Myofascial Pain Syndrome - NeckPhase 4NCT07866443
Combination of Pregabalin and Trigger Point Injection With Ropivacaine in the Treatment of Myofascial Pain Syndrome of the Neck and Upper Back.
A Phase 4 study testing Ropivacaine and Pregabalin in people with Myofascial Pain Syndrome - Neck, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
This study compared trigger point injections with ropivacaine alone versus trigger point injections combined with oral pregabalin in adults with chronic myofascial pain of the neck and upper back. Participants were randomly assigned to one of the two treatment groups. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myofascial Pain Syndrome - Neck
- What is being tested?
- Ropivacaine and Pregabalin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2025to 20 Dec 2025
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Clinical diagnosis of myofascial pain syndrome according to the Travell and Simons diagnostic criteria
Who cannot join
- Age <18 and >80 years
- Coexisting systemic rheumatic disease
- Current treatment with serotonin-norepinephrine reuptake inhibitors (SNRIs)
- Current treatment with tricyclic antidepressants
- Current treatment with benzodiazepines
- Pregnancy
Show all 9Show fewer
- Breastfeeding women
- Permanent cardiac pacemaker
- N> 20 trigger points
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Pregabalin and Trigger Point Injection With Ropivacaine in the Treatment of Myofascial Pain Syndrome.
This study compared trigger point injections with ropivacaine alone versus trigger point injections combined with oral pregabalin in adults with chronic myofascial pain of the neck and upper back. Participants were randomly assigned to one of the two treatment groups. Pain intensity, number of trigger points, neuropathic pain symptoms, and health-related quality of life were assessed at baseline and at 1 and 3 months after treatment.
- Conditions
- Myofascial Pain Syndrome - Neck
- Being tested
- Ropivacaine, Pregabalin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Ropivacaine 0.2%, administered as a 2 mL injection into each identified trigger point.
PregabalinDrug
Pregabalin 50 mg administered orally twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine Trigger Point Injection | Active comparator | Participants received trigger point injections with 0.2% ropivacaine, 2 mL per trigger point. Receives: Drug: Ropivacaine |
| Ropivacaine Trigger Point Injection Plus Pregabalin | Experimental | Participants received trigger point injections with 0.2% ropivacaine, 2 mL per trigger point, combined with oral pregabalin 50 mg twice daily. Receives: Drug: Ropivacaine; Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity measured by the Numerical Rating Scale (NRS)
Pain intensity was assessed using the 0-10 Numerical Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Baseline, 1 month and 3 months after treatment
Secondary outcomes (3)
Change in the number of active trigger points
The number of clinically identified active trigger points in the neck and upper back was recorded during physical examination
Measured: Baseline, 1 month, and 3 months after treatment
Change in neuropathic pain assessed using the DN4 questionnaire
The Douleur Neuropathique 4 Questions (DN4) questionnaire is a widely validated (including the greek population) clinician-administered screening tool designed to evaluate the presence of a neuropathic pain component in clinical trials. This tool measures sensory descriptors and clinical examination findings through a single, aggregated scale consisting of 10 binary items. The Douleur Neuropathique 4 Questions scale uses a binary scoring system with a minimum value of 0 and a maximum value of 10, where higher scores indicate a worse outcome (a higher probability and greater presentation of neuropathic pain features). By combining a 7-item patient interview with a 3-item bedside sensory examination, the DN4 provides a standardized, efficient method to identify neuropathic characteristics, with a score of 4 or higher serving as the established clinical threshold indicating a likely neuropathic pain component.
Measured: Baseline, 1 month, and 3 months after treatment
Change in health-related quality of life assessed using the SF-12 questionnaire
Health-related quality of life was assessed using the 12-item Short Form Health Survey (SF-12). The 12-Item Short-Form Health Survey (SF-12) is a widely validated (including greek population), patient-reported instrument designed to evaluate health-related quality of life in clinical trials. This tool measures functional health across two primary domains: the Physical Component Summary scale and the Mental Component Summary scale. Both scales use a norm-based scoring system where the theoretical minimum value is 0 and the maximum value is 100 (standardized to a general population mean of 50 and a standard deviation of 10), where higher scores indicate a better outcome (superior physical or mental health-related quality of life).
Measured: Baseline, 1 month, and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Mar 2025
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome - NeckStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Polyxeni Botou, National and Kapodistrian University of Athens
- Investigators
- Chrysoula Staikou, PhD, Study chair, National and Kapodistrian University f Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866443
- Sponsor's protocol ID
- TRPsBOTOU
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because participant consent did not include public sharing of de-identified individual-level data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Pregabalin and Trigger Point Injection With Ropivacaine in the Treatment of Myofascial Pain Syndrome.
- ClinicalTrials.gov ID
- NCT07866443
- Acronym / sponsor ID
- TRPsBOTOU
- Conditions
- Myofascial Pain Syndrome - Neck
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 8 Oct 2026 (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.
This study compared trigger point injections with ropivacaine alone versus trigger point injections combined with oral pregabalin in adults with chronic myofascial pain of the neck and upper back. Participants were randomly assigned to one of the two treatment groups. Pain intensity, number of trigger points, neuropathic pain symptoms, and health-related quality of life were assessed at baseline and at 1 and 3 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine Trigger Point Injection | Active comparator | Drug: RopivacaineParticipants received trigger point injections with 0.2% ropivacaine, 2 mL per trigger point. |
| Ropivacaine Trigger Point Injection Plus Pregabalin | Experimental | Drug: Ropivacaine, Drug: PregabalinParticipants received trigger point injections with 0.2% ropivacaine, 2 mL per trigger point, combined with oral pregabalin 50 mg twice daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80 years
- Clinical diagnosis of myofascial pain syndrome according to the Travell and Simons diagnostic criteria
Key exclusion criteria (9 listed)
- Age <18 and >80 years
- Coexisting systemic rheumatic disease
- Current treatment with serotonin-norepinephrine reuptake inhibitors (SNRIs)
- Current treatment with tricyclic antidepressants
- Current treatment with benzodiazepines
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 |
|---|---|---|
| RopivacaineRopivacaine 0.2%, administered as a 2 mL injection into each identified trigger point. | Drug | Ropivacaine Trigger Point Injection, Ropivacaine Trigger Point Injection Plus Pregabalin |
| PregabalinPregabalin 50 mg administered orally twice daily. | Drug | Ropivacaine Trigger Point Injection Plus Pregabalin |
Primary outcome
Change in pain intensity measured by the Numerical Rating Scale (NRS)
Time frame: Baseline, 1 month and 3 months after treatment
Pain intensity was assessed using the 0-10 Numerical Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
3 secondary outcomes
Change in the number of active trigger points
Time frame: Baseline, 1 month, and 3 months after treatment
Change in neuropathic pain assessed using the DN4 questionnaire
Time frame: Baseline, 1 month, and 3 months after treatment
Change in health-related quality of life assessed using the SF-12 questionnaire
Time frame: Baseline, 1 month, and 3 months after treatment
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 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because participant consent did not include public sharing of de-identified individual-level data.
Related trials for Myofascial Pain Syndrome - Neck
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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.
Chrysoula Staikou, PhD study chair
National and Kapodistrian University f Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Pregabalin in people with Myofascial Pain Syndrome - Neck, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 2 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 8 Oct 2026. 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 Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in pain intensity measured by the Numerical Rating Scale (NRS) (time frame: Baseline, 1 month and 3 months after treatment). 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 8 Oct 2026.