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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01250184
Recruitment Status : Completed
First Posted : November 30, 2010
Results First Posted : October 10, 2014
Last Update Posted : October 10, 2014
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Luz Helena Lugo Agudelo, Grupo Rehabilitacion en Salud

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Myofascial Pain Syndrome
Pain
Myofascial Trigger Point Pain
Musculoskeletal Pain
Interventions Other: Physical therapy
Drug: Lidocaine injection
Other: Lidocaine injection + physical therapy
Enrollment 127
Recruitment Details In the databases of two general and specialized medical institutions, 762 patients were identified to have non-specific myalgia or muscle disorders diagnoses. A nurse by phone and two medical physiatrists at the hospitals, with over 10 years of research experience evaluated the MPS patients and their medical history.
Pre-assignment Details The randomization process was performed using permuted blocks.This process was performed by an investigator (HIG) who had no contact with the patients. The allocations to each treatment were placed in consecutive sealed, opaque envelopes, were kept in the research headquarters and were taken to the site according to the number of patients referred.
Arm/Group Title Physical Therapy Lidocaine Injection + Physical Therapy Lidocaine Injection
Hide Arm/Group Description

Twelve sessions, 3 per week.

Physical therapy: Twelve sessions (3 per week)

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

blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

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

Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

Period Title: Overall Study
Started 43 41 43
Completed 43 41 43
Not Completed 0 0 0
Arm/Group Title Blocking the MTP Plus Physical Therapy Physical Therapy Blocking the MTP Total
Hide Arm/Group Description

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

blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

Twelve sessions, 3 per week.

Physical therapy: Twelve sessions (3 per week)

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

Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

Total of all reporting groups
Overall Number of Baseline Participants 41 43 43 127
Hide Baseline Analysis Population Description
This was calculated with the software "Sample Size Javeriana University" it was took in to account a error type I of 0.05, type II of 0.2, number of measurements before randomization = 1, after performing the randomization = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a number of patients = 45 each
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 43 participants 43 participants 127 participants
37.2  (11.1) 42.6  (9.7) 37.7  (11.8) 39.19  (11.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 43 participants 43 participants 127 participants
Female
35
  85.4%
36
  83.7%
33
  76.7%
104
  81.9%
Male
6
  14.6%
7
  16.3%
10
  23.3%
23
  18.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Colombia Number Analyzed 41 participants 43 participants 43 participants 127 participants
41 43 43 127
Concomitant factors   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 43 participants 43 participants 127 participants
Stress 34 29 30 93
Sleeplessness 24 18 23 65
Longer positions 27 34 29 90
[1]
Measure Description: A patient could have more than one Concomitant factor
Muscles with trigger point   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 43 participants 43 participants 127 participants
Trapezius muscle 37 42 39 118
Levator scapulae 31 27 26 84
Infraspinatus muscle 12 12 13 37
[1]
Measure Description: A patient could have more than one trigger point
Physical examination   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 43 participants 43 participants 127 participants
Sensitive Alteration 8 7 8 23
Referred pain 22 36 23 81
Local twitch response 29 26 22 77
[1]
Measure Description: A patient could have more than one alteration on the physical examination.
Visual Analogue Scale for Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 41 participants 43 participants 43 participants 127 participants
63.5  (13.9) 68.7  (17) 64.2  (16.2) 65.54  (15.9)
[1]
Measure 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
Patient Health Questionnaire – 9   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 41 participants 43 participants 43 participants 127 participants
5.6  (3.2) 5.9  (4.2) 5.6  (3.5) 5.72  (3.68)
[1]
Measure 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
Patient Health Questionnaire – 9 How often   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 43 participants 43 participants 127 participants
Not at all 30 30 29 89
Several days 9 8 14 31
More than half the days 2 4 0 6
Nearly every day 0 1 0 1
[1]
Measure Description: Here we are reporting how often the patient presents symptoms? 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   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 41 participants 43 participants 43 participants 127 participants
Body pain 38.8  (14.4) 35.2  (14.3) 38.5  (16.4) 37.52  (15.2)
Role-emotional 66.4  (35.0) 75.8  (38.7) 67.2  (36.8) 69.92  (36.89)
Role-physical 51.2  (40) 51.1  (37.7) 42.4  (37.6) 48.21  (48.36)
Physical functioning 79.5  (17.8) 72.5  (20.5) 81.7  (11.9) 77.91  (17.5)
Social Function 69.5  (22) 68  (26.6) 71.8  (23.6) 69.83  (24.06)
General health 67.4  (18.3) 57.3  (21.9) 70.7  (15.4) 65.12  (19.47)
Mental health 67.8  (14.2) 65.5  (18.9) 67.4  (17.5) 66.93  (16.95)
Vitality 54.2  (13.9) 54.7  (19.2) 60.7  (19.3) 56.61  (17.85)
[1]
Measure 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
1.Primary Outcome
Title Visual Analogue Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Was calculated with the software "Sample Size from Javeriana University", was taken into account an error type I of 0.05 and error type II of 0.2, number of measurements before randomization = 1, after performing scrambling = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a total number of = 45 each
Arm/Group Title Lidocaine Injection + Physical Therapy Lidocaine Injection Physical Therapy
Hide Arm/Group Description:

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

blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

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

Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

Twelve sessions, 3 per week.

