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

NCT05239091 | Completed

• 1 other identifier: FTRinjection
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myofascial Pain Syndrome of Neck

Keywords

Lidocaine; dextrose prolotherapy; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain intensity

  Change from baseline pain intensity score at 2,4,6 and 8 weeks.

• Pain tolerance measurement

  change from baseline pain tolerance at 2,4,6 and 8 weeks.

• SF-36 (Short Form-36) Survey

  Change from baseline SF-36 Short Form Survey score at 8 week.

Study Arms (2)

Dextrose prolotherapy

EXPERIMENTAL

:%15 dextrose prolotherapy injection will be applied to trigger point

Drug: Dextrose solution

Lidocaine

ACTIVE COMPARATOR

%2 lidocaine injection will be applied to trigger point

Drug: Lidocain

Interventions

Dextrose solution DRUG

A total of 3 doses of dextrose prolotherapy will be administered with an interval of 2 weeks.

Also known as: Dextrose prolotherapy

Dextrose prolotherapy

Lidocain DRUG

A total of 3 doses of lidocaine will be administered with an interval of 2 weeks.

Also known as: Local anesthetic

Lidocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Fatmanur Kesiktaş, Prof

  Istanbul Physical Medicine Rehabilitation Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, Outcomes Assessor, and Investigator (statistician) will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, triple blinded, clinical trials

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 14, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 22, 2022
• Last Updated: December 13, 2023

Record last verified: 2022-08

Locations

TU (1)