Frozen ShoulderNCT06530602
3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.
A study testing 3 D SPA (shoulder complex pain alignment) Moblization and Shoulder Moblization (KaltenBorn) in people with Frozen Shoulder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Ongoing research aims to assess the enhancement of shoulder mobility by specifically addressing restrictions in all three planes of movement. current studies seek to investigate the impact of three-dimensional mobilization technique on their recovery and to prevent progression of disease to reduce pain, alleviate… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- 3 D SPA (shoulder complex pain alignment) Moblization and Shoulder Moblization (KaltenBorn)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Aug 2024to 10 Jan 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Local shoulder pain, often present either above the antero-medial and Lateral aspect of the shoulder.
- Stage II\& III unilateral frozen shoulder Symptoms.
- Marked loss Of AROM \& PROM with at least 50%loss of external rotation.
- Positive Apley's Scratch test.
Who cannot join
- Radiculopathy.
- Thoracic-outlet syndrome.
- Fractures and tumors of the upper extremity.
- Neurological disorders causing muscle weakness in the shoulder.
- Corticosteroid injection for frozen shoulder in last 3 months.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Railway General Hospital
Rawalpindi, Punjab Province, 44000
Madiha Ali, MSOMPT, 0331-3360064, madiha.ali@riphah.edu.pk
Muniba Shah, MSOMPT*
About this study
Official title: Effect of 3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.
Ongoing research aims to assess the enhancement of shoulder mobility by specifically addressing restrictions in all three planes of movement. current studies seek to investigate the impact of three-dimensional mobilization technique on their recovery and to prevent progression of disease to reduce pain, alleviate muscle tightness, facilitate tissue healing, and ultimately improve the range of motion in patients. A randomized control trial that will include total 36 participants. The first group will receive 3 Dimensional shoulder pain alignment (3-D SPA) mobilization along with conventional therapy and 2nd group will receive Shoulder mobilization along with conventional therapy. Data collected will be analyzed through SPSS 27.
Read the detailed description
Decrease capacity of non contractile tissue ( such as joint capsule ) inflammation of capsule and ligament adhesion affects the shoulder joint, triggering stiffness and pain in Frozen shoulder. About 2% to 5% of the general population reported frozen shoulder without well known cause defined ,out of which Female patients 35 - 65 years of age.
hindrance in quality of life reported with performance of basic activities of daily living due to pain that worsen with movement and specifically at night , stiffness that cause mobility deficit.70% of female population are prone to get frozen shoulder. When reaching overhead, the arm is lifted by movements in the sternoclavicular , acromioclavicular (AC), scapulothoracic (ST), and gleno-humeral joints while overhead activities got limited in frozen shoulder.
Abnormal glenohumeral rhythm at scapulothoracic joint by posterior tilting of scapula and early upward motion of scapula occur. hence a capsular pattern developed in patient that comprise of External rotation, Abduction and Internal rotation.
Physiotherapy encompassed variety of treatment protocols for frozen shoulder including therapeutic modalities and manual therapy technique's consisting moblization, muscle energy techniques ,spencer's technique ,PNF and some of invasive treatments dry needling and therapeutic exercises.
3 D SPA is latest technique with no literature available for this to be applied to check its effectiveness on frozen shoulder rather it merely applied for post stroke shoulder pain prior in clinical setting . In group A 3-D SPA Moblization is employed that target moblization of AC joint (mobilizing it upward posteriorly) synchronously Scapula mobilized (abduction-adduction, anterior-posterior tilting) with glenohumeral Active motion in (flexion, horizontal abduction, horizontal adduction \& External Internal rotation) all at once in all 3 planes frontal, sagittal, transverse plane while kaltenborn mobilization in anterior, posterior and inferior direction that is employed in group B, that has been a treatment of choice over the time is effective to treat frozen shoulder.
the study aim to evaluate the effect of 3-Dimensional Shoulder complex Pain Alignment (3-D SPA) mobilization technique on pain, disability, Range of Motion and quality of life.
- Conditions
- Frozen Shoulder
- Being tested
- 3 D SPA (shoulder complex pain alignment) Moblization, Shoulder Moblization (KaltenBorn)
- Keywords
- Frozen shoulder, QOL, Clinical trail, 3 D SPA, SPADI
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 D SPA (shoulder complex pain alignment) MoblizationOther
3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.
Shoulder Moblization (KaltenBorn)Other
3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 3-D SPA (shoulder complex pain alignment) Moblization. Conventional therapy \& Home Plan Treatment session: 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.
