Shoulder PainNCT02558686
Exercise and Post-dry Needling Soreness
A study testing Eccentric Exercise and Detuned Ultrasound in people with Shoulder Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Manual therapies and exercise strategies targeting to decrease post-dry needling soreness need to be investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Eccentric Exercise and Detuned Ultrasound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral non-traumatic shoulder pain
- Shoulder pain from at least 6 months
- Shoulder pain of more than 3 points on a NPRS
- Presence of active trigger point in the infraspinatus muscle
Who cannot join
- bilateral shoulder pain
- younger than 18 or older than 65 years
- shoulder injury
- upper extremity surgery
- fibromyalgia syndrome
- neck or shoulder surgery
Show all 9Show fewer
- cervical radiculopathy
- whiplash
- any type of intervention for the neck-shoulder the previous year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Eccentric Exercise, Sham or Placebo on Post-Needling Soreness by Dry Needling on Active Trigger Points
Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Manual therapies and exercise strategies targeting to decrease post-dry needling soreness need to be investigated.
- Conditions
- Shoulder Pain
- Being tested
- Eccentric Exercise, Detuned Ultrasound, Placebo
- Keywords
- trigger points, disability, post-dry needling soreness, eccentric exercise
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric ExerciseOther
Individuals will perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling
Detuned UltrasoundOther
Individuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling
PlaceboOther
Individuals will not perform any action after the application of trigger point dry needling
| Study group | Role | What they receive |
|---|---|---|
| Eccentric Exercise | Experimental | Individuals will perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling Receives: Other: Eccentric Exercise |
| Detuned Ultrasound | Sham comparator | Individuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling Receives: Other: Detuned Ultrasound |
| Placebo | Placebo comparator | Individuals will not perform any action after the application of trigger point dry needling Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in post-dry needling pain intensity before and after the intervention
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness and pain
Measured: Baseline, 24 hours after, 48 hours after and 72 hours after treatment
Secondary outcomes (3)
Changes in spontaneous shoulder pain before and after the intervention
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous shoulder pain
Measured: Baseline and 72 hours after treatment
Changes in disability before and after the intervention
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to assess disability induced by shoulder pain.
Measured: Baseline and 72 hours after treatment
Changes in functionality before and after the intervention
The Shoulder Pain and Disability Index (SPADI) questionnaire will be used to assess function of the uppr extremity related to shoulder pain
Measured: Baseline and 72 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- Cesar Fernández-de-las-Peñas, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558686
- Sponsor's protocol ID
- URJC 2015-12
- Status last verified
- Jan 2016
- First submitted
- 21 Sep 2015
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eccentric Exercise, Sham or Placebo on Post-Needling Soreness by Dry Needling on Active Trigger Points
- ClinicalTrials.gov ID
- NCT02558686
- Acronym / sponsor ID
- URJC 2015-12
- Conditions
- Shoulder Pain
- Keywords
- trigger points, disability, post-dry needling soreness, eccentric exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Sep 2015 (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.
Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Manual therapies and exercise strategies targeting to decrease post-dry needling soreness need to be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eccentric Exercise | Experimental | Other: Eccentric ExerciseIndividuals will perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling |
| Detuned Ultrasound | Sham comparator | Other: Detuned UltrasoundIndividuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling |
| Placebo | Placebo comparator | Other: PlaceboIndividuals will not perform any action after the application of trigger point dry needling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral non-traumatic shoulder pain
- Shoulder pain from at least 6 months
- Shoulder pain of more than 3 points on a NPRS
- Presence of active trigger point in the infraspinatus muscle
Key exclusion criteria (9 listed)
- bilateral shoulder pain
- younger than 18 or older than 65 years
- shoulder injury
- upper extremity surgery
- fibromyalgia syndrome
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 |
|---|---|---|
| Eccentric ExerciseIndividuals will perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling | Other | Eccentric Exercise |
| Detuned UltrasoundIndividuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling | Other | Detuned Ultrasound |
| PlaceboIndividuals will not perform any action after the application of trigger point dry needling | Other | Placebo |
Primary outcome
Changes in post-dry needling pain intensity before and after the intervention
Time frame: Baseline, 24 hours after, 48 hours after and 72 hours after treatment
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness and pain
3 secondary outcomes
Changes in spontaneous shoulder pain before and after the intervention
Time frame: Baseline and 72 hours after treatment
Changes in disability before and after the intervention
Time frame: Baseline and 72 hours after treatment
Changes in functionality before and after the intervention
Time frame: Baseline and 72 hours after treatment
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 Jan 2016.
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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.
Cesar Fernández-de-las-Peñas, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Exercise and Detuned Ultrasound in people with Shoulder Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 9 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 Jan 2016. 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 Spain. 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.
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?
Changes in post-dry needling pain intensity before and after the intervention (time frame: Baseline, 24 hours after, 48 hours after and 72 hours after treatment). 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 Jan 2016.