Adhesive CapsulitisNCT06404814
Effectiveness of Functional Electrical Stimulation Versus Spencer Technique in Patients With Adhesive Capsulitis
A study testing Transcutaneous electrical nerve stimulation (TENS) and Muscle Energy Technique in people with Adhesive Capsulitis, run by Superior University at 1 site in Pakistan.
Trial summary
This study focus on the rehabilitation of patients with frozen shoulder through a manual technique called "Spencer MET".The purpose of this approach is to reduce the pain and improve the ROM and quality of life. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS) and Muscle Energy Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 30 Sep 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
- Patients with diabetic frozen shoulder
- Patients having frozen shoulder after stroke
- Subjects having stiff shoulder for at least 3 months
- Subjects with bilateral/unilateral frozen shoulder
- Subjects with idiopathic frozen shoulder
Who cannot join
- Bone fracture within past 12 weeks
- Patients with hyper mobile joints
- Subjects with Rotator cuff pathology
- Dislocated shoulder
- Subjects who had shoulder arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
This study focus on the rehabilitation of patients with frozen shoulder through a manual technique called "Spencer MET".The purpose of this approach is to reduce the pain and improve the ROM and quality of life.
Read the detailed description
By comparing the effectiveness of functional electrical stimulation versus the Spencer technique in patients with adhesive capsuilitis is to determine which treatment approach will yields better outcomes in order to reduce the detrimental effects of disease process.Spencer METs consist of series of seven steps taken in order to decrease pain and stiffness in sholder regiegionn.
- Conditions
- Adhesive Capsulitis
- Being tested
- Transcutaneous electrical nerve stimulation (TENS), Muscle Energy Technique
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation (TENS)Behavioural
(TENS) is a method of pain relief involving the use of a mild electrical current
Muscle Energy TechniqueDiagnostic test
n Spencer's technique, there are seven steps as follows: shoulder extension along with elbow flexion, shoulder flexion with elbow extension, circumduction with compression, circumduction with distraction, shoulder abduction and internal rotation with elbow flexion, shoulder adduction and external rotation with elbow
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Other | Not described Receives: Behavioral: Transcutaneous electrical nerve stimulation (TENS) |
| Muscle Energt Techinique (METs) | Experimental | Not described Receives: Diagnostic Test: Muscle Energy Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS):
It is tool widely used to measure the intensity of pain and discomfort.VAS effectively used in randomized controlled trials for outcome measures,consisting of 10 cm straight line from 0 to 10.0 represents "No pain" and 10 represent "Worst pain". Patients can mark their severity of pain.
Measured: 12 Months
Goniometer
Goniometer is instrument used to measure the range of motion of a joint.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Sep 2023
- Primary completion1 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404814
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/707
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Functional Electrical Stimulation Versus Spencer Technique in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06404814
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/707
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 8 May 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.
This study focus on the rehabilitation of patients with frozen shoulder through a manual technique called "Spencer MET".The purpose of this approach is to reduce the pain and improve the ROM and quality of life.
Detailed description
By comparing the effectiveness of functional electrical stimulation versus the Spencer technique in patients with adhesive capsuilitis is to determine which treatment approach will yields better outcomes in order to reduce the detrimental effects of disease process.Spencer METs consist of series of seven steps taken in order to decrease pain and stiffness in sholder regiegionn.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Other | Behavioral: Transcutaneous electrical nerve stimulation (TENS) |
| Muscle Energt Techinique (METs) | Experimental | Diagnostic Test: Muscle Energy Technique |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with diabetic frozen shoulder
- Patients having frozen shoulder after stroke
- Subjects having stiff shoulder for at least 3 months
- Subjects with bilateral/unilateral frozen shoulder
- Subjects with idiopathic frozen shoulder
Key exclusion criteria (5 listed)
- Bone fracture within past 12 weeks
- Patients with hyper mobile joints
- Subjects with Rotator cuff pathology
- Dislocated shoulder
- Subjects who had shoulder arthroplasty
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS)(TENS) is a method of pain relief involving the use of a mild electrical current | Behavioural | Transcutaneous electrical nerve stimulation (TENS) |
| Muscle Energy Techniquen Spencer's technique, there are seven steps as follows: shoulder extension along with elbow flexion, shoulder flexion with elbow extension, circumduction with compression, circumduction with distraction, shoulder abduction and internal rotation with elbow flexion, shoulder adduction and external rotation with elbow | Diagnostic test | Muscle Energt Techinique (METs) |
Primary outcome
Visual Analogue Scale (VAS):
Time frame: 12 Months
It is tool widely used to measure the intensity of pain and discomfort.VAS effectively used in randomized controlled trials for outcome measures,consisting of 10 cm straight line from 0 to 10.0 represents "No pain" and 10 represent "Worst pain". Patients can mark their severity of pain.
Goniometer
Time frame: 12 months
Goniometer is instrument used to measure the range of motion of a joint.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
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Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation (TENS) and Muscle Energy Technique in people with Adhesive Capsulitis, run by Superior University at 1 site in Pakistan.
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 5 inclusion and 5 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 8 May 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 Pakistan. 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?
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?
Visual Analogue Scale (VAS): (time frame: 12 Months). 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?
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 8 May 2024.