Myofascial Pain Syndrome and Dextrose Prolotherapy

Sponsor

Mustafa Kemal University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04941118

Collaborator

(none)

Enrollment

Location

Arms

5.6

Anticipated Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome	Drug: Injection of dextrose, local anesthetic and saline to the myofascial trigger point Drug: Local anesthetic and saline injection to the myofascial trigger point	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Effect of Dextrose Prolotherapy on Pain and Function in Women With Myofascial Pain Syndrome

Actual Study Start Date :

Jul 15, 2021

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Control group Only saline and local anesthetic (lidocaine)	Drug: Local anesthetic and saline injection to the myofascial trigger point 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.
Active Comparator: Dextrose prolotherapy group Dextrose, saline and local anesthetic (lidocaine)	Drug: Injection of dextrose, local anesthetic and saline to the myofascial trigger point 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.

Arm

Intervention/Treatment

Sham Comparator: Control group

Only saline and local anesthetic (lidocaine)

Drug: Local anesthetic and saline injection to the myofascial trigger point

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.

Active Comparator: Dextrose prolotherapy group

Dextrose, saline and local anesthetic (lidocaine)

Drug: Injection of dextrose, local anesthetic and saline to the myofascial trigger point

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.

Outcome Measures

Primary Outcome Measures

Visual Analog Scale [First month post-treatment]
0-10 cm visual scale (0: no pain, 10: most severe pain)
Neck Disability Index [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 [First month post-treatment]
Active neck range of motion, which shows the movement of the neck in all directions, is evaluated by goniometric measurement.

Secondary Outcome Measures

Side effects [Through study completion, an average of 6 month.]
Edema, ecchymosis, hematoma, allergic reaction, exacerbation of pain, systemic or distant side effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

60 women aged 20-50 years with a diagnosis of myofascial pain syndrome

Exclusion Criteria:

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