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

This study has been completed.
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Luz Helena Lugo Agudelo, Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier:
NCT01250184
First received: November 27, 2010
Last updated: October 4, 2014
Last verified: October 2014
Results First Received: September 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Physical Therapy

Twelve sessions, 3 per week.

Physical therapy: Twelve sessions (3 per week)

Lidocaine Injection + Physical Therapy

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)

Lidocaine Injection

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.


Participant Flow:   Overall Study
    Physical Therapy   Lidocaine Injection + Physical Therapy   Lidocaine Injection
STARTED   43   41   43 
COMPLETED   43   41   43 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

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

Physical Therapy

Twelve sessions, 3 per week.

Physical therapy: Twelve sessions (3 per week)

Blocking the MTP

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 Total of all reporting groups

Baseline Measures
   Blocking the MTP Plus Physical Therapy   Physical Therapy   Blocking the MTP   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   43   43   127 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.2  (11.1)   42.6  (9.7)   37.7  (11.8)   39.19  (11.12) 
Gender 
[Units: Participants]
       
Female   35   36   33   104 
Male   6   7   10   23 
Region of Enrollment 
[Units: Participants]
       
Colombia   41   43   43   127 
Concomitant factors [1] 
[Units: Participants]
       
Stress   34   29   30   93 
Sleeplessness   24   18   23   65 
Longer positions   27   34   29   90 
[1] A patient could have more than one Concomitant factor
Muscles with trigger point [1] 
[Units: Participants]
       
Trapezius muscle   37   42   39   118 
Levator scapulae   31   27   26   84 
Infraspinatus muscle   12   12   13   37 
[1] A patient could have more than one trigger point
Physical examination [1] 
[Units: Participants]
       
Sensitive Alteration   8   7   8   23 
Referred pain   22   36   23   81 
Local twitch response   29   26   22   77 
[1] A patient could have more than one alteration on the physical examination.
Visual Analogue Scale for Pain [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 63.5  (13.9)   68.7  (17)   64.2  (16.2)   65.54  (15.9) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.6  (3.2)   5.9  (4.2)   5.6  (3.5)   5.72  (3.68) 
[1] 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] 
[Units: 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] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
       
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] 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


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Analogue Scale   [ Time Frame: 4 weeks ]

2.  Primary:   Visual Analogue Scale   [ Time Frame: 12 weeks ]

3.  Secondary:   PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication   [ Time Frame: 4 weeks ]

4.  Secondary:   Quality of Life SF-36   [ Time Frame: 4 weeks ]

5.  Secondary:   PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication   [ Time Frame: 12 weeks ]

6.  Secondary:   Quality of Life SF-36   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
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
e-mail: luzh.lugo@gmail.com



Responsible Party: Luz Helena Lugo Agudelo, Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier: NCT01250184     History of Changes
Other Study ID Numbers: GrupoRS0001
Study First Received: November 27, 2010
Results First Received: September 27, 2014
Last Updated: October 4, 2014