Shoulder PainNCT02338908
Dry Needling and Exercises in Shoulder Pain
A study testing exercise program and TrP-DN in people with Shoulder Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Shoulder pain is highly prevalent in the society. The role of muscle tissues in this pathology has received increasing interest. Some studies have proposed the role of myofascial trigger points in this population. 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?
- exercise program and TrP-DN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Mar 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 3 months
- Shoulder pain of more than 4 points on a NPRS
Who cannot join
- bilateral shoulder symptoms
- younger than 18 or older than 65 years
- history of shoulder fractures or dislocation
- cervical radiculopathy
- previous interventions with steroid injections
- fibromyalgia syndrome
- previous history of shoulder or neck surgery
- any type of intervention for the neck-shoulder area during the previous year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dry Needling and Eccentric Exercises in Unspecific Shoulder Pain
Shoulder pain is highly prevalent in the society. The role of muscle tissues in this pathology has received increasing interest. Some studies have proposed the role of myofascial trigger points in this population. The purpose of the current clinical trial is to compare the effects of physiotherapy treatment consisting of an eccentric exercise protocol versus the same physical therapy program plus the addition of trigger point dry needling (TrP-DN) on pain and function in patients suffering from unspecific shoulder pain.
- Conditions
- Shoulder Pain
- Being tested
- exercise program, TrP-DN
- Keywords
- dry needling, trigger point, 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.
exercise programOther
Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks.
TrP-DNOther
In addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks. In addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles Receives: Other: exercise program; Other: TrP-DN |
| Control group | Active comparator | Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks. Receives: Other: exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in disability between baseline and follow-up periods
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
Measured: Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention
Secondary outcomes (1)
Changes in shoulder pain between baseline and follow-up periods
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain and the worst level of pain experienced in the preceding week in the shoulder area.
Measured: Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- César Fernández-de-las-Peñas, PT, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338908
- Sponsor's protocol ID
- URJC 31/2140
- Status last verified
- Mar 2016
- First submitted
- 11 Jan 2015
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arias-Buria JL, Fernandez-de-Las-Penas C, Palacios-Cena M, Koppenhaver SL, Salom-Moreno J. Exercises and Dry Needling for Subacromial Pain Syndrome: A Randomized Parallel-Group Trial. J Pain. 2017 Jan;18(1):11-18. doi: 10.1016/j.jpain.2016.08.013. Epub 2016 Oct 5.
PubMed 27720812
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling and Eccentric Exercises in Unspecific Shoulder Pain
- ClinicalTrials.gov ID
- NCT02338908
- Acronym / sponsor ID
- URJC 31/2140
- Conditions
- Shoulder Pain
- Keywords
- dry needling, trigger point, eccentric exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Jan 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.
Shoulder pain is highly prevalent in the society. The role of muscle tissues in this pathology has received increasing interest. Some studies have proposed the role of myofascial trigger points in this population. The purpose of the current clinical trial is to compare the effects of physiotherapy treatment consisting of an eccentric exercise protocol versus the same physical therapy program plus the addition of trigger point dry needling (TrP-DN) on pain and function in patients suffering from unspecific shoulder pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: exercise program, Other: TrP-DNPatients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks. In addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles |
| Control group | Active comparator | Other: exercise programPatients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral non-traumatic shoulder pain
- Shoulder pain from at least 3 months
- Shoulder pain of more than 4 points on a NPRS
Key exclusion criteria (8 listed)
- bilateral shoulder symptoms
- younger than 18 or older than 65 years
- history of shoulder fractures or dislocation
- cervical radiculopathy
- previous interventions with steroid injections
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 |
|---|---|---|
| exercise programPatients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks. | Other | Control group, Experimental group |
| TrP-DNIn addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles | Other | Experimental group |
Primary outcome
Changes in disability between baseline and follow-up periods
Time frame: Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
1 secondary outcome
Changes in shoulder pain between baseline and follow-up periods
Time frame: Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention
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 15 Mar 2016.
- Derived from this study: PubMed 27720812Arias-Buria JL, Fernandez-de-Las-Penas C, Palacios-Cena M, Koppenhaver SL, Salom-Moreno J. Exercises and Dry Needling for Subacromial Pain Syndrome: A Randomized Parallel-Group Trial. J Pain. 2017 Jan;18(1):11-18. doi: 10.1016/j.jpain.2016.08.013. Epub 2016 Oct 5.
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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.
César Fernández-de-las-Peñas, PT, 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 exercise program and TrP-DN 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 3 inclusion and 8 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 15 Mar 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. 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 disability between baseline and follow-up periods (time frame: Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention). 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 NCT02338908, which also lists 1 linked publication.
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 15 Mar 2016.