Neck SyndromeNCT04674904
Effects of Dry Needling in Patients With Upper Cross Syndrome
A study testing Dry Needling and Hot pack , TENS , Stretching in people with Neck Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be done to evaluate the effectiveness of dry needling of muscles involved in Upper Cross Syndrome. Muscles involved in upper cross syndrome are tight upper trap, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Neck Syndrome
- What is being tested?
- Dry Needling and Hot pack , TENS , Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Mar 2020to 30 Jan 2021
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Stiffness and gradual pain in neck and shoulder
- Pain due to Postural Dysfunction
- Trauma or insidious onset
Who cannot join
- Any systemic soft tissue and bony disease.
- Patient with spinal tuberculosis, spinal fractures, pregnancy, cancer.
- Any recent surgery.
- Patient with any cervical or thoracic problem.
- Patients with any other serious pathology/red flags
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dry Needling on Pain, Range of Motion and Function in Patient With Upper Cross Syndrome
The study will be done to evaluate the effectiveness of dry needling of muscles involved in Upper Cross Syndrome. Muscles involved in upper cross syndrome are tight upper trap, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids. Physical assessment of trigger points will locate the target area for dry needling. After pre treatment measurements, dry needling will be performed to treatment group and stretching, hot pack and tens will be apply in control group. Study design will be randomized controlled trial and sample size will be 34 participants. Data will be collected from Riphah Rehabilitation Center. Patients of 20-50 years old with UCS diagnosed through observation and physical examination will be included. Patients with systemic soft tissue and bony diseases will be excluded. Intervention duration will be two session of DNT with two weeks routine management. Basic tools will be Visual analog scale (VAS), Neck Disability Index (NDI) and Goniometry
Read the detailed description
Dry needling is relatively new method for the management of musculoskeletal pain.Different methods of dry needling, its effectiveness, and physiologic and adverse effects are discussed. Dry needling is a treatment modality that is minimally invasive, cheap, easy to learn with appropriate training, and carries a low risk. The deep method of dry needling has been shown to be more effective than the superficial one for the treatment of pain associated with myofascial trigger points. However, over areas with potential risk of significant adverse events, such as lungs and large blood vessels, we suggest using the superficial technique, which has also been shown to be effective. Questionnaire for assessing the improvement in quality of life is by NDI and ranges like neck flexion/extension, side bending and rotation will be measured by standard goniometry. Neck disability index will use to check the patient's ability to perform his ADL before and after the treatment/control. Data will be collected from Riphah rehab center. Assessed patients of UCS of age 20 to 50 will be the targeted population of this study. Patients with systematic and bony disease excluded from the study. Population having stiff upper back, tight trap and stiff upper thoracic spine have UCS. Ethical guidelines will be followed for both treatment and control group. SPSS version 21 will be use for data analysis with sample size of 34 participants, 17 participants each group that will randomly allocated in treatment/control group.
- Conditions
- Neck Syndrome
- Being tested
- Dry Needling, Hot pack , TENS , Stretching
- Keywords
- Dry needling, upper cross syndrome, VAS, NDI, goniometry
- Medical subject headings
- Oculocerebral hypopigmentation syndrome type Preus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
Dry needling on Upper trapezius, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids for 10 min
Hot pack , TENS , StretchingOther
Treatments are
- Hot Pack for 15 minutes
- TENS for 10 minutes
- Stretching
The third treatment which is Stretching will be given one time on each muscle (tight upper trap, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids) of upper spine
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Dry Needling Receives: Other: Dry Needling |
| Group B | Active comparator | Hot pack , TENS , Stretching Receives: Other: Hot pack , TENS , Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured
Measured: 2nd Week
Secondary outcomes (1)
Neck Disability Index Questionnaire
Neck disability index is a self report questionnaire use to determine how neck pain effects the patients daily life and to assess the self rated disability of patients with neck pain. Area of assessment are activities of daily life, attention ,work memory ,functional mobility ,pain ,occupational performance ,quality of life and sleep. Totally based on patient reported outcome
Measured: 2nd Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start30 Mar 2020
- Primary completion30 Dec 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil Ur Rehman, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674904
- Sponsor's protocol ID
- REC/LHR/20/1049 Komal Arooj
- Status last verified
- Mar 2021
- First submitted
- 16 Dec 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25143704Tough EA, White AR, Cummings TM, Richards SH, Campbell JL. Acupuncture and dry needling in the management of myofascial trigger point pain: a systematic review and meta-analysis of randomised controlled trials. Eur J Pain. 2009 Jan;13(1):3-10. doi: 10.1016/j.ejpain.2008.02.006. Epub 2008 Apr 18.
PubMed 18395479Gerber LH, Shah J, Rosenberger W, Armstrong K, Turo D, Otto P, Heimur J, Thaker N, Sikdar S. Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects With Chronic Myofascial Pain. PM R. 2015 Jul;7(7):711-718. doi: 10.1016/j.pmrj.2015.01.020. Epub 2015 Feb 4.
PubMed 25661462Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
PubMed 20823359Liu 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 25576642Gonzalez-Perez LM, Infante-Cossio P, Granados-Nunez M, Urresti-Lopez FJ. Treatment of temporomandibular myofascial pain with deep dry needling. Med Oral Patol Oral Cir Bucal. 2012 Sep 1;17(5):e781-5. doi: 10.4317/medoral.17822.
PubMed 22549679Ahmad Z, ur Rehman S, Ahmad S, Afzal MF. Effects of combined manual postural correction technique in patient with upper cross syndrome. Rawal Medical Journal. 2019;44(3):486-9.
Thacker D, Jameson J, Baker J, Divine J, Unfried A. Management of upper cross syndrome through the use of active release technique and prescribed exercises. Logan College of Chiropractic. 2011 Apr
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.
PubMed 26304789
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling on Pain, Range of Motion and Function in Patient With Upper Cross Syndrome
- ClinicalTrials.gov ID
- NCT04674904
- Acronym / sponsor ID
- REC/LHR/20/1049 Komal Arooj
- Conditions
- Neck Syndrome
- Keywords
- Dry needling, upper cross syndrome, VAS, NDI, goniometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 19 Dec 2020 (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.
The study will be done to evaluate the effectiveness of dry needling of muscles involved in Upper Cross Syndrome. Muscles involved in upper cross syndrome are tight upper trap, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids. Physical assessment of trigger points will locate the target area for dry needling. After pre treatment measurements, dry needling will be performed to treatment group and stretching, hot pack and tens will be apply in control group. Study design will be randomized controlled trial and sample size will be 34 participants. Data will be collected from Riphah Rehabilitation Center. Patients of 20-50 years old with UCS diagnosed through observation and physical examination will be included. Patients with systemic soft tissue and bony diseases will be excluded. Intervention duration will be two session of DNT with two weeks routine management. Basic tools will be Visual analog scale (VAS), Neck Disability Index (NDI) and Goniometry
Detailed description
Dry needling is relatively new method for the management of musculoskeletal pain.Different methods of dry needling, its effectiveness, and physiologic and adverse effects are discussed. Dry needling is a treatment modality that is minimally invasive, cheap, easy to learn with appropriate training, and carries a low risk. The deep method of dry needling has been shown to be more effective than the superficial one for the treatment of pain associated with myofascial trigger points. However, over areas with potential risk of significant adverse events, such as lungs and large blood vessels, we suggest using the superficial technique, which has also been shown to be effective. Questionnaire for assessing the improvement in quality of life is by NDI and ranges like neck flexion/extension, side bending and rotation will be measured by standard goniometry. Neck disability index will use to check the patient's ability to perform his ADL before and after the treatment/control. Data will be collected from Riphah rehab center. Assessed patients of UCS of age 20 to 50 will be the targeted population of this study. Patients with systematic and bony disease excluded from the study. Population having stiff upper back, tight trap and stiff upper thoracic spine have UCS. Ethical guidelines will be followed for both treatment and control group. SPSS version 21 will be use for data analysis with sample size of 34 participants, 17 participants each group that will randomly allocated in treatment/control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Dry NeedlingDry Needling |
| Group B | Active comparator | Other: Hot pack , TENS , StretchingHot pack , TENS , Stretching |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Stiffness and gradual pain in neck and shoulder
- Pain due to Postural Dysfunction
- Trauma or insidious onset
Key exclusion criteria (5 listed)
- Any systemic soft tissue and bony disease.
- Patient with spinal tuberculosis, spinal fractures, pregnancy, cancer.
- Any recent surgery.
- Patient with any cervical or thoracic problem.
- Patients with any other serious pathology/red flags
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 |
|---|---|---|
| Dry NeedlingDry needling on Upper trapezius, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids for 10 min | Other | Group A |
| Hot pack , TENS , StretchingTreatments are 1. Hot Pack for 15 minutes 2. TENS for 10 minutes 3. Stretching The third treatment which is Stretching will be given one time on each muscle (tight upper trap, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids) of upper spine | Other | Group B |
Primary outcome
Visual Analogue Scale
Time frame: 2nd Week
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured
1 secondary outcome
Neck Disability Index Questionnaire
Time frame: 2nd Week
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 8 Mar 2021.
- Background: PubMed 25143704Dunning 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.
- Background: PubMed 18395479Tough EA, White AR, Cummings TM, Richards SH, Campbell JL. Acupuncture and dry needling in the management of myofascial trigger point pain: a systematic review and meta-analysis of randomised controlled trials. Eur J Pain. 2009 Jan;13(1):3-10. doi: 10.1016/j.ejpain.2008.02.006. Epub 2008 Apr 18.
- Background: PubMed 25661462Gerber LH, Shah J, Rosenberger W, Armstrong K, Turo D, Otto P, Heimur J, Thaker N, Sikdar S. Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects With Chronic Myofascial Pain. PM R. 2015 Jul;7(7):711-718. doi: 10.1016/j.pmrj.2015.01.020. Epub 2015 Feb 4.
- Background: PubMed 20823359Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
- 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.
- Background: PubMed 22549679Gonzalez-Perez LM, Infante-Cossio P, Granados-Nunez M, Urresti-Lopez FJ. Treatment of temporomandibular myofascial pain with deep dry needling. Med Oral Patol Oral Cir Bucal. 2012 Sep 1;17(5):e781-5. doi: 10.4317/medoral.17822.
- BackgroundAhmad Z, ur Rehman S, Ahmad S, Afzal MF. Effects of combined manual postural correction technique in patient with upper cross syndrome. Rawal Medical Journal. 2019;44(3):486-9.
- BackgroundThacker D, Jameson J, Baker J, Divine J, Unfried A. Management of upper cross syndrome through the use of active release technique and prescribed exercises. Logan College of Chiropractic. 2011 Apr
- Background: PubMed 26304789Yeganeh 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.
- 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.
Syed Shakil Ur Rehman principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Hot pack , TENS , Stretching 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 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 8 Mar 2021. 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?
Visual Analogue Scale (time frame: 2nd Week). 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 NCT04674904, which also lists 9 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 8 Mar 2021.