Frozen ShoulderNCT06739824
Comparison of Spencer Technique and Conventional Treatment in Adjuncts to Corticosteroid Injection in Frozen Shoulder
A study testing Conventional Treatment(CI) and Spencer Technique (CI) in people with Frozen Shoulder, run by Superior University at 1 site in Pakistan.
Trial summary
This study will compare the effectiveness of the Spencer Technique combined with intra-articular injection versus conventional therapy combined with intra-articular injection in managing frozen shoulder. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Conventional Treatment(CI) and Spencer Technique (CI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 30 years 60 years old.
- Diagnosed with unilateral adhesive capsulitis presenting symptoms of pain.
- restricted range of motion of frozen shoulder Stage 2 and 3
Who cannot join
- Rotator cuff injury
- Long-term Systemic Corticosteroid use
- Previous Ipsilateral shoulder CSI within 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare the effectiveness of the Spencer Technique combined with intra-articular injection versus conventional therapy combined with intra-articular injection in managing frozen shoulder. The research problem addresses the need for optimal therapeutic approaches to improve pain relief, range of motion, and functional recovery in patients with frozen shoulder.
Read the detailed description
Utilizing a randomized controlled trial, the study will recruit 100 participants, divided into two groups: Group A receiving the Spencer Technique with intra-articular injection and Group B receiving conventional therapy with intra-articular injection. Outcome measures will include pain levels, range of motion, shoulder functional status and patient satisfaction, assessed through validated tools. The significance of this study lies in its potential to provide robust comparative data to guide clinical decisions and enhance patient outcomes, particularly in populations with a high prevalence of diabetes
- Conditions
- Frozen Shoulder
- Being tested
- Conventional Treatment(CI), Spencer Technique (CI)
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Treatment(CI)Diagnostic test
Patients receive a corticosteroid injection followed by conventional treatment, such as standard physical therapy exercises focused on range of motion and strengthening, without the specific manual techniques of the Spencer method.
Spencer Technique (CI)Combination product
Patients receive a corticosteroid injection followed by the Spencer technique, which involves a series of specific manual mobilization maneuvers aimed at improving shoulder mobility and reducing pain.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Not described Receives: Diagnostic Test: Conventional Treatment(CI) |
| EXP group | Active comparator | Not described Receives: Combination Product: Spencer Technique (CI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Shoulder Scale
This tool includes a pain scale with a score of 1 to 10 and daily activity scales, including 10 activities. Each activity has a score of 1 to 10.
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 posted18 Dec 2024
- Study start28 Feb 2024
- Primary completion1 Aug 2024
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- 2 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
- NCT06739824
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/762
- Status last verified
- Dec 2024
- First submitted
- 14 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
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
- Comparison of Spencer Technique and Conventional Treatment in Adjuncts to Corticosteroid Injection in Frozen Shoulder
- ClinicalTrials.gov ID
- NCT06739824
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/762
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- 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.
This study will compare the effectiveness of the Spencer Technique combined with intra-articular injection versus conventional therapy combined with intra-articular injection in managing frozen shoulder. The research problem addresses the need for optimal therapeutic approaches to improve pain relief, range of motion, and functional recovery in patients with frozen shoulder.
Detailed description
Utilizing a randomized controlled trial, the study will recruit 100 participants, divided into two groups: Group A receiving the Spencer Technique with intra-articular injection and Group B receiving conventional therapy with intra-articular injection. Outcome measures will include pain levels, range of motion, shoulder functional status and patient satisfaction, assessed through validated tools. The significance of this study lies in its potential to provide robust comparative data to guide clinical decisions and enhance patient outcomes, particularly in populations with a high prevalence of diabetes
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Diagnostic Test: Conventional Treatment(CI) |
| EXP group | Active comparator | Combination Product: Spencer Technique (CI) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 30 years 60 years old.
- Diagnosed with unilateral adhesive capsulitis presenting symptoms of pain.
- restricted range of motion of frozen shoulder Stage 2 and 3
Key exclusion criteria (3 listed)
- Rotator cuff injury
- Long-term Systemic Corticosteroid use
- Previous Ipsilateral shoulder CSI within 12 months.
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 |
|---|---|---|
| Conventional Treatment(CI)Patients receive a corticosteroid injection followed by conventional treatment, such as standard physical therapy exercises focused on range of motion and strengthening, without the specific manual techniques of the Spencer method. | Diagnostic test | Control Group |
| Spencer Technique (CI)Patients receive a corticosteroid injection followed by the Spencer technique, which involves a series of specific manual mobilization maneuvers aimed at improving shoulder mobility and reducing pain. | Combination product | EXP group |
Primary outcome
Functional Shoulder Scale
Time frame: 12 Months
This tool includes a pain scale with a score of 1 to 10 and daily activity scales, including 10 activities. Each activity has a score of 1 to 10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- 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.
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 Conventional Treatment(CI) and Spencer Technique (CI) in people with Frozen Shoulder, 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 3 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: under way, not looking for participants, 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Functional Shoulder Scale (time frame: 12 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 18 Dec 2024.