search
Back to results

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

Primary Purpose

Myofascial Pain Syndrome of Neck

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dextrose solution
Lidocain
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome of Neck focused on measuring Lidocaine, dextrose prolotherapy, pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Physical Medicine Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dextrose prolotherapy

Lidocaine

Arm Description

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

%2 lidocaine injection will be applied to trigger point

Outcomes

Primary Outcome Measures

Pressure pain threshold
It will be measured by algometer. Its unit is kg/cm2

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
January 24, 2022
Last Updated
August 24, 2022
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05239091
Brief Title
Comparison of the Efficacy of Prolotherapy Injection Therapy & Local Anesthetic Injection Therapy.
Official Title
Comparison of the Efficacy of Prolotherapy Injection Therapy and Local Anesthetic (Lidocaine) Injection Therapy in Myofascial Pain Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome of Neck
Keywords
Lidocaine, dextrose prolotherapy, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, triple blinded, clinical trials
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Patients, Outcomes Assessor, and Investigator (statistician) will be blinded
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dextrose prolotherapy
Arm Type
Experimental
Arm Description
:%15 dextrose prolotherapy injection will be applied to trigger point
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
%2 lidocaine injection will be applied to trigger point
Intervention Type
Drug
Intervention Name(s)
Dextrose solution
Other Intervention Name(s)
Dextrose prolotherapy
Intervention Description
A total of 3 doses of dextrose prolotherapy will be administered with an interval of 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Lidocain
Other Intervention Name(s)
Local anesthetic
Intervention Description
A total of 3 doses of lidocaine will be administered with an interval of 2 weeks.
Primary Outcome Measure Information:
Title
Pressure pain threshold
Description
It will be measured by algometer. Its unit is kg/cm2
Time Frame
Change from baseline pressure pain threshold at 2,4,6 and 8 weeks.
Secondary Outcome Measure Information:
Title
Pain intensity
Description
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
Time Frame
Change from baseline pain intensity score at 2,4,6 and 8 weeks.
Title
Pain tolerance measurement
Description
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.
Time Frame
change from baseline pain tolerance at 2,4,6 and 8 weeks.
Title
SF-36 (Short Form-36) Survey
Description
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.
Time Frame
Change from baseline SF-36 Short Form Survey score at 8 week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatmanur Kesiktaş, Prof
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs