Capsulitis of ShoulderNCT06497348
Application of an Exercise Program Versus Exercise Plus Manual Therapy in the Treatment of Adhesive Capsulitis.
A study of Capsulitis of Shoulder and Frozen Shoulder, run by University of Alcala at 1 site in Spain.
Trial summary
The main objective is to evaluate whether a treatment program combining manual therapy (joint mobilization) and exercise is more effective in the treatment of adhesive capsulitis than an exercise program applied in isolation. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Capsulitis of Shoulder, Frozen Shoulder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2024to 15 Dec 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- men and women from 40 to 60 years old, whether or not they carry out physical activity
- intervention through therapeutic exercise and/or joint mobility.
Who cannot join
- children
- older people
- people with previous shoulder pathology
- people with cognitive impairment who cannot complete questionnaires
- treatment that does not include exercise or joint mobility
- treatment with machines.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Enfermeria y Fisioterapia de la Universidad de Alcalá de Henares
Madrid, 28801
About this study
The main objective is to evaluate whether a treatment program combining manual therapy (joint mobilization) and exercise is more effective in the treatment of adhesive capsulitis than an exercise program applied in isolation.
The researchers will compare both groups (experimental group and control group) using the different techniques.
During the sessions, mobility will be evaluated with a goniometer and data will be recorded to monitor progress, maintaining a confidential record of the data.
- Conditions
- Capsulitis of Shoulder, Frozen Shoulder
- Being tested
- manual therapy and exercises (experimental group) or only exercises (control group) in people with frozen shoulder
- Keywords
- "adhesive capsulitis", "frozen shoulder", "manual therapy", "therapeutic exercise"
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapy and exercises (experimental group) or only exercises (control group) in people with frozen shoulderOther
They will be divided into two groups, one experimental (they will be mobilized and given exercises to see whether or not they gain joint range in the different movements of flexion-extension, abduction-adduction and internal rotation-external rotation) and another control group ( The patients will be blindly evaluated and they will be given the same exercises as the experimental group)
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group will receive mobilization treatment and exercises, while the control group will receive only exercises. Weekly one-hour sessions will be held, from Monday to Friday, with two times available for each patient. Changes in pain, mobility and functionality will be recorded in an Excel document to monitor progress.
To the experimental group, treated by physiotherapists who know the pathology, Maitland mobilization techniques will be applied, focused on passive neural and joint mobilizations. Flexion-extension, abduction-adduction, and external and internal rotation movements will be performed. Receives: Other: manual therapy and exercises (experimental group) or only exercises (control group) in people with frozen shoulder |
| control group | Active comparator | The control group, treated by physiotherapists who will blindly evaluate the patients, will only be prescribed exercises, the same as the experimental group. Receives: Other: manual therapy and exercises (experimental group) or only exercises (control group) in people with frozen shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the improvement of shoulder mobility in patients with adhesive capsulitis by performing by an exercise program, mobilization or boths techniques.
study and measure if there is improvement in adhesive capsulitis of the shoulder with the proposed exercise programs versus exercise plus manual therapy in 108 subjects, 54 subjects in each group and a descriptive analysis of the data will be carried out, examining the initial homogeneity between the groups. in terms of the variables age, sex, pain, range of motion and functionality. The Shoulder Pain and Disability Index (SPADI) questionnaire and the visual analogue scale (VAS) will be used to assess pain.
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion10 Nov 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsulitis of ShoulderStudies 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
- Model description
- The evaluation of each group will be carried out in different rooms of the university, a team of 6 physiotherapists divided into two groups, where 3 will evaluate with knowledge of the pathology and the other 3 without knowledge of it. The experimental group will receive mobilization treatment and exercises, while the control group will receive only exercises. Weekly one-hour sessions will be held, from Monday to Friday, with two times available for each patient. The experimental group, treated by physiotherapists who know the pathology, will be applied Maitland mobilization techniques, focused on passive neural and joint mobilizations. Flexion-extension, abduction-adduction, and external and internal rotation movements will be performed. The control group, treated by physiotherapists who will blindly evaluate the patients, will only be prescribed exercises, the same as the experimental group.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Sánchez Pérez, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497348
- Sponsor's protocol ID
- 10111999
- Status last verified
- Jul 2024
- First submitted
- 17 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD, since patient data will be recorded along with informed consent, to which only patients and researchers will have access.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of an Exercise Program Versus Exercise Plus Manual Therapy in the Treatment of Adhesive Capsulitis.
- ClinicalTrials.gov ID
- NCT06497348
- Acronym / sponsor ID
- 10111999
- Conditions
- Capsulitis of Shoulder, Frozen Shoulder
- Keywords
- "adhesive capsulitis", "frozen shoulder", "manual therapy", "therapeutic exercise"
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 10 Nov 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 11 Jul 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.
The main objective is to evaluate whether a treatment program combining manual therapy (joint mobilization) and exercise is more effective in the treatment of adhesive capsulitis than an exercise program applied in isolation.
The researchers will compare both groups (experimental group and control group) using the different techniques.
During the sessions, mobility will be evaluated with a goniometer and data will be recorded to monitor progress, maintaining a confidential record of the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The evaluation of each group will be carried out in different rooms of the university, a team of 6 physiotherapists divided into two groups, where 3 will evaluate with knowledge of the pathology and the other 3 without knowledge of it. The experimental group will receive mobilization treatment and exercises, while the control group will receive only exercises. Weekly one-hour sessions will be held, from Monday to Friday, with two times available for each patient. The experimental group, treated by physiotherapists who know the pathology, will be applied Maitland mobilization techniques, focused on passive neural and joint mobilizations. Flexion-extension, abduction-adduction, and external and internal rotation movements will be performed. The control group, treated by physiotherapists who will blindly evaluate the patients, will only be prescribed exercises, the same as the experimental group.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: manual therapy and exercises (experimental group) or only exercises (control group) in people with frozen shoulderThe experimental group will receive mobilization treatment and exercises, while the control group will receive only exercises. Weekly one-hour sessions will be held, from Monday to Friday, with two times available for each patient. Changes in pain, mobility and functionality will be recorded in an Excel document to monitor progress. To the experimental group, treated by physiotherapists who know the pathology, Maitland mobilization techniques will be applied, focused on passive neural and joint mobilizations. Flexion-extension, abduction-adduction, and external and internal rotation movements will be performed. |
| control group | Active comparator | Other: manual therapy and exercises (experimental group) or only exercises (control group) in people with frozen shoulderThe control group, treated by physiotherapists who will blindly evaluate the patients, will only be prescribed exercises, the same as the experimental group. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- men and women from 40 to 60 years old, whether or not they carry out physical activity
- intervention through therapeutic exercise and/or joint mobility.
Key exclusion criteria (6 listed)
- children
- older people
- people with previous shoulder pathology
- people with cognitive impairment who cannot complete questionnaires
- treatment that does not include exercise or joint mobility
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 and exercises (experimental group) or only exercises (control group) in people with frozen shoulderThey will be divided into two groups, one experimental (they will be mobilized and given exercises to see whether or not they gain joint range in the different movements of flexion-extension, abduction-adduction and internal rotation-external rotation) and another control group ( The patients will be blindly evaluated and they will be given the same exercises as the experimental group) | Other | control group, experimental group |
Primary outcome
evaluation of the improvement of shoulder mobility in patients with adhesive capsulitis by performing by an exercise program, mobilization or boths techniques.
Time frame: 3-4 months
study and measure if there is improvement in adhesive capsulitis of the shoulder with the proposed exercise programs versus exercise plus manual therapy in 108 subjects, 54 subjects in each group and a descriptive analysis of the data will be carried out, examining the initial homogeneity between the groups. in terms of the variables age, sex, pain, range of motion and functionality. The Shoulder Pain and Disability Index (SPADI) questionnaire and the visual analogue scale (VAS) will be used to assess pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No. There is no plan to share IPD, since patient data will be recorded along with informed consent, to which only patients and researchers will have access.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Capsulitis of Shoulder and Frozen Shoulder, 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 2 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: status not confirmed, as of the sponsor's last update on 11 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Sánchez Pérez (655515548, cecilia.sanchezperez@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the improvement of shoulder mobility in patients with adhesive capsulitis by performing by an exercise program, mobilization or boths techniques. (time frame: 3-4 months). 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 11 Jul 2024.