Comparative Effects of Dry Needling and Ischemic Compression Technique on Scalene Myofascial Pain Syndrome
Primary Purpose
Scalenus Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Ischemic compression
Dry needling
Sponsored by
About this trial
This is an interventional treatment trial for Scalenus Syndrome focused on measuring dry needing, myofascial pain, pain, disability
Eligibility Criteria
Inclusion Criteria:
- Patients with scalene myofascial pain syndrome
- Age from 18 years to 45
- Patients with positive Scalene Cramp Test
Exclusion Criteria:
- Whiplash injury
- Thoracic dysfunction any cervical radiculopathy
- Age below 18 and more than 45 years
- Any psychiatry disorder or
- Any contraindication to Dry Needling
Sites / Locations
- Sikandar Medical Complex
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ischemic compression
Dry Needling
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05356416
First Posted
April 28, 2022
Last Updated
November 8, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05356416
Brief Title
Comparative Effects of Dry Needling and Ischemic Compression Technique on Scalene Myofascial Pain Syndrome
Official Title
Comparative Effects of Dry Needling and Ischemic Compression Technique on Pain, Disability and Range of Motion With Scalene Myofascial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
October 6, 2022 (Actual)
Study Completion Date
October 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
A Randomized clinical trial will be conducted at DHQ Gujranwala and Sikandar medical complex Gujranwala through convenience sampling technique on 24 patients. Patients with scalene myofascial pain syndrome between age from 18 years to 45 with positive Scalene Cramp Test will be included in study. Patients will be accessed for neck pain, disability and active range of motion. They will be allocated through simple random sampling through sealed opaque envelopes into group A and group B. Patients in dry needling (DN) group will receive a single session of DN 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. Patients in Group B will receive a single session of ischemic compression technique for this ischemic compression technique sustained pressure on the trigger points will be maintained for 30 seconds. Control treatment will be same for both groups. Pre and post treatment values will be identified after one month follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalenus Syndrome
Keywords
dry needing, myofascial pain, pain, disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ischemic compression
Arm Type
Experimental
Arm Description
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.
Arm Title
Dry Needling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ischemic compression
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
follow up at 4th week
Title
Neck Disability Index (NDI)
Description
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.
Time Frame
follow up at 4th week
Title
Universal Goniometer (UG)
Description
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.
Time Frame
follow up at 4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with scalene myofascial pain syndrome
Age from 18 years to 45
Patients with positive Scalene Cramp Test
Exclusion Criteria:
Whiplash injury
Thoracic dysfunction any cervical radiculopathy
Age below 18 and more than 45 years
Any psychiatry disorder or
Any contraindication to Dry Needling
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
samrood Akram, MPhil
Organizational Affiliation
Riphah International University,Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sikandar Medical Complex
City
Gujranwala
State/Province
Punjab
ZIP/Postal Code
52250
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
30429897
Citation
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.
Results Reference
background
PubMed Identifier
30821833
Citation
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.
Results Reference
background
PubMed Identifier
33219086
Citation
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.
Results Reference
background
PubMed Identifier
32089962
Citation
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.
Results Reference
background
PubMed Identifier
31580695
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
34159691
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Learn more about this trial
Comparative Effects of Dry Needling and Ischemic Compression Technique on Scalene Myofascial Pain Syndrome
We'll reach out to this number within 24 hrs