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Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy.

Primary Purpose

Myofascial Pain Syndrome, Pain, Myofascial Trigger Point Pain

Status
Completed
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
Physical therapy
Lidocaine injection
Lidocaine injection + physical therapy
Sponsored by
Grupo Rehabilitacion en Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Myofascial pain, Trigger points., Lidocaine injection., Physical therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Cervical Pain at least six weeks
  • At least 40 mm in the VAS
  • They cannot been received treatment like physical therapy or analgesics
  • Maximum score of PHQ 16 points

Exclusion Criteria:

  • Depression
  • Fibromyalgia
  • Cervical Radiculopathy

Sites / Locations

  • Clinica de Las Américas
  • Ips Universitaria

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Physical Therapy

Lidocaine injection

Lidocaine injection + physical therapy

Arm Description

Twelve sessions, 3 per week.

Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.

Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.

Outcomes

Primary Outcome Measures

Visual Analogue Scale
VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously
Visual Analogue Scale
VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously

Secondary Outcome Measures

PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe
Quality of Life SF-36
The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.
PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe
Quality of Life SF-36
The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.

Full Information

First Posted
November 27, 2010
Last Updated
October 4, 2014
Sponsor
Grupo Rehabilitacion en Salud
Collaborators
Universidad de Antioquia
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1. Study Identification

Unique Protocol Identification Number
NCT01250184
Brief Title
Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy.
Official Title
Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy, Alone or in Combination: a Single-blind, Randomized, Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo Rehabilitacion en Salud
Collaborators
Universidad de Antioquia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Myofascial pain syndrome (MPS) of the shoulder girdle and cervical region is a common musculoskeletal problem that is often chronic or recurrent. It has demonstrated the effectiveness of different treatments such as exercise, injection but not comparing them with each other. The objective of this research was to demonstrate whether lidocaine injection into trigger points combined with a physical therapy program was more effective than each separatetreatment in improving pain, function and quality of life in a group of patients with myofascial pain syndrome (MPS) of the shoulder girdle and cervical region. Design: Single-blind, randomized, controlled clinical trial with three parallel groups in the departments of physical medicine and rehabilitation of two urban hospitals. There were 127 patients with myofascial pain in the shoulder girdle for more than six weeks in length and pain greater than 40 mm on the visual analog scale (VAS). There were three intervention groups: physical therapy (PT), lidocaine injection (LI), or the combination of both (PT + LI). The primary outcome at one month was the VAS, and the secondary outcomes were measured using the SF36 pain scaleat one and three months. Keywords: Myofascial pain, trigger points, lidocaine injection, physical therapy.
Detailed Description
We propose a double blind randomized controlled clinical trial, in different health centers in Medellin. The subjects are patients with myofascial trigger points (MTP) in muscles of the shoulder girdle (levator scapulae, trapezius, infraspinatus) diagnosed by neck ans shoulder pain lasting langer than 6 weeks, and that have not received rehabilitation treatment and are not currently taking analgesic medications. We have calculated a sample of 45 patients in each group. The physical and rehabilitation doctors who evaluated the patients and the nurse who assessed the patients were blinded to treatment allocation. Physicians who performed the MTP injection did not participate in the evaluation of primary and secondary outcomes. Physical therapists who conducted the therapeutic exercise program did not participate in the evaluation of primary and secondary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome, Pain, Myofascial Trigger Point Pain, Musculoskeletal Pain
Keywords
Myofascial pain, Trigger points., Lidocaine injection., Physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
Twelve sessions, 3 per week.
Arm Title
Lidocaine injection
Arm Type
Active Comparator
Arm Description
Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Arm Title
Lidocaine injection + physical therapy
Arm Type
Experimental
Arm Description
Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
Intervention Type
Other
Intervention Name(s)
Physical therapy
Other Intervention Name(s)
standardized therapeutic exercise program
Intervention Description
Twelve sessions (3 per week)
Intervention Type
Drug
Intervention Name(s)
Lidocaine injection
Other Intervention Name(s)
blocking the Myofascial trigger point
Intervention Description
blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
Intervention Type
Other
Intervention Name(s)
Lidocaine injection + physical therapy
Other Intervention Name(s)
blocking plus a standarized therapeutic exercise program
Intervention Description
blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously
Time Frame
4 weeks
Title
Visual Analogue Scale
Description
VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
Description
The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe
Time Frame
4 weeks
Title
Quality of Life SF-36
Description
The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.
Time Frame
4 weeks
Title
PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
Description
The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe
Time Frame
12 weeks
Title
Quality of Life SF-36
Description
The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cervical Pain at least six weeks At least 40 mm in the VAS They cannot been received treatment like physical therapy or analgesics Maximum score of PHQ 16 points Exclusion Criteria: Depression Fibromyalgia Cervical Radiculopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luz H Lugo Agudelo, Professor
Organizational Affiliation
Universidad de Antioquia Grupo Rehabilitacion en Salud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica de Las Américas
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Ips Universitaria
City
Medellin
State/Province
Antioquia
Country
Colombia

12. IPD Sharing Statement

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Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy.

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