Shoulder PainNCT04440046
Real Versus Sham Manual Therapy for RCRSP
A study testing Manual therapy thoracic spine, Manual therapy glenohumeral joint and Therapeutic exercise in people with Shoulder Pain, run by University of Alcala at 1 site in Spain.
Trial summary
A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita Universidad Autonoma de Puebla will be treated with an exercise program with sham or real manual therapy for 5 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Manual therapy thoracic spine, Manual therapy glenohumeral joint and Therapeutic exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2020to 18 Apr 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- unilateral shoulder pain of non-traumatic origing lasting more than three months.
- Pain evoked with active shoulder movements.
- Pain and weakness evoked with manual muscle strength tests for abduction and/or external rotation.
- Minimal or no rest pain (less than 3 points in a numeric pain rating scale).
Who cannot join
- Other shoulder pathologies than RCRSP.
- Systemic diseases.
- Neural symptoms.
- Neck pain.
- Radiculopathy.
- To have been treated for shoulder pain in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real Versus Sham Manual Therapy in Addition to Therapeutic Exercise in the Treatment of Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial
A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita Universidad Autonoma de Puebla will be treated with an exercise program with sham or real manual therapy for 5 weeks.
The hypothesis of the present study is that the addition of manual therapy to a therapeutic exercise program produces better benefits in comparison to the same exercise program with sham manual therapy procedures in the management of patients with RCRSP.
Read the detailed description
The objective of this study is to demonstrate that the combination of manual therapy and therapeutic exercise achieves better results in the management of the patient with shoulder pain.
For this, manual therapy techniques in the thoracic region and in the shoulder together with a therapeutic exercise program will be applied.
The investigators will compare this intervention protocol with placebo manual therapy techniques and the same therapeutic exercise protocol.
- Conditions
- Shoulder Pain
- Being tested
- Manual therapy thoracic spine, Manual therapy glenohumeral joint, Sham thoracic manual therapy, Sham glenohumeral manual therapy, Therapeutic 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.
Manual therapy thoracic spineOther
Manual therapy mobilization directed to the costovertebral joint.
Manual therapy glenohumeral jointOther
Manual therapy mobilization directed to the glenohumeral joint.
Sham thoracic manual therapyOther
Sham manual therapy directed to the costovertebral joint.
Sham glenohumeral manual therapyOther
Sham manual therapy directed to the glenohumeral joint.
Therapeutic exerciseOther
Therapeutic exercise program consisting on isometric exercise with progressive load.
| Study group | Role | What they receive |
|---|---|---|
| Real manual therapy | Experimental | Real manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program Receives: Other: Manual therapy thoracic spine; Other: Manual therapy glenohumeral joint; Other: Therapeutic exercise |
| Sham thoracic manual therapy | Sham comparator | Sham manual therapy directed to the thoracic spine with real manual therapy directed to the glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group Receives: Other: Manual therapy glenohumeral joint; Other: Sham thoracic manual therapy; Other: Therapeutic exercise |
| Sham manual therapy | Sham comparator | Sham manual therapy directed to the thoracic spine and glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group Receives: Other: Sham thoracic manual therapy; Other: Sham glenohumeral manual therapy; Other: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (SPADI)
The SPADI points from 0 (no disability) to 130 (maximum degree of disability)
Measured: Change from Baseline at 17- week
Secondary outcomes (2)
Pain intensity measured with a visual analogue scale
10-cm scale where 0 is no pain and 10 is the worst pain imaginable
Measured: Change from Baseline at 17-week
Pain-free range of movement of the shoulder
Flexion, extension, abduction, internal rotation and external rotation measured with a two-arm goniometer
Measured: Change from Baseline at 17-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start15 Dec 2020
- Primary completion18 Apr 2021
- Study completion18 Apr 2021
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, PhD, Study director, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440046
- Sponsor's protocol ID
- 2/111/729
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Versus Sham Manual Therapy in Addition to Therapeutic Exercise in the Treatment of Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04440046
- Acronym / sponsor ID
- 2/111/729
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 18 Apr 2021 (actual)
- Study completion
- 18 Apr 2021 (actual)
- First posted
- 19 Jun 2020 (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.
A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita Universidad Autonoma de Puebla will be treated with an exercise program with sham or real manual therapy for 5 weeks.
The hypothesis of the present study is that the addition of manual therapy to a therapeutic exercise program produces better benefits in comparison to the same exercise program with sham manual therapy procedures in the management of patients with RCRSP.
Detailed description
The objective of this study is to demonstrate that the combination of manual therapy and therapeutic exercise achieves better results in the management of the patient with shoulder pain.
For this, manual therapy techniques in the thoracic region and in the shoulder together with a therapeutic exercise program will be applied.
The investigators will compare this intervention protocol with placebo manual therapy techniques and the same therapeutic exercise protocol.
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 |
|---|---|---|
| Real manual therapy | Experimental | Other: Manual therapy thoracic spine, Other: Manual therapy glenohumeral joint, Other: Therapeutic exerciseReal manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program |
| Sham thoracic manual therapy | Sham comparator | Other: Manual therapy glenohumeral joint, Other: Sham thoracic manual therapy, Other: Therapeutic exerciseSham manual therapy directed to the thoracic spine with real manual therapy directed to the glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group |
| Sham manual therapy | Sham comparator | Other: Sham thoracic manual therapy, Other: Sham glenohumeral manual therapy, Other: Therapeutic exerciseSham manual therapy directed to the thoracic spine and glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- unilateral shoulder pain of non-traumatic origing lasting more than three months.
- Pain evoked with active shoulder movements.
- Pain and weakness evoked with manual muscle strength tests for abduction and/or external rotation.
- Minimal or no rest pain (less than 3 points in a numeric pain rating scale).
Key exclusion criteria (6 listed)
- Other shoulder pathologies than RCRSP.
- Systemic diseases.
- Neural symptoms.
- Neck pain.
- Radiculopathy.
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 |
|---|---|---|
| Manual therapy thoracic spineManual therapy mobilization directed to the costovertebral joint. | Other | Real manual therapy |
| Manual therapy glenohumeral jointManual therapy mobilization directed to the glenohumeral joint. | Other | Real manual therapy, Sham thoracic manual therapy |
| Sham thoracic manual therapySham manual therapy directed to the costovertebral joint. | Other | Sham manual therapy, Sham thoracic manual therapy |
| Sham glenohumeral manual therapySham manual therapy directed to the glenohumeral joint. | Other | Sham manual therapy |
| Therapeutic exerciseTherapeutic exercise program consisting on isometric exercise with progressive load. | Other | Real manual therapy, Sham manual therapy, Sham thoracic manual therapy |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: Change from Baseline at 17- week
The SPADI points from 0 (no disability) to 130 (maximum degree of disability)
2 secondary outcomes
Pain intensity measured with a visual analogue scale
Time frame: Change from Baseline at 17-week
Pain-free range of movement of the shoulder
Time frame: Change from Baseline at 17-week
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 29 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Daniel Pecos-Martin, PhD study director
University of Alcala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy thoracic spine, Manual therapy glenohumeral joint and Therapeutic exercise in people with Shoulder Pain, run by University of Alcala 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 6 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 29 Jun 2021. 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?
Shoulder Pain and Disability Index (SPADI) (time frame: Change from Baseline at 17- week). 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 29 Jun 2021.