Neck SyndromeNCT06459804
Effects of Electro Dry Needling Versus Dry Needling in Levator Scapulae Syndrome
A study testing Electro Dry Needling and Dry Needling in people with Neck Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Mechanical neck pain is posteriorly occurring non-specific pain that originates from the superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by sustained neck postures, neck movements or cervical muscle palpation. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Neck Syndrome
- What is being tested?
- Electro Dry Needling and Dry Needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2024to 10 Oct 2024
- 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
- Age ranges of 18-45 years
- Both genders, males and females
- Positive Levator Scapular length Test (7)
- Positive Simon's criteria for Levator scapulae
- Neck pain -NPRS < 7 (8)
- Neck and upper back pain for at least 3months.
Show all 9Show fewer
- Examination - Increased muscle tone and tenderness at neck and upper back
- Reduced ROM-Side flexion and Rotation of neck
- Non traumatic unilateral mechanical neck pain of three or more months of duration, presenting an latent MTrP in the levator scapulae muscle on the painful side
Who cannot join
- Neuropathies
- Radiated pain towards the arm
- Vertebral fractures
- Traumatic neck injury
- whiplash injury (9)
- previous surgical procedures in the cervical spine
Show all 9Show fewer
- Previous cognitive and functional disorders
- psychological disorders (mood and psychotic disorders such as schizophrenia, depression,and anxiety disorders),
- Fibromyalgia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Electro Dry Needling Versus Dry Needling on Pain, Muscle Strength, and Range of Motion in Patients With Levator Scapulae Syndrome
Mechanical neck pain is posteriorly occurring non-specific pain that originates from the superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by sustained neck postures, neck movements or cervical muscle palpation. The aim of study will be to compare the effects of Electro Dry Needling and Dry Needling on pain, muscle strength, disability and range of motion in patients with Levator Scapulae Syndrome.
Read the detailed description
A Randomized Clinical Trial will be conducted at Shalamar Hospital, (SIHS Physiotherapy Clinic Lahore) through convenience sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will receive Electro Dry Needling along with conventional physiotherapy in which parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated and Group B will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes. Standard Physiotherapy will include a Hot pack (10 min), Stretching of levator scapulae (3 times with 30 second hold), and Scapular stabilization exercises (10 times with 5 second hold).There will be 3 sessions per week, Needling in both groups will be for performed 2 times per week for total 3rd week of treatment comprising of 6 sessions, 3rd session will comprise of standard physical therapy. Pre and Post treatment measures will be recorded.Outcome measures will be conducted through pain, *muscle strength,* disability and range of motion questionnaire. Data will be analyzed during *SPSS software version 25.After assessing the normality of data by the Shapiro-Wilk test, it will be decided whether a parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Neck Syndrome
- Being tested
- Electro Dry Needling, Dry Needling
- Keywords
- neck pain, disability, muscle strength, Range of Motion
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro Dry NeedlingProcedure or surgery
Standard Physiotherapy:
It will include Hot pack (10 min), Stretching of levator scapulae (3 times with 30 seconds hold), Scapular stabilization exercises (10 times with 5 seconds hold).
Scapular Stabilization exercises will be comprised of four exercise programs. The participants will sit on the knees in 90° flexion position, and a Swiss ball will be propped up between the stomach and chest.
Dry NeedlingProcedure or surgery
Dry Needling
| Study group | Role | What they receive |
|---|---|---|
| Group A: Electro Dry Needling | Experimental | Group A: will receive Electro Dry Needling along with conventional physiotherapy. The parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated. Receives: Procedure: Electro Dry Needling |
| Group B: Dry Needling | Active comparator | Group B will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated. Receives: Procedure: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rate scale (NPRS)
The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. the NPRS is anchored by terms describing pain severity extremes.
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").
Measured: upto 3 weeks
Neck Disability index (NDI)
The results of this questionnaire have been utilized to evaluate the disability. It consists of 10 items: 7 linked to activities of daily living, 2 to pain, and 1 to concentration. From 0 to 5, each item received a score. Higher scores corresponded to more disability, and the total score was reported as a percentage.
Measured: upto 3 weeks
Universal Goniometer
An instrument called a goniometer is used to measure a joint's range of motion. Physical therapists typically use a goniometer to measure a range of motion. At the initial evaluation, the therapist can determine the possible range of motion using a goniometer .
Range of motion: Side flexion and Rotation of neck measured with Goniometer.
Measured: upto 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start30 Jun 2024
- Primary completion30 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neck SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aqsa Wahid, MSPT*, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459804
- Sponsor's protocol ID
- REC/RCRS/1021 Aqsa
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-de-Miguel S, Pecos-Martin D, Larroca-Sanz T, Sanz-de-Vicente B, Garcia-Montes L, Fernandez-Matias R, Gallego-Izquierdo T. Short-Term Effects of PENS versus Dry Needling in Subjects with Unilateral Mechanical Neck Pain and Active Myofascial Trigger Points in Levator Scapulae Muscle: A Randomized Controlled Trial. J Clin Med. 2020 Jun 1;9(6):1665. doi: 10.3390/jcm9061665.
PubMed 32492884Hernandez-Secorun M, Abenia-Benedi H, Borrella-Andres S, Marques-Garcia I, Lucha-Lopez MO, Herrero P, Iguacel I, Tricas-Moreno JM, Hidalgo-Garcia C. Effectiveness of Dry Needling in Improving Pain and Function in Comparison with Other Techniques in Patients with Chronic Neck Pain: A Systematic Review and Meta-Analysis. Pain Res Manag. 2023 Aug 23;2023:1523834. doi: 10.1155/2023/1523834. eCollection 2023.
PubMed 37664417ALchlaihawi A, Tajali SB, Malmir K, Mahdi TS (2023) Effects of Dry Needling and Dry Needling Combined with Electrical Stimulation on Pain and Function in Patients with Subacute Musculoskeletal Neck Pain Following Myofascial Trigger Points. History of Medicine 9(1): 1845-1858. https://doi.org/10.17720/24095834.v9.1.2023.237
Song Young-mun, Weon Jong-hyuck, Jung Do-young. Reliability of a New Test of Levator Scapula Muscle Length. J Musculoskelet Sci Technol 2019;3(1):1-6. https://doi.org/10.29273/jmst.2019.3.1.1
Gattie E, Cleland JA, Snodgrass S. The Effectiveness of Trigger Point Dry Needling for Musculoskeletal Conditions by Physical Therapists: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Mar;47(3):133-149. doi: 10.2519/jospt.2017.7096. Epub 2017 Feb 3.
PubMed 28158962Liu 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.
PubMed 25576642
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electro Dry Needling Versus Dry Needling on Pain, Muscle Strength, and Range of Motion in Patients With Levator Scapulae Syndrome
- ClinicalTrials.gov ID
- NCT06459804
- Acronym / sponsor ID
- REC/RCRS/1021 Aqsa
- Conditions
- Neck Syndrome
- Keywords
- neck pain, disability, muscle strength, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 14 Jun 2024 (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.
Mechanical neck pain is posteriorly occurring non-specific pain that originates from the superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by sustained neck postures, neck movements or cervical muscle palpation. The aim of study will be to compare the effects of Electro Dry Needling and Dry Needling on pain, muscle strength, disability and range of motion in patients with Levator Scapulae Syndrome.
Detailed description
A Randomized Clinical Trial will be conducted at Shalamar Hospital, (SIHS Physiotherapy Clinic Lahore) through convenience sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will receive Electro Dry Needling along with conventional physiotherapy in which parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated and Group B will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes. Standard Physiotherapy will include a Hot pack (10 min), Stretching of levator scapulae (3 times with 30 second hold), and Scapular stabilization exercises (10 times with 5 second hold).There will be 3 sessions per week, Needling in both groups will be for performed 2 times per week for total 3rd week of treatment comprising of 6 sessions, 3rd session will comprise of standard physical therapy. Pre and Post treatment measures will be recorded.Outcome measures will be conducted through pain, *muscle strength,* disability and range of motion questionnaire. Data will be analyzed during *SPSS software version 25.After assessing the normality of data by the Shapiro-Wilk test, it will be decided whether a parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Electro Dry Needling | Experimental | Procedure: Electro Dry NeedlingGroup A: will receive Electro Dry Needling along with conventional physiotherapy. The parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated. |
| Group B: Dry Needling | Active comparator | Procedure: Dry NeedlingGroup B will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age ranges of 18-45 years
- Both genders, males and females
- Positive Levator Scapular length Test (7)
- Positive Simon's criteria for Levator scapulae
- Neck pain -NPRS < 7 (8)
Key exclusion criteria (9 listed)
- Neuropathies
- Radiated pain towards the arm
- Vertebral fractures
- Traumatic neck injury
- whiplash injury (9)
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 |
|---|---|---|
| Electro Dry NeedlingStandard Physiotherapy: It will include Hot pack (10 min), Stretching of levator scapulae (3 times with 30 seconds hold), Scapular stabilization exercises (10 times with 5 seconds hold). Scapular Stabilization exercises will be comprised of four exercise programs. The participants will sit on the knees in 90° flexion position, and a Swiss ball will be propped up between the stomach and chest. | Procedure or surgery | Group A: Electro Dry Needling |
| Dry NeedlingDry Needling | Procedure or surgery | Group B: Dry Needling |
Primary outcome
Numeric pain rate scale (NPRS)
Time frame: upto 3 weeks
The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. the NPRS is anchored by terms describing pain severity extremes. 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").
Neck Disability index (NDI)
Time frame: upto 3 weeks
The results of this questionnaire have been utilized to evaluate the disability. It consists of 10 items: 7 linked to activities of daily living, 2 to pain, and 1 to concentration. From 0 to 5, each item received a score. Higher scores corresponded to more disability, and the total score was reported as a percentage.
Universal Goniometer
Time frame: upto 3 weeks
An instrument called a goniometer is used to measure a joint's range of motion. Physical therapists typically use a goniometer to measure a range of motion. At the initial evaluation, the therapist can determine the possible range of motion using a goniometer . Range of motion: Side flexion and Rotation of neck measured with Goniometer.
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 15 Oct 2024.
- Background: PubMed 32492884Garcia-de-Miguel S, Pecos-Martin D, Larroca-Sanz T, Sanz-de-Vicente B, Garcia-Montes L, Fernandez-Matias R, Gallego-Izquierdo T. Short-Term Effects of PENS versus Dry Needling in Subjects with Unilateral Mechanical Neck Pain and Active Myofascial Trigger Points in Levator Scapulae Muscle: A Randomized Controlled Trial. J Clin Med. 2020 Jun 1;9(6):1665. doi: 10.3390/jcm9061665.
- Background: PubMed 37664417Hernandez-Secorun M, Abenia-Benedi H, Borrella-Andres S, Marques-Garcia I, Lucha-Lopez MO, Herrero P, Iguacel I, Tricas-Moreno JM, Hidalgo-Garcia C. Effectiveness of Dry Needling in Improving Pain and Function in Comparison with Other Techniques in Patients with Chronic Neck Pain: A Systematic Review and Meta-Analysis. Pain Res Manag. 2023 Aug 23;2023:1523834. doi: 10.1155/2023/1523834. eCollection 2023.
- BackgroundALchlaihawi A, Tajali SB, Malmir K, Mahdi TS (2023) Effects of Dry Needling and Dry Needling Combined with Electrical Stimulation on Pain and Function in Patients with Subacute Musculoskeletal Neck Pain Following Myofascial Trigger Points. History of Medicine 9(1): 1845-1858. https://doi.org/10.17720/24095834.v9.1.2023.237
- BackgroundSong Young-mun, Weon Jong-hyuck, Jung Do-young. Reliability of a New Test of Levator Scapula Muscle Length. J Musculoskelet Sci Technol 2019;3(1):1-6. https://doi.org/10.29273/jmst.2019.3.1.1
- Background: PubMed 28158962Gattie E, Cleland JA, Snodgrass S. The Effectiveness of Trigger Point Dry Needling for Musculoskeletal Conditions by Physical Therapists: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Mar;47(3):133-149. doi: 10.2519/jospt.2017.7096. Epub 2017 Feb 3.
- Background: PubMed 25576642Liu 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.
- Individual participant dataSharing planned: No
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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.
Aqsa Wahid, MSPT* 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 Electro Dry Needling and Dry Needling in people with Neck 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 9 inclusion and 9 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 15 Oct 2024. 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 rate scale (NPRS) (time frame: upto 3 weeks). 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 NCT06459804, which also lists 6 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 15 Oct 2024.