Modality: Ultrasound Mode: continuous 3 MHz, 1.5 w/cm2 for 6 min Receives: Other: 3 D SPA (shoulder complex pain alignment) Moblization |
| Group B | Active comparator | Shoulder mobilization (kaltenborn) Conventional therapy \& Home Plan Treatment session: 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.
Modality: Ultrasound Mode: continuous 3 MHz, 1.5 w/cm2 for 6 min Receives: Other: Shoulder Moblization (KaltenBorn) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index
Questionnaire comprise of 13 items evaluates both the degree of pain and the level of challenge in performing activities of daily living (ADLs) that involve the use of the upper extremities. The pain subscale comprises 5 items, while the Disability subscale consists of 8 items.
Measured: 3rd week
Measure Shoulder Range of Motion in Flexion
changes from baseline ROM of shoulder flexion taken with goniometer
Measured: 3rd week
Measure Shoulder Range of Motion in Extension
changes from baseline ROM of shoulder extension taken with goniometer
Measured: 3rd week
Measure Shoulder Range of Motion in abduction
changes from baseline ROM of shoulder abduction taken with goniometer
Measured: 3rd week
Measure Shoulder Range of Motion in Horizontal abduction
changes from baseline ROM of shoulder horizontal abduction taken with goniometer
Measured: 3rd week
Measure Shoulder Range of Motion in adduction
changes from baseline ROM of shoulder adduction taken with goniometer
Measured: 3rd week
Measure Shoulder Range of Motion in horizontal adduction
changes from baseline ROM of shoulder horizontal adduction taken with goniometer
Measured: 3rd week
Measure Shoulder Range of Motion in Internal rotation
changes from baseline ROM of shoulder Internal rotation taken with goniometer
Measured: 3rd week
Measure Shoulder Range of Motion in External rotation
changes from baseline ROM of shoulder External rotation taken with goniometer
Measured: 3rd week
Visual Analysis Scale
Maximum score 10 minimum score 0 , it is used for both acute and chronic pain.
Measured: 3rd week
Secondary outcomes (2)
WHOQoL-BREF
Measures perception of life quality in four dimensions including physical, psychological, social relationship \& environmental.
Measured: 3rd week
Apley's Scratch Test
to check movements in all functional planes for the shoulder.
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start9 Aug 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion10 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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madiha Ali, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530602
- Sponsor's protocol ID
- Muniba
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.
- ClinicalTrials.gov ID
- NCT06530602
- Acronym / sponsor ID
- Muniba
- Conditions
- Frozen Shoulder
- Keywords
- Frozen shoulder, QOL, Clinical trail, 3 D SPA, SPADI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 31 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.
Ongoing research aims to assess the enhancement of shoulder mobility by specifically addressing restrictions in all three planes of movement. current studies seek to investigate the impact of three-dimensional mobilization technique on their recovery and to prevent progression of disease to reduce pain, alleviate muscle tightness, facilitate tissue healing, and ultimately improve the range of motion in patients. A randomized control trial that will include total 36 participants. The first group will receive 3 Dimensional shoulder pain alignment (3-D SPA) mobilization along with conventional therapy and 2nd group will receive Shoulder mobilization along with conventional therapy. Data collected will be analyzed through SPSS 27.
Detailed description
Decrease capacity of non contractile tissue ( such as joint capsule ) inflammation of capsule and ligament adhesion affects the shoulder joint, triggering stiffness and pain in Frozen shoulder. About 2% to 5% of the general population reported frozen shoulder without well known cause defined ,out of which Female patients 35 - 65 years of age.
hindrance in quality of life reported with performance of basic activities of daily living due to pain that worsen with movement and specifically at night , stiffness that cause mobility deficit.70% of female population are prone to get frozen shoulder. When reaching overhead, the arm is lifted by movements in the sternoclavicular , acromioclavicular (AC), scapulothoracic (ST), and gleno-humeral joints while overhead activities got limited in frozen shoulder.
Abnormal glenohumeral rhythm at scapulothoracic joint by posterior tilting of scapula and early upward motion of scapula occur. hence a capsular pattern developed in patient that comprise of External rotation, Abduction and Internal rotation.
Physiotherapy encompassed variety of treatment protocols for frozen shoulder including therapeutic modalities and manual therapy technique's consisting moblization, muscle energy techniques ,spencer's technique ,PNF and some of invasive treatments dry needling and therapeutic exercises.
3 D SPA is latest technique with no literature available for this to be applied to check its effectiveness on frozen shoulder rather it merely applied for post stroke shoulder pain prior in clinical setting . In group A 3-D SPA Moblization is employed that target moblization of AC joint (mobilizing it upward posteriorly) synchronously Scapula mobilized (abduction-adduction, anterior-posterior tilting) with glenohumeral Active motion in (flexion, horizontal abduction, horizontal adduction \& External Internal rotation) all at once in all 3 planes frontal, sagittal, transverse plane while kaltenborn mobilization in anterior, posterior and inferior direction that is employed in group B, that has been a treatment of choice over the time is effective to treat frozen shoulder.
the study aim to evaluate the effect of 3-Dimensional Shoulder complex Pain Alignment (3-D SPA) mobilization technique on pain, disability, Range of Motion and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: 3 D SPA (shoulder complex pain alignment) Moblization3-D SPA (shoulder complex pain alignment) Moblization. Conventional therapy \& Home Plan Treatment session: 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions. Modality: Ultrasound Mode: continuous 3 MHz, 1.5 w/cm2 for 6 min |
| Group B | Active comparator | Other: Shoulder Moblization (KaltenBorn)Shoulder mobilization (kaltenborn) Conventional therapy \& Home Plan Treatment session: 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions. Modality: Ultrasound Mode: continuous 3 MHz, 1.5 w/cm2 for 6 min |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Local shoulder pain, often present either above the antero-medial and Lateral aspect of the shoulder.
- Stage II\& III unilateral frozen shoulder Symptoms.
- Marked loss Of AROM \& PROM with at least 50%loss of external rotation.
- Positive Apley's Scratch test.
Key exclusion criteria (5 listed)
- Radiculopathy.
- Thoracic-outlet syndrome.
- Fractures and tumors of the upper extremity.
- Neurological disorders causing muscle weakness in the shoulder.
- Corticosteroid injection for frozen shoulder in last 3 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 |
|---|---|---|
| 3 D SPA (shoulder complex pain alignment) Moblization3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions. | Other | Group A |
| Shoulder Moblization (KaltenBorn)3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions. | Other | Group B |
Primary outcome
Shoulder Pain and Disability Index
Time frame: 3rd week
Questionnaire comprise of 13 items evaluates both the degree of pain and the level of challenge in performing activities of daily living (ADLs) that involve the use of the upper extremities. The pain subscale comprises 5 items, while the Disability subscale consists of 8 items.
Measure Shoulder Range of Motion in Flexion
Time frame: 3rd week
changes from baseline ROM of shoulder flexion taken with goniometer
Measure Shoulder Range of Motion in Extension
Time frame: 3rd week
changes from baseline ROM of shoulder extension taken with goniometer
Measure Shoulder Range of Motion in abduction
Time frame: 3rd week
changes from baseline ROM of shoulder abduction taken with goniometer
Measure Shoulder Range of Motion in Horizontal abduction
Time frame: 3rd week
changes from baseline ROM of shoulder horizontal abduction taken with goniometer
Measure Shoulder Range of Motion in adduction
Time frame: 3rd week
changes from baseline ROM of shoulder adduction taken with goniometer
Measure Shoulder Range of Motion in horizontal adduction
Time frame: 3rd week
changes from baseline ROM of shoulder horizontal adduction taken with goniometer
Measure Shoulder Range of Motion in Internal rotation
Time frame: 3rd week
changes from baseline ROM of shoulder Internal rotation taken with goniometer
Measure Shoulder Range of Motion in External rotation
Time frame: 3rd week
changes from baseline ROM of shoulder External rotation taken with goniometer
Visual Analysis Scale
Time frame: 3rd week
Maximum score 10 minimum score 0 , it is used for both acute and chronic pain.
2 secondary outcomes
WHOQoL-BREF
Time frame: 3rd week
Apley's Scratch Test
Time frame: 3rd week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Frozen Shoulder
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Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
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OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
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Maitland Mobilization With and Without Stroking Release Technique of Rotator Cuff Muscle in Frozen Shoulder
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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.
Madiha Ali, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 D SPA (shoulder complex pain alignment) Moblization and Shoulder Moblization (KaltenBorn) in people with Frozen Shoulder, run by Riphah International 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 4 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 15 Aug 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?
Contact Madiha Ali, MSOMPT (0331-3360064, madiha.ali@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability Index (time frame: 3rd week). The study lists 10 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 15 Aug 2024.