Physical therapy: Twelve sessions (3 per week)

Overall Number of Participants Analyzed 41 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
40.8  (25.3) 44.2  (24.9) 37.8  (21.9)
2.Primary Outcome
Title Visual Analogue Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Was calculated with the software "Sample Size from Javeriana University", was taken into account an error type I of 0.05 and error type II of 0.2, number of measurements before randomization = 1, after performing scrambling = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a total number of = 45 each
Arm/Group Title Lidocaine Injection + Physical Therapy Lidocaine Injection Physical Therapy
Hide Arm/Group Description:

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

blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

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

Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

Twelve sessions, 3 per week.

Physical therapy: Twelve sessions (3 per week)

Overall Number of Participants Analyzed 41 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
21.6  (21.8) 28.8  (22.3) 28.2  (23.7)
3.Secondary Outcome
Title PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Injection + Physical Therapy Lidocaine Injection Physical Therapy
Hide Arm/Group Description:

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

blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

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

Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

Twelve sessions, 3 per week.

Physical therapy: Twelve sessions (3 per week)

Overall Number of Participants Analyzed 41 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.33  (3.647) 4.44  (3.03) 4.43  (4.073)
4.Secondary Outcome
Title Quality of Life SF-36
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Injection + Physical Therapy Lidocaine Injection Physical Therapy
Hide Arm/Group Description:

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

blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

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

Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

Twelve sessions, 3 per week.

Physical therapy: Twelve sessions (3 per week)

Overall Number of Participants Analyzed 41 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
Changing Health 70.0  (18.1) 67.8  (16.05) 60.93  (18.5)
Body pain 55.3  (18.4) 51.78  (15.70) 57.12  (20.7)
Emotional performance 78.2  (35.1) 78.76  (33.24) 85.85  (27.58)
Physical performance 73.1  (40.5) 74.39  (33.3) 73.84  (34.48)
Physical Function 86.8  (13.2) 86.83  (11.55) 82.79  (15.52)
Social Function 79.2  (20.7) 78.15  (20.44) 81.51  (22.83)
General Health 72.1  (16.7) 73.54  (13.43) 65.70  (20.16)
Mental Health 73.2  (16.6) 69.95  (17.57) 70.05  (19.82)
Vitality 61.3  (16) 62.56  (17.32) 59.88  (19.83)
5.Secondary Outcome
Title PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Injection + Physical Therapy Lidocaine Injection Physical Therapy
Hide Arm/Group Description:

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

blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

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

Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

Twelve sessions, 3 per week.

Physical therapy: Twelve sessions (3 per week)

Overall Number of Participants Analyzed 41 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.98  (3.97) 3.16  (2.81) 4.12  (4.48)
6.Secondary Outcome
Title Quality of Life SF-36
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Injection + Physical Therapy Lidocaine Injection Physical Therapy
Hide Arm/Group Description:

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

blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

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

Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

Twelve sessions, 3 per week.

Physical therapy: Twelve sessions (3 per week)

Overall Number of Participants Analyzed 41 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
Changing Health 70.5  (18.67) 70.23  (17.11) 69.76  (18.5)
Body pain 66.58  (20.09) 61.19  (17.67) 65.66  (20.9)
Emotional performance 83.25  (32.11) 90.60  (21.15) 84.13  (32.95)
Physical performance 81.88  (30.48) 87.79  (22.07) 82.5  (31.11)
Physical Function 87.75  (16.94) 90  (9.06) 89.13  (12.29)
Social Function 82.6  (20.99) 83.28  (17.44) 83.05  (20.71)
General Health 71.67  (17.26) 77.44  (12.50) 68.25  (22.37)
Mental Health 75.3  (16.79) 78.95  (14.03) 71.32  (17.86)
Vitality 63.38  (16.11) 69.64  (16.17) 61.95  (18.53)
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lidocaine Injection + Physical Therapy Physical Therapy Lidocaine Injection
Hide Arm/Group Description

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

blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

Twelve sessions, 3 per week.

Physical therapy: Twelve sessions (3 per week)

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

Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

All-Cause Mortality
Lidocaine Injection + Physical Therapy Physical Therapy Lidocaine Injection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lidocaine Injection + Physical Therapy Physical Therapy Lidocaine Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      0/43 (0.00%)      0/43 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lidocaine Injection + Physical Therapy Physical Therapy Lidocaine Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/41 (9.76%)      0/43 (0.00%)      3/43 (6.98%)    
Skin and subcutaneous tissue disorders       
Hematomas * 1 [1]  4/41 (9.76%)  4 0/43 (0.00%)  0 2/43 (4.65%)  2
Bleeding  1 [2]  0/41 (0.00%)  0 0/43 (0.00%)  0 1/43 (2.33%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Blood and lymphatic
[1]
shallow hematoma after injection of lidocaine without infectious or hemorrhagic complications.
[2]
Minimal bleeding after injection of lidocaine.
The therapists were not the same throughout the investigation, however all were standardized to interventions; especilaistas doctors who applied the injections were different. No specific measure of patient-centered operation is used.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Luz Helena Lugo, Head of Research Group Rehabilitation in Health
Organization: university of Antioquia, Research Group Rehabilitation in Health
Phone: +57 4 2196475
EMail: luzh.lugo@gmail.com
Layout table for additonal information
Responsible Party: Luz Helena Lugo Agudelo, Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier: NCT01250184     History of Changes
Other Study ID Numbers: GrupoRS0001
First Submitted: November 27, 2010
First Posted: November 30, 2010
Results First Submitted: September 27, 2014
Results First Posted: October 10, 2014
Last Update Posted: October 10, 2014