Proximal Humeral Fracture Fixated With PHILOS© PlateNCT02122315
Dry Needling in Post-operative Shoulder Pain
A study testing Physical therapy plus dry needling and Physical therapy in people with Proximal Humeral Fracture Fixated With PHILOS© Plate and Rotator Cuff Tear Surgical Repair, run by César Fernández-de-las-Peñas at 1 site in Spain.
Trial summary
Fractures of the proximal humerus account for between 5% and 8% off all reported fractures. Post-operative shoulder pain is highly frequent. Due to either surgical procedure, soft tissues surrounding the shoulder area can be damaged. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Proximal Humeral Fracture Fixated With PHILOS© Plate, Rotator Cuff Tear Surgical Repair
- What is being tested?
- Physical therapy plus dry needling and Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2013to Apr 2013
- 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
- proximal humeral fracture
- rotator cuff tear
- open reduction and internal fixation with PHILOS© plate (Synthes, Switzerland)
- rotator cuff tear repair
- post-operative shoulder pain
- active TrPs in the neck-shoulder muscles
Who cannot join
- no active TrPs
- multiple fracture
- previous surgery
- cervical radiculopathy or myelopathy
- diagnosis of fibromialgia
- having undergone any physical therapy intervention in the year before the surgery
- fear of needles
- any contraindication for dry needling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTIVENESS OF THE INCLUSION OF TRIGGER POINT DRY NEEDLING INTO A MULTIMODAL PHYSICAL THERAPY PROGRAM FOR POST-OPERATIVE SHOULDER PAIN
Fractures of the proximal humerus account for between 5% and 8% off all reported fractures. Post-operative shoulder pain is highly frequent. Due to either surgical procedure, soft tissues surrounding the shoulder area can be damaged. The purpose of the current clinical trial was to compare the effects of physiotherapy versus physiotherapy plus TrP-DN on pain and function in patients who exhibit post-operative shoulder pain after a PHILOS procedure for proximal humeral fixation or rotator cuff tear repair.
- Being tested
- Physical therapy plus dry needling, Physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy plus dry needlingOther
Best-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles
Physical therapyOther
Best-evidence physical therapy intervention
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy plus dry needling | Experimental | Best-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles. Receives: Other: Physical therapy plus dry needling |
| Physical therapy | Active comparator | Best-evidence physical therapy intervention Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Constant-Murley score before and after the intervention
The Constant-Murley score is a 100-point scoring system that is divided into 4 main sub-scales: pain (15 points); activities of daily living (20 points); range of motion (40 points); and strength (25 points). Higher score represents better function
Measured: Baseline and one week 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 posted24 Apr 2014 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 2013
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 Proximal Humeral Fracture Fixated With PHILOS© PlateStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- César Fernández-de-las-Peñas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- Cesar Fernández-de-las-Peñas, PhD, Study chair, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122315
- Sponsor's protocol ID
- CP13-060
- Status last verified
- Apr 2014
- First submitted
- 19 Apr 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PubMed 35727196
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF THE INCLUSION OF TRIGGER POINT DRY NEEDLING INTO A MULTIMODAL PHYSICAL THERAPY PROGRAM FOR POST-OPERATIVE SHOULDER PAIN
- ClinicalTrials.gov ID
- NCT02122315
- Acronym / sponsor ID
- CP13-060
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- César Fernández-de-las-PeñasUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Apr 2014 (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.
Fractures of the proximal humerus account for between 5% and 8% off all reported fractures. Post-operative shoulder pain is highly frequent. Due to either surgical procedure, soft tissues surrounding the shoulder area can be damaged. The purpose of the current clinical trial was to compare the effects of physiotherapy versus physiotherapy plus TrP-DN on pain and function in patients who exhibit post-operative shoulder pain after a PHILOS procedure for proximal humeral fixation or rotator cuff tear repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical therapy plus dry needling | Experimental | Other: Physical therapy plus dry needlingBest-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles. |
| Physical therapy | Active comparator | Other: Physical therapyBest-evidence physical therapy intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- proximal humeral fracture
- rotator cuff tear
- open reduction and internal fixation with PHILOS© plate (Synthes, Switzerland)
- rotator cuff tear repair
- post-operative shoulder pain
Key exclusion criteria (8 listed)
- no active TrPs
- multiple fracture
- previous surgery
- cervical radiculopathy or myelopathy
- diagnosis of fibromialgia
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 |
|---|---|---|
| Physical therapy plus dry needlingBest-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles | Other | Physical therapy plus dry needling |
| Physical therapyBest-evidence physical therapy intervention | Other | Physical therapy |
Primary outcome
Changes in Constant-Murley score before and after the intervention
Time frame: Baseline and one week after the intervention
The Constant-Murley score is a 100-point scoring system that is divided into 4 main sub-scales: pain (15 points); activities of daily living (20 points); range of motion (40 points); and strength (25 points). Higher score represents better function
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 24 Apr 2014.
- Derived from this study: PubMed 35727196Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
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 study chair
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 Physical therapy plus dry needling and Physical therapy in people with Proximal Humeral Fracture Fixated With PHILOS© Plate and Rotator Cuff Tear Surgical Repair, run by César Fernández-de-las-Peñas 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 6 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 24 Apr 2014. 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 Constant-Murley score before and after the intervention (time frame: Baseline and one week 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 NCT02122315, 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 24 Apr 2014.