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

This study has been completed.
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Luz Helena Lugo Agudelo, Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier:
NCT01250184
First received: November 27, 2010
Last updated: October 4, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Myofascial Pain Syndrome
Pain
Myofascial Trigger Point Pain
Musculoskeletal Pain
Other: Physical therapy
Drug: Lidocaine injection
Other: Lidocaine injection + physical therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Grupo Rehabilitacion en Salud:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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

  • Visual Analogue Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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

  • Quality of Life SF-36 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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

  • Quality of Life SF-36 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 127
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250184

Locations
Colombia
Ips Universitaria
Medellin, Antioquia, Colombia
Clinica de Las Américas
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

No publications provided

Responsible Party: Luz Helena Lugo Agudelo, Associate Professor, Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier: NCT01250184     History of Changes
Other Study ID Numbers: GrupoRS0001
Study First Received: November 27, 2010
Results First Received: September 27, 2014
Last Updated: October 4, 2014
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Grupo Rehabilitacion en Salud:
Myofascial pain
Trigger points.
Lidocaine injection.
Physical therapy

Additional relevant MeSH terms:
Somatoform Disorders
Myofascial Pain Syndromes
Musculoskeletal Pain
Syndrome
Fibromyalgia
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Disease
Pathologic Processes
Rheumatic Diseases
Neuromuscular Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on October 19, 2014