Myofascial Pain SyndromeNCT04600037
Pregabalin Treatment for Trigger Points
A study testing Pregabalin 150mg in people with Myofascial Pain Syndrome, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Myofascial pain syndrome (MPS) is a common problem in the general population. MPS should not be a local/peripheral painful syndrome and considered to be a syndrome of central sensitivity. We aimed to investigate the effect of pregabalin in patients with MPS in this study Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Pregabalin 150mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Apr 2014to 26 Jan 2015
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who diagnosed fibromyalgia syndrome,
- Patients who were also diagnosed as cervical myofascial pain syndrome based on the upper trapezius muscle
Who cannot join
- Patients who had received dry needling or local anesthetic injection to trigger point in the dominant upper trapezius muscle within 3 months of the start of the study.
- renal insufficiency,
- impaired liver function,
- malignancy,
- pregnancy
- infections,
- history of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34752
About this study
Official title: Effectiveness of Pregabalin Treatment for Trigger Points in Patients With Comorbid Myofascial Pain Syndrome and Fibromyalgia Syndrome: a Randomized Controlled Trial
Myofascial pain syndrome (MPS) is a common problem in the general population. MPS should not be a local/peripheral painful syndrome and considered to be a syndrome of central sensitivity. We aimed to investigate the effect of pregabalin in patients with MPS in this study
Read the detailed description
We randomized 40 patients into two groups, and 17 patients per group completed the study. Patients in group I received pregabalin and exercise therapy, whereas those in group II received exercise therapy alone. All patients were evaluated as follows: for pain by VAS; trigger-point pressure pain threshold-(PPT) by algometry; neuropathic pain using DN4 and quality of life with the SF36. Evaluations were performed pretreatment and at the end of the first and third months of treatment.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Pregabalin 150mg
- Keywords
- fibromyalgia, trigger point, myofascial pain, pregabalin
- Medical subject headings
- Myofascial Pain Syndromes, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
Patients in group I received pregabalin at a dose of 75 mg twice daily during the first week that was increased to 150 mg twice daily thereafter and maintained at that level for 12 weeks.
Patients in two groups received exercise therapy (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients received pregabalin (target dose 300 mg/day) and exercise therapy (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months Receives: Drug: Pregabalin 150mg |
| Group 2 | No intervention | Patients received exercise therapy alone (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
VAS is psychometric measuring instrument designed to document the characteristics of disease-related symptom severity in each patient and use this to achieve a rapid classification of symptom severity and disease control. Patients were instructed to rate their pain between 0 and 10
Measured: 3 months
Pressure pain thresholds (PPT) assessment
We assessed PPTs in upper trapezius trigger points with an algometer in all patients. PPT is defined as the minimal amount of pressure required to change a sensation of pressure to pain. An electronic algometer (Baseline Push Pull Force Gauge) was used, which consisted of a metal piston with a 1-cm circular rubber tip. Pressure measurements were recorded as kilograms per square centimeter (kg/cm2) with the patient in a seated position. The algometer was placed at a selected trigger point with the metal rod perpendicular to the surface of the skin, the pressure applied to the muscles was increased at a rate of approximately 1 kg per second, and the patient was instructed to state when pain was perceived. This procedure was repeated three times per patient, with 1-minute intervals. The mean of three trials (intra-examiner reliability) was calculated and used for the main analysis. If trigger points were in both upper trapezius muscle, the dominant side was evaluated.
Measured: 3 months
DN4 - Questionnaire (DN4)
DN4 was used to evaluate neuropathic pain. DN4 is used to identify neuropathic pain and consists of ten questions. Seven questions are concerned with symptoms and three are concerned with clinical findings. Symptoms assessed are burning, painful cold, electric shocks, tingling, pins and needles, numbness, and itching. The physician assesses whether there is reduced sensation (hypoesthesia) to touch or pinprick, and if light brushing increases or causes pain (allodynia) by examination. Each item is scored "yes" (1 point) or "no" (0 points). If the total score is ≥4, the pain is likely to be neuropathic
Measured: 3 months
Short Form-36 (SF36)
The SF36 is a self-reported questionnaire widely used to measure quality of life. The questions are summarized into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. The initial four items form the physical component summary measuring physical health domains, while the latter four items form the mental component summary measuring mental health domains. Scores can range from 0 (worst health status) to 100 (best health status) per domain. Higher scores indicate better health status for the calculated sub item
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start26 Apr 2014
- Primary completion26 Jul 2014
- Study completion26 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duygu Silte Karamanlioglu, MD, Principal investigator, Fatih Sultan Mehmet Training and Research HospitalDuygu Geler Kulcu, prof, Study director, Haydarpaşa Numune Training and Research HospitalGulcan Ozturk, MD, Study chair, Fatih Sultan Mehmet Training and Research HospitalPinar Akpinar, Assoc prof, Study chair, Fatih Sultan Mehmet Training and Research HospitalFeyza Unlu Ozkan, Assoc prof, Study chair, Fatih Sultan Mehmet Training and Research HospitalIlknur Aktas, Prof, Study chair, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600037
- Sponsor's protocol ID
- FSMEAH-KAEK 2014/20
- Status last verified
- Oct 2020
- First submitted
- 18 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karamanlioglu DS, Geler Kulcu D, Ozturk G, Akpinar P, Unlu Ozkan F, Aktas I. Effectiveness of pregabalin treatment for trigger points in patients with comorbid myofascial pain syndrome and fibromyalgia syndrome: a randomized controlled trial. Somatosens Mot Res. 2021 Dec;38(4):327-332. doi: 10.1080/08990220.2021.1977265. Epub 2021 Sep 20.
