search
Back to results

Comparison of Maitland Oscillatory Mobilizations With Kaltenborn Sustained Stretch Mobilizations in Cervicogenic Headache Patients

Primary Purpose

Cervicogenic Headache

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Maitland Oscillatory Mobilization
Kaltenborn Sustained Stretch Mobilization
Conventional therapy
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Fauji Foundation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Maitland + Conventional PT Group

Kaltenborn + Conventional PT Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity
Pain will be measured on the basis of Numeric Pain Rating Scale score.
Cervical range of motion
Cervical rotation will be measured through CROM device

Secondary Outcome Measures

Full Information

First Posted
March 9, 2023
Last Updated
March 9, 2023
Sponsor
Foundation University Islamabad
search

1. Study Identification

Unique Protocol Identification Number
NCT05777395
Brief Title
Comparison of Maitland Oscillatory Mobilizations With Kaltenborn Sustained Stretch Mobilizations in Cervicogenic Headache Patients
Official Title
Comparison of Maitland Oscillatory Mobilizations With Kaltenborn Sustained Stretch Mobilizations in Cervicogenic Headache Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
The outcome assessor will not be aware of which group the participant belongs to.
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maitland + Conventional PT Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Kaltenborn + Conventional PT Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Maitland Oscillatory Mobilization
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Kaltenborn Sustained Stretch Mobilization
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Conventional therapy
Intervention Description
Moist heat, TENS, Neck Muscle Stretching, Neck muscle isometrics
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain will be measured on the basis of Numeric Pain Rating Scale score.
Time Frame
2 weeks
Title
Cervical range of motion
Description
Cervical rotation will be measured through CROM device
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Fauji Foundation Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
4600
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Comparison of Maitland Oscillatory Mobilizations With Kaltenborn Sustained Stretch Mobilizations in Cervicogenic Headache Patients

We'll reach out to this number within 24 hrs