Scalenus SyndromeNCT05356416
Comparative Effects of Dry Needling and Ischemic Compression Technique on Scalene Myofascial Pain Syndrome
A study testing Ischemic compression and Dry needling in people with Scalenus Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Scalenus Syndrome
- What is being tested?
- Ischemic compression and Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 6 May 2022to 18 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with scalene myofascial pain syndrome
- Age from 18 years to 45
- Patients with positive Scalene Cramp Test
Who cannot join
- Whiplash injury
- Thoracic dysfunction any cervical radiculopathy
- Age below 18 and more than 45 years
- Any psychiatry disorder or
- Any contraindication to Dry Needling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Dry Needling and Ischemic Compression Technique on Pain, Disability and Range of Motion With Scalene Myofascial Pain Syndrome
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.
Read the 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.
- Conditions
- Scalenus Syndrome
- Being tested
- Ischemic compression, Dry needling
- Keywords
- dry needing, myofascial pain, pain, disability
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic compressionOther
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.
Dry needlingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: follow up at 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start6 May 2022
- Primary completion6 Oct 2022
- Study completion18 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Scalenus SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- samrood Akram, MPhil, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356416
- Sponsor's protocol ID
- REC/Lhr/22/0113 Arooj
- Status last verified
- Nov 2022
- First submitted
- 28 Apr 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 30429897Ortega-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.
PubMed 30821833Bagcier 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.
PubMed 33219086Boyce 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.
PubMed 32089962Nasb 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.
PubMed 31580695Maayah 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.
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.
PubMed 34159691Toghtamesh 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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Dry Needling and Ischemic Compression Technique on Pain, Disability and Range of Motion With Scalene Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT05356416
- Acronym / sponsor ID
- REC/Lhr/22/0113 Arooj
- Conditions
- Scalenus Syndrome
- Keywords
- dry needing, myofascial pain, pain, disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic compression | Experimental | Other: Ischemic compressionPatients 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. |
| Dry Needling | Active comparator | Other: Dry needlingPatients 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with scalene myofascial pain syndrome
- Age from 18 years to 45
- Patients with positive Scalene Cramp Test
Key exclusion criteria (5 listed)
- Whiplash injury
- Thoracic dysfunction any cervical radiculopathy
- Age below 18 and more than 45 years
- Any psychiatry disorder or
- Any contraindication to Dry Needling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic compressionIschemic 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. | Other | Ischemic compression |
| Dry needlingTrigger-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. | Other | Dry Needling |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: follow up at 4th week
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)
Time frame: follow up at 4th week
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)
Time frame: follow up at 4th week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- BackgroundGohil 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: PubMed 30429897Kisilewicz 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.
- Background: PubMed 30821833Ortega-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.
- Background: PubMed 33219086Bagcier 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.
- Background: PubMed 32089962Boyce 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.
- Background: PubMed 31580695Nasb 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.
- BackgroundMaayah 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: PubMed 34159691Yasar 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.
- BackgroundToghtamesh 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.
- BackgroundLamba 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
samrood Akram, MPhil principal investigator
Riphah International University,Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic compression and Dry needling in people with Scalenus Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: follow up at 4th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05356416, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.