NCT03946995

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

May 9, 2019

Last Update Submit

August 8, 2019

Conditions

Keywords

Trigger AreaMyofascial Pain SyndromesInstrument assisted soft tissue tecnique

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Post 2nd Week

Secondary Outcomes (2)

  • Neck Disability Index (NDI)

    Baseline

  • Neck Disability Index (NDI)

    Post 2nd week

Study Arms (2)

Dry needling

EXPERIMENTAL

Dry needling will be applied on active myofascial trigger points in upper trapezius along with conservative physical therapy management.

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.

Other: Graston Technique Group

Interventions

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.

Dry needling

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.

Graston

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawal General and Dental Hospital,

Islamabad, 44000, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 25661462BACKGROUND
  • 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.

    PMID: 25143704BACKGROUND
  • 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.

    PMID: 25383083BACKGROUND
  • 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.

    PMID: 29167092BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Huma Riaz

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This is a single blinded randomized controlled trial in which patients will be randomized into groups by sealed envelope method.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 13, 2019

Study Start

March 19, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations