Shoulder PainMTEACNCT02976974
Efficacy of Manual Therapy and Exercise in Patients With Shoulder Adhesive Capsulitis. A Randomized Clinical Trial.
A study testing Manual therapy and Therapeutic exercise in people with Shoulder Pain, run by University of Malaga at 3 sites in Spain.
Trial summary
The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive capsulitis of the shoulder will be studied. Furthermore, different biomechanic and psychosocial factors will be measured with a nine month follow-up Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Manual therapy and Therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSpain
- Study dates
- 30 Jul 2016to Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- People suffering from adhesive capsulitis as indicated by passive range of motion loss >25% in at least 2 movement planes, together with at least 50% loss of passive external rotation in comparison with the uninvolved shoulder.
Who cannot join
- Shoulder pain that was deemed to be originating from any passive and/or neck movement or if there was a neurological impairment, osteoporosis, haemophilia and/or malignancies
- Corticoid injections during the six months prior to the study
- Analgesic-antiinflammatory medication intake during the intervention phase of the study.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Las Albarizas primary care centre
Fuengirola, Malaga, 29603
Juan Luis Díaz Cerrillo, PT, +34627911441, juanlu1x2@hotmail.com
Susana Clavero Cano, PT, +34600142510, susclavero@gmail.com
- Recruiting
Las Lagunas Care Centre
Fuengirola, Malaga, 29651
Antonio Rondón Ramos, PT, +34600142611, antonio.rondon.sspa@juntadeandalucia.es
- Recruiting
San Pedro primary care centre
Marbella, Malaga, 29670
Gina Rocío Ariza Hurtado, PT, ginarizado@gmail.com
About this study
Official title: Efficacy of Manual Therapy and Therapeutic Exercise in Patients With Shoulder Adhesive Capsulitis. Which Factors Are More Correlated With?
The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive capsulitis of the shoulder will be studied. Furthermore, different biomechanic and psychosocial factors will be measured with a nine month follow-up
Read the detailed description
Adhesive capsulitis of the shoulder is a painful entity characterized by stiffness in the shoulder joint. There exist different clinical trial related to this pathology, however a lack of information of both efficacy and methodology used in manual therapy treatment remains unclear, as well as therapeutic exercise treatment. Furthermore, the duration of the improvement after different conservative treatments is also unknown. Besides, little is known about which factors are more correlated with pain and function.Thus, biomechanic and psychosocial factors together with ultrasound measurements and blood glucose concentration (see "outcome and secondary measures" section ) will be analyzed before and after the treatment, with a nine months follow up. Results will be spread showing short term effects and long term effects in different publications.
Hence, the aim of this study is twofold: i)To analyze the efficacy of manual therapy and therapeutic exercise in patients with shoulder adhesive capsulitis; ii) To correlate pain and function with ultrasonography, biomechanic and psychosocial factors, as well as blood glucose concentration, before and after the treatments proposed with a nine months follow up.
Method
This study is designed as a clinical trial, with two randomised parallel groups comparing two different conservative intervention (MT vs MT+E) (See "Arms and Interventions" section). It will be carried out in different Hospital and primary care centers where patients suffering from adhesive capsulitis of the shoulder will be asked to participate in the project. If participants are eligible then they will be include in the study. All participants will have to sign informed consent after be shown about the whole project as by written (informative sheet) as by speech from the physiotherapist in charge.
Once include in the study definitely, all factors detailed (see "outcome measures" section) will be measured. Also, every factor will be correlated with shoulder pain and function. This way, the investigators could predict which factor are more correlated with. Furthermore, if significant correlations are found, such factors could be used as predictors or monitoring tool when patients with shoulder adhesive capsulitis are treated
- Conditions
- Shoulder Pain
- Being tested
- Manual therapy, Therapeutic exercise
- Keywords
- chronic pain, central sensitization, function, force, ultrasonography
- Medical subject headings
- Shoulder Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done.
Therapeutic exerciseOther
- Shoulder extension: Elastic bands.
- Shoulder flexion: Elastic bands
- Shoulder external rotation: Elastic bands.
- Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing "push up" on the wall.
- Thoracic column movements: Flexion-extension
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy (MT) | Experimental | MT: Manual Therapy. Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done. Receives: Other: Manual therapy |
| Therapeutic exercise (E) | Experimental | E: Therapeutic Exercise.
Shoulder extension: Elastic bands. Shoulder flexion: Elastic bands Shoulder external rotation: Elastic bands. Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing "push up" on the wall.
Thoracic column movements: Flexion-extension Receives: Other: Manual therapy; Other: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at nine months
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Secondary outcomes (14)
Change from baseline pressure algometry at nine months
Assessment of central sensitization:
It will be carried out on the affected and unaffected shoulder (mid belly of medium deltoid muscle: 2 cm under acromion). Also, the quadriceps rectus femoris (ipsilateral to frozen shoulder, middle spine iliac antero-superior (SIAS) and top patella) will be assessed.
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline ultrasonography at nine months
Different structures will be measured by ultrasonography such as tendons (supraspinatus, infraspinatus, subscapularis and long head biceps tendon) and ligaments (coracohumeral and upper glenohumeral ligaments). Furthermore, acromiohumeral distance and coracohumeral distance will be analyzed. In addition, presence of neovascularization will be studied.
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline electromyography at nine months
It will be investigated the surface electromyographic (EMG) relative muscle activity of the upper (UT) and lower trapezius (LT) as well as serratus anterior (SA) muscles during both ascending and descending phases of arm elevation in participants with adhesive capsulitis of the shoulder
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline dynamometry at nine months
Assessment of shoulder force (unit of measure: kilograms) in seated position (handheld dynamometer) :
- Elevation in the scapular plane at 90°
- Outer rotation with flexion elbow at 90°
- Inner rotation with flexion elbow at 90°
- Lift off position: Patient places arm behind the back, 90° flexion elbow.
Three measurements will be carried out in each position. The mean will be the final value.
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline blood glucose concentration at nine months
To assess metabolic factors venous blood samples will be collected.Information about a person's average levels of blood glucose, over the past 3 months (A1C) will be obtained with the "A1C" test or glycohemoglobin test.
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline range of movement (ROM) at nine months
Measurement of mobility in different planes:
Active shoulder flexion and abduction will be measured with the patient seated, in the scapular plane and relative to the thorax. In addition, active external and internal rotation will be measured in neutral (shoulder in adduction), 30°, 60° and 90° of abducted position.
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline heart rate variability (HRV) at nine months
Measurement of Autonomic nervous system activity:
Resting HRV provides quantitative information regarding cardiac autonomic tone.
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline CSI questionnaire at nine months
Measurement of central sensitization (CS):
The Central Sensitization Inventory (CSI) was developed to assess the overlapping health-related symptom dimensions of CS
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline "pain vigilance and awareness" questionnaire at nine months
The Pain Vigilance and Awareness Questionnaire(PVAQ) is a 16-item measure of pain-related awareness and vigilance. It shows predicted relations with measures of attention-related pain coping strategies, supporting the validity of the total score as a measure of attention to pain
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline pain Catastrophizing Scale questionnaire at nine months
Assessment of the mechanisms by which catastrophizing impacts on pain experience.
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline short form-36 (SF-36) at nine months
Measurement of Quality of life:
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline McGill questionnaire at nine months
Measurement of pain:
The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention.
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at nine months
Assessment of quality of life.:
This questionnaire measure upper limb symptoms as well as patient ability to do certain activities.
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline Autonomic Symptom Profile questionnaire (ASP) at nine months
Measurement of Autonomic nervous system activity:
The Autonomic Symptom Profile (ASP) is a validated self-report questionnaire that comprehensively assesses autonomic symptoms across 11 subscales and yields a composite autonomic symptom score
Measured: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start30 Jul 2016
- Primary completion31 Dec 2019 (estimated)
- Study completionDec 2020 (estimated)
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Luque-Suarez, University of Malaga
- Investigators
- ALEJANDRO LUQUE-SUAREZ, PT, PhD, Principal investigator, UNIVERSITY OF MALAGA, SPAIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976974
- Sponsor's protocol ID
- UMA MTEAC
- Acronym
- MTEAC
- Status last verified
- Oct 2018
- First submitted
- 22 Nov 2016
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results obtained in this project will be disseminated to the research community through different vias such as publications and oral/poster presentations
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Manual Therapy and Therapeutic Exercise in Patients With Shoulder Adhesive Capsulitis. Which Factors Are More Correlated With?
