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Comparing the Effectiveness of Dry Needling and Ischemic Compression on Tension Type Headache

Primary Purpose

Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dry Needling and Ischemic Compression Technique
Sponsored by
Ziauddin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tension-Type Headache

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 20-50 aged individuals years
  • Trigger point related Tension Type Headache diagnosed by Neurologist.
  • Patients having trigger points in the muscles taken in the study.

Exclusion Criteria:

  • Medical Red flags
  • Major Depression
  • Neurological or Cardiovascular Disease.

Sites / Locations

  • Ziauddin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling

Ischemic Compression Technique

Arm Description

Dry needling will be performed on the patients of group A after the diagnosis of trigger points in particular muscles.The complete treatment session will be comprised of 3 sessions per week for two weeks followed by follow up after 1 month until the symptoms have been improved.

Ischemic Compression technique will be performed on the patients of group B after the diagnosis of trigger points in particular muscles by diagnostic ultrasound. The complete treatment session will be comprised of 3 sessions per week for two weeks followed by follow up after 1 month until the symptoms have been improved.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale to assess headache intensity
Pain will be assessed through Numeric Pain Rating Scale NPRS among trigger point tension type headache individuals, where high values indicate greater pain intensity.
Numeric Pain Rating Scale to assess headache intensity
Pain will be assessed through Numeric Pain Rating Scale NPRS among trigger point tension type headache individuals where high values indicate greater pain intensity.
Short Form-36 Questionnaire to measure Health related quality of life.
All the domains of Health related quality of life assessment will be carried out through the individual's scoring.
Short Form-36 Questionnaire to measure Health related quality of life
All the domains of Health related quality of life assessment will be carried out through the individual's scoring.
Diagnostic Ultrasound to measure muscle thickness
An ultrasound examination will be performed to find out the muscle thickness of cervical muscles in which trigger points are present.
Diagnostic Ultrasound to measure muscle thickness
An ultrasound examination will be performed to find out the muscle thickness of cervical muscles in which trigger points are present.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2022
Last Updated
January 24, 2023
Sponsor
Ziauddin University
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1. Study Identification

Unique Protocol Identification Number
NCT05496010
Brief Title
Comparing the Effectiveness of Dry Needling and Ischemic Compression on Tension Type Headache
Official Title
Comparing the Effectiveness of Dry Needling and Ischemic Compression Technique on Muscle Thickness and Health Related Quality of Life in Trigger Point Tension Type Headache
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
August 3, 2022 (Actual)
Study Completion Date
August 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin 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
Headaches are the main health problem as one of the prevalent type of all symptoms in the world population. Among different types of headaches, the most prevailing primary headache in general population is Tension-type headache (TTH). According to Global Burden Disease study conducted in 2016 tension-type headache ranks the third highest primary headache syndromes among 32 diseases and injuries in 195 countries from the Period of 1990 to 2016.These types of headaches are associated with significant reductions in productivity of an individual with prominent increase in socioeconomic costs. There are various treatments suggested for improving the symptoms in trigger point related tension type headaches such as usage of hot packs, cryotherapy, ultrasound therapy, mobilization and manipulation techniques, Dry needling, MET and ICT. None of the study has been conducted in Pakistan which has compared two specific techniques to resolve trigger points with the accuracy of diagnosis by diagnostic ultrasound in limited time period, which is cost friendly, and provides quick relief to patients without causing a lot of pain. Therefore, more studies are needed to overcome the gap area in the use of specific techniques in clinics with accurate diagnosis by the clinicians of Pakistan.
Detailed Description
The research aims to compare the effectiveness of Dry Needling and Ischemic Compression Technique on muscle thickness & health related quality of life in trigger point related tension type headache. Headaches are the major health concern as one of the prevalent type of all symptoms in the worldwide population and are the cause of disabilities and hindrance in productivity of an individual. The treatment approaches performed for trigger point related tension type headache are non-specific, vigorous, time consuming and costly. It is due to the inaccurate location of the trigger points present in cervical musculature. The studies related to comparison of specific treatment procedures to treat trigger point related tension type headaches such as dry needling and Ischemic Compression technique with the knowledge of accurate location of trigger points present in cervical musculature are lacking in Pakistani population. Hence the current study is aimed to determine the effect of dry needling and Ischemic Compression technique with the use of diagnostic ultrasound on muscle thickness, pain and health related quality of life in Trigger point related tension type headache. The study will be conducted on the tension type headache diagnosed individuals aged 20 to 50 years of age, at Physical Therapy OPD of Saifee and Ziauddin Hospital with the help of envelope method as a randomization technique. Dry needling will be performed on Group A whereas Group B will be given Ischemic Compression technique on trigger points diagnosed by Musculoskeletal Ultrasound. Patient's headache, muscle thickness and health related quality of life will be assessed by Numeric Pain rating scale, Musculoskeletal Ultrasound and Short Form-36 Questionnaire respectively. If the data will be found to be normally distributed, Pair T-test will be run for with the group analysis. Between the groups an alysis will be perform by Independent t test. In case data found to be deviated from the assumption of normal distribution, Paired T-test will be replaced by Wilcoxon test and Independent T test will be replaced by Mann Whitney U Test. The level of significance will be kept at 95% alpha-0.05.

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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A: Dry Needling treatment given for 6 sessions, 3 days/week for 2 weeks on the trigger points located in Upper Trapezius, Sternocleidomastoid, Sub occipitalis and Temporalis muscles. Group B: Ischemic Compression technique given for 6 sessions, 3 days/week for 2 weeks on the trigger points located in Upper Trapezius, Sternocleidomastoid, Sub occipitalis and Temporalis muscles.
Masking
Participant
Masking Description
All participants will be blinded regarding treatment. A total of 30 patients will be recruited and assigned into two groups. Group A will receive Dry needling sessions and group B will receive Ischemic compression technique.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling
Arm Type
Experimental
Arm Description
Dry needling will be performed on the patients of group A after the diagnosis of trigger points in particular muscles.The complete treatment session will be comprised of 3 sessions per week for two weeks followed by follow up after 1 month until the symptoms have been improved.
Arm Title
Ischemic Compression Technique
Arm Type
Active Comparator
Arm Description
Ischemic Compression technique will be performed on the patients of group B after the diagnosis of trigger points in particular muscles by diagnostic ultrasound. The complete treatment session will be comprised of 3 sessions per week for two weeks followed by follow up after 1 month until the symptoms have been improved.
Intervention Type
Other
Intervention Name(s)
Dry Needling and Ischemic Compression Technique
Intervention Description
For Group A, Dry needling will be applied into trigger points which are active and present in the muscles, efficiently and within the safe limits taking all the safety precautions. For group B, Ischemic Compression Technique will be applied on trigger points. The complete treatment session will be comprised of 3 sessions per week for two weeks followed by follow up after 1 month until the symptoms have been improved for both the groups.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale to assess headache intensity
Description
Pain will be assessed through Numeric Pain Rating Scale NPRS among trigger point tension type headache individuals, where high values indicate greater pain intensity.
Time Frame
Baseline
Title
Numeric Pain Rating Scale to assess headache intensity
Description
Pain will be assessed through Numeric Pain Rating Scale NPRS among trigger point tension type headache individuals where high values indicate greater pain intensity.
Time Frame
After 2 weeks
Title
Short Form-36 Questionnaire to measure Health related quality of life.
Description
All the domains of Health related quality of life assessment will be carried out through the individual's scoring.
Time Frame
Pre-Treatment
Title
Short Form-36 Questionnaire to measure Health related quality of life
Description
All the domains of Health related quality of life assessment will be carried out through the individual's scoring.
Time Frame
After 2 weeks. (Follow up)
Title
Diagnostic Ultrasound to measure muscle thickness
Description
An ultrasound examination will be performed to find out the muscle thickness of cervical muscles in which trigger points are present.
Time Frame
Pre-Treatment
Title
Diagnostic Ultrasound to measure muscle thickness
Description
An ultrasound examination will be performed to find out the muscle thickness of cervical muscles in which trigger points are present.
Time Frame
After 2 weeks. (Follow up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20-50 aged individuals years Trigger point related Tension Type Headache diagnosed by Neurologist. Patients having trigger points in the muscles taken in the study. Exclusion Criteria: Medical Red flags Major Depression Neurological or Cardiovascular Disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziauddin University
Organizational Affiliation
Ziauddin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziauddin University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30496104
Citation
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Results Reference
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Citation
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PubMed Identifier
22364330
Citation
Alonso-Blanco C, de-la-Llave-Rincon AI, Fernandez-de-las-Penas C. Muscle trigger point therapy in tension-type headache. Expert Rev Neurother. 2012 Mar;12(3):315-22. doi: 10.1586/ern.11.138.
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Citation
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Comparing the Effectiveness of Dry Needling and Ischemic Compression on Tension Type Headache

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