Myofascial Pain Syndrome of NeckNCT05239091
Comparison of the Efficacy of Prolotherapy Injection Therapy & Local Anesthetic Injection Therapy.
A study testing Dextrose solution and Lidocain in people with Myofascial Pain Syndrome of Neck, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Myofascial pain syndrome is a disease characterized by pain over the trigger point in a taut muscle band. After the correct diagnosis is made, many treatment methods can be applied. One of these treatments is the treatment with prolotherapy injection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome of Neck
- What is being tested?
- Dextrose solution and Lidocain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 22 Aug 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary myofascial pain syndrome (MAS) in the upper trapezius muscle
- At least one active myofascial trigger point in the upper trapezius muscle
- Patients with symptoms between 1 day and 2 months
- Age:18 to 65 years old
- Cases who did not receive any physical therapy or medication to relieve pain
Who cannot join
- Having a sensory defect in the area to be injected
- Active inflammatory, rheumatic, or infectious disease
- Peripheral nerve lesions such as polyneuropathy, radiculopathy
- Those who use anticoagulants, those with bleeding diathesis
- Patients whose skin surface is not intact in the area to be injected
- Patients diagnosed with fibromyalgia or other common musculoskeletal pain syndromes
Show all 12Show fewer
- Patients with a history of panic attacks
- Those who are allergic to local anesthetic drug
- People showing symptoms of Covid-19
- Those who have had a trigger point injection in the last 6 months
- Those who are pregnant
- Those who have undergone vertebral or shoulder surgery in the last 1 year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Hospital
Istanbul
About this study
Official title: Comparison of the Efficacy of Prolotherapy Injection Therapy and Local Anesthetic (Lidocaine) Injection Therapy in Myofascial Pain Syndrome.
Myofascial pain syndrome is a disease characterized by pain over the trigger point in a taut muscle band. After the correct diagnosis is made, many treatment methods can be applied.
One of these treatments is the treatment with prolotherapy injection. Proliferant reveals defense mechanisms remove them and then start the healing process in the damaged area. Usually, dextrose water is used. Lidocaine is an anesthetic. With lidocaine injection, the passage of painful stimuli is prevented and the opioid system is activated. The aim of the study is to compare the efficacy of prolotherapy and lidocaine treatment in the myofascial pain syndrome.
Read the detailed description
This is a prospective randomized controlled study. The population of the study consists of volunteer patients who can apply to Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, and meet the inclusion criteria. Twenty-eight people will be selected from the participants who volunteered for the study and will be divided into the study group and control groups with the permutation block randomization method. At the beginning, all patients will be asked about their gender, age, body mass index, education level, occupation, duration of complaint, previous treatments, and the last time received treatment.
Patients will be recruited equally to the control and study groups, with 14 patients in each group. 15% dextrose injection treatment will be applied to the study group. 2% lidocaine injection treatment will be applied to the control group. The subjects will be asked to sit on a chair and the trigger point will be determined in the upper trapezius muscle in both groups. A total of 3 sessions of injection treatment will be applied to the trigger points (at the beginning, at the 2nd, and 4th weeks). It will be planned to be 2 weeks between each injection session. 1 month after the third session injection, patients will be called for control purposes.
The application will be made using a 25 gauge injector. Before the injection, the skin will be cleaned with alcohol and then dried. All patients will be injected into the trigger points in the upper trapezius muscle. Trigger point injection, on the other hand, is the compression of the isolated skin with the help of the thumb and middle finger and advancing the needle into the muscle at a 90-degree angle. Before the injection, a puncture will be made to make sure the needle is not in the blood vessel. Some of the mixtures will be injected into the trigger point and the rest around the trigger point. The same injection technique will be applied in both the control and study groups. Measurements will be made at the beginning (week 0), week 2, and week 4 before and after the injection when they come to the 1-month control. Adverse events related to injections will be recorded.
- Conditions
- Myofascial Pain Syndrome of Neck
- Being tested
- Dextrose solution, Lidocain
- Keywords
- Lidocaine, dextrose prolotherapy, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose solutionDrug
Also called Dextrose prolotherapy
A total of 3 doses of dextrose prolotherapy will be administered with an interval of 2 weeks.
LidocainDrug
Also called Local anesthetic
A total of 3 doses of lidocaine will be administered with an interval of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dextrose prolotherapy | Experimental | :%15 dextrose prolotherapy injection will be applied to trigger point Receives: Drug: Dextrose solution |
| Lidocaine | Active comparator | %2 lidocaine injection will be applied to trigger point Receives: Drug: Lidocain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold
It will be measured by algometer. Its unit is kg/cm2
Measured: Change from baseline pressure pain threshold at 2,4,6 and 8 weeks.
Secondary outcomes (3)
Pain intensity
Pain intensity will be evaluated by using a visual analog scale (VAS).The maximum score is 10 points. A higher score indicates a worse pain level
Measured: Change from baseline pain intensity score at 2,4,6 and 8 weeks.
Pain tolerance measurement
A pressure of 2.5 kg/cm2 will be applied to the trigger point using an algometer (WAGNER -FPK20) and patients will be asked to express their pain intensity according to the visual analog scale (VAS) scale. All patients will be informed that VAS is 0 (no pain) and 10 (worst pain imaginable), and will be asked to indicate the point between 0 and 10 that can represent the severity of their pain.
Measured: change from baseline pain tolerance at 2,4,6 and 8 weeks.
SF-36 (Short Form-36) Survey
The scale consists of 36 items and these provide the measurement of 8 dimensions. Instead of giving only a single total score, the scale gives a total score for each subscale separately. Subscales evaluate health on a scale of 0 to 100, with 0 indicating poor health and 100 indicating good health.
Measured: Change from baseline SF-36 Short Form Survey score at 8 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome of NeckStudies 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
- Model description
- Prospective, randomized, triple blinded, clinical trials
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Necat Akgun, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Fatmanur Kesiktaş, Prof, Study director, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239091
- Sponsor's protocol ID
- FTRinjection
- Status last verified
- Aug 2022
- First submitted
- 24 Jan 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Prolotherapy Injection Therapy and Local Anesthetic (Lidocaine) Injection Therapy in Myofascial Pain Syndrome.
- ClinicalTrials.gov ID
- NCT05239091
- Acronym / sponsor ID
- FTRinjection
- Conditions
- Myofascial Pain Syndrome of Neck
- Keywords
- Lidocaine, dextrose prolotherapy, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 14 Feb 2022 (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 is a disease characterized by pain over the trigger point in a taut muscle band. After the correct diagnosis is made, many treatment methods can be applied.
One of these treatments is the treatment with prolotherapy injection. Proliferant reveals defense mechanisms remove them and then start the healing process in the damaged area. Usually, dextrose water is used. Lidocaine is an anesthetic. With lidocaine injection, the passage of painful stimuli is prevented and the opioid system is activated. The aim of the study is to compare the efficacy of prolotherapy and lidocaine treatment in the myofascial pain syndrome.
Detailed description
This is a prospective randomized controlled study. The population of the study consists of volunteer patients who can apply to Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, and meet the inclusion criteria. Twenty-eight people will be selected from the participants who volunteered for the study and will be divided into the study group and control groups with the permutation block randomization method. At the beginning, all patients will be asked about their gender, age, body mass index, education level, occupation, duration of complaint, previous treatments, and the last time received treatment.
Patients will be recruited equally to the control and study groups, with 14 patients in each group. 15% dextrose injection treatment will be applied to the study group. 2% lidocaine injection treatment will be applied to the control group. The subjects will be asked to sit on a chair and the trigger point will be determined in the upper trapezius muscle in both groups. A total of 3 sessions of injection treatment will be applied to the trigger points (at the beginning, at the 2nd, and 4th weeks). It will be planned to be 2 weeks between each injection session. 1 month after the third session injection, patients will be called for control purposes.
The application will be made using a 25 gauge injector. Before the injection, the skin will be cleaned with alcohol and then dried. All patients will be injected into the trigger points in the upper trapezius muscle. Trigger point injection, on the other hand, is the compression of the isolated skin with the help of the thumb and middle finger and advancing the needle into the muscle at a 90-degree angle. Before the injection, a puncture will be made to make sure the needle is not in the blood vessel. Some of the mixtures will be injected into the trigger point and the rest around the trigger point. The same injection technique will be applied in both the control and study groups. Measurements will be made at the beginning (week 0), week 2, and week 4 before and after the injection when they come to the 1-month control. Adverse events related to injections will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, triple blinded, clinical trials
| Arm | Type | Receives |
|---|---|---|
| Dextrose prolotherapy | Experimental | Drug: Dextrose solution:%15 dextrose prolotherapy injection will be applied to trigger point |
| Lidocaine | Active comparator | Drug: Lidocain%2 lidocaine injection will be applied to trigger point |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary myofascial pain syndrome (MAS) in the upper trapezius muscle
- At least one active myofascial trigger point in the upper trapezius muscle
- Patients with symptoms between 1 day and 2 months
- Age:18 to 65 years old
- Cases who did not receive any physical therapy or medication to relieve pain
Key exclusion criteria (12 listed)
- Having a sensory defect in the area to be injected
- Active inflammatory, rheumatic, or infectious disease
- Peripheral nerve lesions such as polyneuropathy, radiculopathy
- Those who use anticoagulants, those with bleeding diathesis
- Patients whose skin surface is not intact in the area to be injected
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 |
|---|---|---|
| Dextrose solutionAlso: Dextrose prolotherapyA total of 3 doses of dextrose prolotherapy will be administered with an interval of 2 weeks. | Drug | Dextrose prolotherapy |
| LidocainAlso: Local anestheticA total of 3 doses of lidocaine will be administered with an interval of 2 weeks. | Drug | Lidocaine |
Primary outcome
Pressure pain threshold
Time frame: Change from baseline pressure pain threshold at 2,4,6 and 8 weeks.
It will be measured by algometer. Its unit is kg/cm2
3 secondary outcomes
Pain intensity
Time frame: Change from baseline pain intensity score at 2,4,6 and 8 weeks.
Pain tolerance measurement
Time frame: change from baseline pain tolerance at 2,4,6 and 8 weeks.
SF-36 (Short Form-36) Survey
Time frame: Change from baseline SF-36 Short Form Survey score at 8 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 13 Dec 2023.
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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.
Fatmanur Kesiktaş, Prof study director
Istanbul Physical Medicine Rehabilitation 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 Dextrose solution and Lidocain in people with Myofascial Pain Syndrome of Neck, run by Istanbul Physical Medicine Rehabilitation 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 5 inclusion and 12 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 13 Dec 2023. 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?
Pressure pain threshold (time frame: Change from baseline pressure pain threshold at 2,4,6 and 8 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 13 Dec 2023.