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;   Endpoint Classification: Efficacy Study;   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  
Number of Participants  
[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  
Study-Specific Measure [1]
[units: participants]
       
Stress     34     29     30     93  
Sleeplessness     24     18     23     65  
Longer positions     27     34     29     90  
Study-Specific Measure [2]
[units: participants]
       
Trapezius muscle     37     42     39     118  
Levator scapulae     31     27     26     84  
Infraspinatus muscle     12     12     13     37  
Study-Specific Measure [3]
[units: participants]
       
Sensitive Alteration     8     7     8     23  
Referred pain     22     36     23     81  
Local twitch response     29     26     22     77  
Study-Specific Measure [4]
[units: units on a scale]
Mean ± Standard Deviation
  63.5  ± 13.9     68.7  ± 17     64.2  ± 16.2     65.54  ± 15.9  
Study-Specific Measure [5]
[units: units on a scale]
Mean ± Standard Deviation
  5.6  ± 3.2     5.9  ± 4.2     5.6  ± 3.5     5.72  ± 3.68  
Study-Specific Measure [6]
[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  
Study-Specific Measure [7]
[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] A patient could have more than one Concomitant factor
[2] A patient could have more than one trigger point
[3] A patient could have more than one alteration on the physical examination.
[4] 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
[5] 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
[6] 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.
[7] 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


No publications provided


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
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos