- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01250184
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Antioquia
-
Medellin, Antioquia, Colombia
- Clínica de Las Américas
-
Medellin, Antioquia, Colombia
- IPS Universitaria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Physical Therapy
Twelve sessions, 3 per week.
|
Twelve sessions (3 per week)
Other Names:
|
ACTIVE_COMPARATOR: Lidocaine injection
Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
|
blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
Other Names:
|
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.
|
blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 weeks
|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 weeks
|
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.
|
4 weeks
|
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
|
12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Luz H Lugo Agudelo, Professor, Universidad de Antioquia Grupo Rehabilitacion en Salud
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Disease
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Syndrome
- Fibromyalgia
- Somatoform Disorders
- Myofascial Pain Syndromes
- Musculoskeletal Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- GrupoRS0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Physical therapy
-
Riphah International UniversityCompleted
-
Mayo ClinicDePuy OrthopaedicsCompleted
-
International Hellenic UniversityNot yet recruitingChronic Pain | Neuropathic Pain | Cognitive Therapy
-
Universidad de ZaragozaCompletedPlagiocephaly | Plagiocephaly, Nonsynostotic | Plagiocephaly, PositionalSpain
-
Ragaee Saeed MahmoudRecruiting
-
Iuliu Hatieganu University of Medicine and PharmacyCompletedParkinson DiseaseRomania
-
Universidad Rey Juan CarlosCompleted
-
University of AarhusCompleted
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan