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| Name | Class |
|---|---|
| Universidad de Antioquia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Therapy | Active Comparator | Twelve sessions, 3 per week. |
|
| Lidocaine injection | Active Comparator | Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose. |
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| Lidocaine injection + physical therapy | Experimental | Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical therapy | Other | Twelve sessions (3 per week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luz H Lugo Agudelo, Professor | Universidad de Antioquia Grupo Rehabilitacion en Salud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica de Las Américas | Medellín | Antioquia | Colombia | |||
| Ips Universitaria |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Therapy | Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Lidocaine injection | Drug | blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose. |
|
|
| Lidocaine injection + physical therapy | Other | blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week) |
|
|
| 4 weeks |
| 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. | 4 weeks |
| 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 | 12 weeks |
| 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. | 12 weeks |
| Medellín |
| Antioquia |
| Colombia |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
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
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Physical Therapy | Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week) |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Concomitant factors | A patient could have more than one Concomitant factor | Number | participants |
| |||||||||||||||
| Muscles with trigger point | A patient could have more than one trigger point | Number | participants |
| |||||||||||||||
| Physical examination | A patient could have more than one alteration on the physical examination. | Number | participants |
| |||||||||||||||
| Visual Analogue Scale for Pain | 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 | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Patient Health Questionnaire - 9 | 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 | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Patient Health Questionnaire - 9 How often | 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. | Number | participants |
| |||||||||||||||
| 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 | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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 | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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 | Mean | Standard Deviation | units on a scale | 4 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | Mean | Standard Deviation | units on a scale | 4 weeks |
| |||||||||||||||||||||||||||||||||||
| Primary | 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 | 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 | Mean | Standard Deviation | units on a scale | 12 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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 | Mean | Standard Deviation | units on a scale | 12 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | Mean | Standard Deviation | units on a scale | 12 weeks |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 0 | 41 | 4 | 41 | ||
| EG001 | Physical Therapy | Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week) | 0 | 43 | 0 | 43 | ||
| EG002 | 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. | 0 | 43 | 3 | 43 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematomas | Skin and subcutaneous tissue disorders | Blood and lymphatic | Non-systematic Assessment | shallow hematoma after injection of lidocaine without infectious or hemorrhagic complications. |
|
| Bleeding | Skin and subcutaneous tissue disorders | Blood and lymphatic | Systematic Assessment | 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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Luz Helena Lugo, Head of Research Group Rehabilitation in Health | university of Antioquia, Research Group Rehabilitation in Health | +57 4 2196475 | luzh.lugo@gmail.com |
| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| D010146 | Pain |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
|
| Sleeplessness |
|
| Longer positions |
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| Levator scapulae |
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| Infraspinatus muscle |
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| Referred pain |
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| Local twitch response |
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| Several days |
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| More than half the days |
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| Nearly every day |
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| Role-emotional |
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| Role-physical |
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| Physical functioning |
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| Social Function |
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| General health |
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| Mental health |
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| Vitality |
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Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)
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Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)
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| OG002 |
| Physical Therapy |
Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week) |
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Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)
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Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)
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