Neck PainNCT06780904
Comparing Efficacy of Dry Needling Combined with Passive Stretching and Muscle Energy Technique on Myofascial Trigger Points
A study testing Dry Needling in people with Neck Pain, run by University of Peradeniya at 1 site in Sri Lanka.
Trial summary
The goal of this clinical trial is to assess and compare the efficacy of dry needling (minimally invasive treatment by using a tiny needle) combined with two types of stretching techniques in patients with neck pain for more than 3 months. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Dry Needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSri Lanka
- Study dates
- 1 Sep 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of neck pain for at least 3 months or more
- Presence of trigger points in the upper trapezius muscle, either unilaterally or bilaterally
- Age between 18 and 60 years
Who cannot join
- Having an ongoing infection or fever
- Presence of shoulder pathology, such as tendinopathy, impingement syndrome, capsulitis, or bursitis
- History of direct trauma to the shoulder or neck
- Immunosuppressed individuals (e.g., those with cancer)
- Pregnant or recently delivered
- Diagnosis of fibromyalgia
Show all 16Show fewer
- History of previous neck or shoulder surgery
- Previous local steroid injection or acupuncture
- Any abnormality that restricts cervical range of motion (e.g., degenerative changes, cervical spine spondylolisthesis, disc protrusion, extrusion, or sequestration observed in MRI)
- Uncontrolled diabetes mellitus
- Needle phobia
- Metal allergies
- Cervical instability
- Presence of local skin lesions or infections
- Significant cognitive impairment or uncooperative behavior
- Participants who have previously undergone any form of physiotherapy intervention for the treatment of neck pain or related conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sri Lanka1 site, 1 recruiting
- Recruiting
National Hospital Kandy
Kandy, Central Province, 20000
Meemure D.M.T.D Dissanayake, B.Sc (Hons) in Physiotherapy, +94 702 797 349, dilmini008.dd@gmail.com
Doctor, Master of Philosophy, +94 812 369 265, jayamkd@yahoo.com
About this study
Official title: Comparing the Efficacy of Dry Needling Combined with Passive Stretching and Muscle Energy Technique on Upper Trapezius Myofascial Trigger Points Associated with Neck Pain
The goal of this clinical trial is to assess and compare the efficacy of dry needling (minimally invasive treatment by using a tiny needle) combined with two types of stretching techniques in patients with neck pain for more than 3 months. The main questions it aims to answer are:
Which combination of treatment will 1.give faster relief of pain? 2.improve neck range of motion? and 3.improve disability level of a person with neck pain.
Participants who are interested will be selected according to eligibility criteria. Participants will be divided into two groups. Initially researcher will assess and interview the participants. Two groups will receive two different combinations of interventions. Pre and post measurements will be obtained and then treatment efficacy will be assessed.
Read the detailed description
46 participants who are interested in this study will be recruited by using convenient sampling method and according to the inclusion and exclusion criteria. Participants then will be divided into two groups by using opaque sealed envelop method.
Initially participants will be interviewed an outcome measures will be taken. As outcome measures Pain will be assessed by using Visual Analogue Scale (VAS), Disability level will be assessed by using Neck Disability Index(NDI), and Neck Range of Motion will be measured by using Universal Goniometer. Participants will receive interventions, two times per week for two weeks. Soon after the last intervention, same outcome measures will be taken again.
Statistical Package for Social Science (SPSS) version 27 (IBM, USA) for Windows will be used for data analysis. The data will be examined using exploratory statistics, and the distributions will be inspected for violations of normality using graphical methods and the Shapiro-Wilk test. Descriptive statistics of the demographic variables and test measurements will be calculated. Based on the satisfaction or violation of normal distribution assumptions, pain intensity (VAS), neck ROMs, pain intensity, and Neck Disability Index (NDI) will be analyzed using parametric or non-parametric tests. Baseline data for pain intensity, neck ROMs and NDI and pain intensity will be compared between the two intervention groups using paired t-test or Wilcoxon signed-rank test. The difference-in changes in each outcome relative to the baseline between intervention groups will be compared using paired t-test or Wilcoxon signed-rank test
- Conditions
- Neck Pain
- Being tested
- Dry Needling
- Keywords
- myofascial trigger points, passive stretching, dry needling, Muscle Energy Technique (MET), Randomized clinical trial, Upper trapezius
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or surgery
Also called Passive Stretching, Muscle energy Technique
Treatment protocol:
- Dry needling: Prone position, identify trigger points in upper trapezius, use Hong technique with 50mm/0.25 gauge needle, eliciting local twitch response.
- Passive stretching: Supine position, cervical spine stretched just short of restriction, hold for 30s with 20s rest, repeat 3 times.
- Muscle Energy Technique: Supine position, identify restriction barrier, move spine away from barrier, instruct patient to isometrically contract opposing movement (25% strength), hold for 7-10s, then stretch towards new barrier for 30s, repeat 3 times.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Active comparator | Dry needling + Passive stretching Receives: Procedure: Dry Needling |
| Treatment group 2 | Other | Dry needling + Muscle Energy technique Receives: Procedure: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain
Visual Analog Scale (VAS) 0: Represents the minimum value, such as "no pain" or "no discomfort." 100: Represents the maximum value, such as "worst pain imaginable" or "extreme discomfort.
Measured: 2 weeks
Secondary outcomes (2)
Neck Range of Motion
Neck flexion, Extension, Side flexion to affected side, Side flexion to unaffected side, Rotation to affected side and Rotation to unaffected side
Measured: 2 weeks
Neck disability level
Neck Disability Index Structure: Contains 10 items, each scored on a 0-5 scale Scoring: Total score ranges from 0 to 50, Higher scores indicate greater disability.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Sep 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Peradeniya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.D.M.T.D.Dissanayake, University of Peradeniya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780904
- Sponsor's protocol ID
- DPTAHS
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Dry Needling Combined with Passive Stretching and Muscle Energy Technique on Upper Trapezius Myofascial Trigger Points Associated with Neck Pain
- ClinicalTrials.gov ID
- NCT06780904
- Acronym / sponsor ID
- DPTAHS
- Conditions
- Neck Pain
- Keywords
- myofascial trigger points, passive stretching, dry needling, Muscle Energy Technique (MET), Randomized clinical trial, Upper trapezius
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of PeradeniyaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 17 Jan 2025 (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 goal of this clinical trial is to assess and compare the efficacy of dry needling (minimally invasive treatment by using a tiny needle) combined with two types of stretching techniques in patients with neck pain for more than 3 months. The main questions it aims to answer are:
Which combination of treatment will 1.give faster relief of pain? 2.improve neck range of motion? and 3.improve disability level of a person with neck pain.
Participants who are interested will be selected according to eligibility criteria. Participants will be divided into two groups. Initially researcher will assess and interview the participants. Two groups will receive two different combinations of interventions. Pre and post measurements will be obtained and then treatment efficacy will be assessed.
Detailed description
46 participants who are interested in this study will be recruited by using convenient sampling method and according to the inclusion and exclusion criteria. Participants then will be divided into two groups by using opaque sealed envelop method.
Initially participants will be interviewed an outcome measures will be taken. As outcome measures Pain will be assessed by using Visual Analogue Scale (VAS), Disability level will be assessed by using Neck Disability Index(NDI), and Neck Range of Motion will be measured by using Universal Goniometer. Participants will receive interventions, two times per week for two weeks. Soon after the last intervention, same outcome measures will be taken again.
Statistical Package for Social Science (SPSS) version 27 (IBM, USA) for Windows will be used for data analysis. The data will be examined using exploratory statistics, and the distributions will be inspected for violations of normality using graphical methods and the Shapiro-Wilk test. Descriptive statistics of the demographic variables and test measurements will be calculated. Based on the satisfaction or violation of normal distribution assumptions, pain intensity (VAS), neck ROMs, pain intensity, and Neck Disability Index (NDI) will be analyzed using parametric or non-parametric tests. Baseline data for pain intensity, neck ROMs and NDI and pain intensity will be compared between the two intervention groups using paired t-test or Wilcoxon signed-rank test. The difference-in changes in each outcome relative to the baseline between intervention groups will be compared using paired t-test or Wilcoxon signed-rank test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Active comparator | Procedure: Dry NeedlingDry needling + Passive stretching |
| Treatment group 2 | Other | Procedure: Dry NeedlingDry needling + Muscle Energy technique |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of neck pain for at least 3 months or more
- Presence of trigger points in the upper trapezius muscle, either unilaterally or bilaterally
- Age between 18 and 60 years
Key exclusion criteria (16 listed)
- Having an ongoing infection or fever
- Presence of shoulder pathology, such as tendinopathy, impingement syndrome, capsulitis, or bursitis
- History of direct trauma to the shoulder or neck
- Immunosuppressed individuals (e.g., those with cancer)
- Pregnant or recently delivered
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 NeedlingAlso: Passive Stretching, Muscle energy TechniqueTreatment protocol: 1. Dry needling: Prone position, identify trigger points in upper trapezius, use Hong technique with 50mm/0.25 gauge needle, eliciting local twitch response. 2. Passive stretching: Supine position, cervical spine stretched just short of restriction, hold for 30s with 20s rest, repeat 3 times. 3. Muscle Energy Technique: Supine position, identify restriction barrier, move spine away from barrier, instruct patient to isometrically contract opposing movement (25% strength), hold for 7-10s, then stretch towards new barrier for 30s, repeat 3 times. | Procedure or surgery | Treatment group 1, Treatment group 2 |
Primary outcome
Neck pain
Time frame: 2 weeks
Visual Analog Scale (VAS) 0: Represents the minimum value, such as "no pain" or "no discomfort." 100: Represents the maximum value, such as "worst pain imaginable" or "extreme discomfort.
2 secondary outcomes
Neck Range of Motion
Time frame: 2 weeks
Neck disability level
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- 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.
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 in people with Neck Pain, run by University of Peradeniya at 1 site in Sri Lanka.
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 16 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: looking for participants now, as of the sponsor's last update on 17 Jan 2025. 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 Sri Lanka. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dissanayake (0702797349 ext. +94, dilmini008.dd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2025.