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Clinical Trial NCT06530602 for Frozen Shoulder is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder. 36 Randomized
Clinical Trial NCT06530602 is an interventional study for Frozen Shoulder that is recruiting. It started on 9 August 2024 with plans to enroll 36 participants. Led by Riphah International University, it is expected to complete by 10 January 2025. The latest data from ClinicalTrials.gov was last updated on 15 August 2024.
Brief 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 muscle tightness, facilitate tissue healing, and ultimately improve the range of motion in patients. A ra...Show More
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...
Show MoreOfficial Title
Effect of 3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.
Conditions
Frozen ShoulderOther Study IDs
- Muniba
NCT ID Number
Start Date (Actual)
2024-08-09
Last Update Posted
2024-08-15
Completion Date (Estimated)
2025-01-10
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Frozen shoulder
QOL
Clinical trail
3 D SPA
SPADI
QOL
Clinical trail
3 D SPA
SPADI
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalGroup A 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 | 3 D SPA (shoulder complex pain alignment) Moblization 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions. |
Active ComparatorGroup B 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 | Shoulder Moblization (KaltenBorn) 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 3rd week |
Measure Shoulder Range of Motion in Flexion | changes from baseline ROM of shoulder flexion taken with goniometer | 3rd week |
Measure Shoulder Range of Motion in Extension | changes from baseline ROM of shoulder extension taken with goniometer | 3rd week |
Measure Shoulder Range of Motion in abduction | changes from baseline ROM of shoulder abduction taken with goniometer | 3rd week |
Measure Shoulder Range of Motion in Horizontal abduction | changes from baseline ROM of shoulder horizontal abduction taken with goniometer | 3rd week |
Measure Shoulder Range of Motion in adduction | changes from baseline ROM of shoulder adduction taken with goniometer | 3rd week |
Measure Shoulder Range of Motion in horizontal adduction | changes from baseline ROM of shoulder horizontal adduction taken with goniometer | 3rd week |
Measure Shoulder Range of Motion in Internal rotation | changes from baseline ROM of shoulder Internal rotation taken with goniometer | 3rd week |
Measure Shoulder Range of Motion in External rotation | changes from baseline ROM of shoulder External rotation taken with goniometer | 3rd week |
Visual Analysis Scale | Maximum score 10 minimum score 0 , it is used for both acute and chronic pain. | 3rd week |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
WHOQoL-BREF | Measures perception of life quality in four dimensions including physical, psychological, social relationship \& environmental. | 3rd week |
Apley's Scratch Test | to check movements in all functional planes for the shoulder. | 3rd week |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
40 Years
Eligible Sexes
All
- 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.
- 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.
Study Central Contact
Contact: Madiha Ali, MSOMPT, 0331-3360064, [email protected]
1 Study Locations in 1 Countries
Punjab Province
Railway General Hospital, Rawalpindi, Punjab Province, 44000, Pakistan
Madiha Ali, MSOMPT, Contact, 0331-3360064, [email protected]
Muniba Shah, MSOMPT*, Principal Investigator
Recruiting