search
Back to results

Immediate Effects of Suboccipital Muscle Release Combined With Sustained Natural Apophyseal Glides in Patients With Chronic Tension Type Headache

Primary Purpose

Tension-Type Headache

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
sustained natural apophyseal glides (SNAGS)
suboccipital muscle release
Supplemental therapy
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-64 years old Male and Female International classification of headache disorders-3 diagnosis: Headache occurring on 15 days/month on average for >3 months (180 days/year), Lasting hours to days, or unremitting -At least two of the following four characteristics:- Bilateral location Pressing or tightening (non-pulsating) quality Mild or moderate intensity Not aggravated by routine physical activity such as walking or climbing stairs Both of the following: No more than one of photophobia, phonophobia or mild nausea Neither moderate or severe nausea nor vomiting Not better accounted for by another ICHD-3 diagnosis. Exclusion Criteria: Patients with other types of primary or secondary headache e.g cervicogenic headache History of trauma to the cervical spine Vertigo, dizziness, uncompensated neck tension Spurling test positive Flexion compression test positive Extension compression test positive Cervical flexion rotation test positive Pregnancy

Sites / Locations

  • Fauji Foundation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

suboccipital muscle release for 10 mins + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 3 sec hold and 5 reps

suboccipital muscle release for 10 mins + SNAGS: 3 glides with 10 sec hold of each glide + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 10 sec hold and 5 reps

Outcomes

Primary Outcome Measures

cervical range of motion
The cervical range of motion will be measured by using goniometer. The patient will be in sitting position. For flexion and extension, the fulcrum will be placed on external auditory meatus, the stationary arm will be vertical to the ground with moving arm aligned parallel with the base of the ear. For side bending, the fulcrum will be placed on C7 vertebrae, the stationary arm perpendicular to the ground and moving arm parallel to the external occipital protuberence. For rotation, the fulcrum will be placed on the central cranial aspect of head, stationary arm parallel to the acromion process and moving arm align with tip of the nose. The angle between the stationary and moving arm will be measured.

Secondary Outcome Measures

Pain intensity
Will be measured with NPRS
Blood pressure
Will be measured with sphygmomanometer

Full Information

First Posted
May 22, 2023
Last Updated
May 22, 2023
Sponsor
Foundation University Islamabad
search

1. Study Identification

Unique Protocol Identification Number
NCT05883813
Brief Title
Immediate Effects of Suboccipital Muscle Release Combined With Sustained Natural Apophyseal Glides in Patients With Chronic Tension Type Headache
Official Title
Immediate Effects of Suboccipital Muscle Release Combined With Sustained Natural Apophyseal Glides in Patients With Chronic Tension Type Headache
Study Type
Interventional

2. Study Status

Record Verification Date
May 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
Headache disorder characterized by recurrent headache are among the most common disoredrs of the nervous system. Tension type headache is widely recognized kind of headache that affects 80% of the individuals. Its underlying cause has not been clearly distinguished. It is managed both pharmacology and non-pharmacology which includes dry needling, acupuncture, manual techniques and massage. Several studies conducted which showed that both the soft tissue muscle inhibition and joint mobilization techniques are effective in decreasing pain. But there is lack of evidence which shows combined effects of soft tissue muscle inhibition and sustained natural apophyseal glides(SNAGS) in chronic tension type headache. so this study will compare the effects of soft tissue muscle release and SNAGS on pain intensity and cervical range of motion.
Detailed Description
Headache disorder characterized by recurrent headache are among the most common disoredrs of the nervous system. Tension type headache is one of the widely recognized kind of headache that affects 80% of the individuals. Its underlying cause has not been clearly distinguished.Chronic tension type headache causes tightness in the suboccipital muscle which may result in decrese in range of motion in cervical region. It is managed both pharmacology and non-pharmacology which includes dry needling, acupuncture, manual techniques and massage. Several studies conducted which showed that both the soft tissue muscle inhibition and joint mobilization techniques are effective in decreasing pain. But there is lack of evidence which shows combined effects of soft tissue muscle inhibition and sustained natural apophyseal glides(SNAGS) in chronic tension type headache. so this study will compare the effects of soft tissue muscle release and SNAGS on pain intensity and cervical range of motion. This study will be conducted in fauji foundation hospital using non-probability purposive sampling technique. Sample size calaculated from open epi tool is 48, with 24 patients in each group. Patients are selected on the basis of inclusion criteria. Patients will be guided about the benefits and risks of the study, right to withdraw from the study at any point and confidentiality of the data. After diagnosis by the physician according to the ICHD-3 criteria, written consent will be taken from each participant. Then they randomly assigned into 2 groups via lottery method. Cervical range of motion, blood pressure and pain intensity will be measured before and after the treatment. Suboccipital muscle release and SNAGS will be given to experimental group and suboccipital muscle release only to the control group. Group 1(Control group): suboccipital muscle release for 10 mins + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 3 sec hold and 5 reps. Group 2(Experimental group): suboccipital muscle release for 10 mins + SNAGS: 3 glides with 10 sec hold of each glide + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 10 sec hold and 5 reps. Sub-occipital muscle release: This technique will be performed in the supine position with the patient's eyes closed and the physiotherapist's hands placed under the patient's head, in contact with the sub-occipital muscles. The physiotherapist progressively increased the pressure exerted during the 10 minutes of treatment. SNAGS: This technique will be performed with patient in sitting position and the therapist may be standing behind the patient. The therapist would place the thumb on the spinous process of the vertebra. Move spinous process upward towards the eyeball direction & maintain the glide and ask the patient to turn (rotation) his head slowly in painful direction, sustain the mobilization until head turn to the midline. Three repetitions of each glide were given and maintain for 10 seconds at end range. Pain intensity, cervical range of motion and blood pressure will be measured immediately after the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is randomized controlled trial which consist of 2 groups. One group will be given suboccipital muscle release. Second group will be given SNAGS along with sub-occipital muscle release. All the groups were recruited concurrently.
Masking
Participant
Masking Description
The participant does not know about the group in which he is included.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
suboccipital muscle release for 10 mins + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 3 sec hold and 5 reps
Arm Title
Group 2
Arm Type
Experimental
Arm Description
suboccipital muscle release for 10 mins + SNAGS: 3 glides with 10 sec hold of each glide + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 10 sec hold and 5 reps
Intervention Type
Procedure
Intervention Name(s)
sustained natural apophyseal glides (SNAGS)
Intervention Description
SNAGS will be given with patient in sitting position and the therapist will be standing behind the patient. The therapist will place the thumb on the spinous process of the vertebra. Move spinous process upward towards the eyeball direction & maintain the glide and ask the patient to turn (rotation) his head slowly in painful direction, sustain the mobilization until head turn to the midline. Three repetitions of each glide will be given and each glide will be maintained for 10 seconds at end range.
Intervention Type
Procedure
Intervention Name(s)
suboccipital muscle release
Intervention Description
Sub-occipital muscle release will be applied with the patient in the supine position with the eyes closed and the physiotherapist's hands placed under the patient's head, in contact with the sub-occipital muscles. The physiotherapist progressively increased the pressure exerted during the 10 minutes of treatment.
Intervention Type
Procedure
Intervention Name(s)
Supplemental therapy
Intervention Description
General warm-up exercises, TENS, hot pack, trapezius stretching
Primary Outcome Measure Information:
Title
cervical range of motion
Description
The cervical range of motion will be measured by using goniometer. The patient will be in sitting position. For flexion and extension, the fulcrum will be placed on external auditory meatus, the stationary arm will be vertical to the ground with moving arm aligned parallel with the base of the ear. For side bending, the fulcrum will be placed on C7 vertebrae, the stationary arm perpendicular to the ground and moving arm parallel to the external occipital protuberence. For rotation, the fulcrum will be placed on the central cranial aspect of head, stationary arm parallel to the acromion process and moving arm align with tip of the nose. The angle between the stationary and moving arm will be measured.
Time Frame
Immediate after treatment
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Will be measured with NPRS
Time Frame
Immediate after treatment
Title
Blood pressure
Description
Will be measured with sphygmomanometer
Time Frame
Immediate after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-64 years old Male and Female International classification of headache disorders-3 diagnosis: Headache occurring on 15 days/month on average for >3 months (180 days/year), Lasting hours to days, or unremitting -At least two of the following four characteristics:- Bilateral location Pressing or tightening (non-pulsating) quality Mild or moderate intensity Not aggravated by routine physical activity such as walking or climbing stairs Both of the following: No more than one of photophobia, phonophobia or mild nausea Neither moderate or severe nausea nor vomiting Not better accounted for by another ICHD-3 diagnosis. Exclusion Criteria: Patients with other types of primary or secondary headache e.g cervicogenic headache History of trauma to the cervical spine Vertigo, dizziness, uncompensated neck tension Spurling test positive Flexion compression test positive Extension compression test positive Cervical flexion rotation test positive Pregnancy
Facility Information:
Facility Name
Fauji Foundation Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Immediate Effects of Suboccipital Muscle Release Combined With Sustained Natural Apophyseal Glides in Patients With Chronic Tension Type Headache

We'll reach out to this number within 24 hrs