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

Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy, Alone or in Combination: a Single-blind, Randomized, Controlled Clinical Trial.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01250184
Enrollment
127
Registered
2010-11-30
Start date
2009-05-31
Completion date
2011-09-30
Last updated
2014-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain Syndrome, Pain, Myofascial Trigger Point Pain, Musculoskeletal Pain

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

OTHERPhysical therapy

Twelve sessions (3 per week)

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

OTHERLidocaine injection + physical therapy

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

Sponsors

Universidad de Antioquia
CollaboratorOTHER
Grupo Rehabilitacion en Salud
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Visual Analogue Scale4 weeksVAS 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

MeasureTime frameDescription
PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication4 weeksThe 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-364 weeksThe 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

ArmCount
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
Total127

Baseline characteristics

CharacteristicTotalPhysical TherapyBlocking the MTP Plus Physical TherapyBlocking the MTP
Age, Continuous39.19 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 participants34 participants27 participants29 participants
Concomitant factors
Sleeplessness
65 participants18 participants24 participants23 participants
Concomitant factors
Stress
93 participants29 participants34 participants30 participants
Muscles with trigger point
Infraspinatus muscle
37 participants12 participants12 participants13 participants
Muscles with trigger point
Levator scapulae
84 participants27 participants31 participants26 participants
Muscles with trigger point
Trapezius muscle
118 participants42 participants37 participants39 participants
Patient Health Questionnaire - 95.72 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 participants4 participants2 participants0 participants
Patient Health Questionnaire - 9 How often
Nearly every day
1 participants1 participants0 participants0 participants
Patient Health Questionnaire - 9 How often
Not at all
89 participants30 participants30 participants29 participants
Patient Health Questionnaire - 9 How often
Several days
31 participants8 participants9 participants14 participants
Physical examination
Local twitch response
77 participants26 participants29 participants22 participants
Physical examination
Referred pain
81 participants36 participants22 participants23 participants
Physical examination
Sensitive Alteration
23 participants7 participants8 participants8 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 participants43 participants41 participants43 participants
Sex: Female, Male
Female
104 Participants36 Participants35 Participants33 Participants
Sex: Female, Male
Male
23 Participants7 Participants6 Participants10 Participants
Visual Analogue Scale for Pain65.54 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 typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
4 / 410 / 433 / 43
serious
Total, serious adverse events
0 / 410 / 430 / 43

Outcome results

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

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

ArmMeasureValue (MEAN)Dispersion
Lidocaine Injection + Physical TherapyVisual Analogue Scale40.8 units on a scaleStandard Deviation 25.3
Lidocaine InjectionVisual Analogue Scale44.2 units on a scaleStandard Deviation 24.9
Physical TherapyVisual Analogue Scale37.8 units on a scaleStandard Deviation 21.9
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

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

ArmMeasureValue (MEAN)Dispersion
Lidocaine Injection + Physical TherapyVisual Analogue Scale21.6 units on a scaleStandard Deviation 21.8
Lidocaine InjectionVisual Analogue Scale28.8 units on a scaleStandard Deviation 22.3
Physical TherapyVisual Analogue Scale28.2 units on a scaleStandard Deviation 23.7
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

Time frame: 4 weeks

ArmMeasureValue (MEAN)Dispersion
Lidocaine Injection + Physical TherapyPHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication4.33 units on a scaleStandard Deviation 3.647
Lidocaine InjectionPHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication4.44 units on a scaleStandard Deviation 3.03
Physical TherapyPHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication4.43 units on a scaleStandard Deviation 4.073
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

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
Lidocaine Injection + Physical TherapyPHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication3.98 units on a scaleStandard Deviation 3.97
Lidocaine InjectionPHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication3.16 units on a scaleStandard Deviation 2.81
Physical TherapyPHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication4.12 units on a scaleStandard Deviation 4.48
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.

Time frame: 4 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Lidocaine Injection + Physical TherapyQuality of Life SF-36Physical performance73.1 units on a scaleStandard Deviation 40.5
Lidocaine Injection + Physical TherapyQuality of Life SF-36Vitality61.3 units on a scaleStandard Deviation 16
Lidocaine Injection + Physical TherapyQuality of Life SF-36Social Function79.2 units on a scaleStandard Deviation 20.7
Lidocaine Injection + Physical TherapyQuality of Life SF-36Physical Function86.8 units on a scaleStandard Deviation 13.2
Lidocaine Injection + Physical TherapyQuality of Life SF-36Changing Health70.0 units on a scaleStandard Deviation 18.1
Lidocaine Injection + Physical TherapyQuality of Life SF-36Mental Health73.2 units on a scaleStandard Deviation 16.6
Lidocaine Injection + Physical TherapyQuality of Life SF-36Emotional performance78.2 units on a scaleStandard Deviation 35.1
Lidocaine Injection + Physical TherapyQuality of Life SF-36Body pain55.3 units on a scaleStandard Deviation 18.4
Lidocaine Injection + Physical TherapyQuality of Life SF-36General Health72.1 units on a scaleStandard Deviation 16.7
Lidocaine InjectionQuality of Life SF-36Physical Function86.83 units on a scaleStandard Deviation 11.55
Lidocaine InjectionQuality of Life SF-36Changing Health67.8 units on a scaleStandard Deviation 16.05
Lidocaine InjectionQuality of Life SF-36Body pain51.78 units on a scaleStandard Deviation 15.7
Lidocaine InjectionQuality of Life SF-36Emotional performance78.76 units on a scaleStandard Deviation 33.24
Lidocaine InjectionQuality of Life SF-36Physical performance74.39 units on a scaleStandard Deviation 33.3
Lidocaine InjectionQuality of Life SF-36Social Function78.15 units on a scaleStandard Deviation 20.44
Lidocaine InjectionQuality of Life SF-36General Health73.54 units on a scaleStandard Deviation 13.43
Lidocaine InjectionQuality of Life SF-36Mental Health69.95 units on a scaleStandard Deviation 17.57
Lidocaine InjectionQuality of Life SF-36Vitality62.56 units on a scaleStandard Deviation 17.32
Physical TherapyQuality of Life SF-36Emotional performance85.85 units on a scaleStandard Deviation 27.58
Physical TherapyQuality of Life SF-36Changing Health60.93 units on a scaleStandard Deviation 18.5
Physical TherapyQuality of Life SF-36General Health65.70 units on a scaleStandard Deviation 20.16
Physical TherapyQuality of Life SF-36Body pain57.12 units on a scaleStandard Deviation 20.7
Physical TherapyQuality of Life SF-36Vitality59.88 units on a scaleStandard Deviation 19.83
Physical TherapyQuality of Life SF-36Physical Function82.79 units on a scaleStandard Deviation 15.52
Physical TherapyQuality of Life SF-36Physical performance73.84 units on a scaleStandard Deviation 34.48
Physical TherapyQuality of Life SF-36Mental Health70.05 units on a scaleStandard Deviation 19.82
Physical TherapyQuality of Life SF-36Social Function81.51 units on a scaleStandard Deviation 22.83
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.

Time frame: 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Lidocaine Injection + Physical TherapyQuality of Life SF-36Physical performance81.88 units on a scaleStandard Deviation 30.48
Lidocaine Injection + Physical TherapyQuality of Life SF-36Vitality63.38 units on a scaleStandard Deviation 16.11
Lidocaine Injection + Physical TherapyQuality of Life SF-36Social Function82.6 units on a scaleStandard Deviation 20.99
Lidocaine Injection + Physical TherapyQuality of Life SF-36Physical Function87.75 units on a scaleStandard Deviation 16.94
Lidocaine Injection + Physical TherapyQuality of Life SF-36Changing Health70.5 units on a scaleStandard Deviation 18.67
Lidocaine Injection + Physical TherapyQuality of Life SF-36Mental Health75.3 units on a scaleStandard Deviation 16.79
Lidocaine Injection + Physical TherapyQuality of Life SF-36Emotional performance83.25 units on a scaleStandard Deviation 32.11
Lidocaine Injection + Physical TherapyQuality of Life SF-36Body pain66.58 units on a scaleStandard Deviation 20.09
Lidocaine Injection + Physical TherapyQuality of Life SF-36General Health71.67 units on a scaleStandard Deviation 17.26
Lidocaine InjectionQuality of Life SF-36Physical Function90 units on a scaleStandard Deviation 9.06
Lidocaine InjectionQuality of Life SF-36Changing Health70.23 units on a scaleStandard Deviation 17.11
Lidocaine InjectionQuality of Life SF-36Body pain61.19 units on a scaleStandard Deviation 17.67
Lidocaine InjectionQuality of Life SF-36Emotional performance90.60 units on a scaleStandard Deviation 21.15
Lidocaine InjectionQuality of Life SF-36Physical performance87.79 units on a scaleStandard Deviation 22.07
Lidocaine InjectionQuality of Life SF-36Social Function83.28 units on a scaleStandard Deviation 17.44
Lidocaine InjectionQuality of Life SF-36General Health77.44 units on a scaleStandard Deviation 12.5
Lidocaine InjectionQuality of Life SF-36Mental Health78.95 units on a scaleStandard Deviation 14.03
Lidocaine InjectionQuality of Life SF-36Vitality69.64 units on a scaleStandard Deviation 16.17
Physical TherapyQuality of Life SF-36Emotional performance84.13 units on a scaleStandard Deviation 32.95
Physical TherapyQuality of Life SF-36Changing Health69.76 units on a scaleStandard Deviation 18.5
Physical TherapyQuality of Life SF-36General Health68.25 units on a scaleStandard Deviation 22.37
Physical TherapyQuality of Life SF-36Body pain65.66 units on a scaleStandard Deviation 20.9
Physical TherapyQuality of Life SF-36Vitality61.95 units on a scaleStandard Deviation 18.53
Physical TherapyQuality of Life SF-36Physical Function89.13 units on a scaleStandard Deviation 12.29
Physical TherapyQuality of Life SF-36Physical performance82.5 units on a scaleStandard Deviation 31.11
Physical TherapyQuality of Life SF-36Mental Health71.32 units on a scaleStandard Deviation 17.86
Physical TherapyQuality of Life SF-36Social Function83.05 units on a scaleStandard Deviation 20.71

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026