NCT05777395

Brief Summary

Cervicogenic headache is a common headache that causes disability and affects everyday activities. Headache related disorders are the second most common reason for years lived with disability all over the world. According to the latest International Headache Society model, cervicogenicheadache (CGH) is a secondary headache having C1-C2 dysfunction. There is marked limitation in cervical ROM specially rotation. Treatment indicated involves use of electrotherapy and thermal modalities. In addition, use of different manual therapy techniques are advocated to eliminate the root cause i.e. C1-C2 dysfunction. Maitland mobilizations for cervical spine have been found to be effective in treating CGH patients. Maitland mobilizations uses oscillatory mobilizations and has four grades. Kaltenborn, on the other hand, applies sustained stretches and has 3 grades.So, the study will be focusing on comparing the effectiveness of these two mobilizations on cervicogenic headache patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 9, 2023

Last Update Submit

March 9, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

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

    2 weeks

  • Cervical range of motion

    Cervical rotation will be measured through CROM device

    2 weeks

Study Arms (2)

Maitland + Conventional PT Group

EXPERIMENTAL

Participants of this group will receive the conventional physical therapy protocol mentioned above. In addition to this, they will receive Maitland oscillatory mobilizations. 3 sets of 15 repetitions. Each set is of 30 seconds and each repetition is given in 2 seconds. * Frequency: 3 times a week for 2 weeks. 6 sessions in total. * Mobilizations will be performed in Grade 1 initially and then progressed to Grade 2 and 3. * Techniques used are postero-anterior unilateral vertebral pressure and Maitland rotation.

Procedure: Maitland Oscillatory MobilizationProcedure: Conventional therapy

Kaltenborn + Conventional PT Group

EXPERIMENTAL

Participants of this Group will receive the conventional physical therapy protocol mentioned above. In addition to this, they will receive Kaltenborn sustained stretch mobilizations. 3 sets of 15 repetitions for 3 seconds. * Frequency: 3 times a week for 2 weeks. 6 sessions in total. * Mobilizations will be performed in Grade 1 and then progressed to 2 and 3. * Kaltenborn technique used will be atlas-axis rotation.

Procedure: Kaltenborn Sustained Stretch MobilizationProcedure: Conventional therapy

Interventions

Maitland Posteroanterior unilateral vertebral pressure and Maitland cervical rotation technique will be used.3 sets of 15 repetitions. Each set is of 30 seconds and each repetition is given for 2 seconds.

Maitland + Conventional PT Group

Kaltenborn sustained stretch mobilizations. 3 sets of 15 repetitions for 3 seconds. * Frequency: 3 times a week for 2 weeks. 6 sessions in total. * Mobilizations will be performed in Grade 1 and then progressed to 2 and 3. * Kaltenborn technique used will be atlas-axis rotation

Kaltenborn + Conventional PT Group

Moist heat, TENS, Neck Muscle Stretching, Neck muscle isometrics

Kaltenborn + Conventional PT GroupMaitland + Conventional PT Group

Eligibility Criteria

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

You may qualify if:

  • Age 18-45 years
  • Both males and females
  • Unilateral headache with no shift of side
  • C1-C2 dysfunction
  • Headache with neck stiffness
  • Headache at least once a month in the last 3 months
  • Positive flexion rotation test (Rotation restriction is greater than 10 degrees)
  • Headache with a score of at least 4 in the Numeric pain rating scale

You may not qualify if:

  • Cervical spondylosis
  • Headache of non-cervical origin
  • Dizziness or visual disturbance
  • Cervical radiculopathy/ nerve root involvement/ disc herniation
  • Cervical instability/ fracture
  • Vertebrobasilar insufficiency
  • Thoracic outlet syndrome
  • Cervical spine surgery
  • Cervical spondylolisthesis
  • Spinal infection or tumors
  • Osteoporosis
  • History of trauma
  • Metabolic disorders
  • Rheumatoid Arthritis
  • Inflammatory Arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, Punjab Province, 4600, Pakistan

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will not be aware of which group the participant belongs to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy along with Maitland oscillatory mobilizations and the second will receive Kaltenborn sustained stretch mobilizations with conventional physical therapy. Both groups will be recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 21, 2023

Study Start

January 1, 2023

Primary Completion

June 15, 2023

Study Completion

July 1, 2023

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations