Shoulder PainNCT06739694
Neuroscience Education in Shoulder Pain: Clinical Trial
A study testing PNE and Manual therapy in people with Shoulder Pain, run by Universidad de León at 1 site in Spain.
Trial summary
Objectives: The purpose of this study was to assess the efficacy of a pain neuroscience education programme applied to patients with shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- PNE and Manual therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2024to 1 Oct 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18-70 years of age.
- History of shoulder pain of more than 3 months duration.
- Presence of a painful arc
- Medical diagnosis of shoulder pain with at least 2 positive impingement tests including Neer, Hawkins, or Jobe test
Who cannot join
- Diagnosis of fibromyalgia.
- Pregnancy.
- A history of traumatic onset of shoulder pain.
- Other histories of shoulder injury.
- Torn tendons.
- Ligamentous laxity based on a positive Sulcus and apprehension tests.
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- Numbness or tingling in the upper extremity.
- Previous shoulder or cervical spine surgery.
- Systemic illness.
- Corticosteroid injection on the shoulder within 1 year of the study.
- Physical therapy 6 months before the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of a Pain Neuroscience Education Programme in Shoulder Pain: a Randomised Clinical Trial
Objectives: The purpose of this study was to assess the efficacy of a pain neuroscience education programme applied to patients with shoulder pain.
Read the detailed description
A randomised controlled trial was performed. Fifty-five patients satisfied eligibility criteria, agreed to participate, and were randomized into an experimental group (n = 27) or control group (n =28). A manual therapy and exercises program was administered for both groups. In addition, a pain neuroscience education protocol was administered for the experimental group for a whole period of 4 weeks (1 session/week, 75mins per session).
- Conditions
- Shoulder Pain
- Being tested
- PNE, Manual therapy
- Keywords
- exercise, manual therapy, shoulder pain, pain neuroscience education
- Medical subject headings
- Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNEBehavioural
Also called Manual therapy, Exercise
A manual therapy(Mulligan´s Mobilization with Movement) and 4 sessions of strenght exercises program was administered for both groups. In addition, a pain neuroscience education protocol was administered for the experimental group for a whole period of 4 weeks (1 session/week, 75mins per session).
Manual therapyProcedure or surgery
5 sessions of Mulligan´s Mobilization with Movement and 4 sessions of strenght exercises
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants will receive 4 sessions of PNE and 5 sessions of manual therapy and exercises. Receives: Behavioral: PNE; Procedure: Manual therapy |
| Control group | Active comparator | Participants will receive 5 sessions of manual therapy and exercises. Receives: Procedure: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Reduction in pain intensity using the Shoulder Pain and Disability Index (SPADI)
Measured: Baseline and 5 weeks.
Disability
Improving functionality using the Shoulder Pain and Disability Index (SPADI)
Measured: Baseline and five weeks.
Secondary outcomes (1)
kinesiophobia
Tampa Scale of Kinesiophobia (TSK11)
Measured: Baseline and 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start2 Jan 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Prado Robles, Universidad de León
- Investigators
- Eva Prado Robles, Principal investigator, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739694
- Sponsor's protocol ID
- SALUD DOCTORADO
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared due to ethical and legal restrictions on the privacy of participants.
Publications
Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.
PubMed 30178503
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Pain Neuroscience Education Programme in Shoulder Pain: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06739694
- Acronym / sponsor ID
- SALUD DOCTORADO
- Conditions
- Shoulder Pain
- Keywords
- exercise, manual therapy, shoulder pain, pain neuroscience education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 18 Dec 2024 (actual)
- 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.
Objectives: The purpose of this study was to assess the efficacy of a pain neuroscience education programme applied to patients with shoulder pain.
Detailed description
A randomised controlled trial was performed. Fifty-five patients satisfied eligibility criteria, agreed to participate, and were randomized into an experimental group (n = 27) or control group (n =28). A manual therapy and exercises program was administered for both groups. In addition, a pain neuroscience education protocol was administered for the experimental group for a whole period of 4 weeks (1 session/week, 75mins per session).
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 | Behavioral: PNE, Procedure: Manual therapyParticipants will receive 4 sessions of PNE and 5 sessions of manual therapy and exercises. |
| Control group | Active comparator | Procedure: Manual therapyParticipants will receive 5 sessions of manual therapy and exercises. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18-70 years of age.
- History of shoulder pain of more than 3 months duration.
- Presence of a painful arc
- Medical diagnosis of shoulder pain with at least 2 positive impingement tests including Neer, Hawkins, or Jobe test
Key exclusion criteria (11 listed)
- Diagnosis of fibromyalgia.
- Pregnancy.
- A history of traumatic onset of shoulder pain.
- Other histories of shoulder injury.
- Torn tendons.
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 |
|---|---|---|
| PNEAlso: Manual therapy, ExerciseA manual therapy(Mulligan´s Mobilization with Movement) and 4 sessions of strenght exercises program was administered for both groups. In addition, a pain neuroscience education protocol was administered for the experimental group for a whole period of 4 weeks (1 session/week, 75mins per session). | Behavioural | Experimental group |
| Manual therapy5 sessions of Mulligan´s Mobilization with Movement and 4 sessions of strenght exercises | Procedure or surgery | Control group, Experimental group |
Primary outcome
Pain
Time frame: Baseline and 5 weeks.
Reduction in pain intensity using the Shoulder Pain and Disability Index (SPADI)
Disability
Time frame: Baseline and five weeks.
Improving functionality using the Shoulder Pain and Disability Index (SPADI)
1 secondary outcome
kinesiophobia
Time frame: Baseline and 5 weeks.
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 18 Dec 2024.
- Background: PubMed 30178503Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.
- Individual participant dataSharing planned: No. Individual data will not be shared due to ethical and legal restrictions on the privacy of participants.
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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.
Eva Prado Robles principal investigator
Universidad de León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNE and Manual therapy in people with Shoulder Pain, run by Universidad de León 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 11 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 18 Dec 2024. 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?
Pain (time frame: Baseline and 5 weeks.). 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?
On the ClinicalTrials.gov record for NCT06739694, 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 18 Dec 2024.