained neck positions, or pressure over sensitive cervical structures. Commonly involved muscles include the suboccipital muscles, upper trapezius, and levator scapulae. Unlike primary headache disorders, such as migraine, cervicogenic headache is associated with an underlying cervical musculoskeletal source. Clinical assessment may include evaluation of cervical mobility, muscle tenderness, headache characteristics, and the Flexion-Rotation Test (FRT), which helps identify restricted movement of the upper cervical spine. Accurate diagnosis is important because other conditions, including migraine, cluster headache, cervical radiculopathy, and structural cervical disorders, may produce similar symptoms. Cervicogenic headache can interfere with daily activities, concentration, physical functioning, and overall quality of life.

The study is a randomized control trail. Participants are selected from the Physiotherapy Department of Sir Ganga Ram Hospital, Lahore. Thirty-four participants will be recruited from this hospital. Adult females from 18 to 45 years of age suffering from cervicogenic headache (CGH) are included in this study. The participants will experience a headache for a minimum period of 3 months and palpable tenderness of upper cervical muscles. Those who had migraine, previous cervical surgery, cervical fracture, tumor, infection, radiculopathy, or disc herniation are excluded.

The intervention is conducted over a period of six weeks among 34 female participants with cervicogenic headache, who were randomly allocated into two equal groups: Group A received Strain Counterstrain (SCS), and Group B received Post-Isometric Relaxation (PIR), with 17 participants in each group. In Group A, the therapist identified tender myofascial points in the upper cervical region, particularly around C1-C3, including the suboccipital muscles, upper trapezius, and levator scapulae. The cervical spine is gently positioned in a comfortable position of ease using appropriate flexion, extension, rotation, or side-bending until tenderness decreased by approximately 70% or more. This position is maintained for approximately 90 seconds while the participant remained relaxed, after which the neck was slowly returned to the neutral position. In Group B, the therapist positioned the cervical spine toward the first restrictive barrier, and participants performed gentle isometric contractions against manual resistance at approximately 10-25% of maximum voluntary effort for 7-10 seconds, followed by 2-3 seconds of relaxation. The therapist then moved the cervical segment gently toward the new restrictive barrier, and the contraction-relaxation cycle was repeated three to five times according to the participant's tolerance and clinical response. Outcomes will be assessed at baseline, at the end of the third week, and at the end of the sixth week using the Numeric Pain Rating Scale (NPRS), Headache Impact Test-6 (HIT-6), and Headache Frequency Diary to evaluate changes in pain intensity, headache-related functional impact, and headache frequency.

Being tested
Post Isometric Relaxation, Strain Counterstrain
Keywords
Cervicogenic Headache, Headache Frequency, Headache related quality of life, Pain intensity, Strain- counterstrain
Medical subject headings
Post-Traumatic Headache, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Post Isometric RelaxationOther

    Post-Isometric Relaxation (PIR) was provided over a period of six weeks, and the outcomes were assessed at baseline, at the end of the third week, and at the end of the sixth week. During each treatment session, the physiotherapist positioned the participant's cervical spine toward the first restrictive barrier in the direction of the identified movement restriction. The participant was then instructed to perform a gentle isometric contraction against the therapist's manual resistance, using approximately 10-25% of maximum voluntary effort, for 7-10 seconds while breathing normally and avoiding movement of other body parts. After the contraction, the participant was asked to relax the involved muscles completely for 2-3 seconds. The therapist then gently moved the cervical segment toward the new restrictive barrier without causing pain or overstretching. This contraction-relaxation cycle was repeated 3-5 times per treatment session, depending on the participant's tolerance and clinical

  • Strain CounterstrainOther

    Strain Counterstrain (SCS) was provided over a period of six weeks, and the outcomes were assessed at baseline, the end of the third week, and the end of the sixth week. During each treatment session, the physiotherapist identified tender myofascial points in the upper cervical region, particularly around C1-C3, including the suboccipital, upper trapezius, and levator scapulae muscles. The therapist then gently positioned the participant's neck into a comfortable position of ease using appropriate side-bending, rotation, flexion, or extension, depending on the location of the tender point. The position was adjusted until tenderness decreased by approximately 70% or more and was maintained for about 90 seconds while the participant remained relaxed and avoided voluntary muscle movements

Study groups in NCT07897695
Study groupRoleWhat they receive
Strain CounterstrainActive comparatorStrain Counterstrain (SCS) is provided over a period of six weeks, and the outcomes were assessed at baseline, the end of the third week, and the end of the sixth week. During each treatment session, the physiotherapist identified tender myofascial points in the upper cervical region, particularly around C1-C3, including the suboccipital, upper trapezius, and levator scapulae muscles. The therapist then gently positioned the participant's neck into a comfortable position of ease using appropriate side-bending, rotation, flexion, or extension, depending on the location of the tender point. The position was adjusted until tenderness decreased by approximately 70% or more and was maintained for about 90 seconds while the participant remained relaxed and avoided voluntary muscle movements. Afterward, the therapist slowly and passively returned the neck to the neutral position. The procedure was performed gently.
Receives: Other: Strain Counterstrain
Post-isometric RelaxationExperimentalPost-Isometric Relaxation (PIR) was provided over a period of six weeks, and the outcomes were assessed at baseline, at the end of the third week, and at the end of the sixth week. During each treatment session, the physiotherapist positioned the participant's cervical spine toward the first restrictive barrier in the direction of the identified movement restriction. The participant was then instructed to perform a gentle isometric contraction against the therapist's manual resistance, using approximately 10-25% of maximum voluntary effort, for 7-10 seconds while breathing normally and avoiding movement of other body parts. After the contraction, the participant was asked to relax the involved muscles completely for 2-3 seconds. The therapist then gently moved the cervical segment toward the new restrictive barrier without causing pain or overstretching. This contraction-relaxation cycle was repeated 3-5 times per treatment session, depending on the participant's tolerance and clinica
Receives: Other: Post Isometric Relaxation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Measured by Numeric Pain Rating Scale

    It's an unidimensional pain scale, a self-reported measurement with an 11-point number rating that ranges from no pain (0) to the worst pain (10). Interpreted as mild (1-3), moderate (4-6), or severe (7-10).

    Measured: AT Baseline to 6 weeks

  2. Headache episode measured by the Headache Frequency Diary

    Headache episodes will be recorded using the Headache Frequency Diary each week, which includes the number, duration, characteristics, triggers, and functional impact of headache attacks. Headache frequency was classified into 4 groups: 0-1, 2-3, 4-5, and 6-7 episodes per week

    Measured: AT Baseline to 6 weeks

Secondary outcomes (1)
  1. Headache-Related Quality of Life and Functional Impact

    The overall effect of headache on participant's functioning and quality of life was measured using the Headache Impact Test (HIT-6™). The six items are answered on a scale ranging from never (6) to always (13) with five answer options for each item. The total score is from 36 points to 78 points, with higher scores representing a higher impact on headaches in daily life. A score of ≤49 indicates little or no impact, 50-55 indicates some impact, 56-59 indicates substantial impact, and 60-78 indicates severe impact. The HIT-6 has shown good psychometric properties, including high internal consistency (Cronbach's α = 0.89-0.90) and good test-retest reliability (ICC = 0.78-0.80) over 14 days. It has been validated by its correlation with known QOL instruments such as the SF-8, SF-36, and MIDAS. The instrument was 93.1% sensitive and 79.4% specific at a cut-off point of ≥56, with an overall classification accuracy of 88.7% for migraine impact.

    Measured: AT Baseline to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start22 Oct 2025
  3. Primary completion10 Jun 2026
  4. Study completion17 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07897695
Sponsor's protocol ID
REHAB/04/26/MS/RS-4023
Acronym
SCS-PIR
Status last verified
Oct 2026
First submitted
20 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Saleh M, Farag M, Kamel R. Suboccipital release versus muscle energy technique in patients with mechanical neck pain and forward head posture. Int J Yoga Physiother Phys Educ. 2023;8:28-34

Questions about this trial

What is this clinical trial studying?

A study testing Post Isometric Relaxation and Strain Counterstrain in people with Cervicogenic Headache, run by Qurat Ul Ain Ashfaq at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Measured by Numeric Pain Rating Scale (time frame: AT Baseline to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07897695, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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