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

• ClinicalTrials.gov Identifier: NCT01250184
• Recruitment Status: Completed
• First Posted: November 30, 2010
• Results First Posted: October 10, 2014
• Last Update Posted: October 10, 2014
• Sponsor: Grupo Rehabilitacion en Salud
• Collaborator: Universidad de Antioquia
• Information provided by (Responsible Party): Luz Helena Lugo Agudelo, Grupo Rehabilitacion en Salud

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myofascial Pain Syndrome; Pain; Myofascial Trigger Point Pain; Musculoskeletal Pain	Other: Physical therapy; Drug: Lidocaine injection; Other: Lidocaine injection + physical therapy	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy, Alone or in Combination: a Single-blind, Randomized, Controlled Clinical Trial.
• Study Start Date: May 2009
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Physical Therapy; Twelve sessions, 3 per week.	Other: Physical therapy; Twelve sessions (3 per week); Other Name: standardized therapeutic exercise program
Active Comparator: Lidocaine injection; Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.	Drug: Lidocaine injection; blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.; Other Name: blocking the Myofascial trigger point
Experimental: Lidocaine injection + physical therapy; Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.	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); Other Name: blocking plus a standarized therapeutic exercise program

Outcome Measures

Primary Outcome Measures :

1. Visual Analogue Scale [ Time Frame: 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
2. Visual Analogue Scale [ Time Frame: 12 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 Outcome Measures :

1. PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication [ Time Frame: 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
2. Quality of Life SF-36 [ Time Frame: 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.
3. PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication [ Time Frame: 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
4. Quality of Life SF-36 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Colombia

Clinica de Las Américas

Medellin, Antioquia, Colombia

Ips Universitaria

Medellin, Antioquia, Colombia

Sponsors and Collaborators

Grupo Rehabilitacion en Salud

Universidad de Antioquia

Investigators

• Principal Investigator: Luz H Lugo Agudelo, Professor; Universidad de Antioquia Grupo Rehabilitacion en Salud

More Information

• Responsible Party: Luz Helena Lugo Agudelo, Associate Professor, Grupo Rehabilitacion en Salud
• ClinicalTrials.gov Identifier: NCT01250184
• Other Study ID Numbers: GrupoRS0001
• First Posted: November 30, 2010
• Results First Posted: October 10, 2014
• Last Update Posted: October 10, 2014
• Last Verified: October 2014

Keywords provided by Luz Helena Lugo Agudelo, Grupo Rehabilitacion en Salud:

Myofascial pain; Trigger points.; Lidocaine injection.; Physical therapy

Additional relevant MeSH terms:

Musculoskeletal Pain; Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders; Disease; Pathologic Processes; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action