- ClinicalTrials.gov ID
- NCT02976974
- Acronym / sponsor ID
- MTEAC / UMA MTEAC
- Conditions
- Shoulder Pain
- Keywords
- chronic pain, central sensitization, function, force, ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 30 Jul 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Nov 2016 (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.
The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive capsulitis of the shoulder will be studied. Furthermore, different biomechanic and psychosocial factors will be measured with a nine month follow-up
Detailed description
Adhesive capsulitis of the shoulder is a painful entity characterized by stiffness in the shoulder joint. There exist different clinical trial related to this pathology, however a lack of information of both efficacy and methodology used in manual therapy treatment remains unclear, as well as therapeutic exercise treatment. Furthermore, the duration of the improvement after different conservative treatments is also unknown. Besides, little is known about which factors are more correlated with pain and function.Thus, biomechanic and psychosocial factors together with ultrasound measurements and blood glucose concentration (see "outcome and secondary measures" section ) will be analyzed before and after the treatment, with a nine months follow up. Results will be spread showing short term effects and long term effects in different publications.
Hence, the aim of this study is twofold: i)To analyze the efficacy of manual therapy and therapeutic exercise in patients with shoulder adhesive capsulitis; ii) To correlate pain and function with ultrasonography, biomechanic and psychosocial factors, as well as blood glucose concentration, before and after the treatments proposed with a nine months follow up.
Method
This study is designed as a clinical trial, with two randomised parallel groups comparing two different conservative intervention (MT vs MT+E) (See "Arms and Interventions" section). It will be carried out in different Hospital and primary care centers where patients suffering from adhesive capsulitis of the shoulder will be asked to participate in the project. If participants are eligible then they will be include in the study. All participants will have to sign informed consent after be shown about the whole project as by written (informative sheet) as by speech from the physiotherapist in charge.
Once include in the study definitely, all factors detailed (see "outcome measures" section) will be measured. Also, every factor will be correlated with shoulder pain and function. This way, the investigators could predict which factor are more correlated with. Furthermore, if significant correlations are found, such factors could be used as predictors or monitoring tool when patients with shoulder adhesive capsulitis are treated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy (MT) | Experimental | Other: Manual therapyMT: Manual Therapy. Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done. |
| Therapeutic exercise (E) | Experimental | Other: Manual therapy, Other: Therapeutic exerciseE: Therapeutic Exercise. Shoulder extension: Elastic bands. Shoulder flexion: Elastic bands Shoulder external rotation: Elastic bands. Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing "push up" on the wall. Thoracic column movements: Flexion-extension |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- People suffering from adhesive capsulitis as indicated by passive range of motion loss >25% in at least 2 movement planes, together with at least 50% loss of passive external rotation in comparison with the uninvolved shoulder.
Key exclusion criteria (3 listed)
- Shoulder pain that was deemed to be originating from any passive and/or neck movement or if there was a neurological impairment, osteoporosis, haemophilia and/or malignancies
- Corticoid injections during the six months prior to the study
- Analgesic-antiinflammatory medication intake during the intervention phase of the study.
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 therapyApplication of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done. | Other | Manual therapy (MT), Therapeutic exercise (E) |
| Therapeutic exercise* Shoulder extension: Elastic bands. * Shoulder flexion: Elastic bands * Shoulder external rotation: Elastic bands. * Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing "push up" on the wall. * Thoracic column movements: Flexion-extension | Other | Therapeutic exercise (E) |
Primary outcome
Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
14 secondary outcomes
Change from baseline pressure algometry at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline ultrasonography at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline electromyography at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline dynamometry at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline blood glucose concentration at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline range of movement (ROM) at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline heart rate variability (HRV) at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline CSI questionnaire at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline "pain vigilance and awareness" questionnaire at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline pain Catastrophizing Scale questionnaire at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline short form-36 (SF-36) at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline McGill questionnaire at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline Autonomic Symptom Profile questionnaire (ASP) at nine months
Time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Individual participant dataSharing planned: Yes. The results obtained in this project will be disseminated to the research community through different vias such as publications and oral/poster presentations
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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.
ALEJANDRO LUQUE-SUAREZ, PT, PhD principal investigator
UNIVERSITY OF MALAGA, SPAIN
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and Therapeutic exercise in people with Shoulder Pain, run by University of Malaga at 3 sites 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANTONIO RONDON-RAMOS, PT (0034 610566313, antonio.rondon.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at nine months (time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)). 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 24 Oct 2018.