Myofascial Pain SyndromePhase 4NCT01250184

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

A Phase 4 study testing Physical therapy, Lidocaine injection and Lidocaine injection + physical therapy in people with Myofascial Pain Syndrome and Pain, run by Grupo Rehabilitacion en Salud at 2 sites in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Myofascial Pain Syndrome, Pain, Myofascial Trigger Point Pain
What is being tested?: Physical therapy, Lidocaine injection and Lidocaine injection + physical therapy
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 2 sitesColombia
Study dates: May 2009to Sep 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Depression
Fibromyalgia
Cervical Radiculopathy

Trial locations and contacts

2 sites in 1 country.

Colombia2 sites

Clinica de Las Américas
Medellín, Antioquia
Ips Universitaria
Medellín, Antioquia

Other trials in Colombia

About this study

Official title: 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.

Read the 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.

Conditions: Myofascial Pain Syndrome, Pain, Myofascial Trigger Point Pain, Musculoskeletal Pain
Being tested: Physical therapy, Lidocaine injection, Lidocaine injection + physical therapy
Keywords: Myofascial pain, Trigger points., Lidocaine injection., Physical therapy
Medical subject headings: Myofascial Pain Syndromes, Pain, Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical therapyOther
Also called standardized therapeutic exercise program
Twelve sessions (3 per week)
Lidocaine injectionDrug
Also called blocking the Myofascial trigger point
blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
Lidocaine injection + physical therapyOther
Also called blocking plus a standarized therapeutic exercise program
blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

Study groups in NCT01250184
Study group	Role	What they receive
Physical Therapy	Active comparator	Twelve sessions, 3 per week. Receives: Other: Physical therapy
Lidocaine injection	Active comparator	Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose. Receives: Drug: Lidocaine injection
Lidocaine injection + physical therapy	Experimental	Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week. Receives: Other: Lidocaine injection + physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 4 weeks
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
Measured: 12 weeks

Secondary outcomes (4)

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
Measured: 4 weeks
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.
Measured: 4 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Sep 2011

First posted30 Nov 2010 (estimated)
Study startMay 2009
Primary completionJun 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01250184
Sponsor's protocol ID: GrupoRS0001
Status last verified: Oct 2014
First submitted: 27 Nov 2010
Last updated: 10 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myofascial Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy, Alone or in Combination: a Single-blind, Randomized, Controlled Clinical Trial.
ClinicalTrials.gov ID: NCT01250184
Acronym / sponsor ID: GrupoRS0001
Conditions: Myofascial Pain Syndrome, Pain, Myofascial Trigger Point Pain, Musculoskeletal Pain
Keywords: Myofascial pain, Trigger points., Lidocaine injection., Physical therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: Grupo Rehabilitacion en SaludResearch network
Collaborators: Universidad de Antioquia
Study start: May 2009
Primary completion: Jun 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 30 Nov 2010 (estimated)
Results: Posted 10 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Keywords: Myofascial pain, trigger points, lidocaine injection, physical therapy.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Physical Therapy	Active comparator	Other: Physical therapyTwelve sessions, 3 per week.
Lidocaine injection	Active comparator	Drug: Lidocaine injectionBlocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Lidocaine injection + physical therapy	Experimental	Other: Lidocaine injection + physical therapyBlocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

Depression
Fibromyalgia
Cervical Radiculopathy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical therapyAlso: standardized therapeutic exercise programTwelve sessions (3 per week)	Other	Physical Therapy
Lidocaine injectionAlso: blocking the Myofascial trigger pointblocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.	Drug	Lidocaine injection
Lidocaine injection + physical therapyAlso: blocking plus a standarized therapeutic exercise programblocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)	Other	Lidocaine injection + physical therapy

Primary outcome

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
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

4 secondary outcomes

PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
Time frame: 4 weeks
Quality of Life SF-36
Time frame: 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
Quality of Life SF-36
Time frame: 12 weeks

Results and safety

Results posted to the registry on 10 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Physical Therapy	43	43
Lidocaine Injection + Physical Therapy	41	41
Lidocaine Injection	43	43

Primary outcome: Visual Analogue Scale

Time frame: 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Lidocaine Injection + Physical Therapy n = 41	Lidocaine Injection n = 43	Physical Therapy n = 43
Value	40.8 (25.3)	44.2 (24.9)	37.8 (21.9)

Population analysed: Was calculated with the software "Sample Size from Javeriana University", was taken into account an error type I of 0.05 and error type II of 0.2, number of measurements before randomization = 1, after performing scrambling = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a total number of = 45 each

Primary outcome: Visual Analogue Scale

Time frame: 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Lidocaine Injection + Physical Therapy n = 41	Lidocaine Injection n = 43	Physical Therapy n = 43
Value	21.6 (21.8)	28.8 (22.3)	28.2 (23.7)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lidocaine Injection + Physical Therapy	0 of 41 (0%)	4 of 41 (9.8%)	Not reported
Physical Therapy	0 of 43 (0%)	0 of 43 (0%)	Not reported
Lidocaine Injection	0 of 43 (0%)	3 of 43 (7%)	Not reported

Limitations and caveats (from the sponsor): The therapists were not the same throughout the investigation, however all were standardized to interventions; especilaistas doctors who applied the injections were different. No specific measure of patient-centered operation is used.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myofascial Pain Syndrome

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Luz H Lugo Agudelo, Professor principal investigator

Universidad de Antioquia Grupo Rehabilitacion en Salud

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01250184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2014.