PubMed 34544324
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pregabalin Treatment for Trigger Points in Patients With Comorbid Myofascial Pain Syndrome and Fibromyalgia Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04600037
- Acronym / sponsor ID
- FSMEAH-KAEK 2014/20
- Conditions
- Myofascial Pain Syndrome
- Keywords
- fibromyalgia, trigger point, myofascial pain, pregabalin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 26 Apr 2014 (actual)
- Primary completion
- 26 Jul 2014 (actual)
- Study completion
- 26 Jan 2015 (actual)
- First posted
- 23 Oct 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.
Myofascial pain syndrome (MPS) is a common problem in the general population. MPS should not be a local/peripheral painful syndrome and considered to be a syndrome of central sensitivity. We aimed to investigate the effect of pregabalin in patients with MPS in this study
Detailed description
We randomized 40 patients into two groups, and 17 patients per group completed the study. Patients in group I received pregabalin and exercise therapy, whereas those in group II received exercise therapy alone. All patients were evaluated as follows: for pain by VAS; trigger-point pressure pain threshold-(PPT) by algometry; neuropathic pain using DN4 and quality of life with the SF36. Evaluations were performed pretreatment and at the end of the first and third months of treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Pregabalin 150mgPatients received pregabalin (target dose 300 mg/day) and exercise therapy (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months |
| Group 2 | No intervention | –Patients received exercise therapy alone (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who diagnosed fibromyalgia syndrome,
- Patients who were also diagnosed as cervical myofascial pain syndrome based on the upper trapezius muscle
Key exclusion criteria (7 listed)
- Patients who had received dry needling or local anesthetic injection to trigger point in the dominant upper trapezius muscle within 3 months of the start of the study.
- renal insufficiency,
- impaired liver function,
- malignancy,
- pregnancy
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 |
|---|---|---|
| Pregabalin 150mgPatients in group I received pregabalin at a dose of 75 mg twice daily during the first week that was increased to 150 mg twice daily thereafter and maintained at that level for 12 weeks. Patients in two groups received exercise therapy (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months | Drug | Group 1 |
Primary outcome
Visual analog scale (VAS)
Time frame: 3 months
VAS is psychometric measuring instrument designed to document the characteristics of disease-related symptom severity in each patient and use this to achieve a rapid classification of symptom severity and disease control. Patients were instructed to rate their pain between 0 and 10
Pressure pain thresholds (PPT) assessment
Time frame: 3 months
We assessed PPTs in upper trapezius trigger points with an algometer in all patients. PPT is defined as the minimal amount of pressure required to change a sensation of pressure to pain. An electronic algometer (Baseline Push Pull Force Gauge) was used, which consisted of a metal piston with a 1-cm circular rubber tip. Pressure measurements were recorded as kilograms per square centimeter (kg/cm2) with the patient in a seated position. The algometer was placed at a selected trigger point with the metal rod perpendicular to the surface of the skin, the pressure applied to the muscles was increased at a rate of approximately 1 kg per second, and the patient was instructed to state when pain was perceived. This procedure was repeated three times per patient, with 1-minute intervals. The mean of three trials (intra-examiner reliability) was calculated and used for the main analysis. If trigger points were in both upper trapezius muscle, the dominant side was evaluated.
DN4 - Questionnaire (DN4)
Time frame: 3 months
DN4 was used to evaluate neuropathic pain. DN4 is used to identify neuropathic pain and consists of ten questions. Seven questions are concerned with symptoms and three are concerned with clinical findings. Symptoms assessed are burning, painful cold, electric shocks, tingling, pins and needles, numbness, and itching. The physician assesses whether there is reduced sensation (hypoesthesia) to touch or pinprick, and if light brushing increases or causes pain (allodynia) by examination. Each item is scored "yes" (1 point) or "no" (0 points). If the total score is ≥4, the pain is likely to be neuropathic
Short Form-36 (SF36)
Time frame: 3 months
The SF36 is a self-reported questionnaire widely used to measure quality of life. The questions are summarized into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. The initial four items form the physical component summary measuring physical health domains, while the latter four items form the mental component summary measuring mental health domains. Scores can range from 0 (worst health status) to 100 (best health status) per domain. Higher scores indicate better health status for the calculated sub item
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 23 Oct 2020.
- Derived from this study: PubMed 34544324Karamanlioglu DS, Geler Kulcu D, Ozturk G, Akpinar P, Unlu Ozkan F, Aktas I. Effectiveness of pregabalin treatment for trigger points in patients with comorbid myofascial pain syndrome and fibromyalgia syndrome: a randomized controlled trial. Somatosens Mot Res. 2021 Dec;38(4):327-332. doi: 10.1080/08990220.2021.1977265. Epub 2021 Sep 20.
- 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.
Duygu Silte Karamanlioglu, MD principal investigator
Fatih Sultan Mehmet Training and Research Hospital
Duygu Geler Kulcu, prof study director
Haydarpaşa Numune Training and Research Hospital
Gulcan Ozturk, MD study chair
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin 150mg in people with Myofascial Pain Syndrome, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 7 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 23 Oct 2020. 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 Turkey (Türkiye). 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 analog scale (VAS) (time frame: 3 months). The study lists 4 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 NCT04600037, which also lists 1 linked publication.
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 23 Oct 2020.