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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250184
• Other study ID #: GrupoRS0001
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2010
• Last updated: October 4, 2014
• Start date: May 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2014
• Source: Grupo Rehabilitacion en Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Musculoskeletal Pain
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain
• Pain
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Physical therapy
Twelve sessions (3 per week)

Drug:
• Lidocaine injection
blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

Other:
• Lidocaine injection + physical therapy
blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

Locations

Country	Name	City	State
Colombia	Clinica de Las Américas	Medellin	Antioquia
Colombia	Ips Universitaria	Medellin	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Grupo Rehabilitacion en Salud	Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	4 weeks	No
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	12 weeks	No
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	4 weeks	No
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.	4 weeks	No
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	12 weeks	No
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.	12 weeks	No