NCT05090332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

October 12, 2021

Last Update Submit

April 12, 2023

Conditions

Keywords

Trapezius Trigger PointsRange of motionPain thresholdThera GunDry Needling

Outcome Measures

Primary Outcomes (3)

  • 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

    Three weeks

  • 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

    Three weeks

  • 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.

    Three weeks

Secondary Outcomes (1)

  • Neck Disability Index

    Three weeks

Study Arms (2)

Facial Gun

EXPERIMENTAL

Vibrations through Facial gun along with conventional Therapy

Other: Facial GunOther: Dry Needling

Dry needling

EXPERIMENTAL

Dry needling along with conventional treatment.

Other: Facial GunOther: Dry Needling

Interventions

Vibration massage applied for five Minutes directly on the trigger point

Dry needlingFacial Gun

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

Dry needlingFacial Gun

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal Government Polyclinic Hospital

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Asghar Khan, DSc PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2021

First Posted

October 22, 2021

Study Start

November 1, 2021

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations