Myofascial Pain Syndrome, Pain, Myofascial Trigger Point Pain, Musculoskeletal Pain
Conditions
Keywords
Myofascial pain, Trigger points., Lidocaine injection., Physical therapy
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.
Interventions
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)
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 4 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication | 4 weeks | 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 | 4 weeks | 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. |
Countries
Colombia
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 41 |
| Physical Therapy Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week) | 43 |
| 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. | 43 |
| Total | 127 |
Baseline characteristics
| Characteristic | Total | Physical Therapy | Blocking the MTP Plus Physical Therapy | Blocking the MTP |
|---|---|---|---|---|
| Age, Continuous | 39.19 years STANDARD_DEVIATION 11.12 | 42.6 years STANDARD_DEVIATION 9.7 | 37.2 years STANDARD_DEVIATION 11.1 | 37.7 years STANDARD_DEVIATION 11.8 |
| Concomitant factors Longer positions | 90 participants | 34 participants | 27 participants | 29 participants |
| Concomitant factors Sleeplessness | 65 participants | 18 participants | 24 participants | 23 participants |
| Concomitant factors Stress | 93 participants | 29 participants | 34 participants | 30 participants |
| Muscles with trigger point Infraspinatus muscle | 37 participants | 12 participants | 12 participants | 13 participants |
| Muscles with trigger point Levator scapulae | 84 participants | 27 participants | 31 participants | 26 participants |
| Muscles with trigger point Trapezius muscle | 118 participants | 42 participants | 37 participants | 39 participants |
| Patient Health Questionnaire - 9 | 5.72 units on a scale STANDARD_DEVIATION 3.68 | 5.9 units on a scale STANDARD_DEVIATION 4.2 | 5.6 units on a scale STANDARD_DEVIATION 3.2 | 5.6 units on a scale STANDARD_DEVIATION 3.5 |
| Patient Health Questionnaire - 9 How often More than half the days | 6 participants | 4 participants | 2 participants | 0 participants |
| Patient Health Questionnaire - 9 How often Nearly every day | 1 participants | 1 participants | 0 participants | 0 participants |
| Patient Health Questionnaire - 9 How often Not at all | 89 participants | 30 participants | 30 participants | 29 participants |
| Patient Health Questionnaire - 9 How often Several days | 31 participants | 8 participants | 9 participants | 14 participants |
| Physical examination Local twitch response | 77 participants | 26 participants | 29 participants | 22 participants |
| Physical examination Referred pain | 81 participants | 36 participants | 22 participants | 23 participants |
| Physical examination Sensitive Alteration | 23 participants | 7 participants | 8 participants | 8 participants |
| Quality of Life SF-36 Body pain | 37.52 units on a scale STANDARD_DEVIATION 15.2 | 35.2 units on a scale STANDARD_DEVIATION 14.3 | 38.8 units on a scale STANDARD_DEVIATION 14.4 | 38.5 units on a scale STANDARD_DEVIATION 16.4 |
| Quality of Life SF-36 General health | 65.12 units on a scale STANDARD_DEVIATION 19.47 | 57.3 units on a scale STANDARD_DEVIATION 21.9 | 67.4 units on a scale STANDARD_DEVIATION 18.3 | 70.7 units on a scale STANDARD_DEVIATION 15.4 |
| Quality of Life SF-36 Mental health | 66.93 units on a scale STANDARD_DEVIATION 16.95 | 65.5 units on a scale STANDARD_DEVIATION 18.9 | 67.8 units on a scale STANDARD_DEVIATION 14.2 | 67.4 units on a scale STANDARD_DEVIATION 17.5 |
| Quality of Life SF-36 Physical functioning | 77.91 units on a scale STANDARD_DEVIATION 17.5 | 72.5 units on a scale STANDARD_DEVIATION 20.5 | 79.5 units on a scale STANDARD_DEVIATION 17.8 | 81.7 units on a scale STANDARD_DEVIATION 11.9 |
| Quality of Life SF-36 Role-emotional | 69.92 units on a scale STANDARD_DEVIATION 36.89 | 75.8 units on a scale STANDARD_DEVIATION 38.7 | 66.4 units on a scale STANDARD_DEVIATION 35 | 67.2 units on a scale STANDARD_DEVIATION 36.8 |
| Quality of Life SF-36 Role-physical | 48.21 units on a scale STANDARD_DEVIATION 48.36 | 51.1 units on a scale STANDARD_DEVIATION 37.7 | 51.2 units on a scale STANDARD_DEVIATION 40 | 42.4 units on a scale STANDARD_DEVIATION 37.6 |
| Quality of Life SF-36 Social Function | 69.83 units on a scale STANDARD_DEVIATION 24.06 | 68 units on a scale STANDARD_DEVIATION 26.6 | 69.5 units on a scale STANDARD_DEVIATION 22 | 71.8 units on a scale STANDARD_DEVIATION 23.6 |
| Quality of Life SF-36 Vitality | 56.61 units on a scale STANDARD_DEVIATION 17.85 | 54.7 units on a scale STANDARD_DEVIATION 19.2 | 54.2 units on a scale STANDARD_DEVIATION 13.9 | 60.7 units on a scale STANDARD_DEVIATION 19.3 |
| Region of Enrollment Colombia | 127 participants | 43 participants | 41 participants | 43 participants |
| Sex: Female, Male Female | 104 Participants | 36 Participants | 35 Participants | 33 Participants |
| Sex: Female, Male Male | 23 Participants | 7 Participants | 6 Participants | 10 Participants |
| Visual Analogue Scale for Pain | 65.54 units on a scale STANDARD_DEVIATION 15.9 | 68.7 units on a scale STANDARD_DEVIATION 17 | 63.5 units on a scale STANDARD_DEVIATION 13.9 | 64.2 units on a scale STANDARD_DEVIATION 16.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 41 | 0 / 43 | 3 / 43 |
| serious Total, serious adverse events | 0 / 41 | 0 / 43 | 0 / 43 |
Outcome results
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
Time frame: 4 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Injection + Physical Therapy | Visual Analogue Scale | 40.8 units on a scale | Standard Deviation 25.3 |
| Lidocaine Injection | Visual Analogue Scale | 44.2 units on a scale | Standard Deviation 24.9 |
| Physical Therapy | Visual Analogue Scale | 37.8 units on a scale | Standard Deviation 21.9 |
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
Time frame: 12 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Injection + Physical Therapy | Visual Analogue Scale | 21.6 units on a scale | Standard Deviation 21.8 |
| Lidocaine Injection | Visual Analogue Scale | 28.8 units on a scale | Standard Deviation 22.3 |
| Physical Therapy | Visual Analogue Scale | 28.2 units on a scale | Standard Deviation 23.7 |
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
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Injection + Physical Therapy | PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication | 4.33 units on a scale | Standard Deviation 3.647 |
| Lidocaine Injection | PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication | 4.44 units on a scale | Standard Deviation 3.03 |
| Physical Therapy | PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication | 4.43 units on a scale | Standard Deviation 4.073 |
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
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Injection + Physical Therapy | PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication | 3.98 units on a scale | Standard Deviation 3.97 |
| Lidocaine Injection | PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication | 3.16 units on a scale | Standard Deviation 2.81 |
| Physical Therapy | PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication | 4.12 units on a scale | Standard Deviation 4.48 |
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.
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Physical performance | 73.1 units on a scale | Standard Deviation 40.5 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Vitality | 61.3 units on a scale | Standard Deviation 16 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Social Function | 79.2 units on a scale | Standard Deviation 20.7 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Physical Function | 86.8 units on a scale | Standard Deviation 13.2 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Changing Health | 70.0 units on a scale | Standard Deviation 18.1 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Mental Health | 73.2 units on a scale | Standard Deviation 16.6 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Emotional performance | 78.2 units on a scale | Standard Deviation 35.1 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Body pain | 55.3 units on a scale | Standard Deviation 18.4 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | General Health | 72.1 units on a scale | Standard Deviation 16.7 |
| Lidocaine Injection | Quality of Life SF-36 | Physical Function | 86.83 units on a scale | Standard Deviation 11.55 |
| Lidocaine Injection | Quality of Life SF-36 | Changing Health | 67.8 units on a scale | Standard Deviation 16.05 |
| Lidocaine Injection | Quality of Life SF-36 | Body pain | 51.78 units on a scale | Standard Deviation 15.7 |
| Lidocaine Injection | Quality of Life SF-36 | Emotional performance | 78.76 units on a scale | Standard Deviation 33.24 |
| Lidocaine Injection | Quality of Life SF-36 | Physical performance | 74.39 units on a scale | Standard Deviation 33.3 |
| Lidocaine Injection | Quality of Life SF-36 | Social Function | 78.15 units on a scale | Standard Deviation 20.44 |
