NCT04348097

Brief Summary

The aim of this study was to compare the effects of Dry needling and Activator trigger point therapy on upper trapezius trigger points.Randomized controlled trial was conducted on Sixty-eight patients with active upper trapezius trigger points meeting the inclusion criteria i.e Age limit 20-45 both genders, presence of unilateral or bilateral upper trapezius Trigger Points. For bilateral presence of trigger points, the more painful side was selected. If more than one trigger points were present on the side to be treated, most painful trigger point was treated. Patients fulfilling essential criteria to identify the trigger points. According to Simon's criteria, which included a palpable taut band that was detected with palpation, the presence of a sensitive nodule in the taut band which was determined with algometry and referral pain. Exclusion criteria was specific neck pain, e.g. radiculopathy, systemic or inflammatory pain., evidence of spinal cord compression, recent neck surgery or trauma, long-term use of corticosteroids, anticoagulant use, e.g. Warfarin, presence of a blood coagulation disorder, contraindication for needling such as local infection, pregnancy with threatened abortion. Participants were selected by purposive sampling, group randomization using lottery method technique. All the participants were assessed using Numeric pain rating scale to measure pain, algometer to measure pain pressure threshold and inclinometer to measure cervical lateral flexion range of motion. A demographic form was used to collect data from patients. Patients were randomly assigned in dry needling and activator therapy group. Treatment was given at a frequency of 2 sessions per week and total 6 sessions were given to both group during a course of 3 weeks. The data was analyzed using SPSS 21.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 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

July 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

March 6, 2020

Last Update Submit

April 14, 2020

Conditions

Keywords

Activator therapyDry needling,Myofascial painUpper trapezius.

Outcome Measures

Primary Outcomes (3)

  • Numeric pain rating scale (NPRS)

    The NPRS was used to measure the pain intensity of myofasial trigger points of the upper trapezius muscle . NPRS is a valid and reliable tool to assess pain. It consists of 10cm long line scale on which patient reports his/her pain from 0 (no pain) to (10 (worst possible pain)

    for three weeks

  • Inclinometer

    PAOMPT Bubble inclinometer was used in our study. Patient was educated abot the procedure. Inclinometer was placed on patients head. Cervical lateral flexion was recorded by stabilizing the shoulder of the patient and asking him/her to bring his/her ear towards the shoulder. Reading was recorded by the tilt of fluid inside the inclinometer.

    for three weeks

  • Algometer

    The pain pressre threshold was taken by applying vertical pressure over selected trigger point by a sixty pound baseline algometer. Pressure was increased at the rate of 1kg/cm until the patient reported the pain by saying 'yes'. 3 readings were taken at the interval of ten seconds and mean was considered as the selected measurement

    for three weeks

Study Arms (2)

activator trigger point therapy

EXPERIMENTAL

The Activator adjusting instrument used had force settings ranging from 1 to 6 . For this study a force setting of 3 was used.

Device: Activator instrumentDevice: dry needle

Trigger point dry needling

ACTIVE COMPARATOR

First, a tight band was held between the index finger and the thumb of the non-dominant hand and the needle (0.25-40 mm - Shen Long) was perpendicularly inserted into the muscle with the dominant hand.

Device: Activator instrumentDevice: dry needle

Interventions

activator instrument was placed perpendicular over the identified trigger point and 10 thrusts were delivered, with a rate of one thrust per second

Trigger point dry needlingactivator trigger point therapy

By wrist flexion and extension movements, the trigger point was needled in different directions and tried to elicit at least one local twitch response during the procedure and patient's familiar referral pain was tried to obtain . Each dry needling procedure lasted 1-2 minutes

Trigger point dry needlingactivator trigger point therapy

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age limit 20-45
  • male and female .
  • Presence of unilateral or bilateral upper trapezius Trigger Points.
  • Patients identified with presence of trigger points.

You may not qualify if:

  • Specific neck pain,
  • Evidence of spinal cord compression
  • Recent neck surgery or trauma.
  • Long-term use of corticosteroids. Anticoagulant use, e.g. Warfarin. Presence of a blood coagulation disorder. Contraindication for needling such as local infection, pregnancy with threatened abortion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Medical Rehabilitation

Islamabad, Punjab Province, 46000, Pakistan

Location

Related Publications (8)

  • Ziaeifar M, Arab AM, Karimi N, Nourbakhsh MR. The effect of dry needling on pain, pressure pain threshold and disability in patients with a myofascial trigger point in the upper trapezius muscle. J Bodyw Mov Ther. 2014 Apr;18(2):298-305. doi: 10.1016/j.jbmt.2013.11.004. Epub 2013 Nov 9.

    PMID: 24725800BACKGROUND
  • Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.

    PMID: 25768071BACKGROUND
  • Ramsey FE, Tomlanovich MC, Nowak RM. Cricothyrotomy instrumentation. JACEP. 1978 Sep;7(9):345-6. doi: 10.1016/s0361-1124(78)80362-1. No abstract available.

    PMID: 45708BACKGROUND
  • Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.

    PMID: 25724849BACKGROUND
  • Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.

    PMID: 26304789BACKGROUND
  • 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
  • Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7.

    PMID: 25576642BACKGROUND
  • Jensen EV, Block GE, Ferguson DJ, DeSombre ER. Estrogen receptors in breast cancer. World J Surg. 1977 May;1(3):341-2. doi: 10.1007/BF01556853. No abstract available.

    PMID: 883334BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

April 15, 2020

Study Start

July 1, 2019

Primary Completion

November 1, 2019

Study Completion

February 20, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations