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Sustained Natural Apophyseal Glide and Deep Friction Massage in Patients With Cervicogenic Headache

Primary Purpose

Headache Disorders

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
sustained natural apophyseal glide
deep friction massage
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache Disorders focused on measuring Sustained natural apophyseal glide/SNAG, deep friction massage, Cervicogenic headache

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria; Both males & females. Aged 18 years old and above. International Classification of Headache Disorders (ICHD-III) Diagnostic Criteria for cervicogenic headache

Evidence of causation demonstrated by at least two of the following:

  • headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion
  • headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion
  • cervical range of motion is reduced and headache is made significantly worse by provocative maneuvers (Flexion Rotation Test FRT)
  • headache is abolished following diagnostic blockade of a cervical structure or its nerve supply • A headache frequency that is more than 2 months.

Exclusion Criteria:

  • Bilateral headaches (typifying tension headache) & features suggestive of migraine.
  • Known cases of Hydrocephalus.
  • Known cases of neurological impairments.
  • Known cases of malignancy.
  • Involvement in physiotherapy or chiropractic treatment for headache in the previous 12 months.

Sites / Locations

  • Northwest Institute of Health Sciences and Northwest General Hospital Peshawar.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

sustained natural apophyseal glide

deep friction massage

Arm Description

Mulligan's C1-C2 self-SNAG + Conventional PT

Cyriax deep friction massage+ Conventional PT

Outcomes

Primary Outcome Measures

Neck Disability Index NDI
This questionnaire gives us the information as to how the neck pain has affected one's ability to manage in everyday life. Questions are scored on a vertical scale of 0-5, Likert type scale. A score of 22% or more is considered a significant ADL disability.

Secondary Outcome Measures

Visual Analogue Scale VAS
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. It takes less than a minute to administer. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Pitsburg sleep quality index PSQI
it contains 19 self-rated questions and 5 self-rated by roommate (if available). The 19 self-rated questions are combined to 7 component scores each of which has 0-3 points. In all cases, a score of 0 indicates no difficulty while a score of 3 indicates severe difficulty. The seven score is then added to form one global score with a range of 0-21, 0 meaning no difficulty while 21 indicates severe difficulties in all areas

Full Information

First Posted
April 21, 2022
Last Updated
April 12, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05404113
Brief Title
Sustained Natural Apophyseal Glide and Deep Friction Massage in Patients With Cervicogenic Headache
Official Title
Comparison of Sustained Natural Apophyseal Glide and Deep Friction Massage in Patients With Cervicogenic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
April 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this randomized controlled trial is to compare the effects of sustained natural apophyseal glide and deep friction massage in patients with cervicogenic headache for reducing pain, enhancing cervical range of motion and improving sleep quality.
Detailed Description
Cervicogenic headache CGH is defined as the headache which arises from lesion occurring in the upper three cervical vertebrae and its associated soft tissue structures. Sleep disturbance has been continuously associated with headaches. CGH is a secondary type of headache as classified by the International Classification of Headache Disorders IHD. Physical and manual modes of therapy are important therapeutic modalities for the acute rehabilitation of cervicogenic headache. The "mobilization with movement" concept, known as the Mulligan concept, is entirely distinct from other forms of manual therapy. Mulligan described the sustained natural apophyseal glide (SNAG) on the joint with active movement done by the patient in the direction of the symptoms. This glide should be pain-free, with proper force applied by a trained person). Efficacy of SNAG C1-C2 has been proven in patients experiencing acute to subacute CGH for both short and long-term periods. Mulligan recommended that mobilization should be done towards the restricted site or in the direction of symptom reproduction, which is difficult to find in patients experiencing headache and dizziness in only one direction. There is evidence that mobilizing symptomatic and asymptomatic cervical levels result in immediate improvement of pain and segmental mobility at the same level as well as adjacent areas. James Cyriax proposed a treatment technique, Deep friction massage which has a significant effect in pain relieving. Cyriax friction massage is a widely known and used technique in the field of chronic pain management. It is a type of connective tissue massage applied to the soft tissue structures such as tendon, muscle bellies, musculotendinous junction, ligaments and joint capsules. This approach targets muscles both superficial and deep that can be contributing to headache. Muscles (such as trapezius, sternocleidomastoid, levator scapulae, and deep neck flexors) that contribute in developing CGH can be targeted using this technique. Mulligan's SNAG is a sustained glide that includes a sustained facet glide and active movement simultaneously; this technique targets the joint as well as muscle's active contraction. This reinforces the cervical lesion thus reducing CGH. Deep friction massage enables the skin, fascia; muscles to be involved in order to improve circulation thus promote healing. These techniques will help relieve cervicogenic headache and a proper comparison will be made which is novel. The effectiveness of these techniques in relieving headache, improving ROM and sleep quality will be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders
Keywords
Sustained natural apophyseal glide/SNAG, deep friction massage, Cervicogenic headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sustained natural apophyseal glide
Arm Type
Experimental
Arm Description
Mulligan's C1-C2 self-SNAG + Conventional PT
Arm Title
deep friction massage
Arm Type
Experimental
Arm Description
Cyriax deep friction massage+ Conventional PT
Intervention Type
Other
Intervention Name(s)
sustained natural apophyseal glide
Intervention Description
Mulligan's C1-C2 self-SNAG+ strengthening exercises for anterior and posterior neck muscles (extension, flexion, rotation, lateral flexion) Frequency: 2-3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 20 minutes/session Type: Mobilization with movement SNAG Conventional PT including strengthening exercises neck muscles 10 repetitions, 1 set Resisted neck flexion, extension, lateral flexion, rotation Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 minutes/session Type: Strengthening Exercise
Intervention Type
Other
Intervention Name(s)
deep friction massage
Intervention Description
Cyriax deep friction massage+ strengthening exercises for anterior and posterior neck muscles (extension, flexion, rotation, lateral flexion) Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 20 minutes/session Type: Deep soft tissue massage Conventional PT including strengthening exercises neck muscles 10 repetitions, 1 set Resisted neck flexion, extension, lateral flexion, rotation Frequency: 2-3 times/week for 3 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 minutes/session Type: Strengthening Exercise
Primary Outcome Measure Information:
Title
Neck Disability Index NDI
Description
This questionnaire gives us the information as to how the neck pain has affected one's ability to manage in everyday life. Questions are scored on a vertical scale of 0-5, Likert type scale. A score of 22% or more is considered a significant ADL disability.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale VAS
Description
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. It takes less than a minute to administer. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Time Frame
3 weeks
Title
Pitsburg sleep quality index PSQI
Description
it contains 19 self-rated questions and 5 self-rated by roommate (if available). The 19 self-rated questions are combined to 7 component scores each of which has 0-3 points. In all cases, a score of 0 indicates no difficulty while a score of 3 indicates severe difficulty. The seven score is then added to form one global score with a range of 0-21, 0 meaning no difficulty while 21 indicates severe difficulties in all areas
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria; Both males & females. Aged 18 years old and above. International Classification of Headache Disorders (ICHD-III) Diagnostic Criteria for cervicogenic headache Evidence of causation demonstrated by at least two of the following: headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion cervical range of motion is reduced and headache is made significantly worse by provocative maneuvers (Flexion Rotation Test FRT) headache is abolished following diagnostic blockade of a cervical structure or its nerve supply • A headache frequency that is more than 2 months. Exclusion Criteria: Bilateral headaches (typifying tension headache) & features suggestive of migraine. Known cases of Hydrocephalus. Known cases of neurological impairments. Known cases of malignancy. Involvement in physiotherapy or chiropractic treatment for headache in the previous 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KINZA ANWAR, MS-OMPT
Organizational Affiliation
RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwest Institute of Health Sciences and Northwest General Hospital Peshawar.
City
Peshawar
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Sustained Natural Apophyseal Glide and Deep Friction Massage in Patients With Cervicogenic Headache

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