Clinical Study - RCTPhase 3DIMMSTNCT01708343
Paraspinal Stimulation in Treating MPS
A Phase 3 study testing DIMMST in people with Clinical Study - RCT, run by Hospital de Clinicas de Porto Alegre at 3 sites in Brazil.
Trial summary
To test the hypothesis that the effect of either multiple deep intramuscular stimulation therapy [(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR)] would be more effective than a placebo-sham for the treatment of MPS and that… Read more about this study
- Who is it for?
- Ages 19 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Study - RCT
- What is being tested?
- DIMMST
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesBrazil
- Study dates
- Jan 2011to Nov 2012
- Phase
- Phase 3
- 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 19 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Myofascial pain syndrome (MPS) (defined as regional pain, normal neurologic examination, presence of TrPs, taut bands, tender points, and pain characterized as "dull," "achy," or "deep" were relevant to MPS diagnosis. Additionally, palpable nodules, pain that is exacerbated by stress, decreased range of motion, and ropiness in the muscle).
- Disability in the last three months: (defined if they had one or more these limitation in active and routine activities by MPS : (i) interference with work, (ii) enjoyable activities, (iii) responsibilities at home, (iv) relationships, (v) personal goals, (vi) thinking clearly, and problem solving, concentrating, or remembering during the last three months).
- Women
- Age: 19 to 50 years
Who cannot join
- Rheumatoid arthritis
- Fibromyalgia
- Previous surgery on the affected areas
- Prior experience with acupuncture
- Primary radiculopathy
- Current use of psychotropic drugs (ilicits
- ) Habitual use of anti-inflammatory steroids.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites, 3 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Jose R Goldim, PhD, 55 (51) 3359-8856., jrgoldim@gmail.com
Iraci L Torres, PhD
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Jose R Goldim, PhD, 55 (51) 3359-8856, jrgoldim@gmail.com
José R Goldim, PhD, 55 (51) 3359-8856, jrgoldim@gmail.com
- Recruiting
Hospital de Clínicas E Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
JOSE GOLDIM, PhD, 55 (51) 3359-8856., jrgoldim@gmail.com
WOLNEI CAUMO, PhD
About this study
Official title: Paraspinal Stimulation Combined With Trigger Point Needling and Needle Rotation in Treating Myofascial Pain: Randomized Sham-controlled Clinical Trial
To test the hypothesis that the effect of either multiple deep intramuscular stimulation therapy [(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR)] would be more effective than a placebo-sham for the treatment of MPS and that DIMMST would be more effective than LTrP-I for improving pain relief, sleep quality, and physical and mental state of the patient.
- Conditions
- Clinical Study - RCT
- Being tested
- DIMMST
- Keywords
- Myofascial Pain Syndrome,, intramuscular stimulation,, acupuncture,, sleep quality,, pain threshold.
- Medical subject headings
- Myofascial Pain Syndromes, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIMMSTProcedure or surgery
Also called Eletroacupuncture, Myofascial pain
| Study group | Role | What they receive |
|---|---|---|
| Placebo-sham | Sham comparator | Placebo-sham twice a week during four weeks Receives: Procedure: DIMMST |
| Lidocaine injection | Active comparator | Lidocaine 0.2-0.5 mL of 1% injected each time into the trigger point. Twice a week during four weeks Receives: Procedure: DIMMST |
| DIMMST | Experimental | DIMMST include the combination of trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR).
Twice a week during four weeks Receives: Procedure: DIMMST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
- The intensity of pain was measured by a 10-cm VAS [30]. VAS scores ranged from no pain (zero) to the worst possible pain (10 cm).
Measured: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
Pain threshold
Pain pressure threshold (PPT)
Measured: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
Secondary outcomes (3)
Sleep quality - how did you feel when you woke up
Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS:
In general, how did you feel when you woke up?
Measured: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
Sleep quality - compared to your habitual sleep
Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS:
Assess the sleep quality of the previous night compared to your habitual sleep?
Measured: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
Sleep quality -last night
Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS:
How well did you sleep last night?
Measured: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startJan 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Study - RCTStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolnei Caumo, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708343
- Sponsor's protocol ID
- MPS-DIMS
- Acronym
- DIMMST
- Status last verified
- Oct 2012
- First submitted
- 9 Oct 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraspinal Stimulation Combined With Trigger Point Needling and Needle Rotation in Treating Myofascial Pain: Randomized Sham-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01708343
- Acronym / sponsor ID
- DIMMST / MPS-DIMS
- Conditions
- Clinical Study - RCT
- Keywords
- Myofascial Pain Syndrome,, intramuscular stimulation,, acupuncture,, sleep quality,, pain threshold.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 16 Oct 2012 (estimated)
- 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.
To test the hypothesis that the effect of either multiple deep intramuscular stimulation therapy [(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR)] would be more effective than a placebo-sham for the treatment of MPS and that DIMMST would be more effective than LTrP-I for improving pain relief, sleep quality, and physical and mental state of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo-sham | Sham comparator | Procedure: DIMMSTPlacebo-sham twice a week during four weeks |
| Lidocaine injection | Active comparator | Procedure: DIMMSTLidocaine 0.2-0.5 mL of 1% injected each time into the trigger point. Twice a week during four weeks |
| DIMMST | Experimental | Procedure: DIMMSTDIMMST include the combination of trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR). Twice a week during four weeks |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Myofascial pain syndrome (MPS) (defined as regional pain, normal neurologic examination, presence of TrPs, taut bands, tender points, and pain characterized as "dull," "achy," or "deep" were relevant to MPS diagnosis. Additionally, palpable nodules, pain that is exacerbated by stress, decreased range of motion, and ropiness in the muscle).
- Disability in the last three months: (defined if they had one or more these limitation in active and routine activities by MPS : (i) interference with work, (ii) enjoyable activities, (iii) responsibilities at home, (iv) relationships, (v) personal goals, (vi) thinking clearly, and problem solving, concentrating, or remembering during the last three months).
- Women
- Age: 19 to 50 years
Key exclusion criteria (7 listed)
- Rheumatoid arthritis
- Fibromyalgia
- Previous surgery on the affected areas
- Prior experience with acupuncture
- Primary 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 |
|---|---|---|
| DIMMSTAlso: Eletroacupuncture, Myofascial pain | Procedure or surgery | DIMMST, Lidocaine injection, Placebo-sham |
Primary outcome
Pain severity
Time frame: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
a) The intensity of pain was measured by a 10-cm VAS [30]. VAS scores ranged from no pain (zero) to the worst possible pain (10 cm).
Pain threshold
Time frame: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
Pain pressure threshold (PPT)
3 secondary outcomes
Sleep quality - how did you feel when you woke up
Time frame: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
Sleep quality - compared to your habitual sleep
Time frame: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
Sleep quality -last night
Time frame: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DIMMST in people with Clinical Study - RCT, run by Hospital de Clinicas de Porto Alegre at 3 sites in Brazil.
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 7 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: status not confirmed, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WOLNEI CAUMO, MD, PhD (55-51-3359-8083, caumo@cpovo.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)). 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?
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 16 Oct 2012.