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Comparison of Dry Needling and Thera Gun Treatment on Trapezius Muscle Active Trigger Points.

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Facial Gun
Dry Needling
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Trapezius Trigger Points, Range of motion, Pain threshold, Thera Gun, Dry Needling

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed with cervical pain due to active trigger points of trapezius muscle
  • Numeric Pain Rating Scale> 3

Exclusion Criteria:

  • Any previous history of Trauma or surgery
  • Spondylitis
  • Carcinoma
  • Tuberculosis of spine
  • Diagnosed with cervical pain & stiffness due to disc herniation, radiculopathy or any other cervical malignancy

Sites / Locations

  • Federal Government Polyclinic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Facial Gun

Dry needling

Arm Description

Vibrations through Facial gun along with conventional Therapy

Dry needling along with conventional treatment.

Outcomes

Primary Outcome Measures

Visual Analogue Scale
Visual analogue scale (VAS) very simple and often used method to measure the intensity of pain or the attitude of the individual that may not be measured directly through any test. This scale has high degree of sensitivity i.e a discriminating capacity higher than the other scales. It is the continuous scale for estimation of the extent of pain consist of the straight line shows two extreme ends one is zero pain and the other is extreme pain and in between the words on far extreme 'slight, moderate and severe' too that is experience by the individual. When the patient fills the Visual analogue scale, the patient may mark the level of pain he/she experienced by highlighting the exact level along the line between these two ends. Assessment to be done at baseline, 3rd visit and 9th visit
Goniometer for cervical range of motion
Goniometer is the instrument that measures the available range of the motion of joint. The goniometer is simple 360 degree with fulcrum and two arms. There are many types of goniometer one of them is universal standard goniometer that is consist of one moveable arm and the other is static (immobile) arm. That is either made of plastic or metal tool. It may help to measure the ranges of motions and their lengths. Inter-rater reliability (ICC2,2 = 0.79-0.92). Assessment to be done at baseline, 3rd visit and 9th visit
Algometer
The pressure algometer (PA) is a measuring instrument that may help in the calculation of pain threshold for the involved trigger point. The force recorded is the amount of the pressure that caused pain in the subject called the pressure pain threshold. The inter-examiner reliability if the PA is good or satisfactory with the interclass correlation coefficient (ICC 0.78-0.93) . Assessment will be done at baseline, 3rd and 9th visit.

Secondary Outcome Measures

Neck Disability Index
Neck disability index: it is the assessment tool used for both research and clinical purposes for the measurement of chronic neck pain. The patient is asked to fill the questionnaire by the researcher or clinician in order to know the level of pain while managing its affects in daily life. Basically, the questionnaire is designed to assess the Activities of Daily livings and Instrumental Activities of daily Livings of patient complaining about chronic neck pain. There are 10 questions includes, pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each question is marked on a 0 to 5 rating scale where 0 is considered as 'no pain' and 5 means 'maximum pain'. Assessment to be done at baseline, 3rd and 9th visit.

Full Information

First Posted
October 12, 2021
Last Updated
April 12, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05090332
Brief Title
Comparison of Dry Needling and Thera Gun Treatment on Trapezius Muscle Active Trigger Points.
Official Title
Effects of Dry Needling Versus Fascial Gun on Pain Pressure Threshold, Cervical Ranges in Patients With Active Trigger Points of Trapezius Muscle.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (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
Comparison of dry needling and Thera Gun on treatment of Active trigger points of trapezius Muscle, pain threshold and Range of motion of neck.
Detailed Description
Chronic neck pain related to the myo-facial systems from local muscle fiber contractions referred to "myo-facial trigger points" (MTrPs).MTrPs are highly sensitive spots that lie in the skeletal muscle, and are diagnosed with mechanical pressure, they can also develop as referral pain in a specific pattern. Although MTrPs are found in all muscle groups, they are more prevalent in the upper quarter postural muscles, especially the upper trapezius muscle. Data will be collected from both gender patients having active trigger points in trapezius muscles. Then patients will be divided randomly into two groups. All patient will be given conventional treatment and then group A will be given treatment with Thera Gun and group B will be given dry needling treatment and then will compare effects of both. To date, a wide range of physical therapy interventions have been suggested to address MTrPs including manual therapies (massage, stretching, myofascial release), electrotherapy modalities (surface heat, ultrasound, Transcutaneous Electrical Nerve Stimulator and laser therapy) and invasive techniques such as dry needling (DN) but none of study is done on the effectiveness of facial gun in decreasing pain intensity and increasing range of motion and none of study compare the effect of Dry needling with facial gun. So, this study will determine the effect of facial gun on pain intensity and range of motion and compare that effect with dry needling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Trapezius Trigger Points, Range of motion, Pain threshold, Thera Gun, Dry Needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facial Gun
Arm Type
Experimental
Arm Description
Vibrations through Facial gun along with conventional Therapy
Arm Title
Dry needling
Arm Type
Experimental
Arm Description
Dry needling along with conventional treatment.
Intervention Type
Other
Intervention Name(s)
Facial Gun
Intervention Description
Vibration massage applied for five Minutes directly on the trigger point
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
For dry needling the outer skin should be clean with alcohol and the taut band should be placed between thumb and index finger. Without damaging any nerve or artery the needle is passed though the muscle into the trigger point and breaking it to relief pain
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Visual analogue scale (VAS) very simple and often used method to measure the intensity of pain or the attitude of the individual that may not be measured directly through any test. This scale has high degree of sensitivity i.e a discriminating capacity higher than the other scales. It is the continuous scale for estimation of the extent of pain consist of the straight line shows two extreme ends one is zero pain and the other is extreme pain and in between the words on far extreme 'slight, moderate and severe' too that is experience by the individual. When the patient fills the Visual analogue scale, the patient may mark the level of pain he/she experienced by highlighting the exact level along the line between these two ends. Assessment to be done at baseline, 3rd visit and 9th visit
Time Frame
Three weeks
Title
Goniometer for cervical range of motion
Description
Goniometer is the instrument that measures the available range of the motion of joint. The goniometer is simple 360 degree with fulcrum and two arms. There are many types of goniometer one of them is universal standard goniometer that is consist of one moveable arm and the other is static (immobile) arm. That is either made of plastic or metal tool. It may help to measure the ranges of motions and their lengths. Inter-rater reliability (ICC2,2 = 0.79-0.92). Assessment to be done at baseline, 3rd visit and 9th visit
Time Frame
Three weeks
Title
Algometer
Description
The pressure algometer (PA) is a measuring instrument that may help in the calculation of pain threshold for the involved trigger point. The force recorded is the amount of the pressure that caused pain in the subject called the pressure pain threshold. The inter-examiner reliability if the PA is good or satisfactory with the interclass correlation coefficient (ICC 0.78-0.93) . Assessment will be done at baseline, 3rd and 9th visit.
Time Frame
Three weeks
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
Neck disability index: it is the assessment tool used for both research and clinical purposes for the measurement of chronic neck pain. The patient is asked to fill the questionnaire by the researcher or clinician in order to know the level of pain while managing its affects in daily life. Basically, the questionnaire is designed to assess the Activities of Daily livings and Instrumental Activities of daily Livings of patient complaining about chronic neck pain. There are 10 questions includes, pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each question is marked on a 0 to 5 rating scale where 0 is considered as 'no pain' and 5 means 'maximum pain'. Assessment to be done at baseline, 3rd and 9th visit.
Time Frame
Three weeks

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: Diagnosed with cervical pain due to active trigger points of trapezius muscle Numeric Pain Rating Scale> 3 Exclusion Criteria: Any previous history of Trauma or surgery Spondylitis Carcinoma Tuberculosis of spine Diagnosed with cervical pain & stiffness due to disc herniation, radiculopathy or any other cervical malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asghar Khan, DSc PT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Government Polyclinic Hospital
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Dry Needling and Thera Gun Treatment on Trapezius Muscle Active Trigger Points.

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