Efficacy of Dextrose Prolotherapy in Myofascial Pain SyndromePhase 4NCT04941118
Myofascial Pain Syndrome and Dextrose Prolotherapy
A Phase 4 study testing Injection of dextrose, local anesthetic and saline to the myofascial trigger point and Local anesthetic and saline injection to the myofascial trigger point in people with Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Myofascial pain syndrome is characterized by the presence of hypersensitive points called trigger points that cause pain, tenderness, spasm, stiffness, limitation of movement, weakness, taut band within the muscle, and pain reflected by pressing in a muscle group or a single muscle. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome
- What is being tested?
- Injection of dextrose, local anesthetic and saline to the myofascial trigger point and Local anesthetic and saline injection to the myofascial trigger point
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2021to 31 Dec 2021
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 60 women aged 20-50 years with a diagnosis of myofascial pain syndrome
Who cannot join
- Cervical radiculopathy, cervical degeneration, neck surgery or trauma in the last year, injection history for myofascial pain syndrome in the last 6 months, cognitive impairment and fibromyalgia, rheumatoid arthritis, hypothyroidism, diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hatay Mustafa Kemal University, Tayfur Ata Sökmen Faculty of Medicine
Hatay, 31060
Halil Ogut, M.D., +90 326 229 1000 ext. 5067, oguthalil@gmail.com
About this study
Official title: Evaluation of the Effect of Dextrose Prolotherapy on Pain and Function in Women With Myofascial Pain Syndrome
Myofascial pain syndrome is characterized by the presence of hypersensitive points called trigger points that cause pain, tenderness, spasm, stiffness, limitation of movement, weakness, taut band within the muscle, and pain reflected by pressing in a muscle group or a single muscle.
Prolotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal pain, in which an irritating solution is injected, often hypertonic dextrose, into painful ligament and tendon attachments and adjacent joint spaces.
In this study, it was aimed to examine the effect of prolotherapy application on pain, neck range of motion and neck disability in women with myofascial pain syndrome.
- Being tested
- Injection of dextrose, local anesthetic and saline to the myofascial trigger point, Local anesthetic and saline injection to the myofascial trigger point
- Keywords
- Myofascial pain, dextrose prolotherapy, neck disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of dextrose, local anesthetic and saline to the myofascial trigger pointDrug
An injection of 5 ml of 5% dextrose prolotherapy using 2.5 ml 10% dextrose, 1 ml 2% local anesthetic (lidocaine), 1.5 ml 0.9% saline will be administered to the active group from at least 10 trigger points.
Local anesthetic and saline injection to the myofascial trigger pointDrug
A total of 5 ml of solution created by using 4 ml of 0.9% saline and 1 ml of 2% local anesthetic (lidocaine) will be administered to the control group, with at least 10 trigger points.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Only saline and local anesthetic (lidocaine) Receives: Drug: Local anesthetic and saline injection to the myofascial trigger point |
| Dextrose prolotherapy group | Active comparator | Dextrose, saline and local anesthetic (lidocaine) Receives: Drug: Injection of dextrose, local anesthetic and saline to the myofascial trigger point |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
0-10 cm visual scale (0: no pain, 10: most severe pain)
Measured: First month post-treatment
Neck Disability Index
It measures the functional state of the neck by scoring between 0-5 points according to the severity of pain, consisting of 20 questions.
Measured: First month post-treatment
Neck joint range of motion measurement
Active neck range of motion, which shows the movement of the neck in all directions, is evaluated by goniometric measurement.
Measured: First month post-treatment
Secondary outcomes (1)
Side effects
Edema, ecchymosis, hematoma, allergic reaction, exacerbation of pain, systemic or distant side effects
Measured: Through study completion, an average of 6 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start15 Jul 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Efficacy of Dextrose Prolotherapy in 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ogut, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941118
- Sponsor's protocol ID
- MustafaKUPMR-MPS
- Status last verified
- Jul 2021
- First submitted
- 15 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Farpour HR, Fereydooni F. Comparative effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis: A randomized clinical trial. Electron Physician. 2017 Nov 25;9(11):5663-5669. doi: 10.19082/5663. eCollection 2017 Nov.
PubMed 29403602Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504.
PubMed 23690322
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Dextrose Prolotherapy on Pain and Function in Women With Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT04941118
- Acronym / sponsor ID
- MustafaKUPMR-MPS
- Keywords
- Myofascial pain, dextrose prolotherapy, neck disability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Jun 2021 (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 characterized by the presence of hypersensitive points called trigger points that cause pain, tenderness, spasm, stiffness, limitation of movement, weakness, taut band within the muscle, and pain reflected by pressing in a muscle group or a single muscle.
Prolotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal pain, in which an irritating solution is injected, often hypertonic dextrose, into painful ligament and tendon attachments and adjacent joint spaces.
In this study, it was aimed to examine the effect of prolotherapy application on pain, neck range of motion and neck disability in women with myofascial pain syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Drug: Local anesthetic and saline injection to the myofascial trigger pointOnly saline and local anesthetic (lidocaine) |
| Dextrose prolotherapy group | Active comparator | Drug: Injection of dextrose, local anesthetic and saline to the myofascial trigger pointDextrose, saline and local anesthetic (lidocaine) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 60 women aged 20-50 years with a diagnosis of myofascial pain syndrome
Key exclusion criteria (1 listed)
- Cervical radiculopathy, cervical degeneration, neck surgery or trauma in the last year, injection history for myofascial pain syndrome in the last 6 months, cognitive impairment and fibromyalgia, rheumatoid arthritis, hypothyroidism, diabetes mellitus
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 |
|---|---|---|
| Injection of dextrose, local anesthetic and saline to the myofascial trigger pointAn injection of 5 ml of 5% dextrose prolotherapy using 2.5 ml 10% dextrose, 1 ml 2% local anesthetic (lidocaine), 1.5 ml 0.9% saline will be administered to the active group from at least 10 trigger points. | Drug | Dextrose prolotherapy group |
| Local anesthetic and saline injection to the myofascial trigger pointA total of 5 ml of solution created by using 4 ml of 0.9% saline and 1 ml of 2% local anesthetic (lidocaine) will be administered to the control group, with at least 10 trigger points. | Drug | Control group |
Primary outcome
Visual Analog Scale
Time frame: First month post-treatment
0-10 cm visual scale (0: no pain, 10: most severe pain)
Neck Disability Index
Time frame: First month post-treatment
It measures the functional state of the neck by scoring between 0-5 points according to the severity of pain, consisting of 20 questions.
Neck joint range of motion measurement
Time frame: First month post-treatment
Active neck range of motion, which shows the movement of the neck in all directions, is evaluated by goniometric measurement.
1 secondary outcome
Side effects
Time frame: Through study completion, an average of 6 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Background: PubMed 29403602Farpour HR, Fereydooni F. Comparative effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis: A randomized clinical trial. Electron Physician. 2017 Nov 25;9(11):5663-5669. doi: 10.19082/5663. eCollection 2017 Nov.
- Background: PubMed 23690322Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504.
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.
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 Injection of dextrose, local anesthetic and saline to the myofascial trigger point and Local anesthetic and saline injection to the myofascial trigger point in people with Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome, run by Mustafa Kemal University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 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 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halil Ogut, M.D. (+90 326 229 1000 ext. 5067, oguthalil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: First month post-treatment). The study lists 3 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 NCT04941118, which also lists 2 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 21 Jul 2021.