NCT05356416

Brief Summary

Myofascial Pain Syndrome (MPS) is a medical term used to describe chronic regional pain syndrome that presents with hyperirritable spots called trigger points (TPs) and/or tender spots (TSs) that arise from taut bands (TB) in the skeletal muscle. Scalene myofascial pain syndrome is a regional pain syndrome wherein pain originates over the neck area and radiates down to the arm. Functionally, MPS causes the muscle to become weak and stiff, leading to reductions in range of movement. Thus, MPS is known as a major cause of morbidity, with a significant impact on daily activity, function and quality of life. The aim of this study is to compare the effects of dry needling versus ischemic compression technique on trigger points of scalene in neck pain, related disability and neck active range of motion among patients with scalene myofascial pain syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

First Submitted

Initial submission to the registry

April 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 6, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

April 28, 2022

Last Update Submit

November 8, 2022

Conditions

Keywords

dry needingmyofascial painpaindisability

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    The Numeric Pain Rating Scale (NPRS) an outcome measure that is a unidimensional measure of pain intensity in adults, including those with chronic pain. The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS takes \<1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity; * High test-retest reliability has been (r = 0.96 and 0.95, respectively) * For construct validity, the NPRS was shown to be highly correlated: correlations range from 0.86 to 0.95.

    follow up at 4th week

  • Neck Disability Index (NDI)

    This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. Every section is marked in each section only the one box that applies to you. We realise you may consider that two or more statements in any one section relate to you, but please just mark the box that most closely describes your problem. Intended population includes: Chronic neck or upper back pain and musculoskeletal neck pain. Scoring: 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.

    follow up at 4th week

  • Universal Goniometer (UG)

    A goniometer is an instrument that measures the available range of motion at a joint. To measure the range of motion physical therapists most commonly use a goniometer. It is necessary that a single notation system is used in goniometry. The neutral zero method (0 to 180- degree system) is the most widely used method. The same goniometer should always be used to reduce the chances of instrumental error.

    follow up at 4th week

Study Arms (2)

Ischemic compression

EXPERIMENTAL

Patients in Group B will receive a single session of ischemic compression technique for ischemic compression technique sustained pressure on the trigger points will be maintained for 30 seconds.

Other: Ischemic compression

Dry Needling

ACTIVE COMPARATOR

Patients in dry needling (DN) group will receive a single session of DN of 10 minutes with sterile needles insert on trigger points in scalene muscles as first twitch response will obtained needles will be manipulated in and out of the muscles to get 2 or 3 more local responses.

Other: Dry needling

Interventions

Ischemic compression technique is a massage technique that consists of moderate compression, typically applied with the fingers, to the MTrP. Application of this technique to an MTrP results in a positive effect on pain-pressure threshold. Patients in Group B will receive a single session of ischemic compression technique for ischemic compression technique sustained pressure on the trigger points will be maintained for 30 seconds.

Ischemic compression

Trigger-point dry needling is an invasive procedure where a fine needle or acupuncture needle is inserted into the skin and muscle. Patients in dry needling (DN) group will receive a single session of DN of 10 minutes with sterile needles insert on trigger points in scalene muscles as first twitch response will obtained needles will be manipulated in and out of the muscles to get 2 or 3 more local responses.

Dry Needling

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with scalene myofascial pain syndrome
  • Age from 18 years to 45
  • Patients with positive Scalene Cramp Test

You may not qualify if:

  • Whiplash injury
  • Thoracic dysfunction any cervical radiculopathy
  • Age below 18 and more than 45 years
  • Any psychiatry disorder or
  • Any contraindication to Dry Needling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sikandar Medical Complex

Gujranwala, Punjab Province, 52250, Pakistan

Location

Related Publications (10)

  • Gohil D, Vaishy S, Baxi G, Samson A, Palekar T. Effectiveness of strain-counterstrain technique versus digital ischemic compression on myofascial trigger points. Archives of Medicine and Health Sciences. 2020;8(2):191.

    BACKGROUND
  • Kisilewicz A, Janusiak M, Szafraniec R, Smoter M, Ciszek B, Madeleine P, Fernandez-de-Las-Penas C, Kawczynski A. Changes in Muscle Stiffness of the Trapezius Muscle After Application of Ischemic Compression into Myofascial Trigger Points in Professional Basketball Players. J Hum Kinet. 2018 Oct 15;64:35-45. doi: 10.2478/hukin-2018-0043. eCollection 2018 Sep.

    PMID: 30429897BACKGROUND
  • Ortega-Santiago R, Maestre-Lerga M, Fernandez-de-Las-Penas C, Cleland JA, Plaza-Manzano G. Widespread Pressure Pain Sensitivity and Referred Pain from Trigger Points in Patients with Upper Thoracic Spine Pain. Pain Med. 2019 Jul 1;20(7):1379-1386. doi: 10.1093/pm/pnz020.

    PMID: 30821833BACKGROUND
  • Bagcier F, Yurdakul O, Ozduran E. Three Simple Rules in Pectoral Muscle's Trigger Point Treatment, Which May Be a Cause of Chest Pain: Position, Palpation, and Perpendicular Needling. J Am Board Fam Med. 2020 Nov-Dec;33(6):1031. doi: 10.3122/jabfm.2020.06.200342. No abstract available.

    PMID: 33219086BACKGROUND
  • Boyce D, Wempe H, Campbell C, Fuehne S, Zylstra E, Smith G, Wingard C, Jones R. ADVERSE EVENTS ASSOCIATED WITH THERAPEUTIC DRY NEEDLING. Int J Sports Phys Ther. 2020 Feb;15(1):103-113.

    PMID: 32089962BACKGROUND
  • Nasb M, Qun X, Ruckmal Withanage C, Lingfeng X, Hong C. Dry Cupping, Ischemic Compression, or Their Combination for the Treatment of Trigger Points: A Pilot Randomized Trial. J Altern Complement Med. 2020 Jan;26(1):44-50. doi: 10.1089/acm.2019.0231. Epub 2019 Oct 3.

    PMID: 31580695BACKGROUND
  • Maayah MF, Khabour OF, Gaowgzeh RA, Neamatallah Z, Alfawaz SS. Effects of acupressure versus physical therapy on Enkephalin and Endorphin levels in Scalene Myofascial Pain Syndrome patients: A randomized controlled trial. Advances in Mechanics. 2021;9(3):1141-53.

    BACKGROUND
  • Yasar MF, Yaksi E, Kurul R, Alisik T, Seker Z. Comparison of dry needling and kinesio taping methods in the treatment of myofascial pain syndrome: A single blinded randomised controlled study. Int J Clin Pract. 2021 Oct;75(10):e14561. doi: 10.1111/ijcp.14561. Epub 2021 Jul 12.

    PMID: 34159691BACKGROUND
  • Toghtamesh M, Tajali SB, Jalaei S. Comparing Between the Effects of Dry Needling and Shock Wave in the Treatment of Trapezius Myofascial Pain. Journal of Modern Rehabilitation. 2020;14(4):225-32.

    BACKGROUND
  • Lamba D. Comparison of two different photobiostimulation on pain and functional ability in patients with myofascial trigger points (levator scapulae muscle). International Journal of Medical Research & Health Sciences. 2019;8(7):22-9.

    BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

AcupressureDry Needling

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • samrood Akram, MPhil

    Riphah International University,Lahore

    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

April 28, 2022

First Posted

May 2, 2022

Study Start

May 6, 2022

Primary Completion

October 6, 2022

Study Completion

October 18, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations