Neck PainNCT05090332
Comparison of Dry Needling and Thera Gun Treatment on Trapezius Muscle Active Trigger Points.
A study testing Facial Gun and Dry Needling in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Facial Gun and Dry Needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with cervical pain due to active trigger points of trapezius muscle
- Numeric Pain Rating Scale> 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Federal Government Polyclinic Hospital
Islamabad, Federal, 44000
About this study
Official title: Effects of Dry Needling Versus Fascial Gun on Pain Pressure Threshold, Cervical Ranges in Patients With Active Trigger Points of Trapezius Muscle.
Comparison of dry needling and Thera Gun on treatment of Active trigger points of trapezius Muscle, pain threshold and Range of motion of neck.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Facial Gun, Dry Needling
- Keywords
- Trapezius Trigger Points, Range of motion, Pain threshold, Thera Gun, Dry Needling
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial GunOther
Vibration massage applied for five Minutes directly on the trigger point
Dry NeedlingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Facial Gun | Experimental | Vibrations through Facial gun along with conventional Therapy Receives: Other: Facial Gun; Other: Dry Needling |
| Dry needling | Experimental | Dry needling along with conventional treatment. Receives: Other: Facial Gun; Other: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Three weeks
Secondary outcomes (1)
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.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asghar Khan, DSc PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090332
- Sponsor's protocol ID
- REC-01062 Dr Hira Naz
- Status last verified
- Apr 2023
- First submitted
- 12 Oct 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling Versus Fascial Gun on Pain Pressure Threshold, Cervical Ranges in Patients With Active Trigger Points of Trapezius Muscle.
- ClinicalTrials.gov ID
- NCT05090332
- Acronym / sponsor ID
- REC-01062 Dr Hira Naz
- Conditions
- Neck Pain
- Keywords
- Trapezius Trigger Points, Range of motion, Pain threshold, Thera Gun, Dry Needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facial Gun | Experimental | Other: Facial Gun, Other: Dry NeedlingVibrations through Facial gun along with conventional Therapy |
| Dry needling | Experimental | Other: Facial Gun, Other: Dry NeedlingDry needling along with conventional treatment. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with cervical pain due to active trigger points of trapezius muscle
- Numeric Pain Rating Scale> 3
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial GunVibration massage applied for five Minutes directly on the trigger point | Other | Dry needling, Facial Gun |
| Dry NeedlingFor 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 | Other | Dry needling, Facial Gun |
Primary outcome
Visual Analogue Scale
Time frame: Three weeks
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
Time frame: Three weeks
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
Time frame: Three weeks
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.
1 secondary outcome
Neck Disability Index
Time frame: Three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asghar Khan, DSc PT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial Gun and Dry Needling in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Three weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.