Trial Outcomes & Findings for Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy. (NCT NCT01250184)

NCT ID: NCT01250184

Last Updated: 2014-10-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

127 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-10-10

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
43
41
43
Overall Study
COMPLETED
43
41
43
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Blocking the MTP Plus Physical Therapy
n=41 Participants
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
n=43 Participants
Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week)
Blocking the MTP
n=43 Participants
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
n=127 Participants
Total of all reporting groups
Age, Continuous
37.2 years
STANDARD_DEVIATION 11.1 • n=5 Participants
42.6 years
STANDARD_DEVIATION 9.7 • n=7 Participants
37.7 years
STANDARD_DEVIATION 11.8 • n=5 Participants
39.19 years
STANDARD_DEVIATION 11.12 • n=4 Participants
Sex: Female, Male
Female
35 Participants
n=5 Participants
36 Participants
n=7 Participants
33 Participants
n=5 Participants
104 Participants
n=4 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
7 Participants
n=7 Participants
10 Participants
n=5 Participants
23 Participants
n=4 Participants
Region of Enrollment
Colombia
41 participants
n=5 Participants
43 participants
n=7 Participants
43 participants
n=5 Participants
127 participants
n=4 Participants
Concomitant factors
Stress
34 participants
n=5 Participants
29 participants
n=7 Participants
30 participants
n=5 Participants
93 participants
n=4 Participants
Concomitant factors
Sleeplessness
24 participants
n=5 Participants
18 participants
n=7 Participants
23 participants
n=5 Participants
65 participants
n=4 Participants
Concomitant factors
Longer positions
27 participants
n=5 Participants
34 participants
n=7 Participants
29 participants
n=5 Participants
90 participants
n=4 Participants
Muscles with trigger point
Trapezius muscle
37 participants
n=5 Participants
42 participants
n=7 Participants
39 participants
n=5 Participants
118 participants
n=4 Participants
Muscles with trigger point
Levator scapulae
31 participants
n=5 Participants
27 participants
n=7 Participants
26 participants
n=5 Participants
84 participants
n=4 Participants
Muscles with trigger point
Infraspinatus muscle
12 participants
n=5 Participants
12 participants
n=7 Participants
13 participants
n=5 Participants
37 participants
n=4 Participants
Physical examination
Sensitive Alteration
8 participants
n=5 Participants
7 participants
n=7 Participants
8 participants
n=5 Participants
23 participants
n=4 Participants
Physical examination
Referred pain
22 participants
n=5 Participants
36 participants
n=7 Participants
23 participants
n=5 Participants
81 participants
n=4 Participants
Physical examination
Local twitch response
29 participants
n=5 Participants
26 participants
n=7 Participants
22 participants
n=5 Participants
77 participants
n=4 Participants
Visual Analogue Scale for Pain
63.5 units on a scale
STANDARD_DEVIATION 13.9 • n=5 Participants
68.7 units on a scale
STANDARD_DEVIATION 17 • n=7 Participants
64.2 units on a scale
STANDARD_DEVIATION 16.2 • n=5 Participants
65.54 units on a scale
STANDARD_DEVIATION 15.9 • n=4 Participants
Patient Health Questionnaire - 9
5.6 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
5.9 units on a scale
STANDARD_DEVIATION 4.2 • n=7 Participants
5.6 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
5.72 units on a scale
STANDARD_DEVIATION 3.68 • n=4 Participants
Patient Health Questionnaire - 9 How often
Not at all
30 participants
n=5 Participants
30 participants
n=7 Participants
29 participants
n=5 Participants
89 participants
n=4 Participants
Patient Health Questionnaire - 9 How often
Several days
9 participants
n=5 Participants
8 participants
n=7 Participants
14 participants
n=5 Participants
31 participants
n=4 Participants
Patient Health Questionnaire - 9 How often
More than half the days
2 participants
n=5 Participants
4 participants
n=7 Participants
0 participants
n=5 Participants
6 participants
n=4 Participants
Patient Health Questionnaire - 9 How often
Nearly every day
0 participants
n=5 Participants
1 participants
n=7 Participants
0 participants
n=5 Participants
1 participants
n=4 Participants
Quality of Life SF-36
Body pain
38.8 units on a scale
STANDARD_DEVIATION 14.4 • n=5 Participants
35.2 units on a scale
STANDARD_DEVIATION 14.3 • n=7 Participants
38.5 units on a scale
STANDARD_DEVIATION 16.4 • n=5 Participants
37.52 units on a scale
STANDARD_DEVIATION 15.2 • n=4 Participants
Quality of Life SF-36
Role-emotional
66.4 units on a scale
STANDARD_DEVIATION 35.0 • n=5 Participants
75.8 units on a scale
STANDARD_DEVIATION 38.7 • n=7 Participants
67.2 units on a scale
STANDARD_DEVIATION 36.8 • n=5 Participants
69.92 units on a scale
STANDARD_DEVIATION 36.89 • n=4 Participants
Quality of Life SF-36
Role-physical
51.2 units on a scale
STANDARD_DEVIATION 40 • n=5 Participants
51.1 units on a scale
STANDARD_DEVIATION 37.7 • n=7 Participants
42.4 units on a scale
STANDARD_DEVIATION 37.6 • n=5 Participants
48.21 units on a scale
STANDARD_DEVIATION 48.36 • n=4 Participants
Quality of Life SF-36
Physical functioning
79.5 units on a scale
STANDARD_DEVIATION 17.8 • n=5 Participants
72.5 units on a scale
STANDARD_DEVIATION 20.5 • n=7 Participants
81.7 units on a scale
STANDARD_DEVIATION 11.9 • n=5 Participants
77.91 units on a scale
STANDARD_DEVIATION 17.5 • n=4 Participants
Quality of Life SF-36
Social Function
69.5 units on a scale
STANDARD_DEVIATION 22 • n=5 Participants
68 units on a scale
STANDARD_DEVIATION 26.6 • n=7 Participants
71.8 units on a scale
STANDARD_DEVIATION 23.6 • n=5 Participants
69.83 units on a scale
STANDARD_DEVIATION 24.06 • n=4 Participants
Quality of Life SF-36
General health
67.4 units on a scale
STANDARD_DEVIATION 18.3 • n=5 Participants
57.3 units on a scale
STANDARD_DEVIATION 21.9 • n=7 Participants
70.7 units on a scale
STANDARD_DEVIATION 15.4 • n=5 Participants
65.12 units on a scale
STANDARD_DEVIATION 19.47 • n=4 Participants
Quality of Life SF-36
Mental health
67.8 units on a scale
STANDARD_DEVIATION 14.2 • n=5 Participants
65.5 units on a scale
STANDARD_DEVIATION 18.9 • n=7 Participants
67.4 units on a scale
STANDARD_DEVIATION 17.5 • n=5 Participants
66.93 units on a scale
STANDARD_DEVIATION 16.95 • n=4 Participants
Quality of Life SF-36
Vitality
54.2 units on a scale
STANDARD_DEVIATION 13.9 • n=5 Participants
54.7 units on a scale
STANDARD_DEVIATION 19.2 • n=7 Participants
60.7 units on a scale
STANDARD_DEVIATION 19.3 • n=5 Participants
56.61 units on a scale
STANDARD_DEVIATION 17.85 • n=4 Participants

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure
Lidocaine Injection + Physical Therapy
n=41 Participants
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
n=43 Participants
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.
Physical Therapy
n=43 Participants
Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week)
Visual Analogue Scale
40.8 units on a scale
Standard Deviation 25.3
44.2 units on a scale
Standard Deviation 24.9
37.8 units on a scale
Standard Deviation 21.9

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure
Lidocaine Injection + Physical Therapy
n=41 Participants
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
n=43 Participants
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.
Physical Therapy
n=43 Participants
Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week)
Visual Analogue Scale
21.6 units on a scale
Standard Deviation 21.8
28.8 units on a scale
Standard Deviation 22.3
28.2 units on a scale
Standard Deviation 23.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Lidocaine Injection + Physical Therapy
n=41 Participants
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
n=43 Participants
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.
Physical Therapy
n=43 Participants
Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week)
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
4.44 units on a scale
Standard Deviation 3.03
4.43 units on a scale
Standard Deviation 4.073

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Lidocaine Injection + Physical Therapy
n=41 Participants
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
n=43 Participants
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.
Physical Therapy
n=43 Participants
Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week)
Quality of Life SF-36
Changing Health
70.0 units on a scale
Standard Deviation 18.1
67.8 units on a scale
Standard Deviation 16.05
60.93 units on a scale
Standard Deviation 18.5
Quality of Life SF-36
Body pain
55.3 units on a scale
Standard Deviation 18.4
51.78 units on a scale
Standard Deviation 15.70
57.12 units on a scale
Standard Deviation 20.7
Quality of Life SF-36
Emotional performance
78.2 units on a scale
Standard Deviation 35.1
78.76 units on a scale
Standard Deviation 33.24
85.85 units on a scale
Standard Deviation 27.58
Quality of Life SF-36
Physical performance
73.1 units on a scale
Standard Deviation 40.5
74.39 units on a scale
Standard Deviation 33.3
73.84 units on a scale
Standard Deviation 34.48
Quality of Life SF-36
Physical Function
86.8 units on a scale
Standard Deviation 13.2
86.83 units on a scale
Standard Deviation 11.55
82.79 units on a scale
Standard Deviation 15.52
Quality of Life SF-36
Social Function
79.2 units on a scale
Standard Deviation 20.7
78.15 units on a scale
Standard Deviation 20.44
81.51 units on a scale
Standard Deviation 22.83
Quality of Life SF-36
General Health
72.1 units on a scale
Standard Deviation 16.7
73.54 units on a scale
Standard Deviation 13.43
65.70 units on a scale
Standard Deviation 20.16
Quality of Life SF-36
Mental Health
73.2 units on a scale
Standard Deviation 16.6
69.95 units on a scale
Standard Deviation 17.57
70.05 units on a scale
Standard Deviation 19.82
Quality of Life SF-36
Vitality
61.3 units on a scale
Standard Deviation 16
62.56 units on a scale
Standard Deviation 17.32
59.88 units on a scale
Standard Deviation 19.83

SECONDARY outcome

Timeframe: 12 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

Outcome measures

Outcome measures
Measure
Lidocaine Injection + Physical Therapy
n=41 Participants
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
n=43 Participants
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.
Physical Therapy
n=43 Participants
Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week)
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
3.16 units on a scale
Standard Deviation 2.81
4.12 units on a scale
Standard Deviation 4.48

SECONDARY outcome

Timeframe: 12 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.

Outcome measures

Outcome measures
Measure
Lidocaine Injection + Physical Therapy
n=41 Participants
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
n=43 Participants
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.
Physical Therapy
n=43 Participants
Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week)
Quality of Life SF-36
Changing Health
70.5 units on a scale
Standard Deviation 18.67
70.23 units on a scale
Standard Deviation 17.11
69.76 units on a scale
Standard Deviation 18.5
Quality of Life SF-36
Body pain
66.58 units on a scale
Standard Deviation 20.09
61.19 units on a scale
Standard Deviation 17.67
65.66 units on a scale
Standard Deviation 20.9
Quality of Life SF-36
Emotional performance
83.25 units on a scale
Standard Deviation 32.11
90.60 units on a scale
Standard Deviation 21.15
84.13 units on a scale
Standard Deviation 32.95
Quality of Life SF-36
Physical performance
81.88 units on a scale
Standard Deviation 30.48
87.79 units on a scale
Standard Deviation 22.07
82.5 units on a scale
Standard Deviation 31.11
Quality of Life SF-36
Physical Function
87.75 units on a scale
Standard Deviation 16.94
90 units on a scale
Standard Deviation 9.06
89.13 units on a scale
Standard Deviation 12.29
Quality of Life SF-36
Social Function
82.6 units on a scale
Standard Deviation 20.99
83.28 units on a scale
Standard Deviation 17.44
83.05 units on a scale
Standard Deviation 20.71
Quality of Life SF-36
General Health
71.67 units on a scale
Standard Deviation 17.26
77.44 units on a scale
Standard Deviation 12.50
68.25 units on a scale
Standard Deviation 22.37
Quality of Life SF-36
Mental Health
75.3 units on a scale
Standard Deviation 16.79
78.95 units on a scale
Standard Deviation 14.03
71.32 units on a scale
Standard Deviation 17.86
Quality of Life SF-36
Vitality
63.38 units on a scale
Standard Deviation 16.11
69.64 units on a scale
Standard Deviation 16.17
61.95 units on a scale
Standard Deviation 18.53

Adverse Events

Lidocaine Injection + Physical Therapy

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Physical Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Lidocaine Injection

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Lidocaine Injection + Physical Therapy
n=41 participants at risk
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
n=43 participants at risk
Twelve sessions, 3 per week. Physical therapy: Twelve sessions (3 per week)
Lidocaine Injection
n=43 participants at risk
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.
Skin and subcutaneous tissue disorders
Hematomas
9.8%
4/41 • Number of events 4 • 1 month
0.00%
0/43 • 1 month
4.7%
2/43 • Number of events 2 • 1 month
Skin and subcutaneous tissue disorders
Bleeding
0.00%
0/41 • 1 month
0.00%
0/43 • 1 month
2.3%
1/43 • Number of events 1 • 1 month

Additional Information

Dr. Luz Helena Lugo, Head of Research Group Rehabilitation in Health

university of Antioquia, Research Group Rehabilitation in Health

Phone: +57 4 2196475

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place