Myofascial Pain SyndromeNCT01710735
Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs
A study testing Dry needling in people with Myofascial Pain Syndrome, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will explore muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes. Read more about this study
- Who is it for?
- Ages 20 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Sep 2012
- 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 20 to 46 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A clinically relevant MFTrP of the upper Trapezius musculature
- Self-reported pain of ≥3 on an eleven-point numerical pain rating scale (NRS-101).
- BMI less than 31
Who cannot join
- a history of chronic, systemic pathology (e.g. hemophilia)
- pre-existing neck/shoulder pathology/surgical procedures,
- clinical depression
- health-related legal action
- pregnant
- anti-inflammatory and/or chronic pain medication
- had received dry needling for a shoulder/neck disorder within 6 months prior to the study (to raise the level of patient naiveté) suffered from needle phobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Upper Trapezius Myofascial Trigger Points- a Randomized Intervention Study
In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will explore muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Dry needling
- Keywords
- TP, Myofascial pain
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingProcedure or surgery
Also called Acupuncture
Insertion of acupuncture needle into a myofascial trigger point.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling (deep) | Experimental | Subjects receive dry needle insertion deeper than 1,5cm below the skin of the Trapezius. Receives: Procedure: Dry needling |
| Dry needling (superficial) | Active comparator | Insertion of dry needle less than 1cm. Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle contractility
Measurements of maximal isometric muscle force (Fmax), and rate of force development (RDF)
Measured: 30 minutes
Secondary outcomes (2)
pressure-pain threshold
Algometer measurement of pressure-pain perception
Measured: 60 seconds
NRS-101
Self-reported pain
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startApr 2011
- Primary completionMay 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation, Dansk Kiropraktor Fond, IMK Almene Fond
- Responsible party
- Principal investigator, Corrie Myburgh, University of Southern Denmark
- Investigators
- Jan Hartvigsen Hartvigsen, PhD, Study director, Univ. of Southern DenmarkPer Aagaard, PhD, Study director, Univ. of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710735
- Sponsor's protocol ID
- Muscle and needling
- Status last verified
- Oct 2012
- First submitted
- 17 Oct 2012
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Myburgh C, Hartvigsen J, Aagaard P, Holsgaard-Larsen A. Skeletal muscle contractility, self-reported pain and tissue sensitivity in females with neck/shoulder pain and upper Trapezius myofascial trigger points- a randomized intervention study. Chiropr Man Therap. 2012 Nov 25;20(1):36. doi: 10.1186/2045-709X-20-36.
PubMed 23176709Hofer KA, Ruonala R, Albert VA. The double-corolla phenotype in the Hawaiian lobelioid genus Clermontia involves ectopic expression of PISTILLATA B-function MADS box gene homologs. Evodevo. 2012 Nov 1;3(1):26. doi: 10.1186/2041-9139-3-26.
PubMed 23116179
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Upper Trapezius Myofascial Trigger Points- a Randomized Intervention Study
- ClinicalTrials.gov ID
- NCT01710735
- Acronym / sponsor ID
- Muscle and needling
- Conditions
- Myofascial Pain Syndrome
- Keywords
- TP, Myofascial pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Lundbeck Foundation, Dansk Kiropraktor Fond, IMK Almene Fond
- Study start
- Apr 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 19 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.
In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will explore muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling (deep) | Experimental | Procedure: Dry needlingSubjects receive dry needle insertion deeper than 1,5cm below the skin of the Trapezius. |
| Dry needling (superficial) | Active comparator | Procedure: Dry needlingInsertion of dry needle less than 1cm. |
Who may qualify
- Ages
- 20 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A clinically relevant MFTrP of the upper Trapezius musculature
- Self-reported pain of ≥3 on an eleven-point numerical pain rating scale (NRS-101).
- BMI less than 31
Key exclusion criteria (7 listed)
- a history of chronic, systemic pathology (e.g. hemophilia)
- pre-existing neck/shoulder pathology/surgical procedures,
- clinical depression
- health-related legal action
- pregnant
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 |
|---|---|---|
| Dry needlingAlso: AcupunctureInsertion of acupuncture needle into a myofascial trigger point. | Procedure or surgery | Dry needling (deep), Dry needling (superficial) |
Primary outcome
muscle contractility
Time frame: 30 minutes
Measurements of maximal isometric muscle force (Fmax), and rate of force development (RDF)
2 secondary outcomes
pressure-pain threshold
Time frame: 60 seconds
NRS-101
Time frame: 60 seconds
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 19 Oct 2012.
- Derived from this study: PubMed 23176709Myburgh C, Hartvigsen J, Aagaard P, Holsgaard-Larsen A. Skeletal muscle contractility, self-reported pain and tissue sensitivity in females with neck/shoulder pain and upper Trapezius myofascial trigger points- a randomized intervention study. Chiropr Man Therap. 2012 Nov 25;20(1):36. doi: 10.1186/2045-709X-20-36.
- Derived from this study: PubMed 23116179Hofer KA, Ruonala R, Albert VA. The double-corolla phenotype in the Hawaiian lobelioid genus Clermontia involves ectopic expression of PISTILLATA B-function MADS box gene homologs. Evodevo. 2012 Nov 1;3(1):26. doi: 10.1186/2041-9139-3-26.
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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.
Jan Hartvigsen Hartvigsen, PhD study director
Univ. of Southern Denmark
Per Aagaard, PhD study director
Univ. of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in people with Myofascial Pain Syndrome, run by University of Southern Denmark at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 19 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 1 site in Denmark. 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.
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?
muscle contractility (time frame: 30 minutes). 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 NCT01710735, which also lists 2 linked publications.
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 19 Oct 2012.