- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03946995
Dry Needling Versus Graston Technique in Active Myofascial Trigger Points on Upper Trapezius
Comparison of Dry Needling and Graston Technique in Active Myofascial Trigger Points on Upper Trapezius
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Islamabad, Pakistan, 44000
- Rawal General and Dental Hospital,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dry needling
Dry needling will be applied on active myofascial trigger points in upper trapezius along with conservative physical therapy management.
|
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. |
ACTIVE_COMPARATOR: Graston
Graston Technique will be applied on active myofascial trigger points in upper trapezius along with conservative physical therapy management.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Post 2nd week
|
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.
|
Baseline
|
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.
|
Post 2nd week
|
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. |
Baseline
|
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. |
Post 2nd Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index (NDI)
Time Frame: Baseline
|
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.
|
Baseline
|
Neck Disability Index (NDI)
Time Frame: Post 2nd week
|
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.
|
Post 2nd week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RiphahIU Kiran Haq
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trigger Points
-
Riphah International UniversityCompleted
-
Institute of Technology, CarlowCompleted
-
Taif UniversityNot yet recruiting
-
Cairo UniversityCompleted
-
Pamukkale UniversityCompleted
-
University of Castilla-La ManchaCompleted
-
Goethe UniversityCompletedTrigger PointsGermany
-
GF Strong Rehabilitation CentreCompletedMyofascial Trigger Points
-
University of LahoreCompletedUpper Trapezius Trigger PointsPakistan
-
Mayuben Private ClinicCompletedBilateral Latent Myofascial Trigger Points of Flexor Digitorum BrevisSpain
Clinical Trials on Dry Needling Group
-
Kutahya Health Sciences UniversityRecruitingGreater Trochanteric Pain SyndromeTurkey
-
Karabuk UniversityRecruitingCarpal Tunnel Syndrome | Dry Needling | Myofacial PainTurkey
-
University of the Basque Country (UPV/EHU)FisioAraba Centre Physiotherapy S.C.; Toshiba Medical Systems, S.A.; Metron Medical... and other collaboratorsCompletedMyofascial Pain Syndromes | Elastography | Dry Needling, Technique for the Treatment of the Myofascial Trigger PointsSpain
-
Universidad de ZaragozaUniversidad San JorgeCompleted
-
Universidad San JorgeUniversity of SevilleUnknown
-
Army-Baylor University Doctoral Program in Physical...Brooke Army Medical CenterCompletedChronic Pain | Shoulder Pain | Musculoskeletal InjuryUnited States
-
Brigham Young UniversityTerminatedMyofascial Pain Syndrome | Myofascial Trigger Point PainUnited States
-
University of CadizCompleted
-
Youngstown State UniversityRecruiting
-
Universidad de ZaragozaCompleted