Trigger PointsNCT03946995

Dry Needling Versus Graston Technique in Active Myofascial Trigger Points on Upper Trapezius

A study testing Dry Needling Group and Graston Technique Group in people with Trigger Points, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will compare the effects dry needling and Graston technique in active myofascial trigger points on upper trapezius. Half of the study participants will receive dry needling whereas other half will receive Graston technique. Read more about this study

Who is it for?: Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Trigger Points
What is being tested?: Dry Needling Group and Graston Technique Group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 sitePakistan
Study dates: 19 Mar 2019to 30 Jun 2019
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Patient with non-specific pain in neck (acute and sub-acute)
Age: 20-40 years
Patient agrees to use the dry needling or Graston exclusively

Who cannot join

Patients that were using any medication to reduce the pain and/or have any effect in the skeleton muscle.
Patient taking other treatment in the same period of research.
Patients having malignancy, tuberculosis, spinal cord injury, neurodegenerative diseases radiculopathies and hematoma.
Patients on anticoagulants.
Patient with chronic neck pain.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Rawal General and Dental Hospital,
Islamabad, 44000

Other trials in Pakistan

About this study

Official title: Comparison of Dry Needling and Graston Technique in Active Myofascial Trigger Points on Upper Trapezius

Read the detailed description

This is a single blinded randomized controlled trial, will be conducted at Rawal General \& Dental Hospital, Islamabad. Both dry needling and Graston Techniques are used to release active Myofascial Trigger points with different mechanism.

Dry needling is technique in which without any medication or injection, dry needles are inserted into hyper irritable points in muscle. Graston technique is done with specially designed tools to locate knots within muscle by running the tools over the skin.

This study is planned with objectives to compare both treatment techniques on active myofascial trigger points in patients with neck pain. Effects of these will be measured on Neck Pain, Range of Motion, functional status and trigger points.

Conditions: Trigger Points
Being tested: Dry Needling Group, Graston Technique Group
Keywords: Trigger Area, Myofascial Pain Syndromes, Instrument assisted soft tissue tecnique
Medical subject headings: Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dry Needling GroupOther
Hot Pack will be applied on upper trapezius muscles before session for general relaxation for 7-10 minutes. Generalized Stretching and strengthening neck exercises will be performed. Then after wearing gloves and appropriate personal protective measures, a thin filiform needle will be inserted which will penetrate into the skin and stimulate underlying myofascial trigger points.
The treatment will be continued for 2 weeks with 2 sessions per week.
Graston Technique GroupOther
Hot Pack will be applied on upper trapezius muscles before session for general relaxation for 7-10 minutes. Generalized Stretching and strengthening neck exercises will be performed.
Later, lubricant will be applied to the skin, and Graston technique will be applied using instrument over the active myofascial trigger points in upper trapezius.
The treatment will be continued for 2 weeks with 2 sessions per week.

Study groups in NCT03946995
Study group	Role	What they receive
Dry needling	Experimental	Dry needling will be applied on active myofascial trigger points in upper trapezius along with conservative physical therapy management. Receives: Other: Dry Needling Group
Graston	Active comparator	Graston Technique will be applied on active myofascial trigger points in upper trapezius along with conservative physical therapy management. Receives: Other: Graston Technique Group

What is being measured

The primary outcome is the main question the study is designed to answer.

Numeric Pain Rating Scale (NPRS)
Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Measured: Baseline
Numeric Pain Rating Scale (NPRS)
Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Measured: Post 2nd week
cervical range of motion (CROM)
A cervical range of motion (CROM) inclinometer will be use to assess cervical range of motion in flexion, extension, left right lateral flexion and left-right rotation. Participants will be seated upright and asked to actively move their neck in each direction.
Measured: Baseline
cervical range of motion (CROM)
A cervical range of motion (CROM) inclinometer will be use to assess cervical range of motion in flexion, extension, left right lateral flexion and left-right rotation. Participants will be seated upright and asked to actively move their neck in each direction.
Measured: Post 2nd week
Myofascial Diagnostic Scale (MDS)
It is a scale using the signs of a Myofascial trigger point as indicators to assess the extent to which the patient suffers from Myofascial Pain Syndrome.
The signs include: referred pain in the zone of reference, local twitch response, palpable taut band, and focal or spot tenderness.
Spot tenderness or soft tissue tenderness consisted of five grades or indicators: grade 0 - no tenderness = 0, grade 1 - tenderness to palpation without grimace or flinch = 1, grade 2 - tenderness with grimace and/or flinch to palpation = 2, grade 3 - tenderness with withdrawal = 3, grade 4 - withdrawal to non-noxious stimuli = 4.
The presence of a local twitch response and the presence of a palpable taut band were indicated by a score of 4 on the scale.
The presence of referred pain was indicated by a score of 5. A total score of 9 or more was indicative of active trigger points.
Measured: Baseline
Myofascial Diagnostic Scale (MDS)
It is a scale using the signs of a Myofascial trigger point as indicators to assess the extent to which the patient suffers from Myofascial Pain Syndrome.
The signs include: referred pain in the zone of reference, local twitch response, palpable taut band, and focal or spot tenderness.
Spot tenderness or soft tissue tenderness consisted of five grades or indicators: grade 0 - no tenderness = 0, grade 1 - tenderness to palpation without grimace or flinch = 1, grade 2 - tenderness with grimace and/or flinch to palpation = 2, grade 3 - tenderness with withdrawal = 3, grade 4 - withdrawal to non-noxious stimuli = 4.
The presence of a local twitch response and the presence of a palpable taut band were indicated by a score of 4 on the scale.
The presence of referred pain was indicated by a score of 5. A total score of 9 or more was indicative of active trigger points.
Measured: Post 2nd Week

