Comparison of the Efficacy of Prolotherapy Injection Therapy & Local Anesthetic Injection Therapy.

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome of Neck
• Intervention / Treatment: Drug: Dextrose solution; Drug: Lidocain

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Physical Medicine Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dextrose prolotherapy; :%15 dextrose prolotherapy injection will be applied to trigger point	Drug: Dextrose solution; A total of 3 doses of dextrose prolotherapy will be administered with an interval of 2 weeks.; Other Names: Dextrose prolotherapy
Active Comparator: Lidocaine; %2 lidocaine injection will be applied to trigger point	Drug: Lidocain; A total of 3 doses of lidocaine will be administered with an interval of 2 weeks.; Other Names: Local anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure pain threshold	It will be measured by algometer. Its unit is kg/cm2	Change from baseline pressure pain threshold at 2,4,6 and 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	Change from baseline SF-36 Short Form Survey score at 8 week.

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Investigators: Study Director: Fatmanur Kesiktaş, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: pain; Lidocaine; dextrose prolotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Lidocaine; Anesthetics, Local
• Other Study ID Numbers: FTRinjection

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No