| Lidocaine Injection | Quality of Life SF-36 | General Health | 73.54 units on a scale | Standard Deviation 13.43 |
| Lidocaine Injection | Quality of Life SF-36 | Mental Health | 69.95 units on a scale | Standard Deviation 17.57 |
| Lidocaine Injection | Quality of Life SF-36 | Vitality | 62.56 units on a scale | Standard Deviation 17.32 |
| Physical Therapy | Quality of Life SF-36 | Emotional performance | 85.85 units on a scale | Standard Deviation 27.58 |
| Physical Therapy | Quality of Life SF-36 | Changing Health | 60.93 units on a scale | Standard Deviation 18.5 |
| Physical Therapy | Quality of Life SF-36 | General Health | 65.70 units on a scale | Standard Deviation 20.16 |
| Physical Therapy | Quality of Life SF-36 | Body pain | 57.12 units on a scale | Standard Deviation 20.7 |
| Physical Therapy | Quality of Life SF-36 | Vitality | 59.88 units on a scale | Standard Deviation 19.83 |
| Physical Therapy | Quality of Life SF-36 | Physical Function | 82.79 units on a scale | Standard Deviation 15.52 |
| Physical Therapy | Quality of Life SF-36 | Physical performance | 73.84 units on a scale | Standard Deviation 34.48 |
| Physical Therapy | Quality of Life SF-36 | Mental Health | 70.05 units on a scale | Standard Deviation 19.82 |
| Physical Therapy | Quality of Life SF-36 | Social Function | 81.51 units on a scale | Standard Deviation 22.83 |
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Physical performance | 81.88 units on a scale | Standard Deviation 30.48 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Vitality | 63.38 units on a scale | Standard Deviation 16.11 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Social Function | 82.6 units on a scale | Standard Deviation 20.99 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Physical Function | 87.75 units on a scale | Standard Deviation 16.94 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Changing Health | 70.5 units on a scale | Standard Deviation 18.67 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Mental Health | 75.3 units on a scale | Standard Deviation 16.79 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Emotional performance | 83.25 units on a scale | Standard Deviation 32.11 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | Body pain | 66.58 units on a scale | Standard Deviation 20.09 |
| Lidocaine Injection + Physical Therapy | Quality of Life SF-36 | General Health | 71.67 units on a scale | Standard Deviation 17.26 |
| Lidocaine Injection | Quality of Life SF-36 | Physical Function | 90 units on a scale | Standard Deviation 9.06 |
| Lidocaine Injection | Quality of Life SF-36 | Changing Health | 70.23 units on a scale | Standard Deviation 17.11 |
| Lidocaine Injection | Quality of Life SF-36 | Body pain | 61.19 units on a scale | Standard Deviation 17.67 |
| Lidocaine Injection | Quality of Life SF-36 | Emotional performance | 90.60 units on a scale | Standard Deviation 21.15 |
| Lidocaine Injection | Quality of Life SF-36 | Physical performance | 87.79 units on a scale | Standard Deviation 22.07 |
| Lidocaine Injection | Quality of Life SF-36 | Social Function | 83.28 units on a scale | Standard Deviation 17.44 |
| Lidocaine Injection | Quality of Life SF-36 | General Health | 77.44 units on a scale | Standard Deviation 12.5 |
| Lidocaine Injection | Quality of Life SF-36 | Mental Health | 78.95 units on a scale | Standard Deviation 14.03 |
| Lidocaine Injection | Quality of Life SF-36 | Vitality | 69.64 units on a scale | Standard Deviation 16.17 |
| Physical Therapy | Quality of Life SF-36 | Emotional performance | 84.13 units on a scale | Standard Deviation 32.95 |
| Physical Therapy | Quality of Life SF-36 | Changing Health | 69.76 units on a scale | Standard Deviation 18.5 |
| Physical Therapy | Quality of Life SF-36 | General Health | 68.25 units on a scale | Standard Deviation 22.37 |
| Physical Therapy | Quality of Life SF-36 | Body pain | 65.66 units on a scale | Standard Deviation 20.9 |
| Physical Therapy | Quality of Life SF-36 | Vitality | 61.95 units on a scale | Standard Deviation 18.53 |
| Physical Therapy | Quality of Life SF-36 | Physical Function | 89.13 units on a scale | Standard Deviation 12.29 |
| Physical Therapy | Quality of Life SF-36 | Physical performance | 82.5 units on a scale | Standard Deviation 31.11 |
| Physical Therapy | Quality of Life SF-36 | Mental Health | 71.32 units on a scale | Standard Deviation 17.86 |
| Physical Therapy | Quality of Life SF-36 | Social Function | 83.05 units on a scale | Standard Deviation 20.71 |