Secondary outcomes (2)

Neck Disability Index (NDI)
Neck Disability Index (NDI) is a questionnaire designed to assess how neck pain has affected patient's ability to manage in everyday life. It has total 10 sections, For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated and converted into percentages. The maximum Score of Neck Disability Index (NDI) is 50.
Measured: Baseline
Neck Disability Index (NDI)
Neck Disability Index (NDI) is a questionnaire designed to assess how neck pain has affected patient's ability to manage in everyday life. It has total 10 sections, For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated and converted into percentages. The maximum Score of Neck Disability Index (NDI) is 50.
Measured: Post 2nd week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 201930 Jun 2019

First posted13 May 2019
Study start19 Mar 2019
Primary completion30 Jun 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Trigger PointsStudies of the same condition, open and under way.
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
Model description: There will be two treatment groups of participants, One group will receive Dry Needling whereas other will receive Graston technique for treatment of Myofascial Trigger points.
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03946995
Sponsor's protocol ID: RiphahIU Kiran Haq
Status last verified: Aug 2019
First submitted: 9 May 2019
Last updated: 9 Aug 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gerber LH, Shah J, Rosenberger W, Armstrong K, Turo D, Otto P, Heimur J, Thaker N, Sikdar S. Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects With Chronic Myofascial Pain. PM R. 2015 Jul;7(7):711-718. doi: 10.1016/j.pmrj.2015.01.020. Epub 2015 Feb 4.
PubMed 25661462
Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.
PubMed 25143704
Wang G, Gao Q, Hou J, Li J. Effects of Temperature on Chronic Trapezius Myofascial Pain Syndrome during Dry Needling Therapy. Evid Based Complement Alternat Med. 2014;2014:638268. doi: 10.1155/2014/638268. Epub 2014 Oct 14.
PubMed 25383083
Gattie ER, Cleland JA, Snodgrass SJ. Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial. JMIR Res Protoc. 2017 Nov 22;6(11):e227. doi: 10.2196/resprot.7980.
PubMed 29167092

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Trigger Points trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Dry Needling and Graston Technique in Active Myofascial Trigger Points on Upper Trapezius
ClinicalTrials.gov ID: NCT03946995
Acronym / sponsor ID: RiphahIU Kiran Haq
Conditions: Trigger Points
Keywords: Trigger Area, Myofascial Pain Syndromes, Instrument assisted soft tissue tecnique
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Riphah International UniversityUniversity, hospital or other
Study start: 19 Mar 2019 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 13 May 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: There will be two treatment groups of participants, One group will receive Dry Needling whereas other will receive Graston technique for treatment of Myofascial Trigger points.

Arm	Type	Receives
Dry needling	Experimental	Other: Dry Needling GroupDry needling will be applied on active myofascial trigger points in upper trapezius along with conservative physical therapy management.
Graston	Active comparator	Other: Graston Technique GroupGraston Technique will be applied on active myofascial trigger points in upper trapezius along with conservative physical therapy management.

Who may qualify

Ages: 20 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Patient with non-specific pain in neck (acute and sub-acute)
Age: 20-40 years
Patient agrees to use the dry needling or Graston exclusively

Key exclusion criteria (5 listed)

Patients that were using any medication to reduce the pain and/or have any effect in the skeleton muscle.
Patient taking other treatment in the same period of research.
Patients having malignancy, tuberculosis, spinal cord injury, neurodegenerative diseases radiculopathies and hematoma.
Patients on anticoagulants.
Patient with chronic neck pain.

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
Dry Needling GroupHot Pack will be applied on upper trapezius muscles before session for general relaxation for 7-10 minutes. Generalized Stretching and strengthening neck exercises will be performed. Then after wearing gloves and appropriate personal protective measures, a thin filiform needle will be inserted which will penetrate into the skin and stimulate underlying myofascial trigger points. The treatment will be continued for 2 weeks with 2 sessions per week.	Other	Dry needling
Graston Technique GroupHot Pack will be applied on upper trapezius muscles before session for general relaxation for 7-10 minutes. Generalized Stretching and strengthening neck exercises will be performed. Later, lubricant will be applied to the skin, and Graston technique will be applied using instrument over the active myofascial trigger points in upper trapezius. The treatment will be continued for 2 weeks with 2 sessions per week.	Other	Graston

Primary outcome

Numeric Pain Rating Scale (NPRS)
Time frame: Baseline
Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Numeric Pain Rating Scale (NPRS)
Time frame: Post 2nd week
Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
cervical range of motion (CROM)
Time frame: Baseline
A cervical range of motion (CROM) inclinometer will be use to assess cervical range of motion in flexion, extension, left right lateral flexion and left-right rotation. Participants will be seated upright and asked to actively move their neck in each direction.
cervical range of motion (CROM)
Time frame: Post 2nd week
A cervical range of motion (CROM) inclinometer will be use to assess cervical range of motion in flexion, extension, left right lateral flexion and left-right rotation. Participants will be seated upright and asked to actively move their neck in each direction.
Myofascial Diagnostic Scale (MDS)
Time frame: Baseline
It is a scale using the signs of a Myofascial trigger point as indicators to assess the extent to which the patient suffers from Myofascial Pain Syndrome. The signs include: referred pain in the zone of reference, local twitch response, palpable taut band, and focal or spot tenderness. Spot tenderness or soft tissue tenderness consisted of five grades or indicators: grade 0 - no tenderness = 0, grade 1 - tenderness to palpation without grimace or flinch = 1, grade 2 - tenderness with grimace and/or flinch to palpation = 2, grade 3 - tenderness with withdrawal = 3, grade 4 - withdrawal to non-noxious stimuli = 4. The presence of a local twitch response and the presence of a palpable taut band were indicated by a score of 4 on the scale. The presence of referred pain was indicated by a score of 5. A total score of 9 or more was indicative of active trigger points.
Myofascial Diagnostic Scale (MDS)
Time frame: Post 2nd Week
It is a scale using the signs of a Myofascial trigger point as indicators to assess the extent to which the patient suffers from Myofascial Pain Syndrome. The signs include: referred pain in the zone of reference, local twitch response, palpable taut band, and focal or spot tenderness. Spot tenderness or soft tissue tenderness consisted of five grades or indicators: grade 0 - no tenderness = 0, grade 1 - tenderness to palpation without grimace or flinch = 1, grade 2 - tenderness with grimace and/or flinch to palpation = 2, grade 3 - tenderness with withdrawal = 3, grade 4 - withdrawal to non-noxious stimuli = 4. The presence of a local twitch response and the presence of a palpable taut band were indicated by a score of 4 on the scale. The presence of referred pain was indicated by a score of 5. A total score of 9 or more was indicative of active trigger points.

2 secondary outcomes

Neck Disability Index (NDI)
Time frame: Baseline
Neck Disability Index (NDI)
Time frame: Post 2nd week

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 9 Aug 2019.
Background: PubMed 25661462Gerber LH, Shah J, Rosenberger W, Armstrong K, Turo D, Otto P, Heimur J, Thaker N, Sikdar S. Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects With Chronic Myofascial Pain. PM R. 2015 Jul;7(7):711-718. doi: 10.1016/j.pmrj.2015.01.020. Epub 2015 Feb 4.
Background: PubMed 25143704Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.
Background: PubMed 25383083Wang G, Gao Q, Hou J, Li J. Effects of Temperature on Chronic Trapezius Myofascial Pain Syndrome during Dry Needling Therapy. Evid Based Complement Alternat Med. 2014;2014:638268. doi: 10.1155/2014/638268. Epub 2014 Oct 14.
Background: PubMed 29167092Gattie ER, Cleland JA, Snodgrass SJ. Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial. JMIR Res Protoc. 2017 Nov 22;6(11):e227. doi: 10.2196/resprot.7980.
Individual participant dataSharing planned: No

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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.

Huma Riaz 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 Dry Needling Group and Graston Technique Group in people with Trigger Points, 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 3 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 9 Aug 2019. 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?

Numeric Pain Rating Scale (NPRS) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03946995, which also lists 4 linked publications.

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 9 Aug 2019.