NCT06534606

Brief Summary

Cervicogenic headache is a common type of headache in adults which causes disability and difficulty in everyday activities. According to the latest International Headache Society model, cervicogenic headache (CGH) is a secondary headache having C1-C2 dysfunction. SNAGs are highly effective in the treatment approach for these patients. Sternocleidomastoid muscle receive overactive tension from forward neck posture, increasing muscular fatigue and tone of muscles. This tension in SCM causes referred pain in the head and neck region. SNAGs are very effective but musculoskeletal impairments especially the tightness of sternocleidomastoid muscle still persist and can exacerbate symptoms. Manual therapy targeted to the SCM muscle may be effective for reducing headache and neck pain intensity and increasing performance of deep cervical flexors. Findings of this study will aid the therapists in choosing which technique to use while treating the patients. This will save therapist's time and effort as they will not be using the less effective treatment protocol. Furthermore, patient's time and investment will be used in the right direction.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

June 10, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain intensity

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

    2 weeks

  • Range of motion

    Cervical rotation will be measured through CROM device

    2 weeks

  • Headache Disability

    Headache Disability Index will be used

    2 weeks

  • Cervical Proprioception

    Joint Position Error Test will be used

    2 weeks

Study Arms (2)

Conventional physical therapy Group

ACTIVE COMPARATOR

Both Group A and Group B will receive this conventional physical therapy protocol for cervicogenic headache. * Moist heat therapy: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks. * TENS application: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks. In addition to this, they will receive Headache SNAGs (Sustained Natural Apophyseal Glides) 5 sets of 10 repetitions. Each repetition will be given with a 10 second hold. • Frequency: 3 times a week for 2 weeks. 6 sessions in total.

Procedure: Electrotherapy and physical agentsProcedure: Headache SNAGs

Conventional physical therapy with sternocleidomastoid release

EXPERIMENTAL

Both Group A and Group B will receive this conventional physical therapy protocol for cervicogenic headache. * Moist heat therapy: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks. * TENS application: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks. Headache SNAGs: In addition to the conventional physical therapy protocol, they will receive Headache SNAGs (Sustained Natural Apophyseal Glides) 5 sets of 10 repetitions. Each repetition will be given with a 10 second hold. * Frequency: 3 times a week for 2 weeks. 6 sessions in total. Sternocleidomastoid Release: Group B will also receive Sternocleidomastoid release in addition with headache SNAGs. Release to the sternocleidomastoid muscle will be given once per session for 5-8 minutes. * Frequency: 3 times a week for 2 weeks. 6 sessions in total.

Procedure: Electrotherapy and physical agentsProcedure: Headache SNAGsProcedure: Sternocleidomastoid Release

Interventions

Moist heat therapy: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks. • TENS application: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks.

Conventional physical therapy GroupConventional physical therapy with sternocleidomastoid release

Headache SNAGs (Sustained Natural Apophyseal Glides) 5 sets of 10 repetitions. Each repetition will be given with a 10 second hold. • Frequency: 3 times a week for 2 weeks. 6 sessions in total.

Conventional physical therapy GroupConventional physical therapy with sternocleidomastoid release

Sternocleidomastoid Release: Group B will also receive Sternocleidomastoid release in addition with headache SNAGs. Release to the sternocleidomastoid muscle will be given once per session for 5-8 minutes.Frequency: 3 times a week for 2 weeks. 6 sessions in total.

Conventional physical therapy with sternocleidomastoid release

Eligibility Criteria

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

You may qualify if:

  • Age group: 18-45 years old
  • Both males and females
  • Unilateral headache with no shift of side
  • C1-C2 Dysfunction
  • Positive flexion rotation test (Rotation restriction is greater than 10 degrees)
  • Headache at least once a month in the last 3 months
  • Headache with at least 4 score in NPRS (Sign and Symptoms of Neck Involvement)
  • Headache with restriction of ROM in the neck
  • Headache precipitated by:
  • Sustained neck movements, and awkward head positioning. External Pressure over upper cervical or occipital region
  • Headache Characteristics:
  • Moderate-severe, non-throbbing pain, usually starting in the neck.
  • Episodes of varying duration, or: fluctuating, continuous pain

You may not qualify if:

  • Headache of non-cervical origin
  • Diagnosed Cases of:Cervical spondylosis,Cervical radiculopathy/ nerve root involvement/ disc herniation,Cervical instability/ fracture,Vertebrobasilar insufficiency ,Cervical spine surgery,Cervical spondylolisthesis,Spinal infection or tumors,Osteoporosis,History of trauma,Rheumatoid Arthritis,Inflammatory Arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

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 receive SNAGs and the second will receive Sternocleidomastoid Release along with SNAGS. Both groups will be recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

June 10, 2024

Primary Completion

December 10, 2024

Study Completion

December 30, 2024

Last Updated

August 2, 2024

Record last verified: 2024-07

Locations