PainNCT03222154
EFFECTS OF SHOCK WAVE THERAPY IN WOMEN WITH PAIN IN TRAPÉZIO MUSCLE
A study testing Experimental - Shock wave therapy in people with Pain and Muscle Tonus, run by Rodrigo Marcel Valentim da Silva.
Trial summary
The study consisted of 60 women who had pain-point pains in the upper fibers of the trapezius muscle. They had a medical age of 22.8 years, with a body mass index of 22.8 kg / cm2.They underwent an initial assessment, with a visual analogue pain scale, followed by an assessment of pain threshold, and manual muscle… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pain, Muscle Tonus
- What is being tested?
- Experimental - Shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with painful symptoms, compatible with the referred pain pattern of trigger points in the upper trapezius muscle.
- Age range of 18 to 35 years.
- No upper limb injury in the last 6 months.
- Featuring trigger points identified in the upper trapezius muscle.
- Present pain and / or moderate and / or severe disability after application of specific instruments.
Who cannot join
- Present unbearable pain during the evaluation procedures.
- Missing or not executing the solution correctly.
About this study
Official title: EFFECTS OF SHOCK WAVE THERAPY IN MIOFASCIAL PAIN: RANDOMIZED AND BLIND CLINICAL TEST
The study consisted of 60 women who had pain-point pains in the upper fibers of the trapezius muscle. They had a medical age of 22.8 years, with a body mass index of 22.8 kg / cm2.They underwent an initial assessment, with a visual analogue pain scale, followed by an assessment of pain threshold, and manual muscle strength.Then, they were allocated into three groups: control group with 20 volunteers without intervention, placebo group with 20 volunteers with shock wave simulation and an intervention group with 20 volunteers with shock wave therapy.
All volunteers were evaluated immediately after the protocol (post evaluation) and 48 hours after the intervention protocol (48 hour evaluation). A mixed ANOVA of repeated measurements was used for intra and intergroup comparisons, followed by tukey post hoc. Significance was set at 5% (p <0.05).
Read the detailed description
The objective was to investigate the effects of shock wave therapy on the pain of trigger points in the upper fibers of the trapezius muscle.
A randomized, blinded clinical trial of 60 women (mean age 22.8 years and mean body mass index of 22.8 kg / cm2) with presence of trigger points in the upper fibers of the trapezius muscle. These were submitted to an initial evaluation (AV1), composed of the visual analogical pain scale, followed by an evaluation of the pain threshold, using algometry.
Then, the evaluation of the electromyographic activity of the upper trapezius muscle was performed, as well as of its muscular strength by manual dynamometry. Then allocated randomly in 3 groups: Control (n = 20), without intervention; Placebo (n = 20), simulation of the application of shock wave therapy; And shock wave therapy (n = 20).
Shock wave therapy was performed with the Master Plus 200® Storz Medical equipment, radial emission 2000 pulses, 15 Hz frequency and pressure of 1 Bar. All volunteers were evaluated immediately after the protocol (post evaluation) and 48 hours After the intervention protocol (evaluation 48 hours). A mixed ANOVA of repeated measurements was used for intra and intergroup comparisons, followed by tukey post hoc. Significance was set at 5% (p <0.05).
- Conditions
- Pain, Muscle Tonus
- Being tested
- Experimental - Shock wave therapy, Placebo - Shock wave therapy
- Keywords
- High Energy Shock Waves, physiotherapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental - Shock wave therapyDevice
Also called High energy shock wave therapy
Shock wave therapy was performed with the Master Plus 200® Storz Medical equipment, radial emission 2000 pulses, frequency 15 Hz and pressure 1 Bar.
Placebo - Shock wave therapyDevice
Simulation of shock wave therapy
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 20 volunteers without intervention. At the end of the study they received an application of shock wave therapy. |
| Placebo | Placebo comparator | 20 volunteers who received simulation of the application of shock wave therapy Receives: Device: Placebo - Shock wave therapy |
| Experimental | Experimental | 20 volunteers who received shock wave therapy Receives: Device: Experimental - Shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
The subjective pain intensity was evaluated using the Visual Analogue Scale. Which consists of a horizontal line, 10 centimeters long, marked at one end by a rating of 0 - "No Pain" and the other by the classification "Maximum Pain". The patient had to make a line perpendicular to the line, at the point that represents the intensity of his pain.
Measured: five minutes
Evaluation of trigger points
The presence of trigger points was investigated in the upper trapezius muscle on the side that the volunteer reported pain or bilateral.
The evaluation was performed with the volunteers in the ventral decubitus, and bilaterally evaluated the presence of the trigger points in the upper trapezius. The number of trigger points was recorded according to the classification: active PMG, latent PGM and total PGM. The side that presented a larger number of trigger points was the side used to evaluate the experimental procedures. If the number of active trigger points were equal on both sides, the upper limb considered dominant by the volunteer was chosen for the evaluation.
Measured: fifteen minutes
Evaluation of pressure pain threshold
To evaluate the pain threshold, a WAGNER® FDM algometer was used, which is a device consisting of a 1 cm2 rubber disc connected to a pressure gauge, which shows values in N.
The volunteers were previously advised on how the procedure would be performed. And that when when the pressure with the tip of the apparatus began to evoke pain / threshold it was necessary to say loudly the word "Stop"
Measured: ten minutes
Electromyographic Evaluation (EMG) Electromyographic Evaluation (EMG)
Electromyographic signal processing was performed with a TeleMyo DTS Desk Receiver® electromyography channel (Noraxon USA Inc., Scottsdale, USA) with a 20-500 Hz bandpass filter, gain of 1500 times, and a rejection rate of Common mode greater than 100 dB. The electromyographic evaluation was performed using the bipolar technique, with simple double wireless electrodes.
Measured: twenty minutes
Strength evaluation
The muscle strength test was performed with a manual dynamometer (Lafayette® - model 01165), for the force in the shoulder lift movement. For this evaluation the volunteers were seated, with the shoulder in extension position, and consequently the upper limb on the side of the body. The dynamometer was placed in a fixed bulkhead and the shoulder was elevated, resisting the movement and performing an isometric contraction.
Measured: ten minutes
Assessment by the Change Perception Scale
The Patient Global Impression of Change Scale questionnaire was applied in its Portuguese version, Scale of Perception of Change, being an instrument of easy understanding and application. It becomes a useful tool to quantify the perception of change in health status and satisfaction of a treatment of chronic musculoskeletal pain.
Measured: ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Jul 2016
- Primary completion1 Oct 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups: Control (n = 20), without intervention; Placebo (n = 20), simulation of the application of shock wave therapy; And shock wave therapy (n = 20).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodrigo Marcel Valentim da Silva
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Rio Grande do Norte
- Responsible party
- Sponsor-investigator, Rodrigo Marcel Valentim da Silva, Estácio Ponta Negra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222154
- Sponsor's protocol ID
- UFRN
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF SHOCK WAVE THERAPY IN MIOFASCIAL PAIN: RANDOMIZED AND BLIND CLINICAL TEST
- ClinicalTrials.gov ID
- NCT03222154
- Acronym / sponsor ID
- UFRN
- Conditions
- Pain, Muscle Tonus
- Keywords
- High Energy Shock Waves, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rodrigo Marcel Valentim da SilvaUniversity, hospital or other
- Collaborators
- Universidade Federal do Rio Grande do Norte
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study consisted of 60 women who had pain-point pains in the upper fibers of the trapezius muscle. They had a medical age of 22.8 years, with a body mass index of 22.8 kg / cm2.They underwent an initial assessment, with a visual analogue pain scale, followed by an assessment of pain threshold, and manual muscle strength.Then, they were allocated into three groups: control group with 20 volunteers without intervention, placebo group with 20 volunteers with shock wave simulation and an intervention group with 20 volunteers with shock wave therapy.
All volunteers were evaluated immediately after the protocol (post evaluation) and 48 hours after the intervention protocol (48 hour evaluation). A mixed ANOVA of repeated measurements was used for intra and intergroup comparisons, followed by tukey post hoc. Significance was set at 5% (p <0.05).
Detailed description
The objective was to investigate the effects of shock wave therapy on the pain of trigger points in the upper fibers of the trapezius muscle.
A randomized, blinded clinical trial of 60 women (mean age 22.8 years and mean body mass index of 22.8 kg / cm2) with presence of trigger points in the upper fibers of the trapezius muscle. These were submitted to an initial evaluation (AV1), composed of the visual analogical pain scale, followed by an evaluation of the pain threshold, using algometry.
Then, the evaluation of the electromyographic activity of the upper trapezius muscle was performed, as well as of its muscular strength by manual dynamometry. Then allocated randomly in 3 groups: Control (n = 20), without intervention; Placebo (n = 20), simulation of the application of shock wave therapy; And shock wave therapy (n = 20).
Shock wave therapy was performed with the Master Plus 200® Storz Medical equipment, radial emission 2000 pulses, 15 Hz frequency and pressure of 1 Bar. All volunteers were evaluated immediately after the protocol (post evaluation) and 48 hours After the intervention protocol (evaluation 48 hours). A mixed ANOVA of repeated measurements was used for intra and intergroup comparisons, followed by tukey post hoc. Significance was set at 5% (p <0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 groups: Control (n = 20), without intervention; Placebo (n = 20), simulation of the application of shock wave therapy; And shock wave therapy (n = 20).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –20 volunteers without intervention. At the end of the study they received an application of shock wave therapy. |
| Placebo | Placebo comparator | Device: Placebo - Shock wave therapy20 volunteers who received simulation of the application of shock wave therapy |
| Experimental | Experimental | Device: Experimental - Shock wave therapy20 volunteers who received shock wave therapy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with painful symptoms, compatible with the referred pain pattern of trigger points in the upper trapezius muscle.
- Age range of 18 to 35 years.
- No upper limb injury in the last 6 months.
- Featuring trigger points identified in the upper trapezius muscle.
- Present pain and / or moderate and / or severe disability after application of specific instruments.
Key exclusion criteria (2 listed)
- Present unbearable pain during the evaluation procedures.
- Missing or not executing the solution correctly.
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 |
|---|---|---|
| Experimental - Shock wave therapyAlso: High energy shock wave therapyShock wave therapy was performed with the Master Plus 200® Storz Medical equipment, radial emission 2000 pulses, frequency 15 Hz and pressure 1 Bar. | Device | Experimental |
| Placebo - Shock wave therapySimulation of shock wave therapy | Device | Placebo |
Primary outcome
Pain assessment
Time frame: five minutes
The subjective pain intensity was evaluated using the Visual Analogue Scale. Which consists of a horizontal line, 10 centimeters long, marked at one end by a rating of 0 - "No Pain" and the other by the classification "Maximum Pain". The patient had to make a line perpendicular to the line, at the point that represents the intensity of his pain.
Evaluation of trigger points
Time frame: fifteen minutes
The presence of trigger points was investigated in the upper trapezius muscle on the side that the volunteer reported pain or bilateral. The evaluation was performed with the volunteers in the ventral decubitus, and bilaterally evaluated the presence of the trigger points in the upper trapezius. The number of trigger points was recorded according to the classification: active PMG, latent PGM and total PGM. The side that presented a larger number of trigger points was the side used to evaluate the experimental procedures. If the number of active trigger points were equal on both sides, the upper limb considered dominant by the volunteer was chosen for the evaluation.
Evaluation of pressure pain threshold
Time frame: ten minutes
To evaluate the pain threshold, a WAGNER® FDM algometer was used, which is a device consisting of a 1 cm2 rubber disc connected to a pressure gauge, which shows values in N. The volunteers were previously advised on how the procedure would be performed. And that when when the pressure with the tip of the apparatus began to evoke pain / threshold it was necessary to say loudly the word "Stop"
Electromyographic Evaluation (EMG) Electromyographic Evaluation (EMG)
Time frame: twenty minutes
Electromyographic signal processing was performed with a TeleMyo DTS Desk Receiver® electromyography channel (Noraxon USA Inc., Scottsdale, USA) with a 20-500 Hz bandpass filter, gain of 1500 times, and a rejection rate of Common mode greater than 100 dB. The electromyographic evaluation was performed using the bipolar technique, with simple double wireless electrodes.
Strength evaluation
Time frame: ten minutes
The muscle strength test was performed with a manual dynamometer (Lafayette® - model 01165), for the force in the shoulder lift movement. For this evaluation the volunteers were seated, with the shoulder in extension position, and consequently the upper limb on the side of the body. The dynamometer was placed in a fixed bulkhead and the shoulder was elevated, resisting the movement and performing an isometric contraction.
Assessment by the Change Perception Scale
Time frame: ten minutes
The Patient Global Impression of Change Scale questionnaire was applied in its Portuguese version, Scale of Perception of Change, being an instrument of easy understanding and application. It becomes a useful tool to quantify the perception of change in health status and satisfaction of a treatment of chronic musculoskeletal pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental - Shock wave therapy in people with Pain and Muscle Tonus, run by Rodrigo Marcel Valentim da Silva.
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 5 inclusion and 2 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain assessment (time frame: five minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2017.