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

November 27, 2010
October 4, 2014
May 2009
June 2011   (final data collection date for primary outcome measure)
  • 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
Pain 4 weeks later wich will be measured in a VAS (Visual analogue scale) a successful treatment is defined as a reduction in pain in 20% from the initial score 4 weeks after the first evaluation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01250184 on ClinicalTrials.gov Archive Site
  • 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.
SF-36 bodily pain scale 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 ]
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Myofascial Pain Syndrome
  • Pain
  • Myofascial Trigger Point Pain
  • Musculoskeletal Pain
  • Other: Physical therapy
    Twelve sessions (3 per week)
    Other Name: standardized therapeutic exercise program
  • Drug: Lidocaine injection
    blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
    Other Name: blocking the Myofascial trigger point
  • 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
  • Active Comparator: Physical Therapy
    Twelve sessions, 3 per week.
    Intervention: Other: Physical therapy
  • Active Comparator: Lidocaine injection
    Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
    Intervention: Drug: Lidocaine injection
  • 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.
    Intervention: Other: Lidocaine injection + physical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
September 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT01250184
GrupoRS0001
No
Luz Helena Lugo Agudelo, Grupo Rehabilitacion en Salud
Grupo Rehabilitacion en Salud
Universidad de Antioquia
Principal Investigator: Luz H Lugo Agudelo, Professor Universidad de Antioquia Grupo Rehabilitacion en Salud
Grupo Rehabilitacion en Salud
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP